Positively Aware November/december 2010
More HIV meds, this time for preventionâ€”but will people want to take them?
Nutrition & HIV
The importance of vitamin D
A DAY with hiv in america
The HIV Treatment & Health Journal of
Test Positive Aware Network
1:22 p.m., Chicago: Kenny gets blood drawn
ATRIPLA Important Safety Information and Indication INDICATION ATRIPLA® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate [DF] 300 mg) is a prescription medication used alone as a complete regimen or with other medicines to treat HIV-1 infection in adults. ATRIPLA does not cure HIV-1 and has not been shown to prevent passing HIV-1 to others. The long-term effects of ATRIPLA are not known at this time. People taking ATRIPLA may still get infections that develop because the immune system is weak or other conditions that happen with HIV-1 infection. Do not stop taking ATRIPLA unless directed by your healthcare provider. See your healthcare provider regularly.
•Have ever had seizures: Seizures have occurred in patients taking a component of ATRIPLA, usually in those with a history of seizures. If you have ever had seizures, or take medicine for seizures, your healthcare provider may want to switch you to another medicine or monitor you. •Have ever had mental illness or use drugs or alcohol. Contact your healthcare provider right away if you experience any of the following serious or common side effects:
Serious side effects associated with ATRIPLA: •Severe depression, strange thoughts, or angry behavior have been reported by a small number of patients. Some patients have had thoughts IMPORTANT SAFETY INFORMATION of suicide, and a few have actually committed suicide. These problems Contact your healthcare provider right away if you get the following may occur more often in patients who have had mental illness. side effects or conditions associated with ATRIPLA: •Kidney problems (including decline or failure of kidney function). • Nausea, vomiting, unusual muscle pain, and/or weakness. These If you have had kidney problems, or take other medicines that may may be signs of a buildup of acid in the blood (lactic acidosis), cause kidney problems, your healthcare provider should do regular which is a serious medical condition. blood tests. Symptoms that may be related to kidney problems include • Light-colored stools, dark-colored urine, and/or if your skin or the a high volume of urine, thirst, muscle pain, and muscle weakness. whites of your eyes turn yellow. These may be signs of serious •Other serious liver problems. Some patients have experienced liver problems. serious liver problems, including liver failure resulting in transplantation or death. Most of these serious side effects occurred in patients with a • If you have HIV-1 and hepatitis B virus (HBV), your liver disease chronic liver disease such as hepatitis infection, but there have also may suddenly get worse if you stop taking ATRIPLA. been a few reports in patients without any existing liver disease. Do not take ATRIPLA if you are taking the following medicines •Bone changes. Lab tests show changes in the bones of patients treated because serious and life-threatening side effects may occur when with tenofovir DF, a component of ATRIPLA. Some HIV patients treated taken together: Vascor® (bepridil), Propulsid® (cisapride), with tenofovir DF developed thinning of the bones (osteopenia), which Versed® (midazolam), Orap® (pimozide), Halcion® (triazolam), ® ® could lead to fractures. Also, bone pain and softening of the bone or ergot medications (for example, Wigraine and Cafergot ). (which may lead to fractures) may occur as a consequence of kidney In addition, ATRIPLA should not be taken with: problems. If you have had bone problems in the past, your healthcare Combivir® (lamivudine/zidovudine), EMTRIVA® (emtricitabine), Epivir® provider may want to check your bones. or Epivir-HBV® (lamivudine), Epzicom® (abacavir sulfate/lamivudine), SUSTIVA® (efavirenz), Trizivir® (abacavir sulfate/lamivudine/zidovudine), Common side effects: TRUVADA® (emtricitabine/tenofovir DF), or VIREAD® (tenofovir DF), because they contain the same or similar active ingredients as ATRIPLA. •Dizziness, headache, trouble sleeping, drowsiness, trouble concentrating, and/or unusual dreams. These side effects tend to ATRIPLA should not be used with HEPSERA® (adefovir dipivoxil). go away after taking ATRIPLA for a few weeks. These symptoms may Vfend® (voriconazole) or REYATAZ® (atazanavir sulfate) with or without be more severe with the use of alcohol and/or mood-altering (street) Norvir® (ritonavir) should not be taken with ATRIPLA since they may drugs. If you are dizzy, have trouble concentrating, and/or are drowsy, lose their effect and may also increase the chance of having side effects avoid activities that may be dangerous, such as driving or operating ® ® from ATRIPLA. Fortovase or Invirase (saquinavir) should not be used machinery. as the only protease inhibitor in combination with ATRIPLA. •Rash is a common side effect that usually goes away without any Taking ATRIPLA with St. John’s wort or products containing St. John’s wort change in treatment, but may be serious in a small number of patients. is not recommended as it may cause decreased levels of ATRIPLA, •Other common side effects include: tiredness, upset stomach, vomiting, increased viral load, and possible resistance to ATRIPLA or gas, and diarrhea. cross-resistance to other anti-HIV drugs. This list of medicines is not complete. Discuss with your healthcare Other possible side effects: provider all prescription and nonprescription medicines, vitamins, •Changes in body fat have been seen in some people taking anti-HIV-1 or herbal supplements you are taking or plan to take. medicines. The cause and long-term health effects are not known. Tell your healthcare provider if you: •Skin discoloration (small spots or freckles) may also happen. •Are pregnant: Women should not become pregnant while taking •If you notice any symptoms of infection, contact your healthcare ATRIPLA and for 12 weeks after stopping ATRIPLA. Serious birth defects provider right away. have been seen in children of women treated during pregnancy with one of the medicines in ATRIPLA. Women must use a reliable form of •Additional side effects are inflammation of the pancreas, allergic barrier contraception, such as a condom or diaphragm, even if they also reaction (including swelling of the face, lips, tongue, or throat), use other methods of birth control, while on ATRIPLA and for 12 weeks shortness of breath, pain, stomach pain, weakness, and indigestion. after stopping ATRIPLA. You should take ATRIPLA once daily on an empty stomach. Taking ATRIPLA at bedtime may make some side effects less bothersome. •Are breastfeeding: Women with HIV should not breastfeed because they can pass HIV through their milk to the baby. Also, ATRIPLA is one of several treatment options your doctor may consider. ATRIPLA may pass through breast milk and cause serious harm to the baby. You are encouraged to report negative side effects •Have liver problems, including hepatitis B or C virus infection.
of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Patient Information on the following pages. © 2010 Bristol-Myers Squibb & Gilead Sciences, LLC. All rights reserved. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. EMTRIVA, VIREAD, and TRUVADA are trademarks of Gilead Sciences, Inc. SUSTIVA and REYATAZ are registered trademarks of Bristol-Myers Squibb. All other trademarks are owned by third parties. 697US09AB07040/TR6109 07/10
“My entire HIV regimen in one pill daily. For me, that’s great.” Phil li p
on ATRIPLA for 2 years
ATRIPLA is the #1 prescribed HIV regimen.* About ATRIPLA: • Only ATRIPLA combines 3 HIV medications in 1 pill daily. †
• Proven to lower viral load to undetectable in approximately 7 out of 10 patients new to therapy, and also raise T-cell‡ (CD4+) count to help control HIV through 3 years of a clinical study.§ • ATRIPLA does not cure HIV-1 and has not been shown to prevent passing HIV-1 to others.
Selected Important Safety Information: Some people who have taken medicine like ATRIPLA have developed the following: a serious condition of acid buildup in the blood (lactic acidosis), and serious liver problems (hepatotoxicity). For patients with both HIV-1 and hepatitis B virus (HBV), hepatitis may suddenly worsen if ATRIPLA is discontinued. Please see detailed and additional Important Safety Information, including the bolded information to the left. †
Defined as a viral load of less than 400 copies/mL. Average increase of 312 cells/mm3. § In this study, 227 patients took the meds in ATRIPLA. ‡
Patient model. Individual results may vary.
Your doctor may prescribe ATRIPLA alone or with other HIV medications.
Talk to your doctor to see if ATRIPLA is right for you. * Synovate Healthcare Data; US HIV Monitor, Q1 2010.
To learn more, visit www.ATRIPLA.com
FDA-Approved Patient Labeling Patient Information ATRIPLA® (uh TRIP luh) Tablets ALERT: Find out about medicines that should NOT be taken with ATRIPLA. Please also read the section “MEDICINES YOU SHOULD NOT TAKE WITH ATRIPLA.” Generic name: efavirenz, emtricitabine and tenofovir disoproxil fumarate (eh FAH vih renz, em tri SIT uh bean and te NOE’ fo veer dye soe PROX il FYOU mar ate) Read the Patient Information that comes with ATRIPLA® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) before you start taking it and each time you get a refill since there may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. You should stay under a healthcare provider’s care when taking ATRIPLA. Do not change or stop your medicine without first talking with your healthcare provider. Talk to your healthcare provider or pharmacist if you have any questions about ATRIPLA. What is the most important information I should know about ATRIPLA? • Some people who have taken medicine like ATRIPLA (which contains nucleoside analogs) have developed a serious condition called lactic acidosis (buildup of an acid in the blood). Lactic acidosis can be a medical emergency and may need to be treated in the hospital. Call your healthcare provider right away if you get the following signs or symptoms of lactic acidosis: • You feel very weak or tired. • You have unusual (not normal) muscle pain. • You have trouble breathing. • You have stomach pain with nausea and vomiting. • You feel cold, especially in your arms and legs. • You feel dizzy or lightheaded. • You have a fast or irregular heartbeat. • Some people who have taken medicines like ATRIPLA have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Call your healthcare provider right away if you get the following signs or symptoms of liver problems: • Your skin or the white part of your eyes turns yellow (jaundice). • Your urine turns dark. • Your bowel movements (stools) turn light in color. • You don’t feel like eating food for several days or longer. • You feel sick to your stomach (nausea). • You have lower stomach area (abdominal) pain. • You may be more likely to get lactic acidosis or liver problems if you are female, very overweight (obese), or have been taking nucleoside analog-containing medicines, like ATRIPLA, for a long time. • If you also have hepatitis B virus (HBV) infection and you stop taking ATRIPLA, you may get a “flare-up” of your hepatitis. A “flare-up” is when the disease suddenly returns in a worse way than before. Patients with HBV who stop taking ATRIPLA need close medical follow-up for several months, including medical exams and blood tests to check for hepatitis that could be getting worse. ATRIPLA is not approved for the treatment of HBV, so you must discuss your HBV therapy with your healthcare provider. What is ATRIPLA? ATRIPLA contains 3 medicines, SUSTIVA® (efavirenz), EMTRIVA® (emtricitabine) and VIREAD® (tenofovir disoproxil fumarate also called tenofovir DF) combined in one pill. EMTRIVA and VIREAD are HIV-1 (human immunodeficiency virus) nucleoside analog reverse transcriptase inhibitors (NRTIs) and SUSTIVA is an HIV-1 non-nucleoside analog reverse transcriptase inhibitor (NNRTI). VIREAD and EMTRIVA are the components of TRUVADA®. ATRIPLA can be used alone as a complete regimen, or in combination with other anti-HIV-1 medicines to treat people with HIV-1 infection. ATRIPLA is for adults age 18 and over. ATRIPLA has not been studied in children under age 18 or adults over age 65. HIV infection destroys CD4+ T cells, which are important to the immune system. The immune system helps fight infection. After a large number of T cells are destroyed, acquired immune deficiency syndrome (AIDS) develops. ATRIPLA helps block HIV-1 reverse transcriptase, a viral chemical in your body (enzyme) that is needed for HIV-1 to multiply. ATRIPLA lowers the amount of HIV-1 in the blood (viral load). ATRIPLA may also help to increase the number of T cells (CD4+ cells), allowing your immune system to improve. Lowering the amount of HIV-1 in the blood lowers the chance of death or infections that happen when your immune system is weak (opportunistic infections). Does ATRIPLA cure HIV-1 or AIDS? ATRIPLA does not cure HIV-1 infection or AIDS. The long-term effects of ATRIPLA are not known at this time. People taking ATRIPLA may still get opportunistic infections or other conditions that happen with HIV-1 infection. Opportunistic infections are infections that develop because the immune system is weak. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infection. It is very important that you see your healthcare provider regularly while taking ATRIPLA. Does ATRIPLA reduce the risk of passing HIV-1 to others? ATRIPLA has not been shown to lower your chance of passing HIV-1 to other people through sexual contact, sharing needles, or being exposed to your blood. • Do not share needles or other injection equipment. • Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades.
ATRIPLA® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) •
Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom or other barrier to reduce the chance of sexual contact with semen, vaginal secretions, or blood. Who should not take ATRIPLA? Together with your healthcare provider, you need to decide whether ATRIPLA is right for you. Do not take ATRIPLA if you are allergic to ATRIPLA or any of its ingredients. The active ingredients of ATRIPLA are efavirenz, emtricitabine, and tenofovir DF. See the end of this leaflet for a complete list of ingredients. What should I tell my healthcare provider before taking ATRIPLA? Tell your healthcare provider if you: • Are pregnant or planning to become pregnant (see “What should I avoid while taking ATRIPLA?”). • Are breast-feeding (see “What should I avoid while taking ATRIPLA?”). • Have kidney problems or are undergoing kidney dialysis treatment. • Have bone problems. • Have liver problems, including hepatitis B virus infection. Your healthcare provider may want to do tests to check your liver while you take ATRIPLA. • Have ever had mental illness or are using drugs or alcohol. • Have ever had seizures or are taking medicine for seizures. What important information should I know about taking other medicines with ATRIPLA? ATRIPLA may change the effect of other medicines, including the ones for HIV-1, and may cause serious side effects. Your healthcare provider may change your other medicines or change their doses. Other medicines, including herbal products, may affect ATRIPLA. For this reason, it is very important to let all your healthcare providers and pharmacists know what medications, herbal supplements, or vitamins you are taking. MEDICINES YOU SHOULD NOT TAKE WITH ATRIPLA • The following medicines may cause serious and life-threatening side effects when taken with ATRIPLA. You should not take any of these medicines while taking ATRIPLA: Vascor (bepridil), Propulsid (cisapride), Versed (midazolam), Orap (pimozide), Halcion (triazolam), ergot medications (for example, Wigraine and Cafergot). • ATRIPLA also should not be used with Combivir (lamivudine/zidovudine), EMTRIVA, Epivir, Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), Trizivir (abacavir sulfate/lamivudine/zidovudine), SUSTIVA, TRUVADA, or VIREAD. • Vfend (voriconazole) should not be taken with ATRIPLA since it may lose its effect or may increase the chance of having side effects from ATRIPLA. • Do not take St. John’s wort (Hypericum perforatum), or products containing St. John’s wort with ATRIPLA. St. John’s wort is an herbal product sold as a dietary supplement. Talk with your healthcare provider if you are taking or are planning to take St. John’s wort. Taking St. John’s wort may decrease ATRIPLA levels and lead to increased viral load and possible resistance to ATRIPLA or cross-resistance to other anti-HIV-1 drugs. • ATRIPLA should not be used with HEPSERA® (adefovir dipivoxil). It is also important to tell your healthcare provider if you are taking any of the following: • Fortovase, Invirase (saquinavir), Biaxin (clarithromycin), Noxafil (posaconazole), or Sporanox (itraconazole); these medicines may need to be replaced with another medicine when taken with ATRIPLA. • Calcium channel blockers such as Cardizem or Tiazac (diltiazem), Covera HS or Isoptin (verapamil) and others; Crixivan (indinavir), Selzentry (maraviroc); the immunosuppressant medicines cyclosporine (Gengraf, Neoral, Sandimmune, and others), Prograf (tacrolimus), or Rapamune (sirolimus); Methadone; Mycobutin (rifabutin); Rifampin; cholesterol-lowering medicines such as Lipitor (atorvastatin), Pravachol (pravastatin sodium), and Zocor (simvastatin); or Zoloft (sertraline); these medicines may need to have their dose changed when taken with ATRIPLA. • Videx, Videx EC (didanosine); tenofovir DF (a component of ATRIPLA) may increase the amount of didanosine in your blood, which could result in more side effects. You may need to be monitored more carefully if you are taking ATRIPLA and didanosine together. Also, the dose of didanosine may need to be changed. • Reyataz (atazanavir sulfate) or Kaletra (lopinavir/ritonavir); these medicines may increase the amount of tenofovir DF (a component of ATRIPLA) in your blood, which could result in more side effects. Reyataz is not recommended with ATRIPLA. You may need to be monitored more carefully if you are taking ATRIPLA and Kaletra together. Also, the dose of Kaletra may need to be changed. • Medicine for seizures [for example, Dilantin (phenytoin), Tegretol (carbamazepine), or phenobarbital]; your healthcare provider may want to switch you to another medicine or check drug levels in your blood from time to time. These are not all the medicines that may cause problems if you take ATRIPLA. Be sure to tell your healthcare provider about all medicines that you take. Keep a complete list of all the prescription and nonprescription medicines as well as any herbal remedies that you are taking, how much you take, and how often you take them. Make a new list when medicines or herbal remedies are added or stopped, or if the dose changes. Give copies of this list to all of your healthcare providers and pharmacists every time you visit your healthcare provider or fill a prescription. This will give your healthcare provider a complete picture of the medicines you use. Then he or she can decide the best approach for your situation.
ATRIPLA® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) How should I take ATRIPLA? • Take the exact amount of ATRIPLA your healthcare provider prescribes. Never change the dose on your own. Do not stop this medicine unless your healthcare provider tells you to stop. • You should take ATRIPLA on an empty stomach. • Swallow ATRIPLA with water. • Taking ATRIPLA at bedtime may make some side effects less bothersome. • Do not miss a dose of ATRIPLA. If you forget to take ATRIPLA, take the missed dose right away, unless it is almost time for your next dose. Do not double the next dose. Carry on with your regular dosing schedule. If you need help in planning the best times to take your medicine, ask your healthcare provider or pharmacist. • If you believe you took more than the prescribed amount of ATRIPLA, contact your local poison control center or emergency room right away. • Tell your healthcare provider if you start any new medicine or change how you take old ones. Your doses may need adjustment. • When your ATRIPLA supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to ATRIPLA and become harder to treat. • Your healthcare provider may want to do blood tests to check for certain side effects while you take ATRIPLA. What should I avoid while taking ATRIPLA? • Women should not become pregnant while taking ATRIPLA and for 12 weeks after stopping it. Serious birth defects have been seen in the babies of animals and women treated with efavirenz (a component of ATRIPLA) during pregnancy. It is not known whether efavirenz caused these defects. Tell your healthcare provider right away if you are pregnant. Also talk with your healthcare provider if you want to become pregnant. • Women should not rely only on hormone-based birth control, such as pills, injections, or implants, because ATRIPLA may make these contraceptives ineffective. Women must use a reliable form of barrier contraception, such as a condom or diaphragm, even if they also use other methods of birth control. Efavirenz, a component of ATRIPLA, may remain in your blood for a time after therapy is stopped. Therefore, you should continue to use contraceptive measures for 12 weeks after you stop taking ATRIPLA. • Do not breast-feed if you are taking ATRIPLA. The Centers for Disease Control and Prevention recommend that mothers with HIV not breast-feed because they can pass the HIV through their milk to the baby. Also, ATRIPLA may pass through breast milk and cause serious harm to the baby. Talk with your healthcare provider if you are breast-feeding. You should stop breast-feeding or may need to use a different medicine. • Taking ATRIPLA with alcohol or other medicines causing similar side effects as ATRIPLA, such as drowsiness, may increase those side effects. • Do not take any other medicines, including prescription and nonprescription medicines and herbal products, without checking with your healthcare provider. • Avoid doing things that can spread HIV-1 infection since ATRIPLA does not stop you from passing the HIV-1 infection to others. What are the possible side effects of ATRIPLA? ATRIPLA may cause the following serious side effects: • Lactic acidosis (buildup of an acid in the blood). Lactic acidosis can be a medical emergency and may need to be treated in the hospital. Call your healthcare provider right away if you get signs of lactic acidosis. (See “What is the most important information I should know about ATRIPLA?”) • Serious liver problems (hepatotoxicity), with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Call your healthcare provider right away if you get any signs of liver problems. (See “What is the most important information I should know about ATRIPLA?”) • “Flare-ups” of hepatitis B virus (HBV) infection, in which the disease suddenly returns in a worse way than before, can occur if you have HBV and you stop taking ATRIPLA. Your healthcare provider will monitor your condition for several months after stopping ATRIPLA if you have both HIV-1 and HBV infection and may recommend treatment for your HBV. ATRIPLA is not approved for the treatment of hepatitis B virus infection. If you have advanced liver disease and stop treatment with ATRIPLA, the “flare-up” of hepatitis B may cause your liver function to decline. • Serious psychiatric problems. A small number of patients may experience severe depression, strange thoughts, or angry behavior while taking ATRIPLA. Some patients have thoughts of suicide and a few have actually committed suicide. These problems may occur more often in patients who have had mental illness. Contact your healthcare provider right away if you think you are having these psychiatric symptoms, so your healthcare provider can decide if you should continue to take ATRIPLA. • Kidney problems (including decline or failure of kidney function). If you have had kidney problems in the past or take other medicines that can cause kidney problems, your healthcare provider should do regular blood tests to check your kidneys. Symptoms that may be related to kidney problems include a high volume of urine, thirst, muscle pain, and muscle weakness. • Other serious liver problems. Some patients have experienced serious liver problems including liver failure resulting in transplantation or death. Most of these serious side effects occurred in patients with a chronic liver disease such as hepatitis infection, but there have also been a few reports in patients without any existing liver disease.
