Liz Taylorâ€™s Passion / Positive in the Deep South / LeVar Burton Fights for a Cure
H E A L T H + S P I R I T + C U L T U R E + L I F E
Seeing one doctor for your HIV and a primary care physician for everything else is becoming a relic of the pastâ€”what you need to know about treatment in the 21st century
July/August 2011 www.hivplusmag.com
• EPZICOM, in combination with other antiretroviral agents, is indicated for the treatment of HIV-1 infection in adults. • EPZICOM is one of 3 medicines containing abacavir. Before starting EPZICOM, your healthcare provider will review your medical history in order to avoid the use of abacavir if you have experienced an allergic reaction to abacavir in the past. • In one study, more patients had a severe hypersensitivity reaction in the abacavir once-daily group than in the abacavir twice-daily group. • EPZICOM should not be used as part of a triple-nucleoside regimen. • EPZICOM does not cure HIV infection/AIDS or prevent passing HIV to others.
Important Safety Information EPZICOM contains abacavir, which is also contained in ZIAGEN® (abacavir sulfate) and TRIZIVIR® (abacavir sulfate, lamivudine, and zidovudine). Patients taking abacavir may have a serious allergic reaction (hypersensitivity reaction) that can cause death. Your risk of this allergic reaction is much higher if you have a gene variation called HLA-B*5701 than if you do not. Your healthcare provider can determine with a blood test if you have this gene variation. If you get a symptom from 2 or more of the following groups while taking EPZICOM, call your doctor right away to determine if you should stop taking this medicine. 1. Fever 2. Rash 3. Nausea, vomiting, diarrhea, or abdominal (stomach area) pain 4. Generally ill feeling, extreme tiredness, or achiness 5. Shortness of breath, cough, or sore throat Carefully read the Warning Card that your pharmacist gives you and carry it with you at all times. If you stop EPZICOM because of an allergic reaction, NEVER take EPZICOM or any other abacavir-containing medicine (ZIAGEN, TRIZIVIR) again. If you take EPZICOM or any other abacavir-containing medicine again after you have had an allergic reaction, WITHIN HOURS you may get life-threatening symptoms that may include very low blood pressure or death.
I’ve got the fight in me.
If you stop EPZICOM for any other reason, even for a few days, and you are not allergic to EPZICOM, talk with your healthcare provider before taking it again. Taking EPZICOM again can cause a serious allergic or life-threatening reaction, even if you never had an allergic reaction to it before. If your healthcare provider tells you that you can take EPZICOM again, start taking it when you are around medical help or people who can call a healthcare provider if you need one. A buildup of lactic acid in the blood and an enlarged liver, including fatal cases, have been reported. Do not take EPZICOM if your liver does not function normally. Some patients infected with both hepatitis B virus (HBV) and HIV have worsening of hepatitis after stopping lamivudine (a component of EPZICOM). Discuss any change in treatment with your healthcare provider. If you have both HBV and HIV and stop treatment with EPZICOM, you should be closely monitored by your healthcare provider for at least several months. Worsening of liver disease (sometimes resulting in death) has occurred in patients infected with both HIV and hepatitis C virus who are taking anti-HIV medicines and are also being treated for hepatitis C with interferon with or without ribavirin. If you are taking EPZICOM as well as interferon with or without ribavirin and you experience side effects, be sure to tell your healthcare provider. When you start taking HIV medicines, your immune system may get stronger and could begin to fight infections that have been hidden in your body, such as pneumonia, herpes virus, or tuberculosis. If you have new symptoms after starting your HIV medicines, be sure to tell your healthcare provider. Changes in body fat may occur in some patients taking antiretroviral therapy. These changes may include an 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 occur. The cause and long-term health effects of these conditions are not known at this time. Some HIV medicines, including those containing abacavir (ZIAGEN, EPZICOM, and TRIZIVIR), may increase your risk of heart attack. If you have heart problems, smoke, or suffer from diseases that increase your risk of heart disease, such as high blood pressure, high cholesterol, or diabetes, tell your healthcare provider. The most common side effects seen with the drugs in EPZICOM dosed once daily were allergic reaction, trouble sleeping, depression, headache, tiredness, dizziness, nausea, diarrhea, rash, fever, stomach pain, abnormal dreams, and anxiety. Most of the side effects do not cause people to stop taking EPZICOM. By prescription only. 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. Please see additional important information about EPZICOM, including boxed warnings, on the adjacent pages. Save on your medication!
Ask your doctor about the Patient Savings Card or visit www.mysupportcard.com to learn how