ATRIPLA® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Changes in bone mineral density (thinning bones). Laboratory tests show changes in the bones of patients treated with tenofovir DF, a component of ATRIPLA. Some HIV patients treated with tenofovir DF developed thinning of the bones (osteopenia) which could lead to fractures. If you have had bone problems in the past, your healthcare provider may need to do tests to check your bone mineral density or may prescribe medicines to help your bone mineral density. Additionally, bone pain and softening of the bone (which may contribute to fractures) may occur as a consequence of kidney problems. Common side effects: Patients may have dizziness, headache, trouble sleeping, drowsiness, trouble concentrating, and/or unusual dreams during treatment with ATRIPLA. These side effects may be reduced if you take ATRIPLA at bedtime on an empty stomach. They also tend to go away after you have taken the medicine for a few weeks. If you have these common side effects, such as dizziness, it does not mean that you will also have serious psychiatric problems, such as severe depression, strange thoughts, or angry behavior. Tell your healthcare provider right away if any of these side effects continue or if they bother you. It is possible that these symptoms may be more severe if ATRIPLA is used with alcohol or mood altering (street) drugs. If you are dizzy, have trouble concentrating, or are drowsy, avoid activities that may be dangerous, such as driving or operating machinery. Rash may be common. Rashes usually go away without any change in treatment. In a small number of patients, rash may be serious. If you develop a rash, call your healthcare provider right away. Other common side effects include tiredness, upset stomach, vomiting, gas, and diarrhea. Other possible side effects with ATRIPLA: • Changes in body fat. Changes in body fat develop in some patients taking anti-HIV-1 medicine. These changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), in the breasts, and around the trunk. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these fat changes are not known. • Skin discoloration (small spots or freckles) may also happen with ATRIPLA. • In some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately. • Additional side effects are inflammation of the pancreas, allergic reaction (including swelling of the face, lips, tongue, or throat), shortness of breath, pain, stomach pain, weakness and indigestion. Tell your healthcare provider or pharmacist if you notice any side effects while taking ATRIPLA. Contact your healthcare provider before stopping ATRIPLA because of side effects or for any other reason. This is not a complete list of side effects possible with ATRIPLA. Ask your healthcare provider or pharmacist for a more complete list of side effects of ATRIPLA and all the medicines you will take. How do I store ATRIPLA? • Keep ATRIPLA and all other medicines out of reach of children. • Store ATRIPLA at room temperature 77 °F (25 °C). • Keep ATRIPLA in its original container and keep the container tightly closed. • Do not keep medicine that is out of date or that you no longer need. If you throw any medicines away make sure that children will not find them. General information about ATRIPLA: Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use ATRIPLA for a condition for which it was not prescribed. Do not give ATRIPLA to other people, even if they have the same symptoms you have. It may harm them. This leaflet summarizes the most important information about ATRIPLA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ATRIPLA that is written for health professionals. Do not use ATRIPLA if the seal over bottle opening is broken or missing. What are the ingredients of ATRIPLA? Active Ingredients: efavirenz, emtricitabine, and tenofovir disoproxil fumarate Inactive Ingredients: croscarmellose sodium, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, sodium lauryl sulfate. The film coating contains black iron oxide, polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, and titanium dioxide. •
May 2010 ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. EMTRIVA, TRUVADA, HEPSERA and VIREAD are trademarks of Gilead Sciences, Inc. SUSTIVA is a trademark of Bristol-Myers Squibb Pharma Company. Reyataz and Videx are trademarks of Bristol-Myers Squibb Company. Pravachol is a trademark of ER Squibb & Sons, LLC. Other brands listed are the trademarks of their respective owners.
Editor’s Note Jeff Berry
A picture perfect day A Day with HIV in America is as much about the stories behind the pictures, as it is about the pictures themselves. These are the untold stories of everyday people like you and me, who are bound to together by a common thread. There is Martin from the U.K., who was planning to visit the U.S. on that day and asked if he could participate in the project. And Mark, HIV-positive for 22 years, who fights for LGBT people living with mental health and substance abuse issues and at risk for suicide. Then there is Andrew, HIV-positive for three years, who lives a normal, healthy, and “inspired” life and says “there can be so many difficult days, but way more great days that make life all the more worth living.” And Patricia, HIV-positive for seven years, hiking in the mountains of Utah with her dog Rusty. The seeds for A Day with HIV in America were first planted at a planning meeting back in August, when we were having a discussion about what we would like to do for World AIDS Day in this issue. PA Art Director Rick Guasco came up with the idea of a photo essay that would take place on one day, and would invite participants to answer the question, “What does it mean to live with HIV?” Having virtually no budget for the project, and very little lead time, but armed with a whole lot of enthusiasm and passion, we proceeded “full-tilt boogie” with the one-day project. I’m going to spare you the many details
and minutiae of how it all played out, but suffice it to say that one of the most important lessons I learned was the true value of combining the power of social media with a really good idea. Facebook, and “the Twitter,” as Betty White would say, suddenly made sense to me in the context of this project. It was amazing to watch how quickly an idea whose time has come can spread using social media in a cohesive and well thought out manner. Social media is not for everyone, or everything, for that matter, but it seemed a perfect fit for a visual campaign seeking to raise awareness while creating a sense of community, and showing us that no one is alone in this fight—we have a much stronger voice when we find ways in which we can work together. The responses, as you’ll see, were as varied as the people whose lives are touched by HIV—and we truly are all affected in one way or another. A Day with HIV in America, for me, underscored that point again and again. While I’d like to let the pictures speak for themselves, I keep being drawn back to the stories. One of the many great things that have come about during this project are the new friendships that I and others here at Positively Aware have formed as a result. One new friend, and someone who truly inspires me, is Chuck Panozzo. Chuck, as many of you may know, is the bass player and co-founder of the rock band Styx. I was in high school and college
when Styx was in their heyday, and I came of age—and also came out as a gay man— around the time their album “The Grand Illusion” was popular. I was forwarded a recent story about Chuck as this project was getting off the ground, and decided to reach out and ask him if he’d like to participate. He immediately responded and said he’d be happy to take part. In talking with Chuck on the phone over the next few weeks, and after emailing back and forth a few times, I found out about some of the great work he does educating and advocating for people with HIV. I also learned how sick with AIDS he became at one point, and how difficult it was for him to come out as gay and HIV-positive in an industry that was, and can still be, very homophobic, and AIDSphobic. Thus began a new friendship, and another very valuable lesson learned: Things are never as they appear, and don’t ever judge a book by its cover. Thank you to everyone who took part in A Day with HIV in America. I’m humbled and grateful to each and every person who participated, and for their bravery, courage, and willingness to stand up and be counted—as the saying goes, there’s safety in numbers. I hope you are as moved and inspired by the stories behind the pictures as I am, and please don’t forget to go online to www.adaywithhiv.com, where you will see all of the many wonderful stories and photos that were shared. Take care of yourself, and each other. PHOTO: Chris Knight
On Tuesday, September 21, individuals from around the country came together to form a community, if only for a day, to take part in the Positively Aware photo essay A Day with HIV in America.
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Great coverage First, Enid VÁzquez gave an
ADAP, both as a means of treatment and excellent overview of the International prevention, it is ultimately a stimulus plan AIDS Conference held in Vienna. Thank for the pharmaceutical industry. you for supplying the links and extra infor—Brigid Via the Internet mation. I wasn’t able to attend, but have caught up via the world wide web. Dear Brigid, Second, thank you Thanks for for referencing Dr. Ho, pointing out my who is the visionary mistake as far as CEO of Aaron Diamond POSITIVELY AWARE Ohio is concerned. AIDS Research Center As of October 4, (ADARC) where I serve you do indeed as a clinical research have 244 people technician. Scientists New approaches as the search heats up. on a waiting list, a are stubborn and reduced formulary, everyone here is workand eligibility at ing hard 24/7! 300% of federal Finally, I wanted to poverty level. thank Keith Green for ADAP CRISIS Secondly, his “Lessons from the Republicans to the rescue? VIRTUAL YOU believe me, no one Book of Real.” We have Tips for writing your online profile is naïve about the to stop sugarcoating Big Pharma lobby our commentary and in Washington. be “real” with everyHowever, most of the companies that one when it comes to HIV/AIDS. Until the produce HIV drugs have negotiated with next issue, thank you! Amir Figueroa NASTAD, the Fair Pricing Coalition, and New York, NY other organizations, as well as state ADAP administrators to lower costs for the states and they offer patient assistance programs that make out-of-pocket costs lower for Two points I’d like to make patients, as well as providing medications about Sue Saltmarsh’s article “Republicans free of charge to those who qualify. to ADAP’s Rescue?” are that 1. Ohio was I’m sorry you see this potential legislanot listed as a wait list or cost containment tion as an “ADAP bailout.” ADAP did not, state (as of Aug 12) when in fact we’ve as did Wall Street or GM, create its own instituted both as of July 1; and 2. don’t crisis and the $126 million that Senate bill be so naive to imagine that Big Pharma 3401 seeks is a pittance compared to the isn’t factoring significantly in Republican billions that have been spent on other support for an ADAP bailout. Right now, bailouts. The fact remains that, as Senator many wait-listed patients get their drugs Burr pointed out in our interview, HIV/AIDS for free from these companies. While I funding has traditionally enjoyed strong applaud increased federal funding for bipartisan support and the fact that UPDATE: 2010 INTERNATIONAL AIDS CONFERENCE
THE HIV TREATMENT & HEALTH JOURNAL OF
TEST POSITIVE AWARE NETWORK
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Congress has allowed this crisis to continue unabated is shameful. —Sue Saltmarsh
Where credit is due I have to disagree with the characterization of me as the HIV/AIDS Research and Policy Institute’s “founder” in “Lessons from the Frontline,” in the July/August issue. State Representative Constance Howard, her assistants, and AIDS advisors worked successfully to put into Illinois statute a statement that an HIV Institute would be located at Chicago State University. I had nothing to do with the legislation; for that, Representative Howard and her team of writers and advisors deserve all of the credit. To me, they are the founders. I was given the task of writing a proposal to garner funding so that an AIDS Institute could actually be implemented at Chicago State University. A contract was awarded by the Illinois Department of Public Health and Dr. Joseph A. Balogun, Dean of the College of Health Sciences, agreed to administer the contract and appointed me its first director. In that capacity, I facilitated the hiring of talented coordinators; got HIV programming into several ongoing annual campus events, including the Gwendolyn Brooks Conference; and participated in other activities. These distinctions may not seem significant to you. However, if the legislative backdrop had not already been in place and had research germane to the legislative interests of Illinois not been conducted, I do not believe that the current HIV/AIDS Research and Policy Institute at Chicago State University would exist. That said, thank you for publicizing the horrific statistics that the CDC has documented for blacks in America. A reminder of where we have come from can give us greater hope for the future. —Pat Sloan
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Positively Aware is published bi-monthly by Test Positive Aware Network. © 2010. Positively Aware (ISSN: 1523-2883) is published bi-monthly by Test Positive Aware Network (TPAN), 5537 N. Broadway St, Chicago, IL 60640. TPAN is an Illinois not-for-profit corporation, providing information and support to anyone concerned with HIV and AIDS issues. Positively Aware is a registered trademark of TPAN. All rights reserved. Circulation: 85,000. For reprint permission, contact Sue Saltmarsh. Six issues mailed bulk rate for $30 donation; mailed free to TPAN members or those unable to contribute. We encourage contribution of articles covering medical or personal aspects of HIV/AIDS. We reserve the right to edit or decline submitted articles. When published, the articles become the property of TPAN and its assigns. You may use your actual name or a pseudonym for publication, but please include your name and phone number. Although Positively Aware takes great care to ensure the accuracy of all the information that it presents, Positively Aware staff and volunteers, TPAN, or the institutions and personnel who provide us with information cannot be held responsible for any damages, direct or consequential, that arise from use of this material or due to errors contained herein. Opinions expressed in Positively Aware are not necessarily those of staff or membership or TPAN, its supporters and sponsors, or distributing agencies. Information, resources, and advertising in Positively Aware do not constitute endorsement or recommendation of any medical treatment or product. TPAN recommends that all medical treatments or products be discussed thoroughly and frankly with a licensed and fully HIV-informed medical practitioner, preferably a personal physician. A model, photographer, or author’s HIV status should not be assumed based on their appearance in Positively Aware, membership in TPAN, or contributions to this journal. Distribution of Positively Aware is supported in part through an unrestricted grant from GlaxoSmithKline.
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Day 1 Of my next treatment regimen: KALETRA once a day with my other HIV medicines. Ask your doctor if KALETRA once daily is right for you. KALETRA once daily should not be given to children. KALETRA once daily should not be taken with efavirenz (Atripla® and Sustiva®), nevirapine (Viramune®), amprenavir (Agenerase®), nelfinavir (Viracept®), carbamazepine (Tegretol® and Epitol®), phenobarbital (Luminal®), or phenytoin (Dilantin®). There may be a greater chance of getting diarrhea with the once daily regimen compared with the twice daily regimen. Use KALETRA® is a prescription anti-HIV-1 medicine called a protease inhibitor that contains lopinavir and ritonavir. KALETRA is used with other anti-HIV-1 medicines to increase the chance of treatment response in people with human immunodeficiency virus (HIV-1) infection. It is not known if KALETRA is safe and effective in children under 14 days old. KALETRA does not cure HIV-1 infection or AIDS and does not stop you from passing HIV-1 to others. You may still get opportunistic infections or other conditions that happen with HIV-1. KALETRA Safety Considerations Do not take KALETRA® if you are allergic to any of its ingredients, including lopinavir or ritonavir. Do not take KALETRA with certain medicines, as they can cause serious problems, death, or make KALETRA less effective against HIV. Some patients taking KALETRA can develop inflammation of the pancreas and liver problems, which can cause death. Patients may develop changes in heart rhythm, large increases in triglycerides and cholesterol, diabetes, high blood sugar, changes in body fat, and/or increased bleeding in people with hemophilia. Some patients may develop signs and symptoms of serious infections they already have after starting anti-HIV medicines.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088). If you cannot afford your medication, contact: www.pparx.org or call the toll-free number (1-888-4PPA-NOW) or (1-888-477-2669) for assistance. For additional information about KALETRA, call 1-866-KALETRA (1-866-525-3872) or visit KALETRA.com.
Please see Brief Summary on adjacent pages. Model is for illustrative purposes only. ©2010 Abbott Laboratories Abbott Park, IL 60064 039-403018 July 2010 Printed in U.S.A.
KALETRA® (kuh-LEE-tra) (lopinavir/ritonavir) Tablets KALETRA® (kuh-LEE-tra) (lopinavir/ritonavir) Oral Solution Patient Information What is the most important information I should know about KALETRA? KALETRA may cause serious side effects, including: • Interactions with other medicines. It is important to know the medicines that should not be taken with KALETRA. Read the section “What should I tell my doctor before taking KALETRA?” • Changes in your heart rhythm and the electrical activity of your heart. These changes may be seen on an EKG (electrocardiogram) and can lead to serious heart problems. Your risk for these problems may be higher if you: ° already have a history of abnormal heart rhythm or other types of heart disease. ° take other medicines that can affect your heart rhythm while you take KALETRA. Tell your doctor right away if you have any of these symptoms while taking KALETRA: • dizziness • lightheadedness • fainting • sensation of abnormal heartbeats See the section below “What are the possible side effects of KALETRA?” for more information about serious side effects.
CONSUMER BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION
Read the Medication Guide that comes with KALETRA before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. You and your doctor should talk about your treatment with KALETRA before you start taking it and at regular check-ups. You should stay under your doctor’s care when taking KALETRA.
Who should not take KALETRA? • Do not take KALETRA if you are taking certain medicines. For more information about medicines you should not take with KALETRA, please see “Can I take other medicines with KALETRA?” and consult with your doctor about all other medicines you take. • Do not take KALETRA if you have an allergy to KALETRA or any of its ingredients, including ritonavir and lopinavir.
What should I tell my doctor before taking KALETRA?
KALETRA may not be right for you. Tell your doctor about all your medical conditions, including if you: • have any heart problems, including if you have a condition called Congenital Long QT Syndrome. • have liver problems, including Hepatitis B or Hepatitis C. • have diabetes. • have hemophilia. People who take KALETRA may have increased bleeding. • have low potassium in your blood. • are pregnant or plan to become pregnant. It is not known if KALETRA will harm your unborn baby. Birth control pills or patches may not work as well while you take KALETRA. To prevent pregnancy while taking KALETRA, women who take birth control pills or use estrogen patch for birth control should either use a different type of birth What is KALETRA? control or an extra form of birth control. Talk to your doctor about how to prevent KALETRA is a prescription anti-HIV pregnancy while taking KALETRA. medicine that contains two medicines: lopinavir and ritonavir. KALETRA is called • take KALETRA during pregnancy, talk with your doctor about how you can a protease inhibitor that is used with other take part in an antiretroviral pregnancy anti-HIV-1 medicines to treat people with registry. The purpose of the pregnancy human immunodeficiency virus (HIV-1) registry is to follow the health of you infection. HIV-1 is the virus that causes and your baby. AIDS (Acquired Immune Deficiency • are breast-feeding. Do not breast-feed if Syndrome). you are taking KALETRA. You should not It is not known if KALETRA is safe and breast-feed if you have HIV-1. If you are effective in children under 14 days old.
a woman who has or will have a baby while taking KALETRA, talk with your doctor about the best way to feed your baby. If your baby does not already have HIV-1, there is a chance that HIV-1 can be passed to your baby through your breast milk. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Many medicines interact with KALETRA. Do not start taking a new medicine without telling your doctor or pharmacist. Your doctor can tell you if it is safe to take KALETRA with other medicines. Your doctor may need to change the dose of other medicines while you take KALETRA.
Medicines you should not take with KALETRA. Serious problems or death can happen if you take these medicines with KALETRA: • ergot containing medicines, including: ° ergotamine tartrate (Cafergot®, Migergot, Ergomar, Ergostat, Medihaler Ergotamine, Wigraine, Wigrettes) mesylate ° dihydroergotamine (D.H.E. 45®, Embolex, Migranal®) ° ergonovine, ergonovine and methylergonovine (Ergotrate, Methergine), ergotamine and methylergonovine ° Ergotrate Maleate, methylergonovine maleate (Methergine) • triazolam (Halcion®), midazolam hydrochloride oral syrup • pimozide (Orap®) • the cholesterol lowering medicines lovastatin (Mevacor®) or simvastatin (Zocor®) • sildenafil (Revatio®) only when used for the treatment of pulmonary arterial hypertension. (See “Medicines that may need changes” and “What are the
possible side effects of Kaletra?” for information about the use of sildenafil for erectile problems.) • alfuzosin (Uroxatral®) Medicines that you should not take with KALETRA since they may make KALETRA not work as well: • the herbal supplement St. John’s Wort (hypericum perforatum) • rifampin (Rimactane®, Rifadin®, Rifater®, or Rifamate®) Medicines that may need changes: • birth control pills that contain estrogen (“the pill”) or the birth control (contraceptive) patches • certain anticancer medicines, such as nilotinib (Tasigna®) and dasatinib (Sprycel®) • certain cholesterol lowering medicines, such as atorvastatin (Lipitor®) or rosuvastatin (Crestor®) • certain other antiretroviral medicines, such as efavirenz (Atripla® and Sustiva®), nevirapine (Viramune®), amprenavir (Agenerase®) and nelfinavir (Viracept®) • anti-seizure medicines, such as phenytoin (Dilantin®) carbamazepine, (Tegretol®), phenobarbital • medicines for erectile problems, such as sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®) • medicines for tuberculosis (TB), such as rifabutin (Mycobutin®) • inhaled steroid medicines, such as fluticasone propionate (Flonase®) • inhaled medicines such as salmeterol (Serevent®) or salmeterol in combination with fluticasone propionate (Advair®). Your doctor may need to change to a different medicine • medicines for gout, such as colchicine (Colcrys®) • medicines to treat pulmonary arterial hypertension (PAH), such as bosentan (Tracleer®) or tadalafil (Adcirca®) • pain medicines, such as fentanyl (Duragesic®, IonsysTM, Fentora®) and methadone If you are not sure if you are taking a medicine above, ask your doctor.
• KALETRA tablets can be taken with or without food. • If you are taking both Videx® (didanosine) and KALETRA: ° didanosine can be taken at the same time as KALETRA tablets, without food. ° take didanosine either one hour before or two hours after taking KALETRA oral solution. • Do not miss a dose of KALETRA. This could make the virus harder to treat. If you forget to take KALETRA, take the missed dose right away. If it is almost time for your next dose, do not take the missed dose. Instead, follow your regular dosing schedule by taking your next dose at its regular time. Do not take more than one dose of KALETRA at one time. • If you take more than the prescribed dose of KALETRA, call your local poison control center or emergency room right away. • Take KALETRA oral solution with food to help it work better. • If KALETRA is being used for your child, tell your doctor if your child’s weight changes. • KALETRA should not be given one time each day in children. When giving KALETRA to your child, give KALETRA exactly as prescribed. • KALETRA oral solution contains a large amount of alcohol. ° If a young child drinks more than the recommended dose, it could make them sick from too much alcohol. Contact your local poison control center or emergency room right away. ° Talk with your doctor if you take or plan to take metronidazole or disulfiram. You can have severe nausea and vomiting if you take these medicines with KALETRA. • When your KALETRA supply starts to run low, get more from your doctor or pharmacy. It is important not to run out of KALETRA. The amount of HIV-1 virus in your blood may increase if the medicine is stopped for even a short time. The virus may become resistant to KALETRA and become harder to treat. How should I take KALETRA? • KALETRA can be taken with acid • Take KALETRA every day exactly as reducing agents used for heartburn or prescribed by your doctor. reflux such as omeprazole (Prilosec®) • It is very important to set up a dosing and ranitidine (Zantac® ) with no dose schedule and follow it every day. adjustment. • Do not change your treatment or stop • KALETRA should not be administered treatment without first talking with your once daily in combination with doctor. carbamazepine (Tegretol® and Epitol®), • Swallow KALETRA tablets whole. Do phenobarbital (Luminal®), or phenytoin not chew, break, or crush KALETRA (Dilantin®). tablets.
Avoid doing things that can spread HIV infection. KALETRA does not stop you from passing HIV infection to others. Do not share needles, other injection equipment or personal items that can have blood or body fluids on them, like toothbrushes and razor blades. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.
What are the possible side effects of KALETRA? KALETRA can cause serious side effects. • See “What is the most important information I should know about KALETRA?” • Liver problems. Liver problems, including death, can happen in people who take KALETRA. Blood tests in people who take KALETRA may show possible liver problems. People with liver disease such as Hepatitis B and Hepatitis C who take KALETRA may have worsening liver disease. Tell your healthcare provider right away if you have any of these signs and symptoms of liver problems: ° loss of appetite ° yellow skin and whites of eyes (jaundice) ° dark-colored urine ° pale colored stools, itchy skin ° stomach area (abdominal) pain. • Inflammation of the pancreas (pancreatitis). Some people who take KALETRA get inflammation of the pancreas which may be serious and cause death. You have a higher chance of getting pancreatitis if you have had it before. Tell your doctor if you have nausea, vomiting, or abdominal pain while taking KALETRA. These may be signs of pancreatitis. • Increases in certain fat (triglycerides and cholesterol) levels in your blood. Large increases of triglycerides and cholesterol can be seen in blood test results of some people who take KALETRA. The longterm chance of getting complications such as heart attacks or stroke due to increases in triglycerides and cholesterol caused by protease inhibitors is not known at this time. • Diabetes and high blood sugar (hyperglycemia). Some people who take protease inhibitors including KALETRA get new or more serious diabetes, or high blood sugar. Tell your doctor if you notice an increase in thirst or urinate often while taking KALETRA.
• Changes in body fat. Changes in body fat in some people who take antiretroviral therapy. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the trunk. Loss of fat from the legs, arms and face may also happen. The cause and long-term health effects of these conditions are not known at this time. • Increased bleeding for hemophiliacs. Some people with hemophilia have increased bleeding with protease inhibitors including KALETRA. • Increased risk of certain problems when you take medicines used for the treatment of erectile problems such as sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®) with KALETRA: ° low blood pressure. If you get dizzy or faint, you need to lie down. Tell your doctor if you feel dizzy, or have fainting spells. ° vision changes. Tell your doctor right away if you have vision changes. penis erection lasting more ° than 4 hours. If you are a male and have an erection that lasts longer than 4 hours, get medical help right away to avoid permanent damage to your penis. Your doctor can explain these symptoms to you. • Allergic reactions. Skin rashes, some of them severe, can occur in people who take KALETRA. Tell your healthcare provider if you had a rash when you took another medicine for your HIV infection or if you notice any skin rash when you take KALETRA. Common side effects of KALETRA include:
How should I store KALETRA?
polyethylene glycol 400, hydroxypropyl cellulose, talc, colloidal silicon dioxide, KALETRA tablets: polyethylene glycol 3350, yellow ferric • Store KALETRA tablets at room oxide 172, and polysorbate 80. temperature, between 59°F to 86°F KALETRA 100 mg lopinavir and (15°C to 30°C). • Do not keep KALETRA tablets out of the 25 mg ritonavir tablets: copovidone, sorbitan monolaurate, colloidal silicon container it comes in for longer than dioxide, and sodium stearyl fumarate. The 2 weeks, especially in areas where film coating contains: polyvinyl alcohol, there is a lot of humidity. Keep the titanium dioxide, talc, polytheylene glycol container closed tightly. 3350, and yellow ferric oxide E172. KALETRA oral solution: KALETRA oral solution: acesulfame • Store KALETRA oral solution in a refrigerator, between 36°F to 46°F (2°C potassium, alcohol, artificial cotton candy flavor, citric acid, glycerin, high to 8°C). KALETRA oral solution that is kept refrigerated may be used until the fructose corn syrup, Magnasweet-110 flavor, menthol, natural and artificial expiration date printed on the label. vanilla flavor, peppermint oil, polyoxyl • KALETRA oral solution that is stored at 40 hydrogenated castor oil, povidone, room temperature (less than 77°F or 25°C) should be used within 2 months. propylene glycol, saccharin sodium, sodium chloride, sodium citrate, and • Keep KALETRA away from high heat. water. Throw away any medicine that is out of KALETRA oral solution contains date or that you no longer need. 42.4% alcohol (v/v). “See How Keep KALETRA and all medicines out should I take KALETRA?”. of the reach of children. KALETRA Tablets, 200 mg lopinavir/50 mg General information about ritonavir Manufactured by Abbott Pharmaceuticals KALETRA PR Ltd., Barceloneta, PR 00617 KALETRA does not cure HIV-1 or AIDS. for Abbott Laboratories, North Chicago, IL The long-term effects of KALETRA are not 60064, U.S.A. known at this time. People taking KALETRA KALETRA Tablets, 100 mg lopinavir/25 mg may still get opportunistic infections or ritonavir and KALETRA Oral Solution other conditions that happen with HIV-1 Abbott Laboratories, North Chicago, IL infection. Some of these conditions are 60064, U.S.A. pneumonia, herpes virus infections, and 2010, ALL RIGHTS RESERVED Mycobacterium avium complex (MAC) infections. * The brands listed are trademarks of their Medicines are sometimes prescribed respective owners and are not trademarks for purposes other than those listed in a of Abbott Laboratories. The makers of Medication Guide. Do not use KALETRA for these brands are not affiliated with and a condition for which it was not prescribed. do not endorse Abbott Laboratories or its Do not give KALETRA to other people, even products. if they have the same condition you have. It may harm them. This Medication Guide has been approved by the U.S. Food and Drug Administration. • diarrhea This Medication Guide summarizes • nausea the most important information about Ref: 03-A387-R8 • stomach area (abdominal) pain KALETRA. If you would like more • feeling weak Revised: June, 2010 information, talk with your doctor. You • vomiting 036-395112 MASTER can ask your pharmacist or doctor for • headache information about KALETRA that is • upset stomach written for health professionals. For more These are not all of the possible side information about KALETRA call 1-800effects of KALETRA. For more information, 633-9110 or go to www.KALETRA.com. 039-403018 ask your doctor or pharmacist. Tell your doctor about any side effect that bothers What are the ingredients in KALETRA? you or that does not go away. Active ingredient: lopinavir and ritonavir Call your doctor for medical advice about Inactive ingredients: side effects. You may report side effects KALETRA 200 mg lopinavir and 50 mg to FDA at 1-800-FDA-1088. ritonavir tablets: copovidone, sorbitan monolaurate, colloidal silicon dioxide, and sodium stearyl fumarate. The film coating contains: hypromellose, titanium dioxide,
November/december 2010 V OLUME 2 2 NUM B ER 6
D e pa r t m e n t s
c o v e r F e at u r e
A Day with HIV in America
A picture perfect day.
Positive or negative, we’re all affected by HIV. Our photo essay asks, what does it mean to live with HIV?
PA Reader poll
6 F e at u r e s
Briefly New drug application for TMC278. HIV-negative women and HIV-positive men. Children successfully switch from Kaletra to Viramune.
HIV meds as HIV prevention
PrEP may be emerging as a viable form of prevention. But will people be willing to take HIV medication to avoid getting HIV?
HIV Wellness Series Nutrition and HIV: The importance of vitamin D.
The Buzz Anticipation for a new single-tablet regimen based on rilpivirine (TMC278).
Let the sun shine in
New prevention techniques move beyond a pipe dream.
Conference report: ICAAC 2010 TMC278, Atripla, and resistance. Atripla riva gets good news.
Ask the HIV specialist Being HIV-positive— and having hepatitis C.
Salient Ramblings Sympathy for the devil.
Conference update: IAS/Vienna
Gardasil in men. HIV’s link to poverty. Switching to Isentress. Prezista monotherapy. TBR-652 dual CCR5/CCR2 inhibitor study.
On the cover: When he heard about A Day with HIV in America, Kenny Harty decided to get tested for HIV and other STDs. “As a gay man who has sex, I have an obligation to myself and to future partners, as well as to my family and friends to make sure I am healthy,” he said. Kenny’s tests came back negative. Cover image by Chris Knight This page: Images from A Day with HIv in America
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Briefly reported by enid Vázquez
New drug application for TMC278 Tibotec Pharmaceuticals submitted a New Drug Application (NDA) in late July to the U.S. Food and Drug Administration (FDA) for TMC278 (rilpivirine), an HIV non-nucleoside reverse transcriptase inhibitor (see page 42). TMC278 continued to show good results in data presented at the International AIDS Society Conference held in Vienna in July. Results from two large Phase 3 studies found TMC278 to be non-inferior to the kingpin Sustiva. These are 48-week results from 1,368 study participants. They started out with a median (half above, half below) viral load of 100,000 and T-cells of 256. Tibotec also has a non-nucleoside medication, Intelence (etravirine), currently on the market.
HIV-negative women, HIV-positive men What treatments do HIV-negative women prefer when trying to conceive a child with an HIV-positive male partner? The Bay Area Perinatal AIDS Center (BAPAC) wants to know. BAPAC, run out of the University of California, San Francisco, has an online survey for HIV-negative women who desire to have a baby with an HIV-positive male partner. “Millions of HIV positive men and women are living long and productive lives in the United States,” writes Dr. Deborah Cohan, BAPAC’s medical director. “Many HIV positive men with HIV negative partners would like to become parents but are concerned about the risks of HIV transmission to their partners if they have unprotected sex in order to conceive a child.” Together with Dr. Nena Barnhart, she composed a survey of options available to learn what couples prefer. “We hope this information will be
useful in educating couples, physicians, policy-makers, and advocates for the HIV positive community in addressing this important issue,” she writes. To take the survey, visit www.surveymonkey.com/s/ D5YQ77L. Only one survey can be filled out per computer. For questions, call Dr. Cohan at (415) 206-3658.
A Canadian study of HIV-positive women found that they felt they were being negatively judged by their medical providers for their desire to have children. “Physicians may be following out-of-date guidelines created in the late 1980s recommending that HIV-positive women shouldn’t plan a family, which could explain this perceived stigmatization by these women,” said lead author Anne Wagner, a PhD student at Ryerson University in Toronto, in a university press release. Said study co-author Trevor Hart in the same release, “There need to be more efforts to make physicians aware of the practically nil chance of HIV-positive women transmitting HIV to their newborns as long as the women are continuing to receive appropriate medical treatment. There also needs to be continuing medical education to reduce the stigma perceived 12
| N ovember/ december 2010
by HIV-positive women, which will improve their mental health and well-being.” Ryerson researchers surveyed 159 women. More than half of them were from African or Caribbean countries, and they perceived more stigma than the women from Canada, who nevertheless also experienced negative attitudes. Both groups of women, however, said their family and friends did not play a significant role in the stigma they perceived over their desire to have children. The study was published in the June issue of Archives of Women’s Mental Health. In a separate study, researchers from Johns Hopkins University interviewed HIVpositive women about whether or not they had discussed pregnancy with a medical provider. Of 181 women, two-thirds had what the researchers called a “generalized” discussion about pregnancy and a
third had a “personalized” conversation, two-thirds of the conversations being initiated by the women. Moreover, these women reported a higher level of unmet reproductive counseling needs (56% vs. 23% for the women with a generalized discussion). The researchers reported, “A significant proportion of HIV-infected women want to talk about reproductive plans with their HIV provider; however, many have not. HIV care providers and gynecologists can address their unmet communication needs by discussing reproductive plans with all women of childbearing age so that preconception counseling can be provided when appropriate. Providers will miss opportunities to help women safely plan pregnancy if they only discuss reproductive plans with younger patients.” The study was published in the June issue of AIDS Patient Care and STDs. P os i t i v e lyAwar e .co m
VÁzquez: JOSHUA THORNE
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Children make the switch from Kaletra to Viramune Good news for children’s HIV therapy: researchers found that children could successfully switch from taking Kaletra (lopinavir/ritonavir) to taking Viramune (nevirapine) for HIV therapy. That’s good because the Kaletra formulation taken primarily by children, the liquid formula, has an incredibly nasty taste. Moreover, Kaletra is associated with metabolic dysfunctions, such as increases in cholesterol and triglycerides. On the other hand, the problem with Viramune is that it’s widely used to prevent HIV transmission from mother to child and the development of drug resistance has been seen in both moms and infants. For this reason, Viramune has generally been avoided in HIV-positive infants who had been exposed to the drug. In the September 8 issue of JAMA (Journal of the American Medical
Association), the researchers wrote, “Protease inhibitor-based therapy [such as Kaletra] is recommended for infants infected with [HIV] who were exposed to nevirapine for prevention of mother-to-child HIV transmission. However, there are limitations of continuing PI-based therapy indefinitely and reuse of nevirapine has many advantages.” The study looked at 195 Viramuneexposed children in Johannesburg who started HIV treatment before they were two years old and had a viral load of less than 400 copies per mL for at least three months. Half the children were switched from Kaletra to Viramune. After one year, the children switched to Viramune were more likely to have achieved an undetectable viral load (less than 50 copies per mL) and had a greater increase in their CD4+ T-cell counts. The differences were statistically significant.
However, the children who were switched were also more likely to have a viral load over 1,000 copies compared to those kept on Kaletra. This was associated with greater age, inadequate adherence, and drug resistance in the child’s virus, all of which can presumably be related to an older child’s greater ability to thwart forced medication. Ironically, all the children were taking a background regimen of Epivir, a very tolerable medication, and Zerit, a drug so toxic that it’s rarely taken in the U.S. today. This is due to differences in poorer regions of the world, such as a lower cost for Zerit (and fixed dose combinations of Zerit with Epivir, as well as the two of them with Viramune, that are not available in the U.S.). Better drugs commonly used in wealthier countries may not yet be available or affordable in poorer areas.
Abbott hit with patent challenge over Norvir A New York City public interest group, the Public Patent Foundation (PubPat), has challenged eight patents on the widely used HIV/AIDS protease inhibitor drug Norvir (ritonavir). PubPat has called on the U.S. Patent and Trademark Office to hold a “formal reexamination of a string of awards made between 1996 and 2008.” PubPat claims that Norvir’s maker, Abbott Laboratories, is “attempting to maintain an improper monopoly.” In extensive documents filed on August 26, PubPat asks the Patent Office to “declare the patents invalid because they fail to describe a new invention and are causing significant public harm.” PubPat goes on to say, “The ritonavir patents inflate the cost of therapy for HIV/AIDS patients and restrict research on related drug possibilities.” Abbott has been challenged before over HIV/AIDS therapy. In 2003, a group of consumers sued the company and tried to
overturn its patents on Norvir after Abbott raised the price, boosting the patient’s cost from roughly $1.71 a day to $8.57 a day. Abbott fought the suit for years, but finally agreed to settle in 2008 by distributing $10 million to patient support groups. Lynda Dee of the Fair Pricing Coalition, which advocates with the pharmaceutical industry regarding the price of HIV and hepatitis drugs, commented, “While I wish PubPat well, I doubt they will be successful. We tried a similar tactic years ago based on monopoly and access issues, but were unsuccessful. We had members of Congress on our side and a real concerted
effort of community activists, healthcare providers, and even a few labor unions. If we weren’t successful then, when Abbott first took the unconscionable Norvir price hike based on these same issues, I doubt that PubPat will be successful today when the price of at least the old Norvir formulation costs pennies compared to the original cost, as a result of rebates mandated by the new healthcare reform legislation. But, of course, big corporations have U.S. Supreme Court Justice Scalia on their side. Recent court decisions by Scalia make cases based on a monopoly theory virtually impossible to win.” —Sue Saltmarsh, from PA E-News
ONLY At POSITIVELYAWARE.COM Learn how the legislative process in Washington affects everyone—particularly people living with HIV. Read “Civics 101.”
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IMPORTANT SAFETY INFORMATION
What is the most important information I should Can PREZISTA be taken with other medications? know about PREZISTA? • Taking PREZISTA with certain • PREZISTA, together with Norvir ®, has medicines could cause serious and/ rarely been observed to cause liver or life-threatening side effects or may problems which may be life-threatening. result in loss of its effectiveness. Do PREZISTA is always taken with and at the same It was not always clear if PREZISTA not take PREZISTA if you are taking time as ritonavir (Norvir ®), in combination with caused these liver problems because the following medicines: alfuzosin other HIV medicines for the treatment of HIV some patients had other illnesses or were (Uroxatral®), dihydroergotamine (D.H.E.45®, infection in adults. PREZISTA should also be taking other medicines. Your healthcare Migranal®), ergonovine, ergotamine taken with food. professional should do blood tests (Wigraine®, Ergostat ®, Cafergot ®, Ergomar ®), prior to starting combination treatment methylergonovine, cisapride (Propulsid®), • The use of other medicines active against including PREZISTA. If you have chronic pimozide (Orap®), oral midazolam, triazolam HIV in combination with PREZISTA/ritonavir hepatitis B or C infection, your healthcare (Halcion®), rifampin (Rifadin®, Rifater ®, (Norvir ®) may increase your ability to fight HIV. professional should check your blood tests Rifamate®), sildenafil (Revatio®) when used Your healthcare professional will work with more often because you have an increased to treat pulmonary arterial hypertension, you to find the right combination of chance of developing liver problems indinavir (Crixivan®), lopinavir/ritonavir HIV medicines (Kaletra®), saquinavir (Invirase®), lovastatin Talk to your healthcare professional about • It is important that you remain under the (Mevacor ®, Altoprev®, Advicor ®), pravastatin the signs and symptoms of liver problems. care of your healthcare professional during (Pravachol®), simvastatin (Zocor ®, Simcor ®, These may include yellowing of your treatment with PREZISTA Vytorin®), salmeterol (Serevent ®), or products skin or whites of your eyes, dark (teacontaining St. John’s wort PREZISTA does not cure HIV infection or colored) urine, pale-colored stools (bowel • Before taking PREZISTA, tell your healthcare AIDS, and does not prevent passing HIV movements), nausea, vomiting, loss of professional if you are taking sildenafil to others. appetite, or pain, aching or sensitivity on (Viagra®), vardenafil (Levitra®), tadalafil your right side below your ribs (Cialis®, Adcirca®), atorvastatin (Lipitor ®), • Skin rashes have been reported in patients atorvastatin/amlodipine (Caduet ®), taking PREZISTA. Rarely, PREZISTA has rosuvastatin (Crestor ®), or colchicine been reported to cause a severe or life(Colcrys®). This is not a complete list of threatening rash. Contact your healthcare medicines. Be sure to tell your healthcare professional immediately if you develop a professional about all the medicines rash. Your healthcare professional will advise you are taking or plan to take, including you whether your symptoms can be managed prescription and nonprescription on therapy or whether PREZISTA should medicines, vitamins, and herbal be stopped supplements PREZISTA (darunavir) is a prescription medicine. It is one treatment option in the class of HIV (human immunodeficiency virus) medicines known as protease inhibitors. ®
in myself in my doctor in my meds
ONCE-DAILY PREZISTA FOR ADULTS TAKING HIV MEDS FOR THE FIRST TIME In a clinical study* of almost 2 years (96 weeks) in people who had never taken HIV meds before, ONCE-DAILY PREZISTA with low-dose ritonavir plus Truvada®… • Helped 8 out of 10 people achieve undetectable viral load (less than 50 copies/mL) • May help to increase T-cell count • Was associated with low rates of diarrhea, stomach pain, nausea, and vomiting — Diarrhea (8%), stomach pain (5%), nausea (3%), and vomiting (2%) were reported as moderate to severe PREZISTA must be taken with and at the same time as 100 mg of Norvir® (ritonavir), and with other HIV meds and with food. Once-daily dosing of PREZISTA is not recommended for adults who have taken HIV meds in the past. Please read Important Safety Information below and ask your doctor if once-daily PREZISTA is right for you. Individual results may vary.
What are the possible side effects of PREZISTA? • Tell your healthcare professional if you are taking estrogen-based contraceptives • High blood sugar, diabetes or worsening of (birth control). PREZISTA might reduce diabetes, and increased bleeding in people the effectiveness of estrogen-based with hemophilia have been reported in patients contraceptives. You must take additional taking protease inhibitor medicines, precautions for birth control, such as condoms including PREZISTA • Changes in body fat have been seen in some What should I tell my doctor before I take patients taking HIV medicines, including PREZISTA? PREZISTA. The cause and long-term health • Before taking PREZISTA, tell your healthcare effects of these conditions are not known at professional if you have any medical conditions, including allergy to sulfa medicines, this time diabetes, liver problems (including hepatitis B • As with other protease inhibitors, taking or C), or hemophilia PREZISTA may strengthen the body’s immune response, enabling it to begin to fight infections • Tell your healthcare professional if you are that have been hidden. Patients may experience pregnant or planning to become pregnant, or signs and symptoms of inflammation that can are breastfeeding include swelling, tenderness, or redness – The effects of PREZISTA on pregnant women • The most common side effects related to or their unborn babies are not known. You taking PREZISTA include diarrhea, nausea, and your healthcare professional will need to rash, headache, stomach pain, and vomiting. decide if taking PREZISTA is right for you Uncommon but severe side effects such as – Do not breastfeed if you are taking PREZISTA. inflammation of the pancreas and increased You should not breastfeed if you have HIV blood fat levels have also been rarely reported. because of the chance of passing HIV to This is not a complete list of all possible side your baby effects. If you experience these or other side effects, talk to your healthcare professional. Do not stop taking PREZISTA or any other medicines without first talking to your healthcare professional Distributed by: Tibotec Therapeutics/Division of Centocor Ortho Biotech Products, L.P. Titusville, NJ 08560 ©2010 Tibotec Therapeutics 05/10 28PRZDTC0010BR3 All trademarks are property of their respective owners.
• Please refer to the ritonavir (Norvir ®) Product Information (PI and PPI) for additional information on precautionary measures You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. • For adults taking HIV meds for the first time: PREZISTA 800 mg (two 400-mg tablets) must be taken at the same time with 100 mg Norvir ® once daily every day. PREZISTA must be taken with food Please see Important Patient Information on the next page for more information, or visit www.PREZISTA.com. If you or someone you know needs help paying for medicine, call 1-888-4PPA-NOW (1-888-477-2669) or go to www.pparx.org. *343 adult patients (30% women) received combination therapy with PREZISTA/ritonavir. At the start of the study, the average T-cell count was 245, and 66% of patients had a viral load less than 100,000 copies/mL.
ONCE DAILY www.PREZISTA.com/patient
IMPORTANT PATIENT INFORMATION PREZISTA® (pre-ZIS-ta) [(darunavir) (da-ROO-nuh-veer)] Tablets ALERT: Find out about medicines that should NOT be taken with PREZISTA. Please also read the section “Who should not take PREZISTA?”. Please read this information before you start taking PREZISTA. Also, read the leaflet each time you renew your prescription, just in case anything has changed. Remember, this leaflet does not take the place of careful discussions with your doctor. You and your doctor should discuss your treatment with PREZISTA prior to the first time you take your medicine and at regular checkups. You should remain under a doctor’s care when using PREZISTA and should not change or stop treatment without first talking with a doctor. WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT PREZISTA? PREZISTA, together with NORVIR® (ritonavir), has rarely been observed to cause liver problems which may be life-threatening. It was not always clear if PREZISTA caused these liver problems because some patients had other illnesses or were taking other medicines. Your healthcare professional should do blood tests prior to initiating combination treatment including PREZISTA. If you have chronic hepatitis B or C infection, your healthcare professional should check your blood tests more often because you have an increased chance of developing liver problems. Please also read the section “What are the possible side effects of PREZISTA?”. Rarely, PREZISTA has been reported to cause a severe or life-threatening rash. Contact your healthcare provider immediately if you develop a rash. Your healthcare provider will advise you whether your symptoms can be managed on therapy or whether PREZISTA should be stopped. WHAT IS PREZISTA? PREZISTA is an oral tablet used for the treatment of HIV (Human Immunodeficiency Virus) infection in adults. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). PREZISTA is a type of anti-HIV medicine called a protease (PRO-tee-ase) inhibitor. HOW DOES PREZISTA WORK? PREZISTA blocks HIV protease, an enzyme which is needed for HIV to multiply. When used with other anti-HIV medicines, PREZISTA can help to reduce the amount of HIV in your blood (called “viral load”) and increase your CD4 (T) cell count. HIV infection destroys CD4 (T) cells, which are important to the immune system. The immune system helps fight infection. Reducing the amount of HIV and increasing the CD4 (T) cell count may improve your immune system and, thus, reduce the risk of death or infections that can happen when your immune system is weak (opportunistic infections). PREZISTA is always taken with and at the same time as ritonavir (NORVIR®), in combination with other anti-HIV medicines. PREZISTA should also be taken with food. DOES PREZISTA CURE HIV OR AIDS? PREZISTA does not cure HIV infection or AIDS. At present, there is no cure for HIV infection. People taking PREZISTA may still develop infections or other conditions associated with HIV infection. Because of this, it is very important for you to remain under the care of a doctor. Although PREZISTA is not a cure for HIV or AIDS, PREZISTA can help reduce your risks of getting illnesses associated with HIV infection (AIDS and opportunistic infection) and eventually dying from these conditions. DOES PREZISTA REDUCE THE RISK OF PASSING HIV TO OTHERS? PREZISTA does not reduce the risk of passing HIV to others through sexual contact, sharing needles, or being exposed to your blood. For your health and the health of others, it is important to always practice safer sex by using a latex or polyurethane condom or other barrier method to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood. Never re-use or share needles. Ask your doctor if you have any questions on how to prevent passing HIV to other people. WHAT SHOULD I TELL MY DOCTOR BEFORE I TAKE PREZISTA? Tell your doctor about all of your medical conditions, including if you: • are allergic to sulfa medicines. • have diabetes. In general, anti-HIV medicines, such as PREZISTA, might increase sugar levels in the blood.
• have liver problems, including hepatitis B and/or C. • have hemophilia. Anti-HIV medicines, such as PREZISTA, might increase the risk of bleeding. • are pregnant or planning to become pregnant. The effects of PREZISTA on pregnant women or their unborn babies are not known. You and your doctor will need to decide if taking PREZISTA is right for you. If you take PREZISTA while you are pregnant, talk to your doctor about how you can be included in the Antiretroviral Pregnancy Registry. • are breastfeeding. Do not breastfeed if you are taking PREZISTA. You should not breastfeed if you have HIV because of the chance of passing HIV to your baby. Talk with your doctor about the best way to feed your baby. WHO SHOULD NOT TAKE PREZISTA?** Together with your doctor, you need to decide whether taking PREZISTA is right for you. Do not take PREZISTA if you: • are allergic to darunavir or any of the other ingredients in PREZISTA • are allergic to ritonavir (NORVIR®) • take any of the following types of medicines because you could experience serious side effects: – alfuzosin (Uroxatral®) – dihydroergotamine (D.H.E. 45®, Migranal®), ergonovine, ergotamine (Cafergot®, Ergomar®), methylergonovine – cisapride – pimozide (Orap®) – oral midazolam, triazolam (Halcion®) – St. John’s wort (Hypericum perforatum) – lovastatin (Mevacor®, Altoprev®, Advicor®), simvastatin (Zocor®, Simcor®, Vytorin®) – rifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®) – sildenafil (Revatio®) when used to treat pulmonary arterial hypertension CAN PREZISTA BE TAKEN WITH OTHER MEDICATIONS?** Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. PREZISTA and many other medicines can interact. Sometimes serious side effects will happen if PREZISTA is taken with certain other medicines (see “Who should not take PREZISTA?”). Tell your doctor if you are taking estrogen-based contraceptives (birth control). PREZISTA might reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control such as a condom. Tell your doctor if you take other anti-HIV medicines. PREZISTA can be combined with some other anti-HIV medicines while other combinations are not recommended. Tell your doctor if you are taking any of the following medicines: – bepridil, lidocaine, quinidine, amiodarone (Cordarone®), digoxin (Lanoxin®), flecainide (Tambocor®), propafenone (Rythmol®), – warfarin (Coumadin®) – carbamazepine (Tegretol®, Carbatrol®), phenobarbital, phenytoin (Dilantin®, Phenytek®) – trazodone (Desyrel®), desipramine (Norpramin®) – colchicine (Colcrys®) – clarithromycin (Biaxin®) – ketoconazole (Nizoral®), itraconazole (Sporanox®), voriconazole (Vfend®) – rifabutin (Mycobutin®) – metoprolol (Lopressor®, Toprol-XL®), timolol (Betimol®, Combigan®, Istalol®, Cosopt®, Timoptic®) – midazolam administered by injection – felodipine (Plendil®), nifedipine (Adalat®), nicardipine (Cardene®) – dexamethasone, fluticasone (Advair Diskus®, Cutivate®, Flonase®, Flovent Diskus®) – bosentan (Tracleer®) – atorvastatin (Lipitor®), pravastatin (Pravachol®), rosuvastatin (Crestor®) – cyclosporine (Sandimmune®, Neoral®), tacrolimus (Prograf®), sirolimus (Rapamune®)
IMPORTANT PATIENT INFORMATION – salmeterol (Serevent®) – methadone, buprenorphine/naloxone – risperidone (Risperdal®, Risperdal® Consta®,Risperdal® M-TAB®), thioridazine – sildenafil (Viagra®), vardenafil (Levitra®), tadalafil (Cialis®) – tadalafil (Adcirca®) – paroxetine (Paxil®), sertraline (Zoloft®) Tell your doctor if you are taking any medicines that you obtained without a prescription. This is not a complete list of medicines that you should tell your doctor that you are taking. Know and keep track of all the medicines you take and have a list of them with you. Show this list to all of your doctors and pharmacists any time you get a new medicine. Both your doctor and your pharmacist can tell you if you can take these other medicines with PREZISTA. Do not start any new medicines while you are taking PREZISTA without first talking with your doctor or pharmacist. You can ask your doctor or pharmacist for a list of medicines that can interact with PREZISTA. HOW SHOULD I TAKE PREZISTA? Take PREZISTA tablets every day exactly as prescribed by your doctor. You must take ritonavir (NORVIR®) at the same time as PREZISTA. • For adults who have never taken anti-HIV medicines, the usual dose is 800 mg (two 400 mg tablets) of PREZISTA, together with 100 mg (one 100 mg capsule) of ritonavir (NORVIR®), once daily every day. • For adults who have taken anti-HIV medicines in the past, the usual dose is 600 mg (one 600 mg tablet or two 300 mg tablets) of PREZISTA, together with 100 mg (one 100 mg capsule) of ritonavir (NORVIR®), twice daily every day. Do not take PREZISTA once daily if you have taken anti-HIV medicines in the past. PREZISTA and ritonavir (NORVIR®) should be taken together at the same time every day. If you have questions about when to take PREZISTA and ritonavir (NORVIR®), your doctor can help you decide which schedule works for you. Take PREZISTA and ritonavir (NORVIR®) with food. Swallow the whole tablets with a drink such as water or milk. Do not chew the tablets. Continue taking PREZISTA and ritonavir (NORVIR®) unless your doctor tells you to stop. Take the exact amount of PREZISTA and ritonavir (NORVIR®) that your doctor tells you to take, right from the very start. To help make sure you will benefit from PREZISTA and ritonavir (NORVIR®), you must not skip doses or interrupt therapy. If you don’t take PREZISTA and ritonavir (NORVIR®) as prescribed, the beneficial effects of PREZISTA and ritonavir (NORVIR®) may be reduced or even lost. Patients taking PREZISTA once daily If you miss a dose of PREZISTA or ritonavir (NORVIR®) by more than 12 hours, wait and then take the next dose of PREZISTA and ritonavir (NORVIR®) at the regularly scheduled time. If you miss a dose of PREZISTA or ritonavir (NORVIR®) by less than 12 hours, take your missed dose of PREZISTA and ritonavir (NORVIR®) immediately. Then take your next dose of PREZISTA and ritonavir (NORVIR®) at the regularly scheduled time. Patients taking PREZISTA twice daily If you miss a dose of PREZISTA or ritonavir (NORVIR®) by more than 6 hours, wait and then take the next dose of PREZISTA and ritonavir (NORVIR®) at the regularly scheduled time. If you miss a dose of PREZISTA or ritonavir (NORVIR®) by less than 6 hours, take your missed dose of PREZISTA and ritonavir (NORVIR®) immediately. Then take your next dose of PREZISTA and ritonavir (NORVIR®) at the regularly scheduled time. You should always take PREZISTA and ritonavir (NORVIR®) together with food. If a dose of PREZISTA or ritonavir (NORVIR®) is skipped, do not double the next dose. Do not take more or less than your prescribed dose of PREZISTA or ritonavir (NORVIR®) at any one time. WHAT ARE THE POSSIBLE SIDE EFFECTS OF PREZISTA? Like all prescription drugs, PREZISTA can cause side effects. The following is not a complete list of side effects reported with PREZISTA when taken either alone or with other anti-HIV medicines. Do not rely on this leaflet alone for information about side effects. Your doctor can discuss with you a more complete list of side effects. PREZISTA, together with NORVIR® (ritonavir), has rarely been observed to cause liver problems which may be life-threatening. It was not always clear if PREZISTA caused these liver problems because some patients had other illnesses or were taking other medicines. Your healthcare professional should do blood tests prior to initiating combination treatment including PREZISTA. If
you have chronic hepatitis B or C infection, your healthcare professional should check your blood tests more often because you have an increased chance of developing liver problems. Talk to your healthcare professional about the signs and symptoms of liver problems. These may include yellowing of your skin or whites of your eyes, dark (tea colored) urine, pale colored stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching or sensitivity on your right side below your ribs. Rash has been reported in 10.3% of patients receiving PREZISTA. In few patients, PREZISTA has been reported to cause a severe or life-threatening rash. Contact your healthcare provider immediately if you develop a rash. Your healthcare provider will advise you whether your symptoms can be managed on therapy or whether PREZISTA should be stopped. Other relevant severe side effects reported at an uncommon or rare frequency were inflammation of the liver or pancreas, increased blood fat levels, diabetes, and changes in body fat. Some side effects are typical for anti-HIV medicines in the same family as PREZISTA. These are: • high blood sugar (hyperglycemia) and diabetes. This can happen in patients taking PREZISTA or other protease inhibitor medicines. Some patients have diabetes before starting treatment with PREZISTA which gets worse. Some patients get diabetes during treatment with PREZISTA. Some patients will need changes in their diabetes medicine. Some patients may need new diabetes medicine. • increased bleeding in patients with hemophilia. • changes in body fat. These changes can happen in patients taking anti-HIV medicines, including PREZISTA. The changes may include an increased amount of fat in the upper back and neck, breast, and around the back, chest, and stomach area. Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known. • immune reconstitution syndrome. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment, including PREZISTA, is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. The most common side effects include diarrhea, nausea, rash, headache, abdominal pain and vomiting. Tell your doctor promptly about these or any other unusual symptoms. If the condition persists or worsens, seek medical attention. This medication is prescribed for your particular condition. Do not use it for any other condition or give it to anybody else. Keep PREZISTA and all of your medicines out of the reach of children. If you suspect that more than the prescribed dose of this medicine has been taken, contact your local poison control center or emergency room immediately. This is a brief summary of information about PREZISTA for adult patients with HIV. If you have any questions or concerns about either PREZISTA or HIV, talk to your doctor. For additional information, you may also call Tibotec Therapeutics at 1-877-REACH-TT or 1-877-732-2488. **The brands listed are the registered trademarks of their respective owners and are not trademarks of Tibotec Pharmaceuticals, Ltd.
Manufactured for Tibotec, Inc. by: JOLLC, Gurabo, Puerto Rico Distributed by: Tibotec Therapeutics, Division of Centocor Ortho Biotech Products, L.P., Raritan NJ 08869 Patent Numbers: 5,843,946; 6,248,775; 6,335,460 and other US patents pending NORVIR® is a registered trademark of its respective owner. PREZISTA® is a registered trademark of Tibotec Pharmaceuticals, Ltd.
© Tibotec, Inc. 2006
Revised: April 2010
HIV Meds AS HIV Prevention PrEP may be emerging as a viable form of prevention. But will people be willing to take HIV medication to avoid getting HIV? By Jeff McConnell
An excited murmur had bubbled up through the audience and then washed back and forth across the auditorium like waves across sand. It was February 2006 at the Conference on Retroviruses and Opportunistic Infections (CROI) in Denver. Previously, the CDC had presented data showing that Viread (tenofovir), a drug then commonly used against HIV infection, could prevent new infections by 70% in monkeys.1 Walid Heneine from the CDC had just told us that the combination formulation of tenofovir and FTC (Truvada) had been 100% effective against infection despite repeated exposure in the monkey model.2, 3 “What do you think, Javier?” I said to the principal investigator of the Peruvian sites of the HIV prevention clinical trial that would be called “iPrEx” and would test this idea in men who have sex with men (MSM). “I think that I want Truvada for our trial,” he replied, although planning for the trial with just tenofovir alone was well under way. In 2005 fundraising had failed to support the idea of a design to test tenofovir vs. Truvada vs. placebo, so we had held to the original plan of tenofovir vs. placebo. That is, until this new data on Truvada was presented. “Well, Javier,” I said with certainty, “then you should have it!” Hours later, when a collection of researchers was sitting down to dinner at a restaurant 18
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on Denver’s 16th Street Mall, the iPrEx’s protocol chair and mastermind, Bob Grant, received a call on his cell. Covering the mouthpiece he quipped, “It’s Jim Rooney!” Jim, who was also there for the presentation on Truvada, was vice president of medical affairs at Gilead Sciences, the company that made the combination drug. By the time appetizers were arriving, Bob ended the call with Jim and announced to the suddenly silent group, “I think we have Truvada for the trial!” Glasses rose in toast after toast to Jim Rooney and the drugs at Gilead, to Walid Heneine, and the monkeys at the CDC, and to us—a skeleton of the group that would grow over the next three years into 41 researchers on
four continents making up the iPrEX study team. iPrEx is one trial in the “pre-exposure prophylaxis” (PrEP) research portfolio testing whether once-daily oral dosing of Truvada prevents HIV infection in high-risk HIV-negative individuals. Over the four years since Denver, the murmur of excitement that grew in that convention hall has risen to a drumbeat of anticipation among some researchers and activists. Still, so many men and women who are already HIV-positive, or who are at considerable risk of getting there soon, have simply not heard of PrEP, and the same goes for HIV-affected individuals who serve our communities. It is as if the second coming is upon us, but like that other second coming, if it arrives to find an unprepared mass, no salvation will ensue. And that is why I write today.
The Second Coming: Anti-Retroviral Treatment as HIV Prevention The advent of combination anti-retroviral therapy (ART) for HIV infection around 1996 was a profound turning point in the epidemic. I could throw that reality at you with so many numbers you wouldn’t see straight for days, but I won’t, and you already know it anyway. P os i t i v e lyAwar e .co m
Is ART prevention the second coming in this pandemic? The trials cannot tell us that. That is a question only communities threatened by HIV can answer. Instead, I will tell you that in the fall of 1995, just two months after I tested positive, I found out I had just 130 T-cells, and I was prescribed AZT and Bactrim. I refused the AZT. “Jesus, man, you have AIDS. You need to be on something…at least a double combination, probably triple,” John said to me a month later, very quietly and calmly so as not to scare me, I suppose, all the while holding me in his blue gaze over a table in the Long Island diner where we regularly ate after the HIV-positive support group where we had met. John was gay, so hot I could hardly look at him even if he wasn’t looking back, HIV-positive for at least eight years, and a drywall contractor by trade. It would take a couple of months more to find a doctor who would equal John’s sage medical advice and several months more for ADAP to catch up. John’s advice had become “standard-of-care” treatment for us long before many medical practitioners got it. Meanwhile, I eventually confessed my condition to a graduate school friend who cried herself asleep in my arms and, a few weeks later, passed on a fistful of HIV journals that her mother, top administrator at Boston’s Fenway Community Health Center (with a legendary HIV treatment program), “had around the house.” It was by pouring over these journals that I began my HIV education so that, by the time I was prescribed AZT monotherapy, I knew enough to reject it and the prescribing physician. Soon after I told my mother about my HIV, she discovered TPAN—I don’t know how, she lived in Colorado—and subscribed me to Positively Aware. This magazine immediately became a lifeline in a world suddenly seemingly filled with HIV-negatives who, however well-intentioned (or not), were of little help in learning how to live with HIV. Although the ART drugs have been credited with changing the shape and experience of the epidemic, they were a necessary, but insufficient, cause of those changes. It took peer support, increasingly sophisticated activists, social networks,
political organizing, policy changes, and, eventually, a little help from our friends to save our lives. And this insight is perhaps even more important for HIV prevention, where the biggest miracles happened long before the drugs. The most effective examples of HIV prevention have been demonstrated by grassroots community action starting in the 1980s.4 While the popularity of condoms has waned, sero-adaptive tactics arising from the bottom up among affected communities are increasingly credited with keeping rates of infection stable in some U.S. MSM populations since the mid1990s and through the last decade. 5, 6 But HIV incidence that is stable in some communities of MSM is stable at rates that are too high. In women and among the poor in the U.S., even stability has not been achieved, and worldwide, nearly three million new infections every year convince us that we are losing the battle to beat HIV. A scramble for new options to prevent HIV infection has ensued, but there have been disappointments with vaccines, microbicides, other biomedical interventions, and behavioral interventions. HIV prevention has seemed dead in the water for some time. Perhaps, we will soon be finding out if ARVs (anti-retrovirals) work to prevent HIV infection in clinical trials among MSM, women at high risk, heterosexual couples, and injection drug users. But it is most important that we are not deluded about why the drugs worked so dramatically for treatment; they were the icing on an already baked cake, even if it was the icing that would make the cake. Can Jim Rooney and the drugs from Gilead, Walid Heneine and the monkeys at the CDC, and investigators Javier Lama, Bob Grant, and the clinical trials of PrEP in people turn the tide on HIV? Is ART prevention the second coming in this pandemic? The trials cannot tell us that. That is a question only communities threatened by HIV can answer.
ARVs as Prevention When ARV therapy drove our viral loads to undetectable levels, many of us wondered if it must not also be making us less infectious. It has long been a controversial idea, but the idea’s time has come. Observational studies of sero-discordant couples in Rakai, Uganda a decade ago discovered that no HIV-negative partners of persons living with HIV/AIDS (PLWHAs) who had low viral loads became infected.7 More recently, health records of PLWHA have been used to calculate “community viral load.” The idea is that widespread ARV treatment effectively suppresses viral load in positive individuals and therefore lowers the overall “community viral load” and must also curb the spread of the epidemic in the community. Lowering community viral load as an activity accomplished among PLWHAs is now being pursued as an HIV prevention strategy aimed at the HIV-negative community.8 The new HIV management strategy called “Test and Treat” (or now TLC-Plus—test, link to care, plus treatment) that has emanated from the U.S. Centers for Disease Control and Prevention (CDC) and the Obama administration is not just about identifying and caring for PLWHAs, it is a structural HIV prevention strategy: the more HIV-positive people on treatment, the fewer new infections.9-12 Finally, just this summer, a study in Africa reported that in sero-discordant heterosexual couples ARV treatment that suppressed viral load in the HIV-positive partner reduced infections in their partners by 92%.13 Our decision to start antiretroviral therapy and stick with it is no longer a PLWHA SOS (save our souls). It has become a way of caring for the health of our HIV-negative brothers and sisters too. ART for prophylaxis against infection in HIV-negative individuals is not a new idea. Some had proposed it back when the drug options included ddI, AZT, and the first of the protease inhibitors. Besides making us feel miserable when we took them, however, those drugs preserved life long enough to reveal they also had long-term
P os i t i velyAwa re.com nov e m b e r /d e c e m b e r 2 01 0 |
No one really knows if HIV-negative individua or if they, their insurers, and their governm adverse health outcomes. When HIVpositive individuals began taking treatment interruptions to get a break from the daily side effects and possibly to stave off the longer term ones, it was evident that the drugs themselves were perceived to pose a health threat that, if not quite as severe a threat as HIV itself, clearly had to be measured and balanced against it. Newer generations of ARV medications have been remarkably kinder and gentler, so much so that the idea of the treatment interruptions, structured or otherwise, has somewhat faded from the culture and from research.
Gilead and Tenofovir By 1995 the molecule (yup, that’s where our drugs start) that Gilead Sciences turned into the ARV they named Viread (tenofovir) was already generating some evidence that it might protect against getting HIV.14 As far as I can tell, Gilead simply did not know what to do with this information. They did, however, know what to do with the other potential of Viread; it was soon approved by the FDA (2001) and became our first choice for both initial (or front-line) and salvage therapy. Compared to what we started with, Gilead (other companies have done likewise to be sure) has helped to make HIV treatment tolerable and simple enough for PLWHAs that we were given to revisit the question: instead of waiting to treat individuals who become infected, why not use simple and tolerable ARV drugs to prevent infections in the first place? As the results of tenofovir and Truvada trials are reported, we will learn more about whether the idea of ART pre-exposure prophylaxis works at all. Still, Gilead has played an historical role in biomedical HIV prevention. Though it has sponsored none of the current human HIV-prevention trials using their drug, it has donated the drugs, and provided expert logistical support. Gilead is an example that we can point to when we find other promising PrEP drugs at other HIV ARV-producing companies. 20
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Walid Heneine and the Monkeys at the CDC
ARVs for Negatives: Variations on a Theme
Sometimes science proceeds in a fashion that you can really admire. A variety of researchers have conducted experiments in animal “models” to explore whether tenofovir and/or FTC can be effective at preventing infection. Many had positive results, but the models were so different it was difficult to make general conclusions even for the animals, which were most often monkeys (some great studies have been done in mice too).3 Among others, the research has been led by Walid Heneine and Geraldo Garcia-Lerma. They used oral doses of the drug comparable to once-daily dosing in humans (and apparently the monkeys pose their own challenges about certainty of adherence), concentrations of virus comparable to what one would get from sex, and administered it through a rectal or vaginal exposure procedure that’s more like sex than injection through a needle. At last, the results from the animal model studies began to add up in ways that might apply to people and inform the design of randomized clinical trials.15 During his talk in one smallish conference, the charming Spaniard Garcia-Lerma offered to “jump up and down like a monkey” in excitement about not just what happened in the labs, but also because study sponsors, such as the U.S. National Institutes of Health, the CDC, and Family Health International; co-funders like the Bill and Melinda Gates Foundation; scientific investigators such as Javier Lama and Bob Grant; drug companies like Gilead, often represented by Jim Rooney; activist organizations such as the AVAC and Project Inform; and many others are at last all at the table planning these investigations together. However, when clinical PrEP trials reach their end points and report their results, the question of whether PrEP is a safe and effective alternative for HIV prevention will only just have been posed, a question that can ultimately only be answered by those at risk of contracting HIV.
There are several ways in which ARVs may contribute to HIV prevention among HIVnegative folks. Biomedical effectiveness is but one measure of how useful drugs might be in preventing new infections. Here is what you need to know about various strategies under consideration.
Post-exposure Prophylaxis (PEP) The idea of administering one month of combination ARV therapy as soon as possible after a possible high-risk exposure to HIV has been in practice for several years. Studies have shown that PEP decreases the chance of sero-conversion in medical settings where exposures occur from accidents like needle-sticks. Observational studies have examined humans after sexual exposure, but we do not have good evidence that PEP is effective in these situations. In places such as San Francisco, while PEP may be considered the standard of care for individuals who report high-risk sexual exposure to their physicians soon after it occurs, it appears that use or “uptake” in the community is low. PEP is infrequently requested, and in one Brazilian study, even when individuals were provided with a PEP starter pack (a few days’ supply of ARVs) to begin once exposed, participants sero-converted who never actually started the pills.16 In developing countries, where the expense of ARVs remains a barrier, the lack of evidence that PEP actually works has precluded widespread use. Even in the U.S., outside of urban centers with highly developed HIV treatment and prevention programs, it is unclear how many individuals at risk for HIV, and the physicians that they might consult, really know about PEP.
ARV Topical Microbicides Unlike condoms, which require the active cooperation of male partners, topical microbicides or gels that can be inserted in the vagina or rectum before and after P os i t i v e lyAwar e .co m
als will take to the idea of pills for prevention ments will pay for this kind of prevention. sexual intercourse present the opportunity for women and men to protect themselves without their partner’s cooperation or even knowledge. Several formulas that killed HIV under laboratory conditions have been tested in randomized clinical trials in women. Until this summer, none had been proven to work. In fact, in clinical trials, the once popular nonoxynol-9 spermicide was shown to actually increase risk of infection by as much as 50% in women.17 Interest in the idea of using ARVs formulated into gels as microbicides has been growing for some time. In his address at CROI last February, NIAID Director Anthony Fauci made it clear that while other possible microbicide agents were not off the table, the idea of using ARVs in gels would receive priority in trials until their effectiveness could be rigorously tested in people. (Again, the results in animal models, both monkeys and mice, are promising.) The first great breakthrough in the microbicide field was announced this summer at the International AIDS Society (IAS) Conference in Vienna. The CAPRISA study showed that 1% tenofovir in a gel that was to be inserted in the vagina one hour before and again after sexual intercourse decreased HIV infection by 39%. As it turns out, few women in the trial consistently used the gel as directed, but among those who used it at least 80% of the time as directed, HIV infections were reduced by 54%!18 The story of ARVs used in gels as topical microbicides is still being written (see “Let the Sun Shine In,” page 26). It will be important to understand whether increased concentrations of the gel, or increased adherence to using the gels as directed, might be more effective. Finally, expect a rush toward formulation, and hopefully clinical trials, of ARV gels that can be safely used in the rectum during anal intercourse.
Oral Pre-exposure Prophylaxis (PrEP) Once-daily dosing of tenofovir (Viread)
has proven safe and tolerable in PLWHAs, and effective against HIV infection in monkeys and mice. Compelling ideas for oral PrEP are that, like microbicides, it can be used regardless of a partner’s knowledge or cooperation and, unlike PEP, it can be taken routinely without regard to whether a possible exposure will happen and without having to come to the conclusion that what did happen was a risky exposure. Clinical trials among women in West Africa and MSM in the U.S. have been completed and reported no adverse safety concerns, but the studies were not designed to show if PrEP effectively prevented infection and caused some controversy.19 iPrEx, a study of 2,499 MSM on four continents, is designed to show whether PrEP can prevent infections in this population. The first results from this trial will likely be reported soon after this article goes to press. A CDC study of injection drug users in Thailand may be able to report on efficacy before the end of the year or soon after, too.
Intermittent Pre-exposure Prophylaxis (iPrEP) As nearly as we can tell, one of the most consistent questions about daily PrEP from communities at risk is based on the following logic: “If I don’t have sex every day, at least not risky sex, why should I take a pill every day?” Researchers and activists have been posing the same question. Less frequent dosing would be less expensive, any side effects would be milder, and the more sense the idea makes to folks at risk, the higher uptake is likely to be. Well, Garcia-Lerma and those monkeys have been at work on that one too. Indeed, in monkeys, a variety of intermittent strategies have been highly effective against infection, the most effective always including at least one dose before exposure and another after. Sponsors have warmed up to the idea. Family Health International is conducting a small trial in Africa. The NIH HIV
Prevention Trials Network is planning two small trials in MSM and women. None of these will tell us if iPrEP is effective, but rather if it is feasible. I would bet that if daily PrEP trials show some efficacy, the idea of iPrEP will receive a great deal more attention and funding.
Back to John, ARVs for Prevention, and Community No one really knows if HIV-negative individuals will take to the idea of pills for prevention or if they, their insurers, and their governments will pay for this kind of prevention even if it works in human trials like it works in the monkeys and mice. 20 Remember my friend John, the guy who had the guts to tell me I had AIDS to my face and then what I needed to do about it when my doctor didn’t? I try to picture John across the table from some guy in a Long Island diner saying something like this. “Jesus man, again? That’s three times in the last month without a condom. You need to change something…you need to think about PrEP.” Would John say something like that? You know, if he knew it was effective, even partially, and John would know this, I think he might. Would you? e J. Jeff McConnell is a sociologist who began his career studying suburban homelessness on New York’s Long Island and in Westchester County. For 10 years, he has conducted studies of HIV superinfection and sexual sero-adaptation among HIV-positive couples and singles at the Gladstone Institute of Virology and the University of California in San Francisco. He is currently co-investigator on the HIV prevention clinical trial “iPrEx,” focusing on the social and behavioral impact of PrEP among men who have sex with men. Go to PostivelyAware.com for references.
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INDICATION: REYATAZ is a prescription medicine used in combination with other medicines to treat people who are infected with the human immunodeficiency virus (HIV). REYATAZ has been studied in a 48-week trial in patients who have taken anti-HIV medicines and a 96-week trial in patients who have never taken anti-HIV medicines. REYATAZ does not cure HIV or lower your chance of passing HIV to others.
IMPORTANT SAFETY INFORMATION: Do not take REYATAZ if you are taking the following medicines due to potential for serious, life-threatening side effects or death: Versed® (midazolam) when taken by mouth, Halcion® (triazolam), ergot medicines (dihydroergotamine, ergonovine, ergotamine, and methylergonovine such as Cafergot®, Migranal®, D.H.E. 45®, ergotrate maleate, Methergine®, and others), Propulsid® (cisapride), or Orap® (pimozide). Do not take REYATAZ with the following medicines due to potential for serious side effects: Camptosar® (irinotecan), Crixivan® (indinavir), Mevacor® (lovastatin), Zocor® (simvastatin), Uroxatral® (alfuzosin), or Revatio® (sildenafil). Do not take REYATAZ with the following medicines as they may lower the amount of REYATAZ in your blood, which may lead to increased HIV viral load and resistance to REYATAZ or other anti-HIV medicines: rifampin (also known as Rimactane®, Rifadin®, Rifater®, or Rifamate®), St. John’s wort (Hypericum perforatum)-containing products, or Viramune® (nevirapine). Serevent Diskus® (salmeterol) and Advair® (salmeterol with fluticasone) are not recommended with REYATAZ. Do not take Vfend® (voriconazole) if you are taking REYATAZ and Norvir® (ritonavir). The above lists of medicines are not complete. Taking REYATAZ with some other medicines may require your therapy to be monitored more closely or may require a change in dose or dose schedule of REYATAZ or the other medicine. Discuss with your healthcare provider all prescription and non-prescription medicines, vitamin and herbal supplements, or other health preparations you are taking or plan to take. Tell your healthcare provider if you are pregnant, breast-feeding, planning to become pregnant or breast-feed, or if you have end-stage kidney disease managed with hemodialysis or severe liver dysfunction. Tell your healthcare provider right away if you have any side effects, symptoms, or conditions, including the following: • Mild rash (redness and itching) without other symptoms sometimes occurs in patients taking REYATAZ, most often in the first few weeks after the medicine is started, and usually goes away within 2 weeks with no change in treatment. • Severe rash has occurred in a small number of patients taking REYATAZ. This type of rash is associated with other symptoms that could be serious and potentially cause death. If you develop a rash with any of the following symptoms, stop using REYATAZ and call your healthcare provider right away: – Conjunctivitis (red or inflamed eyes, – Shortness of breath like “pink-eye”) – General ill-feeling or “flu-like” – Blisters symptoms – Mouth sores – Fever – Swelling of your face – Muscle or joint aches • Yellowing of the skin and/or eyes may occur due to increases in bilirubin levels in the blood (bilirubin is made by the liver). • A change in the way your heart beats may occur. You may feel dizzy or lightheaded. These could be symptoms of a heart problem. • Diabetes and high blood sugar may occur in patients taking protease inhibitor medicines like REYATAZ. Some patients may need changes in their diabetes medicine. • If you have liver disease, including hepatitis B or C, it may get worse when you take anti-HIV medicines like REYATAZ. • Kidney stones have been reported in patients taking REYATAZ. Signs or symptoms of kidney stones include pain in your side, blood in your urine, and pain when you urinate. • Some patients with hemophilia have increased bleeding problems with protease inhibitor medicines like REYATAZ. • Changes in body fat have been seen in some patients taking anti-HIV medicines. The cause and long-term effects are not known at this time. • Gallbladder disorders (including gallstones and gallbladder inflammation) have been reported in patients taking REYATAZ. Other common side effects of REYATAZ taken with other anti-HIV medicines include: nausea; headache; stomach pain; vomiting; diarrhea; depression; fever; dizziness; trouble sleeping; numbness, tingling, or burning of hands or feet; and muscle pain. You should take REYATAZ once daily with food (a meal or snack). Swallow the capsules whole; do not open the capsules. You should take REYATAZ and your other anti-HIV medicines exactly as instructed by your healthcare provider.
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Once-daily REYATAZ can help fight your HIV. REYATAZ, a protease inhibitor (PI), in HIV combination therapy: ◆ Can
help lower your viral load and raise your T-cell (CD4+ cell) count
Find out if you can save on REYATAZ. Call 1-888-281-8981 or visit ReyatazSavings.com for details.
a low chance of diarrhea (shown in clinical trials) - REYATAZ in combination therapy had a 1%-3% rate of moderate-to-severe diarrhea in adults
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REYATAZ is one of several treatment options your doctor may consider.
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REYATAZÂŽ (RAY-ah-taz) (generic name = atazanavir sulfate) Capsules
ALERT: Find out about medicines that should NOT be taken with REYATAZ. Read the section â€œWhat important information should I know about taking REYATAZ with other medicines?â€? Read the Patient Information that comes with REYATAZ before you start using it and each time you get a refill. There may be new information. This leaflet provides a summary about REYATAZ and does not include everything there is to know about your medicine. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. What is REYATAZ? REYATAZ is a prescription medicine used with other anti-HIV medicines to treat people who are infected with the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS). REYATAZ is a type of anti-HIV medicine called a protease inhibitor. HIV infection destroys CD4+ (T) cells, which are important to the immune system. The immune system helps fight infection. After a large number of (T) cells are destroyed, AIDS develops. REYATAZ helps to block HIV protease, an enzyme that is needed for the HIV virus to multiply. REYATAZ may lower the amount of HIV in your blood, help your body keep its supply of CD4+ (T) cells, and reduce the risk of death and illness associated with HIV. Does REYATAZ cure HIV or AIDS? REYATAZ does not cure HIV infection or AIDS. At present there is no cure for HIV infection. People taking REYATAZ may still get opportunistic infections or other conditions that happen with HIV infection. Opportunistic infections are infections that develop because the immune system is weak. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infections. It is very important that you see your healthcare provider regularly while taking REYATAZ. REYATAZ does not lower your chance of passing HIV to other people through sexual contact, sharing needles, or being exposed to your blood. For your health and the health of others, it is important to always practice safer sex by using a latex or polyurethane condom or other barrier to lower the chance of sexual contact with semen, vaginal secretions, or blood. Never use or share dirty needles. Who should not take REYATAZ? Do not take REYATAZ if you: t are taking certain medicines. (See â€œWhat important information should I know about taking REYATAZ with other medicines?â€?) Serious life-threatening side effects or death may happen. Before you take REYATAZ, tell your healthcare provider about all medicines you are taking or planning to take. These include other prescription and nonprescription medicines, vitamins, and herbal supplements. t are allergic to REYATAZ or to any of its ingredients. The active ingredient is atazanavir sulfate. See the end of this leaflet for a complete list of ingredients in REYATAZ. Tell your healthcare provider if you think you have had an allergic reaction to any of these ingredients. What should I tell my healthcare provider before I take REYATAZ? Tell your healthcare provider: t If you are pregnant or planning to become pregnant. It is not known if REYATAZ can harm your unborn baby. Pregnant women have experienced serious side effects when taking REYATAZ with other HIV medicines called nucleoside analogues. You and your healthcare provider will need to decide if REYATAZ is right for you. If you use REYATAZ while you are pregnant, talk to your healthcare provider about the Antiretroviral Pregnancy Registry. t If you are breast-feeding. You should not breast-feed if you are HIV-positive because of the chance of passing HIV to your baby. Also, it is not known if REYATAZ can pass into your breast milk and if it can harm your baby. If you are a woman who has or will have a baby, talk with your healthcare provider about the best way to feed your baby. t If you have liver problems or are infected with the hepatitis B or C virus. See â€œWhat are the possible side effects of REYATAZ?â€? t If you have end stage kidney disease managed with hemodialysis. t If you have diabetes. See â€œWhat are the possible side effects of REYATAZ?â€? t If you have hemophilia. See â€œWhat are the possible side effects of REYATAZ?â€? t About all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Keep a list of your medicines with you to show your healthcare provider. For more information, see â€œWhat important information should I know about taking REYATAZ with other medicines?â€? and â€œWho should not take REYATAZ?â€? Some medicines can cause serious side effects if taken with REYATAZ.
REYATAZÂŽ (atazanavir sulfate) How should I take REYATAZ? t Take REYATAZ once every day exactly as instructed by your healthcare provider. Your healthcare provider will prescribe the amount of REYATAZ that is right for you. t 'PSBEVMUTXIPIBWFOFWFSUBLFOBOUJ)*7NFEJDJOFTCFGPSF UIFEPTF is 300 mg once daily with 100 mg of NORVIRÂŽ (ritonavir) once daily taken with food. For adults who are unable to tolerate ritonavir, 400 mg (two 200-mg capsules) once daily (without NORVIRÂŽ) taken with food is recommended. t 'PSBEVMUTXIPIBWFUBLFOBOUJ)*7NFEJDJOFTJOUIFQBTU UIFVTVBM dose is 300 mg plus 100 mg of NORVIRÂŽ (ritonavir) once daily taken with food. t :PVS EPTF XJMM EFQFOE PO ZPVS MJWFS GVODUJPO BOE PO UIF PUIFS BOUJ)*7 medicines that you are taking. REYATAZ is always used with other anti-HIV medicines. If you are taking REYATAZ with SUSTIVAÂŽ (efavirenz) or with VIREADÂŽ (tenofovir disoproxil fumarate), you should also be taking NORVIRÂŽ (ritonavir). t Always take REYATAZ with food (a meal or snack) to help it work better. Swallow the capsules whole. Do not open the capsules. Take REYATAZ at the same time each day. t If you are taking antacids or didanosine (VIDEXÂŽ or VIDEXÂŽ EC), take REYATAZ 2 hours before or 1 hour after these medicines. t If you are taking medicines for indigestion, heartburn, or ulcers such as AXIDÂŽ (nizatidine), PEPCID ACÂŽ (famotidine), TAGAMETÂŽ (cimetidine), ZANTACÂŽ (ranitidine), AcipHexÂŽ (rabeprazole), NEXIUMÂŽ (esomeprazole), PREVACIDÂŽ (lansoprazole), PRILOSECÂŽ (omeprazole), or PROTONIXÂŽ (pantoprazole), talk to your healthcare provider. t Do not change your dose or stop taking REYATAZ without first talking with your healthcare provider. It is important to stay under a healthcare providerâ€™s care while taking REYATAZ. t When your supply of REYATAZ starts to run low, get more from your healthcare provider or pharmacy. It is important not to run out of REYATAZ. The amount of HIV in your blood may increase if the medicine is stopped for even a short time. t If you miss a dose of REYATAZ, take it as soon as possible and then take your next scheduled dose at its regular time. If, however, it is within 6 hours of your next dose, do not take the missed dose. Wait and take the next dose at the regular time. Do not double the next dose. It is important that you do not miss any doses of REYATAZ or your other anti-HIV medicines. t If you take more than the prescribed dose of REYATAZ, call your healthcare provider or poison control center right away. Can children take REYATAZ? Dosing recommendations are available for children 6 years of age and older for REYATAZ Capsules. Dosing recommendations are not available for children from 3 months to less than 6 years of age. REYATAZ should not be used in babies under the age of 3 months. What are the possible side effects of REYATAZ? The following list of side effects is not complete. Report any new or continuing symptoms to your healthcare provider. If you have questions about side effects, ask your healthcare provider. Your healthcare provider may be able to help you manage these side effects. The following side effects have been reported with REYATAZ: t mild rash (redness and itching) without other symptoms sometimes occurs in patients taking REYATAZ, most often in the first few weeks after the medicine is started. Rashes usually go away within 2 weeks with no change in treatment. Tell your healthcare provider if rash occurs. t severe rash: In a small number of patients, a rash can develop that is associated with other symptoms which could be serious and potentially cause death. If you develop a rash with any of the following symptoms stop using REYATAZ and call your healthcare provider right away: t TIPSUOFTTPGCSFBUI t HFOFSBMJMMGFFMJOHPSiGMVMJLFwTZNQUPNT t GFWFS t NVTDMFPSKPJOUBDIFT t DPOKVODUJWJUJT SFEPSJOGMBNFEFZFT MJLFiQJOLFZFw
t CMJTUFST t NPVUITPSFT t TXFMMJOHPGZPVSGBDF t yellowing of the skin or eyes. These effects may be due to increases in bilirubin levels in the blood (bilirubin is made by the liver). Call your healthcare provider if your skin or the white part of your eyes turn yellow. Although these effects may not be damaging to your liver, skin, or eyes, it is important to tell your healthcare provider promptly if they occur.
REYATAZÂŽ (atazanavir sulfate) a change in the way your heart beats (heart rhythm change). Call your healthcare provider right away if you get dizzy or lightheaded. These could be symptoms of a heart problem. t diabetes and high blood sugar (hyperglycemia) sometimes happen in patients taking protease inhibitor medicines like REYATAZ. Some patients had diabetes before taking protease inhibitors while others did not. Some patients may need changes in their diabetes medicine. t if you have liver disease including hepatitis B or C, your liver disease may get worse when you take anti-HIV medicines like REYATAZ. t kidney stones have been reported in patients taking REYATAZ. If you develop signs or symptoms of kidney stones (pain in your side, blood in your urine, pain when you urinate) tell your healthcare provider promptly. t some patients with hemophilia have increased bleeding problems with protease inhibitors like REYATAZ. t changes in body fat. These changes may include an increased amount of fat in the upper back and neck (â€œbuffalo humpâ€?), breast, and around the trunk. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these conditions are not known at this time. Other common side effects of REYATAZ taken with other anti-HIV medicines include nausea; headache; stomach pain; vomiting; diarrhea; depression; fever; dizziness; trouble sleeping; numbness, tingling, or burning of hands or feet; and muscle pain. Gallbladder disorders (which may include gallstones and gallbladder inflammation) have been reported in patients taking REYATAZ. What important information should I know about taking REYATAZ with other medicines? Do not take REYATAZ if you take the following medicines (not all brands may be listed; tell your healthcare provider about all the medicines you take). REYATAZ may cause serious, life-threatening side effects or death when used with these medicines. t &SHPU NFEJDJOFT EJIZESPFSHPUBNJOF FSHPOPWJOF FSHPUBNJOF BOE methylergonovine such as CAFERGOTÂŽ, MIGRANALÂŽ, D.H.E. 45ÂŽ, ergotrate maleate, METHERGINEÂŽ, and others (used for migraine headaches). t 03"1ÂŽ (pimozide, used for Touretteâ€™s disorder). t 13016-4*%ÂŽ (cisapride, used for certain stomach problems). t 5SJB[PMBN BMTPLOPXOBT)"-$*0/ÂŽ (used for insomnia). t .JEB[PMBN BMTP LOPXO BT 7&34&%ÂŽ (used for sedation), when taken by mouth. Do not take the following medicines with REYATAZ because of possible serious side effects: t $".1504"3ÂŽ (irinotecan, used for cancer). t $3*9*7"/ÂŽ JOEJOBWJS VTFE GPS )*7 JOGFDUJPO #PUI 3&:"5"; BOE $3*9*7"/ sometimes cause increased levels of bilirubin in the blood. t Cholesterol-lowering medicines MEVACORÂŽ (lovastatin) or ZOCORÂŽ (simvastatin). t 6309"53"-ÂŽ (alfuzosin, used to treat benign enlargement of the prostate). t 3&7"5*0ÂŽ (sildenafil, used to treat pulmonary arterial hypertension). Do not take the following medicines with REYATAZ because they may lower the amount of REYATAZ in your blood. This may lead to an increased HIV viral load. Resistance to REYATAZ or cross-resistance to other HIV medicines may EFWFMPQ t 3JGBNQJO BMTPLOPXOBT3*."$5"/&ÂŽ, RIFADINÂŽ, RIFATERÂŽ, or RIFAMATEÂŽ, used for tuberculosis). t 4U+PIOTXPSU(Hypericum perforatum), an herbal product sold as a dietary TVQQMFNFOU PSQSPEVDUTDPOUBJOJOH4U+PIOTXPSU t 7*3".6/&ÂŽ (nevirapine, used for HIV infection). The following medicines are not recommended with REYATAZ: t 4&3&7&/5%*4,64ÂŽ (salmeterol) and ADVAIRÂŽ (salmeterol with fluticasone), used to treat asthma, emphysema/chronic obstructive pulmonary disease also known as COPD. Do not take the following medicine if you are taking REYATAZ and NORVIRÂŽ together: t 7'&/%ÂŽ (voriconazole). The following medicines may require your healthcare provider to monitor your therapy more closely (for some medicines a change in the dose or dose schedule may be needed): t $*"-*4ÂŽ (tadalafil), LEVITRAÂŽ (vardenafil), or VIAGRAÂŽ (sildenafil), used to treat erectile dysfunction. REYATAZ may increase the chances of serious side effects that can happen with CIALIS, LEVITRA, or VIAGRA. Do not use CIALIS, LEVITRA, or VIAGRA while you are taking REYATAZ unless your healthcare provider tells you it is okay. t "%$*3$"ÂŽ (tadalafil) or TRACLEERÂŽ (bosentan), used to treat pulmonary arterial hypertension. t -*1*503ÂŽ (atorvastatin) or CRESTORÂŽ (rosuvastatin). There is an increased chance of serious side effects if you take REYATAZ with this cholesterollowering medicine. t
REYATAZÂŽ (atazanavir sulfate) t
FEJDJOFTGPSBCOPSNBMIFBSUSIZUIN$03%"30/&ÂŽ (amiodarone), lidocaine, . quinidine (also known as CARDIOQUINÂŽ 26*/*%&9ÂŽ, and others). t .:$0#65*/ÂŽ (rifabutin, an antibiotic used to treat tuberculosis). t #613&/&9ÂŽ 46#65&9ÂŽ 46#090/&ÂŽ, (buprenorphine or buprenorphine/ naloxone, used to treat pain and addiction to narcotic painkillers). t 7"4$03ÂŽ (bepridil, used for chest pain). t $06."%*/ÂŽ (warfarin). t 5SJDZDMJD BOUJEFQSFTTBOUT TVDI BT &-"7*-ÂŽ (amitriptyline), NORPRAMINÂŽ (desipramine), SINEQUANÂŽ (doxepin), SURMONTILÂŽ (trimipramine), TOFRANILÂŽ (imipramine), or VIVACTILÂŽ (protriptyline). t .FEJDJOFTUPQSFWFOUPSHBOUSBOTQMBOUSFKFDUJPO4"/%*..6/&ÂŽ or NEORALÂŽ (cyclosporin), RAPAMUNEÂŽ (sirolimus), or PROGRAFÂŽ (tacrolimus). t 5IFBOUJEFQSFTTBOUUSB[PEPOF %&4:3&-ÂŽ and others). t 'MVUJDBTPOFQSPQJPOBUF '-0/"4&ÂŽ, FLOVENTÂŽ), given by nose or inhaled to treat allergic symptoms or asthma. Your doctor may choose not to keep you on fluticasone, especially if you are also taking NORVIRÂŽ. t $PMDIJDJOF $0-$3:4ÂŽ), used to prevent or treat gout or treat familial Mediterranean fever. The following medicines may require a change in the dose or dose schedule of either REYATAZ or the other medicine: t */7*3"4&ÂŽ (saquinavir). t /037*3ÂŽ (ritonavir). t 4645*7"ÂŽ (efavirenz). t "OUBDJETPSCVGGFSFENFEJDJOFT t 7*%&9ÂŽ (didanosine). t 7*3&"%ÂŽ (tenofovir disoproxil fumarate). t .:$0#65*/ÂŽ (rifabutin). t $BMDJVN DIBOOFM CMPDLFST TVDI BT $"3%*;&.ÂŽ or TIAZACÂŽ (diltiazem), COVERA-HSÂŽ or ISOPTIN SRÂŽ (verapamil) and others. t #*"9*/ÂŽ (clarithromycin). t .FEJDJOFT GPS JOEJHFTUJPO IFBSUCVSO PS VMDFST TVDI BT "9*%ÂŽ (nizatidine), PEPCID ACÂŽ (famotidine), TAGAMETÂŽ (cimetidine), or ZANTACÂŽ (ranitidine). Talk to your healthcare provider about choosing an effective method of contraception. REYATAZ may affect the safety and effectiveness of hormonal contraceptives such as birth control pills or the contraceptive patch. Hormonal contraceptives do not prevent the spread of HIV to others. Remember: 1. Know all the medicines you take. 2. Tell your healthcare provider about all the medicines you take. 3. Do not start a new medicine without talking to your healthcare provider. How should I store REYATAZ? t 4UPSF3&:"5";$BQTVMFTBUSPPNUFNQFSBUVSF ÂĄUPÂĄ' ÂĄUPÂĄ$ Do not store this medicine in a damp place such as a bathroom medicine cabinet or near the kitchen sink. t ,FFQZPVSNFEJDJOFJOBUJHIUMZDMPTFEDPOUBJOFS t ,FFQBMMNFEJDJOFTPVUPGUIFSFBDIPGDIJMESFOBOEQFUTBUBMMUJNFT%POPU keep medicine that is out of date or that you no longer need. Dispose of unused medicines through community take-back disposal programs when available or place REYATAZ in an unrecognizable, closed container in the household trash. General information about REYATAZ This medicine was prescribed for your particular condition. Do not use REYATAZ for another condition. Do not give REYATAZ to other people, even if they have the same symptoms you have. It may harm them. Keep REYATAZ and all medicines out of the reach of children and pets. This summary does not include everything there is to know about REYATAZ. Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Remember no written summary can replace careful discussion with your healthcare provider. If you would like more information, talk XJUIZPVSIFBMUIDBSFQSPWJEFSPSZPVDBODBMM What are the ingredients in REYATAZ? Active Ingredient: atazanavir sulfate Inactive Ingredients: Crospovidone, lactose monohydrate (milk sugar), magnesium stearate, gelatin, FD&C Blue #2, and titanium dioxide. 7*%&9ÂŽ and REYATAZÂŽ are registered trademarks of Bristol-Myers Squibb Company. COUMADINÂŽ and SUSTIVAÂŽ are registered trademarks of Bristol-Myers Squibb Pharma Company. DESYRELÂŽJTBSFHJTUFSFEUSBEFNBSLPG.FBE+PIOTPO and Company. Other brands listed are the trademarks of their respective owners and are not trademarks of Bristol-Myers Squibb Company. 1SJODFUPO /+64" 1246226A7
Rev April 2010
Let the sun shine in New prevention technologies move beyond a pipe dream by Jim Pickett
There is now a very clear line delineating a before and an after in terms of HIV prevention history. There is a before CAPRISA, and an after CAPRISA—and the world as we know it will never be the same. Thank Goddess. At the International AIDS Conference in Vienna this past July, the husband and wife team of Drs. Salim S. Abdool Karim and Quarraisha Abdool Karim, from the Centre for the AIDS Programme of Research in South Africa (CAPRISA), announced that a vaginal gel had been shown to significantly reduce a woman’s risk of being infected with HIV. The microbicide gel the Karims studied contained 1% tenofovir—an antiretroviral drug commonly used to treat HIV—and was found to be 39% effective in reducing 26
a woman’s risk of becoming infected with HIV during vaginal intercourse and as an added bonus, it was discovered to be a whopping 51% effective in preventing genital herpes among the women in the trial. Significantly, the women who used the gel in more than 80% of their sex acts during the trial had a 54% reduction in HIV infections. Widespread use of the gel, at this level of protection, could prevent millions of new HIV infections among women over the next two decades. This is especially important for South Africa, where the
global pandemic is the most severe. In rural Vulindlela, the prevalence of HIV among young women exceeds 50% by the age of 24. Think about that. Half of all these young women are infected with HIV at such an early age—it’s absolutely horrifying, and, it goes without saying, it’s completely unacceptable. At the conclusion of the Karims’ presentation, an overflow of more than 5,000 researchers and advocates jumped to their feet and gave them a prolonged standing ovation. Hugs, tears, and high fives—I have never seen anything like it. After 20 or so years of microbicide research and dogged international advocacy, several trials had failed and, admittedly, it was looking grim for the field. We’d seen some funders, public health authorities, researchers, and advocates turn away from the work. The P os i t i v e lyAwa r e .co m
After CAPRISA, it’s not exactly rainbows and lollipops, as there is much to be done to confirm and extend these findings and then actually make this drug available, accessible.
naysayers were not exactly gleeful—how can one be happy, after all, about these dead ends in prevention research? But I’d say there was a lot of smug to go around. Finally we have a win. I must say I was feeling a little smug myself when several folks approached me at the conference to say variations of “I never quite understood why you were so passionate about microbicides… I thought you were a little nuts... You must feel vindicated…” Lots of us feel vindicated, thank you very much. After CAPRISA, it’s not exactly rainbows and lollipops, as there is much to be done to confirm and extend these findings and then actually make this drug available, accessible. One study that is currently underway in a number of African countries will be able to confirm whether tenofovir gel works or not. While the 5,000 women in the VOICE trial are using a different dosing regimen than the CAPRISA participants, the data will be very important. Other studies are being planned to follow up on CAPRISA. Obtaining the necessary resources for such trials is the current—big—challenge. But what do these new findings mean for rectal microbicides? “The positive results from the CAPRISA study represent a very significant milestone in HIV prevention research and they increase optimism that we can develop safe and effective antiretroviral rectal microbicides,” said University of Pittsburgh’s Dr. Ian McGowan, International Rectal Microbicide Advocates (IRMA) Scientific Vice-Chair and co-principal investigator of the Microbicide Trials Network. “Phase 1 rectal safety studies with tenofovir are ongoing and these efforts need to be intensified to help us move forward to rectal microbicide effectiveness studies as quickly as possible,” he said. Anal intercourse is a common human sexual behavior, practiced by approximately P os i t i velyAwa re.com
5-10% of the world’s general population, including heterosexual women and men, gay men, and other MSM. Because an act of unprotected anal intercourse is 10 to 20 times more likely to result in HIV transmission compared to unprotected vaginal intercourse, it is likely that unprotected anal intercourse is a significant driver in the HIV epidemic overall. We know that unprotected anal intercourse is the chief cause of HIV infection for gay men/MSM across the world. But gay men are under-represented in most national AIDS strategies, in epidemiology, surveillance, and in research—if they show up at all. They have been woefully underserved by prevention, care, treatment, and support services. Similarly, we have inadequate data regarding anal intercourse—homosexual and heterosexual—due to politics, stigma, criminalization, and outright denial. It’s hard to study a behavior that’s against the law in some places. Globally, gay men/MSM are 19 times more likely to be HIV-positive compared to the general population. These disproportionate rates extend to Africa, where the epidemic is often characterized as “heterosexual.” For instance, according to data from Dr. Chris Beyrer presented at the Global Forum on MSM and HIV’s “Be Heard!” pre-conference on July 17, in Kenya, 15.2% of gay/MSM are HIV-positive compared to 6.1% of the general population; in Uganda, HIV prevalence rates among gay men/MSM are just above 40% compared to 5% for other Ugandan men of reproductive age. Data released by the U.S. Centers for Disease Control and Prevention (CDC) in early 2010 revealed that gay men/MSM in the United States are 44 times more likely to be HIV-positive than other men, and 40 times more likely to be HIV-positive than women. The bottom line is that for the men and women who engage in anal intercourse,
condoms work quite well to prevent HIV, but many people do not use them, or are simply unable to use them due to a number of issues, including power dynamics in sexual relationships, stigma, and a serious lack of availability. According to the Global HIV Prevention Working Group, only 9% of individuals at risk for HIV infection had access to male condoms in 2008. Condom-compatible lubricants are also in dangerously short supply, especially in Africa. We need to do much better with what we have available now, and we should be pushing female condoms more than we are, especially since a new model has come out that has proven to be much more acceptable to women and men, and can be used for anal intercourse as well. While the rectal microbicide field has gained significant momentum, more focus and resources are necessary. In 2010, 7.2 million U.S. dollars are being spent globally on rectal microbicide research. IRMA has calculated that annual investments must increase by 40% from 2011-2014, to $10 million per year and must increase further to $44 million in the years 20152020 to ensure a minimum of candidate products are moving through the research pipeline into late stage testing for effectiveness. Advocates are optimistic that the CAPRISA proof of concept will also be translated into more financial and creative energy being put into rectal microbicide development. With five new infections for every two individuals beginning treatment, it’s absolutely imperative we find new ways to prevent HIV for individuals at risk, gay and straight, women and men. As these new methods become available, it is also of paramount importance that people who are already using condoms correctly and consistently continue doing so. We won’t treat our way out of this global epidemic. As of this writing, over 3,400 individuals in the U.S. bide their N ov e m b e r / D e c e m b e r 2 01 0 |
The new National AIDS Strategy focuses on three pillars to attack the epidemic, one of which is access to care and treatment. Can we ensure this happens? time on AIDS Drug Assistance Program waiting lists in nine states. The new National AIDS Strategy focuses on three pillars to attack the domestic epidemic, one of which is access to care and treatment. Can we ensure this happens? Those waiting lists are made up of people who can’t wait. CAPRISA enrolled 889 women into a double-blind, placebo-controlled, randomized clinical trial. They were instructed to use the gel up to 12 hours before sex and soon after having sex for a maximum of two doses in 24 hours. Participants used the gel for a minimum of one year and a maximum of two and a half years. HIV serostatus, safety, sexual behavior, and gel and condom use were assessed at monthly follow-up visits for 30 months. They were asked to return all used and unused gel applicators. A total of 181,000 applicators were dispensed during the study. In a word, these women were asked to do a lot. And 843 of them did all of that to the very end, with the study achieving a truly extraordinary 95% retention rate. The standing ovation, the hugs, and the tears were as much for the scientists as for these incredibly dedicated women and their exceptional, unwavering commitment to making a difference in the epidemic. For further information on IRMA visit www.rectalmicrobicides.org and read IRMA’s new report, From Promise to Product: Advancing Rectal Microbicide Research and Advocacy. e Jim Pickett is a long-time contributing writer to Positively Aware , Director of Advocacy at the AIDS Foundation of Chicago and Chair of the International Rectal Microbicide Advocates (IRMA). He is also very active in the national gay men’s health movement and has been living with HIV since 1995. 28
P os i t i v e lyAwa r e .co m
A DAY with hiv in america
What does it mean to live with HIV? Positively Aware asked that question, and received dozens of responses for a photo essay entitled “A Day with HIV in America.”
Austin, tx: Darryl Takushi, “I still wake up with a smile.”
To view more photos, go to ADayWithHIVinAmerica.com
8:31 a.m., Chicago, IL: Evany Turk, HIV-positive. “This is a photo of me and my children, DeShawn Turk (oldest) and Kywon Nelson (youngest). This is why I work so hard to live a healthy life with HIV.”
9:30 a.m., Fairfax, VA: Chuck Panozzo, bassist and co-founder of Styx, HIV-positive, before his presentation as guest speaker at the Virginia Organizations Responding to AIDS.
9:00 A.m., Washington, DC: Raul Posas gets ready for another day working at NAPWA (National Association of People with AIDS).
10:00 a.m., Runyon Canyon, outside Los Angeles, CA: Christopher Wilson, HIV-positive. “Running and hiking is what I do to feel that much needed release.”
P os i t i velyAwa re.com nov e m b e r /d e c e m b e r 2 01 0
A Day with HIV in America
10:02 a.m., Chicago, IL: Andrew Espinosa, HIV-positive for 13 years, enjoying an “Uncle Day” with nephew Beni.
12:00 p.m., Philadelphia, PA: Mark Davis, HIV-positive 22 years. “My life has been blessed being in many right places and times with mouth wide open, speaking from left of center, finding a voice to advocate, educate, and make change happen.” Peer friends at the PA Mental Health Consumers’ Association created a special red carpet ceremony for Mark.
1:35 p.m., Chicago, IL: Greg Sanchez, HIV-positive 26 years, with his doctor Kaleo Staszkow at Northstar Medical Center. “Sometimes juggling various doctors appointments can be hard, but I do what I have to do, as often as needed, to be on top of my health and continue living my life. I became HIV-positive at the age of 19, and am now approaching 45. Who knew I’d still be alive? The beat goes on and I’m grateful to still be alive.”
12:46 p.m., Oregon: Jennifer Jako, HIV-positive 20 years, 13 years living with AIDS, swings her daughter, Bianca, 4, born free of HIV thanks to HAART. “My HIV-negative husband and I are so grateful to have a life together with our beautiful little girl thanks to my adherence to life saving medications.” 30
| N ovember/December 2010
2:00 p.m., Washington, DC: National AIDS Fund president and CEO Kandy Feree (right), vice president of External Affairs Victor Barnes, and vice president of Programs and Evaluation Vignetta Charles meeting to discuss NAF’s $3.6 million grant from the Social Innovation Fund for its Access to Care Initiative. P os i t i v e lyAwar e .co m
To view more photos go to www.ADayWithHIVinAmerica.com
2:30 p.m., English Bay, Vancouver, British Columbia: Bradford McIntyre, HIV-positive 26 years, celebrating the last full day of summer.
Southeast Pennsylvania: Robert Breining HIV-positive, HIV/AIDS cyber-activist, blogger at www.poziam.com. “AIDS is a HUGE issue!”
3:00 p.m., Wasatch Mountains, Utah: Patricia Pond, who has been HIV-positive seven years, walks with her dog Rusty.
2:44 p.m., Angeles National Forest above Los Angeles, CA: Faith (HIV-negative) and Michael (HIV-positive) have been married 10 and a half years.
3:35 p.m., Seattle, WA: Michael Louella at work for the University of Washington’s AIDS Clinical Trials Unit.
3:02 p.m., New York City: “I’m taking the M4 bus down Fifth Avenue to work, wondering if people still think they can tell who is poz or neg just by looking at them. I prefer to leave my status ambiguous, and not say whether I am poz or neg.”
P os i t i velyAwa re.com n ov e m b e r /d e c e m b e r 2 01 0 |
A Day with HIV in America
4:30 p.m., Connecticut: Alex G., keeping afloat, paying bills.
3:58 p.m., Chicago, IL: Kevin Irvine, HIV-positive 25 years, shopping at Trader Joe’s with daughter Dominika Tamley.
4:08 p.m., Greensboro, NC: Alicia Diggs at work at John Neal Book Seller.
5:30 p.m., Denver, CO: Ann Wright and twins Sade (left) and Mya; each with their own dog (from left), Chip, Pluto, and Dale. Both girls are HIV-positive. “We are committed to our family and our love for animals; our girls want to be veterinarians.” 32
| N ovember/December 2010
5:45 p.m., San Francisco, CA: Martin Mace, HIV-positive, visiting from England, now that the U.S. has lifted its travel ban on people who are HIV-positive. P os i t i v e lyAwa r e .co m
To view more photos go to www.ADayWithHIVinAmerica.com
6:25 p.m., Long Beach, CA: The Salcido family outside their church.
7:20 p.m., Madison, WI: Teresa Reed-Bowers is HIV-negative; Bob Bowers has been HIV-positive 27 years. “LOVE in the face of AIDS. Serodiscordance rules!”
10:30 p.m., Portland, OR: Michael Lee Howard, who has been HIV-positive five years, at work at a call center.
6:00 p.m., Texas: The reality of the financial cost of staying alive. “This is the receipt for my threemonth supply of Atripla, showing the cost of my medication. If it weren’t for my insurance, I would never be able to afford this (my co-pay is $120). This is a daily reminder of how much being positive costs me in health and finances.”
11:58 p.m., Palm Springs, CA: “My Gorgeous Negative Lover” by photographer Tom Bianchi. “My partner and I were thinking about being a sero-discordant couple and wanted to make a conscious statement that we were not afraid of one another or sex. And that allows us to love safely and extraordinarily lustily. So near midnight, we went out to the pool to see what we’d see in moonlight. This picture is about the beauty I found.”
P os i t i velyAwa re.com nov e m b e r /d e c e m b e r 2 01 0 |
HIV Wellness series Tony M. Mills, MD
Nutrition and HIV: The importance of vitamin D
During the nearly three decades that we have been battling HIV, nutrition has always played an important role in keeping us healthy. In the early days, before the discovery of highly effective treatments for HIV, nutrition was one of the few effective means of keeping the virus in check. HIV-associated weight loss, or wasting, was a common presenting symptom of HIV disease. In Africa, HIV was known early on as “slim disease” because of its profound effects on body weight and composition. Encouraging patients to eat, use appetite stimulants, and take anabolic agents were some of the only effective ways of keeping patients healthy and strong. The idea was to keep people healthy enough that when the inevitable opportunistic infection presented itself, patients had enough weight and strength to survive the illness. We’ve come a long way from those dark days, but nutrition continues to be a very important aspect of HIV care and treatment. While wasting is far less common today, its presence has been replaced with other illnesses that HIV patients have to fight 34
against, such as heart disease, high cholesterol, and bone disease. Nutrition is a fundamental weapon that we can use to tackle these new challenges and nutrition is what will keep us healthy and well and living the normal lifespan that is now projected for us.
Back to basics Nutrition is the organic process of nourishing the body and supplying it with the things it needs for survival and good health. Nutrition is fundamental not only for growth and development of an organism, but also for the maintenance and ongoing fitness of that organism. Nutrition can take several forms. Certainly the mainstay is the food that we eat, but nutrition can also be supplied by nutritional supplements, including vitamins, minerals, proteins, and other compounds that provide benefit to us. The term “nutriceutical” refers to a food or naturally occurring food supplement thought to have a beneficial effect on human health. The nutriceutical market in the U.S. is huge and continues to explode in growth every year. As both the HIV and non-HIV populations realize that their life expectancy is increasing, many look to nutrition and nutritional supplements to keep them healthy and well as they move towards the future. P os i t i v e lyAwar e .co m
Vitamin D is a potent force in regulating cell growth, energy metabolism, and immunity. For people living with HIV, bone health is certainly important, as bone loss may be linked to many HIV meds in use today.
The nutriceutical market has, to a great extent, been unregulated in the past years and companies could introduce a product and make great claims to its benefit without having any clinical research to prove it. As a physician, it’s important to me that there is proven benefit to the therapies that I recommend to my patients. We practice what we call “evidence-based medicine,” which means that we recommend those things that have such proof. Of all the nutritional supplements that have been studied in patients living with HIV, vitamin D has the most evidencebased data behind it and the evaluation and treatment of patients who have inadequate levels of vitamin D is at the forefront of HIV nutrition. The importance of vitamin D to all individuals, but particularly to those living with HIV, has come increasingly to light in recent years. Vitamins are defined as an essential food constituent that the body requires in small concentrations but that it cannot make on its own and thus must be supplied through foods or supplements. By this definition, vitamin D is actually a misnomer because, unlike other vitamins, the body can produce its own vitamin D. Vitamin D is produced from a cholesterol-like precursor in the skin which is then changed into the active form of vitamin D by exposure to the UV rays of sunlight. Vitamin D deficiency was first recognized in children who had abnormally weak and poorly formed bones in a condition known as rickets. Adults can develop a condition called osteomalacia which is distinguished by weakening muscles as well as bones. The recognition of the importance of vitamin D to developing bone led the FDA to mandate many years ago that dairies fortify milk with 100 units of vitamin D per every 8 ounces of milk. Unfortunately, fewer people are consuming milk today and this, combined with the warnings of dermatologists about
the damaging effects of UV rays and the importance of wearing sunscreen, has led to an epidemic of vitamin D deficiency. Vitamin D’s importance in bone health is particularly important for the young whose bones are developing and for older patients whose bones may be breaking down. But vitamin D has more important contributions outside of bone health. Vitamin D has been shown to preserve muscle strength, and to protect against deadly diseases including diabetes, multiple sclerosis, and even cancer. Vitamin D is a potent force in regulating cell growth, energy metabolism, and immunity. For people living with HIV, bone health is certainly important, as bone loss may be linked to many of the HIV meds that are currently used today. Vitamin D’s role in a healthy immune system is still being defined, but we know that CD4 cells and CD8 cells have vitamin D receptors and activation of those receptors can have major impact on immune function. In addition, vitamin D has an important role in controlling inflammation, which we now know is the underlying cause of many health concerns, especially cardiovascular disease, including diabetes and hypertension. Other inflammatory conditions with an association with vitamin D include irritable bowel disease and rheumatoid arthritis. And neurocognitive dysfunction, a great concern for the aging HIV population, has also been associated with low levels of vitamin D. For these reasons, HIV patients have been targeted specifically to evaluate the role of vitamin D in maintaining good health. The importance of vitamin D to the HIV treatment community is underscored by the fact that at the 2010 Conference on Retroviruses and Opportunistic Infections (CROI), there was an afternoon session dealing specifically with vitamin D and the importance of vitamin D deficiency in HIV patients. After a brief review of vitamin D metabolism and a summary of the association of low vitamin D levels with a host
of serious medical problems, researchers from all over the world presented their own research data on vitamin D. Data from the SUN Study in the U.S. was presented by Christine Dau from the U.S. Centers for Disease Control and Prevention (CDC). In their study of 672 patients, 71.6% were found to be vitamin D insufficient. Vitamin D insufficiency was associated with black race, Hispanic ethnicity, low UV light exposure, lack of exercise, increased body mass index, renal (kidney) insufficiency, and ritonavir (Norvir) and efavirenz (Sustiva, also in Atripla) exposure. Efavirenz, through its induction of cytochrome P450 enzymes, is thought to accelerate the breakdown of active vitamin D into inactive compounds. Ritonavir inhibits 1a-hydroxylase, thereby blocking the conversion of vitamin D to its most active form. Thus, two of the most commonly used antiretrovirals can adversely affect vitamin D levels. Similar data were presented from other countries, including the Icona Foundation Study Group in Italy and the Swiss Cohort Study. In both of these, a high incidence of vitamin D insufficiency was also seen with a similar association with the use of antiretrovirals, especially the NNRTIs. The Italian cohort found an additional association with increasing age and with lower CD4 count. Other data looking at HIV-associated conditions, including wasting and thrush in Africa and bacterial vaginosis in the U.S., were presented showing a strong association with vitamin D insufficiency. In all cohorts, between 50-90% of patients studied demonstrated low levels of vitamin D. So how do we go about addressing the issue of low vitamin D? We know that just 30 minutes of daily sun exposure in summer can generate large quantities of vitamin D and indeed, residents of the tropics typically have ample levels. Having darker skin pigment, however, can severely impair the ability of a person to manufacture
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Today, it is not the HIV that presents such a challenge as much as co-morbidities associated with it, such as cardiovascular disease, diabetes, bone disease, and cancer. Today nutrition still plays a vital role in HIV care. vitamin D, and global location (distance from the equator) and seasonal variation have a fixed and marked impact on the ability of a person to maintain adequate levels of vitamin D. The Food and Nutrition Board of the National Academies is currently reevaluating its recommendations regarding vitamin D supplementation and new recommendations are expected in the fall of 2010. Currently, recommendations are that people should get a net of 600 IU (International Units) of vitamin D per day from sun, food, and supplements. Most experts are recommending vitamin D supplementation at 1,000-2,000 IU per day. Vitamin D is a safe supplement to take with relatively little chance of toxicity or overdosage. Hypercalcemia is the biggest risk, but it is only seen with very high serum levels of vitamin D, much higher than what is achieved with routine supplementation.
Conclusion The management of HIV disease has changed remarkably in the past 30 years. Effective antivirals have changed the natural history of the disease and have allowed patients living with HIV to survive and live with a normal life expectancy. Nutrition was one of the few HIV treatments in the early days that actually impacted the course of the disease by allowing patients to be stronger and healthier as they fought their HIV. Today, it is not the HIV that presents such a challenge as much as co-morbidities associated with it, such as cardiovascular disease, diabetes, bone disease, and cancer. Today nutrition still plays a vital role in HIV care as patients strive to live long healthy lives. Vitamin D insufficiency is an important syndrome that contributes to the comorbidities that patients face. Recognition of the condition has led to an intense focus
on its role and its treatment as we work to keep patients healthy. Ask your doctor about your vitamin D level. Remember that even people in warm climates can have too little vitamin D and this may negatively affect your overall health. Optimal vitamin D levels are greater than 75 nmol/L (30 ng/ml) and maintaining these levels may require vitamin D supplementation. e Tony Mills, MD, is a leading clinician in HIV disease and men’s health in Los Angeles. He is a nationally recognized speaker and belongs to many professional organizations. Dr. Mills is also principal investigator on more than 50 HIV trials. Go to PostivelyAware.com for references.
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Conference report: ICAAC
ICAAC2010 New, improved therapies move forward A summary of HIV research presented in September at the 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), held in Boston. Visit www.icaac.org.
TMC278, Atripla, and resistance One of the most talked-about presentations at ICAAC was the delineation of drug resistance with the experimental HIV drug TMC278 (rilpivirine). The comparison of TMC278 to Atripla in the THRIVE and ECHO studies was presented at the International AIDS Conference in July and featured in the September/October issue, “Tales from Vienna.” 38
In Boston, Tibotec Pharmaceuticals reported on drug resistance data from the two studies. Basically, it appeared that in participants who were less adherent with their medication, the people taking TMC278 had a greater risk of developing drug resistance and treatment failure than did the folks on Atripla. Not the best news for the awaited new drug, showing less forgiveness for missed doses, although it was balanced by
greater tolerability compared to Atripla. See The Buzz on page 42 for more information.
Atripla rival gets good news Still in the experimental stage, the Quad tablet—like Atripla—provides a complete HIV regimen in one pill taken once a day. It consists of the experimental integrase inhibitor drug elvitegravir along with an experimental booster medication called cobicistat (see below), plus the popular Truvada (itself a combination drug made up of Viread and Emtriva). Earlier this year, researchers reported that the Quad was non-inferior to the bestselling Atripla in early 24-week data. Now, 48-week data shows that
the Quad continues to be noninferior to Atripla. In virologic suppression (viral load of less than 50 copies per mL), the Quad tablet was 90% successful compared to 83% for Atripla. These results were in a Phase 2 study with small numbers of people, however: 48 study participants taking the Quad and 23 taking Atripla. A large international Phase 3 study with 700 participants is underway.
Goodbye, Norvir—hello, cobicistat? Comparing Reyataz boosted by Norvir to Reyataz boosted by the experimental cobicistat (see below), earlier 24-week data found non-inferiority for the two boosters. Now, at P os i t i v e lyAwar e .co m
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reported by enid VÁzquez
48 weeks, cobicistat continues to show non-inferiority to Norvir. 84% of the cobicistat group vs. 86% of the Norvir group achieved a viral load of less than 50 copies per mL. As with the Quad study above, these results were from small Phase 2 research, with 50 individuals on cobicistat and 29 on Norvir. The clinical trial, in which Truvada is given as the background medication, is now in a large Phase 3 international study with 700 individuals. Unfortunately, there was no advantage for cobicistat in lipid levels or gastrointestinal distress. There was some concern from the earlier 24-week results about potential kidney toxicity (see The Buzz, May/ June), but there doesn’t seem to be a problem so far, although an initial increase in creatinine (a sign of kidney damage) is seen with cobicistat. There may, however, be a decrease in tubular secretion of creatine, which is not evidence of kidney damage.
Unboosted Reyataz In a study of people who started out taking Reyataz with Norvir, those who dumped the Norvir continued to do well out to 120 weeks. Norvir helps improve blood levels of Reyataz and thus increases efficacy and limits the development of drug resistance, but it comes at the price of lipid increases and frequent tolerability problems. The ARIES study had earlier shown the non-inferiority of unboosted Reyataz to Reyataz
boosted by Norvir, out to 84 weeks. People in the study were treatment naïve (taking HIV medication for the first time, a group that generally has the best results). Here, the vast majority (88%) of the 419 participants in ARIES continued on the study out to 144 weeks. These 369 participants, divided between the boosted and the unboosted drug regimens, experienced similar treatment efficacy. About 84% of all participants had a viral load of less than 50 copies per mL at 120 weeks. They also had the same CD4+ T-cell increase: a median of 290 (half had more than this, half had less). All study participants were taking Epzicom (a combination of Ziagen and Epivir) as their background medication. Epzicom, however, is considered an alternative background medication under U.S. HIV treatment guidelines. The preferred background combination drug, Truvada (Viread + Emtriva), cannot be used with Reyataz because Viread lowers Reyataz levels, making Norvir necessary. Also of note: an earlier study showed a higher rate of treatment failure with unboosted Reyataz compared to boosted Reyataz. The difference in results may be because everyone in Aries started with boosted Reyataz, and in the other study there were some who were randomized to start with unboosted Reyataz. Out in the real world, people on boosted Reyataz shouldn’t just stop taking Norvir. An HIV specialist can walk a patient through their options.
Prezista drug resistance
In rare news about Viramune, an experimental once-daily formulation of the drug was found to be non-infeior to the regular twice-daily tablet currently on the market, as first reported at the International AIDS Conference in July. In the VERxVE study, Viramune XR (extended release), a 400 mg pill taken once a day, was compared to Viramune IR (immediate release), a 200 mg tablet taken twice a day, divided between 1,011 participants. Past research had found that while the pharmacokinetics of the IR tablets support once daily dosing, there was greater intolerability when two IR tablets were taken together once a day. “Once-daily dosing with Viramune XR provides patients with a more convenient treatment regimen with comparable efficacy and safety to Viramune IR,” the study concluded. However, the risk of side effects such as liver toxicity and StevensJohnson syndrome (a potentially life-threatening rash) did not decrease. The TRANxITION study looked at switching people from Viramune to Viramune XR. The results are still early, 24 weeks, but showed non-inferiority of treatment effectiveness for the switch group. Viral load remained undetectable (less than 50 copies per mL) in 95% (295 participants) of the switch group, versus 92% (148) of the participants still taking Viramune twice a day.
Tibotec Therapeutics presented a subgroup analysis of drug resistance in their ODIN study, comparing once-daily to twicedaily Prezista. “Virologic failure was low and similar between arms [once daily vs. twice daily], rarely resulting in resistance,” the company reported. See presentation H-1811 at www. icaac.org for details of drug resistance changes found in the study subanalysis. ODIN is a Phase 3 study with nearly 600 treatmentexperienced participants, none of whom had drug resistance to Prezista at the start of the trial and all of whom had more than 1,000 viral load when entering the study. The once-daily dose consisted of 800 mg Prezista with 100 mg Norvir and the twice-daily dose was 600 mg Prezista with 100 mg Norvir. Participants were also given an optimized background therapy (OBT); medications that should work the best for them given the results of their HIV drug resistance testing. An important caveat in this study is that participants from the beginning had minimal drug resistant changes in their virus to Prezista and to the entire class of medications it’s from, the HIV protease inhibitors. Therefore, it’s not surprising that the once-daily dose used in treatment-naïve people would be as effective as the twice-daily dose for highly treatment-experienced patients with drug resistant virus. Thanks to Joel Gallant, MD, for his thoughtful review.
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Conference UPDATE: IAS/VIENNA reported by enid VÁzquez & Jeff Berry
IAS/Vienna For more summaries of reports from the International AIDS Society Conference held in Vienna in July, see the September/October issue, or visit www.aids2010.org.
Retroviruses and Opportunistic Infections (CROI) that Gardasil was safe and immunogenic (producing an immune response) in a study with 112 HIV-positive men. The report recommended further efficacy studies for HIV-positive men and women over age 26 and for younger positive men as well (as allowed in the CROI data).
Gardasil in men In a large international study, the Gardasil vaccine was found to be highly effective in reducing the risk of disease from human papilloma virus (HPV) in men, including precursors to anal cancer, in a sub-group of men who have sex with men (MSM). Gardasil is known to protect both sexes against genital warts, but goes further for girls and women, protecting them against cervical cancer. Might protection against cancer extend to men as well? Gardasil was compared to placebo in more than 4,000 men. In three years of follow up, vaccination was associated with an 86% decrease in incidence of persistent HPV infection, as well as a 90% drop in the incidence of genital warts and other HPVassociated external genital lesions. Two-thirds of the 602 MSM participants underwent anoscopy (micropscopic examination of the anal cavity). The study found a 78% increased risk of pre-cancerous changes in the placebo group (11.5%) compared to the vaccinated men (2.6%). 40
Men allowed into the study had had five or fewer sexual partners and no history of genital warts or lesions. While vaccination works best before exposure to HPV, it may still work for individuals who have not been exposed to the HPV types from which Gardasil provides protection. In addition, most of the men in this study were quite young (between 16 and 26), making it less likely that they would have been exposed to multiple strains of HIV. Whether these results can be applied to older men isn’t clear. According to the Anal Cancer Info website (www.analcancerinfo.ucsf.edu), “It is clear that patients who are HIV-positive are at increased risk to develop anal cancer, as are HIV-negative MSM and women with a history of anal intercourse (although the association is less for women).” Continuing data, as with this study, helps drive recommendations for Gardasil use and with those recommendations, reimbursement by insurance companies and other payers. Earlier this year, a team of U.S. researchers reported at the Conference on
The U.S. Centers for Disease Control and Prevention (CDC) issued an analysis showing that 2.1% of straight people living in poor urban areas in this country are infected with HIV. This is more than four times the overall U.S. incidence of infection of less than half of 1%. “This analysis suggests that many lowincome cities across the United States now have generalized HIV epidemics as defined by the United Nations Joint Program on HIV/AIDS (UNAIDS),” the CDC reported in a press release. The UNAIDS definition of a generalized epidemic is greater than 1% of a general population. The CDC reported that although injection drug users and men who have sex with men (MSM), two groups at particularly high risk of infection, contribute to the spread of HIV in poor areas, heterosexual transmission alone can sustain an epidemic in these communities. “The analysis also shows that poverty is the single most important demographic factor associated with HIV infection among inner-city heterosexuals,” explained the release. “Contrary to severe racial disparities that characterize the overall U.S. epidemic, researchers found no differences in HIV prevalence by race/ethnicity in this population.” HIV prevalence in low income urban areas was 2.1% among blacks, 2.1% among Latinos, and 1.7% among whites. Among the problems contributing to HIV risk mentioned by the CDC report are limited access to health care, which can reduce the level of HIV testing and prevention services; substance abuse, which can increase sexual risk behavior; and high rates of incarceration. P os i t i v e lyAwar e .co m
PhotO © IAS/Marcus Rose/Workers’ Photos
Poverty Linked to HIV
Switching to Isentress The SPIRAL study reported that Isentress was non-inferior to a Norvir-boosted protease inhibitor medication out to 48 weeks. About 88% of study participants had an undetectable viral load whether they stayed on their regimen or switched to Isentress. The 273 study participants were about evenly divided between switching or staying on their current treatment. The ODIS study from Spain also found that switching people from a protease inhibitor therapy to Isentress works well. At 24 weeks after switching to Isentress, 94% of 222 participants remained undetectable. Looking at the 6% of people experiencing treatment failure after the switch, the Spanish researchers found that HIV resistance to the other drugs in the regimens used (nucleoside medications) was the primary reason that treatment failed. Last year, however, a larger study (SWITCHMRK) of 700 people in which half stayed on Kaletra and half were switched to Isentress had to be stopped because there were more treatment failures in the Isentress group. STARTMRK showed that when considering a switch from a boosted protease inhibitor (like Kaletra) to Isentress, it’s important to make sure that the other drugs in the regimen are fully active. ODIS also looked at switching people to once-daily vs. twice-daily Isentress, and while both were similar, there was a tendency for the once-daily dose to perform less well. Doctors at the conference noted that while the small number of participants did not allow for a statistically significant difference between these two groups, the actual numerical difference was large.
Prezista monotherapy Confusing statistics resulted from the international MONET study comparing Prezista by itself to Prezista in combination with two other HIV drugs. Looking at the same individual, Prezista monotherapy might be either successful or unsuccessful, depending on the statistical analysis used. P os i t i velyAwa re.com
MONET looked at 256 individuals who were undetectable on therapy (HIV viral load less than 50 copies), but had never taken Prezista before. They were switched to Prezista treatment, half of them on monotherapy and half taking it with other HIV drugs. In 48-week results presented last year, Prezista monotherapy was found to be non-inferior to a Prezista combination drug regimen. In these later results from 96 weeks of study presented in Vienna, however, Prezista monotherapy was not noninferior to combination therapy. The study presenters, however, showed that when you consider the people experiencing treatment failure with monotherapy who went on to have undetectable viral load at the end of the 96 weeks, the monotherapy was then non-inferior. It’s all in the switch. In most clinical studies, having to switch someone off the medication they’ve been given constitutes a failure for that therapy, no matter what. But if a switch is allowed, then experiencing success (like undetectable viral load) by switching therapy is not considered a failure. In MONET, two viral load measurements above undetectable (above 50 copies) required a switch under study standards. In these cases, monotherapy was intensified by adding back two nucleoside analog drugs. If the viral load re-suppressed to undetectable levels by the end of the study, that was considered a failure under the stricter statistical standard, but a success by the “switch allowed” standard. Intensification with two HIV nucleoside analog drugs in the monotherapy group led to re-suppression of virus below 50 copies in 7 of 8 people (88%). Moreover, most of the people who had to switch their therapy because of increased viral load actually had very low levels of increase, between 50 and 200 copies. Co-infection with hepatitis C was found to significantly increase the risk of treatment failure, and hep C co-infection was higher in the monotherapy group (19% vs. 12% for the combination folks).
As was done in this study, Prezista must always be boosted with a mini-dose (usually 100 mg) of Norvir.
TBR-652 dual CCR5/CCR2 inhibitor Data from a Phase 2a study of oral entry inhibitor TBR-652 were presented by David Martin of Tobira, the company developing the drug. Preliminary data from this study were first presented at CROI in February 2010 (see the May/June issue of Positively Aware). TBR-652 is a dual CCR5/CCR2 inhibitor. HIV uses the CCR5 receptor to gain entry into T-cells, while CCR2 is a receptor found on certain cells and is associated with chronic inflammation. This was a small, 10-day monotherapy dose-finding study, with 54 patients randomized to receive five different doses of the drug or placebo, once daily. There was an up to 1.8 log reduction in viral load for those receiving drug in the study, with one discontinuation which was not related to any adverse event. Inflammatory markers MCP-1, hsCRP, and IL-6 were measured on day 1 and day 10, with increases seen in MCP-1 concentrations and decreases in hsCRP levels. hsCRP stands for high sensitivity C-reactive protein (CRP). CRP is a protein, the levels of which rise in response to inflammation, and MCP-1 (monocyte chemotactic protein-1) has also been implicated in inflammation. To date, no significant safety signals have been identified with CCR2 antagonists. The study authors concluded that “TBR-652 warrants further investigation as an unboosted, once-daily oral CCR5 antagonist with potentially important anti-inflammatory effects.” The Phase 2b study is expected to begin in early 2011 and will include immunologic, cardiovascular, and metabolic substudies. —Jeff Berry Thanks to Joel Gallant, MD, for his thoughtful review. N ov e m b e r / D e c e m b e r 2 01 0 |
THE BUZZ Daniel S. Berger, MD
Rilpivirine causes a stir Anticipation surrounds a new single-tablet regimen There has been much interest and anticipation around rilpivirine (TMC278) and an upcoming second, single-tablet regimen that will contain it. The surrounding buzz at the last two AIDS conferences was about the latest research findings on rilpivirine Phase 3 studies and the development of a single-pill combination of Truvada (Viread + Emtriva) and rilpivirine which we shall call “NewTripla” in this article. The big question is will “NewTripla” become the preferred treatment over the current first-line Atripla? Atripla, composed of Sustiva (efavirenz) and Truvada (tenofovir/emtricitabine), has had a monopoly on the single-pill regimen. To meet this gold standard in treatment, newer therapies needed to match Atripla’s efficacy (show non-inferiority) in clinical studies. Other excellent first-line choices all require several pills, some using twicedaily dosing. Based on U.S. guidelines, the currently preferred nucleoside backbone is Truvada, a duo of nucleoside reverse transcriptase inhibitors, combined with several possible agents including Isentress, boosted Prezista, or boosted Reyataz. By early June of 2011, if FDA approved, “NewTripla,” the new single-tablet treatment, will become available. Perhaps more than one year following, we will have a third single-tablet regimen called the Quad, containing the cobicistat-boosted integrase inhibitor elvitegravir combined with Truvada. Prepare for the seismic shake-up in physicians’ choices for first-line treatment of HIV disease that is imminent.
Atripla’s Drawbacks In the U.S., 5-7% of HIV patients harbor the K103N viral mutation or baseline drug resistance to non-nukes (due to transmission of resistant virus), making the administering of Atripla contraindicated. This number 42
reaches above 20% in various geographic areas, including Northstar’s Chicago neighborhood of Lakeview, parts of southern California, and southern Florida. As with any treatment, Atripla has side effects which may become more carefully weighed as therapeutic alternatives become available. The side effects of the keystone component of Atripla—Sustiva—include CNS (central nervous system) effects. These are marked by various sleep disorders and nightmares, increased anxiety, morning grogginess, and difficulties in concentration. Also, note that Sustiva is associated with elevated cholesterol levels and lipodystrophy, or body habitus changes, including atrophy and visceral adiposity (belly fat) previously described in the sub-analysis of study ACTG 5142. These drawbacks were less discussed in the past, but, as “NewTripla” becomes available, I believe these will surface in discussions.
Rilpivirine Data The components of this new single-tablet formulation, Truvada and rilpivirine, both have long serum (blood) and intracellular half-lives (time that half the drug gets metabolized); rilpivirine’s half life is about 45 hours, making a combination with Truvada a nice pairing and easy to administer once daily.
Two antiretroviral naïve studies, ECHO and THRIVE, randomized the study participants 1:1 to receive either rilpivirine or Sustiva. In ECHO, all study subjects (690) were additionally administered Truvada as the nucleoside backbone. In THRIVE, (678 patients) the investigator chose the backbone treatment; thus, 60% of patients were administered Truvada, 10% were given Epzicom, and 30% received Combivir. As principle investigator at Northstar Healthcare in Chicago, I’ve been involved with the ECHO trial since April of 2008. The patients were demographically diverse: 25% female, 23-24% of African descent, 11-14% Asian and 7-9% co-infected with hepatitis B or C. At baseline, of the patients on rilpivirine versus Sustiva, 52% and 46% had viral loads above 100,000 copies/mL, median CD4 counts were at 249 and 260 cells/mm3 respectively. At 48 weeks, both in the pooled analysis (both studies analyzed together) and in each study individually, rilpivirine was shown to be non-inferior to Sustiva. Overall, 84% versus 82% achieved undetectable levels (less than 50 copies/ml) and CD4 count gains were 190 and 172 cells, in the rilpivirine versus Sustiva arms, respectively. Patients responding to rilpivirine and Sustiva were also not statistically different among participants starting treatment with more than 100,000 copies at baseline—76% vs. 82% in ECHO and 79% vs. 80% in THRIVE. In pooled analysis, of the patients with less than 100,000 copies at baseline, treated with rilpivirine vs. Sustiva, 90% vs. 84% achieved undetectability out to 48 weeks (ECHO, 90% vs. 83%; THRIVE 91% vs. 84%). However, 10% in the rilpivirine versus 6% in the Sustiva arms developed virologic failure. Virologic failure was defined as P os i t i v e lyAwar e .co m
We can expect that if rilpivirine gains FDA approval, this new single-tablet regimen will make its appearance on pharmacy shelves in May or June of 2011.
never achieving two consecutive viral loads below 50 copies and having at least a 0.5log rise from the lowest viral load; reaching consecutive viral loads below 50 copies followed by two consecutive viral loads above 50 copies; or one above 50 copies if it was the last viral load measured. However, suboptimal adherence was associated with virologic failures. In the group with higher baseline viral load, the effect of suboptimal adherence on virologic failure was more apparent with the rilpivirinetreated patients than with the Sustivatreated. Presenting the resistance data at the Boston ICAAC meeting in September, Dr. Joseph Eron commented that these observations may help explain why virologic failure rates were higher with rilpivirine. Interestingly, patients participating in ECHO, who were all administered Truvada— the stronger nuke backbone—did not show any lower failure rates. Of the failures, 86% in whom rilpivirine failed and 72% in whom Sustiva failed had genotype testing (resistance mutations testing) completed. Among these, 68% taking rilpivirine and 32% taking Sustiva had (IAS-USA-defined) nucleoside-associated mutations emerging during treatment, which was a statistically significant difference. The most frequent NRTI mutation with rilpivirine was M184I, an unusual mutation, and we’re uncertain as to why this is occurring here. Dr. Michael Miller of Gilead Sciences commented to me that “the mutation appears to be more stable among rilpivirine/Truvada failures and we’re investigating why.” As of now, we’ve understood that the M184I appears to be another FTC (Emtriva) resistance pattern, but appears to be also seen with rilpivirine treatment. It appears that the most commonly observed non-nucleoside mutation associated with failure of rilpivirine is the E138K. 50% of patients who develop the E138K are expected to have cross resistance to Sustiva and more than 90% to Intelence (etravirine). Intelence is a nonnuke used for treatment of patients with
non-nucleoside resistant virus. Patients who fail rilpivirine during first line therapy will have many other options but will not have the ability to be sequenced to Intelence. I believe that because of the widespread use of more patient-friendly medications, patients tend not to fail treatment at the rates observed years ago, however. Overall, 6.7% discontinued due to adverse events in the Sustiva-treated patients versus 2.2% in the rilpivirine patients, demonstrating better tolerability in patients being treated with rilpivirine. Moreover, neurologic-related adverse events were fewer in the rilpivirine-treated patients than Sustiva (17 versus 38%) and psychiatric associated events were also fewer with rilpivirine (15 vs. 23%). Skin rash was also more common in Sustiva, 3% in rilpivirine-treated patients versus 14% observed in the Sustiva-treated subjects. Lipids (blood fats) data were also reported. For the rilpivirine-treated patients, the mean changes from baseline in total cholesterol, LDL-cholesterol, and triglycerides were statistically significantly lower than for Sustiva-treated patients.
Conclusion Four years ago, Atripla became the first single-tablet, once-daily regimen in HIV disease treatment. Historically, with continued progress and medical advances, newer, more convenient, more patientfriendly medications have replaced older HIV treatments. Visionary pharmaceutical companies set their bar higher to develop competitive treatments that demonstrate an evolution in therapy. There is hardly a simpler therapy than a complete cocktail formulated in a single tablet taken once daily. However, recent news showed that another single-tablet combination in development is better tolerated and may be considered a step towards further innovation in HIV therapy. Rilpivirine combined with Truvada has been shown to be non-inferior virologically
to the gold standard, Atripla. There is pause to consider the particulars of virologic failures in ECHO and THRIVE and the resistance pattern associated with the rilpivirine arm in these studies. In contrast, people taking rilpivirine discontinued treatment less often for adverse events and other reasons than people taking Sustiva. There were significantly fewer side effects related to central nervous system and sleep disorders and significantly less elevation in cholesterol and triglycerides. Available medications, however, are only effective when people do indeed take them as prescribed. In my mind, there is little doubt that an easily administered single-tablet regimen with fewer side effects will help contribute to better adherence. We can expect that if rilpivirine gains FDA approval, this new single-tablet regimen will make its appearance on pharmacy shelves in May or June of 2011. 48-week data from a third single-tablet regimen, referred to as the Quad, which in contrast contains the boosted integrase inhibitor elvitegravir, was just presented in Boston at the 50th ICAAC (see page 38) and has good probability of making it to market in the not too distant future. (See The Buzz, May/June 2010, “Something to CROI About”.) As in the tradition of changing treatments, newer improved options continue to alter the landscape of HIV therapeutics. Dr. Daniel S. Berger is a leading HIV physician in the U.S. and is Clinical Associate Professor of Medicine at the University of Illinois at Chicago and founder and medical director of Northstar Healthcare in Chicago. Dr. Berger has published extensively in, among others, The Lancet and The New England Journal of Medicine and serves on the Medical Issues Committee for the Illinois AIDS Drug Assistance Program and is a member of the board of directors of the AIDS Foundation of Chicago. He can be reached at DSBergerMD@aol.com and www.Nstarmedical.com.
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Ask the HIV Specialist Albert Malek, MD, AAHIVS
Question: I am a 35-year-old male who has been HIV-positive for the last 11 years. I have been compliant with my medications for the last 5-6 years. Currently, I am doing well on a combination of Combivir twice daily, Reyataz 300 mg plus Norvir 100 mg once daily and my viral counts have been undetectable for most of the last five years. About six months ago, I was told that I also have hepatitis C, which I have not sought treatment for since I moved out of the area. I am quite concerned about my hepatitis C and am planning to start with a new HIV doctor in my area. What should I do for it when I see the new doctor?
Answer: First, I would like to assure you that there are so many things that can be done to make a big positive difference in your situation. To start, you have to know that it is quite common for HIV patients to also have hepatitis C (an average of one in every five patients with HIV has hepatitis C). This is due to the fact that both diseases get transmitted in the same way, i.e. through blood and body fluid exchange between an infected and an uninfected person. The most common means of transmission are risky behaviors that may include sharing needles during drug use, unprotected multiple sexual partners, high risk sexual practices, and tattoos from unlicensed/unsupervised personnel. Sometimes, transmission can also happen after bloody fights or from accidental needle sticks in the medical field. The new physician will probably need to find out the type of hepatitis C you have, which is done with a blood test called “hepatitis C genotype.” Different types of virus respond differently to treatment. Also, depending on the type of virus you have, you may need to have a liver biopsy to estimate the degree of the liver inflammation and scarring prior to treatment. The decision about if and when to start treating your hepatitis C will depend on many factors, including your 44
physician’s experience, your overall health, other medical problems you may have, your physical examination, results of blood tests, and possibly the liver biopsy results. Your physician may need to change some of your HIV medications prior to starting hepatitis C treatment due to possible additive side effects from both sets of medications. In your case, he may want to change your Combivir to another agent due to the fact that one of the components of Combivir is zidovudine, which can worsen the anemia (low red blood cells) that is caused by hepatitis C treatment. For treatment of hepatitis C, there are currently two approved medications that need to be taken together and there are more in development. The medications currently approved are interferon, which is administered through injections, and ribavirin tablets and, in your case, treatment may take up to one year. Depending on the type of your virus, the response to these medications can range between 20-70% successful. In contrast to HIV treatment, the medications for hepatitis C, if effective, are curative, so they do not need to be continued past the required treatment duration. In the vast majority of patients, once the duration of treatment is satisfied and the virus is cleared, the virus will not reappear. However, re-infection can occur if risky behavior is resumed. There are several measures that you should try to pursue to keep healthy and decrease long-term complications from these two diseases. Due to differences between patients and their concomitant health conditions, the following
recommended measures should be discussed with your physician. Avoid any future risky behavior, smoking, or alcohol. This will decrease transmission of these viruses and help to avoid further liver damage. Keep active and slowly improve your exercise capacity. Eat healthy, increase your fiber intake, keep your cholesterol down, and get moderate amounts of sun exposure to keep adequate levels of vitamin D (some medications or skin conditions may contraindicate sun exposure). Avoid weight gain and slowly lose extra weight naturally, as it keeps your liver healthy and improves your response to hepatitis C medications. Follow up closely with your physician and take your medications as recommended. Good luck with your new doctor and with managing your HIV and hepatitis C. —Albert Malek, MD, AAHIVS Atascadero State Hospital Central Medical Services Atascadero, CA
Submit your questions to AAHIVM@tpan.com Due to space limitations, not all submitted questions can be answered in this column. For more information about AAHIVM, call 202-659-0699 or visit www.aahivm.org.
Search for an HIV Specialist™ Finding an HIV Specialist™ is easy with AAHIVM’s Find-A-Provider directory at www.aahivm.org. Click on the “Find-A-Provider” window on the home page, enter your location, and click on the search button for a list of HIV Specialists™ near you.
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Salient Ramblings Sal Iacopelli
Sympathy for the devil Recently, there has been encouraging news about progress in preventing HIV/AIDS. PEP, PrEP, and from the IAS conference, a promising new microbicide gel has been developed that could dramatically lower the risk of infection among vulnerable women. Even The Wall Street Journal recently picked up a story that scientists have discovered three powerful antibodies that can neutralize 91% of HIV strains. I have often thought a cure for HIV was beyond reach. I comfort myself and am grateful for the renewed life I have been granted. Crabby, fatigued, bloated due to side effects of HIV meds, yet grateful. But the path we must travel if we are to be able to get past this global disaster is an HIV vaccine. Every man, woman, and child must be inoculated, just as we are for polio, another disease for which there is no cure and which the vaccine enabled us to overcome. Until that vaccine becomes available, each time one has an HIV scare there’s PEP (post-exposure prophylaxis) to turn to, where one can take, for example, tasty, tasty Atripla for a month to prevent sero-conversion. Recently, an HIV-negative buddy called me in tears, frustrated and terrified, experiencing weakness, nausea, fatigue after two weeks of PEP therapy. He waxed poetic about the difficulty of adhering to an HIV medication regimen. He whined to me, someone who has been dutifully ingesting handfuls of pills multiple times a day for 15 years. I tried valiantly to be patient and support him in his struggle— however, after 30 minutes of his panicked diatribe, I told him to shut his whiny ass up, take the goddamned pills for another two weeks, and be grateful he has the chance not to sero-convert.
I had dated him for about a month a few years ago. He was (still is) somewhat over-analytical, deeply religious, and struggling with coming out of the closet. When we happened to run into his fellow churchgoers at dinner one evening and he refused to acknowledge me, I lost all interest in being with him. His gloriously sexy, hairy ass did momentarily sway me, but the deciding factor was that he is HIVnegative. I much prefer to dabble within my own disease pool, thank you. However, why would a smart, extremely analytical, HIV-negative man throw caution to the wind and indulge in barebacking? Why do intelligent, rational men and women succumb to the desires of raw flesh? Why hasn’t the promotion of abstinence made a dent in the numbers of newly diagnosed? After decades of safe sex messages and support to engage in safe sex, why still, still do the numbers of new HIV infections climb? I hold that no amount of education, information dissemination, or fear tactics will be enough. It hasn’t been after nearly 30 years. Why is this particular demon, barebacking, so alluring? Youth may engage in unsafe sex because of their belief in their own invulnerability, of distance from danger. Yet, it’s not only the upcoming generation contributing to the number of newly infected.
Indeed, there are the women in Africa who many times have no choice and are essentially raped. Rather than using the newly touted anti-HIV gel, might I suggest the precise aim of a machete? Some lay blame at the doorstep of alcohol or drugs. Or the fact that they looooove their partner. Ultimately, I think what we’re up against is the sex act itself— all that release of endorphins, clouding the mind. Rational thoughts tend to cease and one is left floating in the experience of carnal bliss. Sure, one returns to reason soon afterward, but the escape from reality can be undeniably pleasurable and compelling. Sex without a condom just feels good, dammit. With life so full of compromises, this is one area in which I no longer wish to settle. I bareback with poz partners and belong to a site where I can find other barebackers. And it’s not only HIV-positive men who hunt raw encounters. There are plenty of HIV-negative guys in hot pursuit. A quick search on the site for HIV-negative members found 500 of them, the highest number the search engine would allow. In no way do I wish to come off as a proponent of barebacking. But expecting the world’s entire population to engage solely in safe sex for an indeterminate amount of time is an absolutely unrealistic expectation. Humans make mistakes. Over and over again. Even after billions of dollars have been spent on informing us why we should not make this particular mistake. Even after witnessing HIV rob us of our friends and loved ones, we will continue to succumb to this seductive demon. We are, after all, only human.
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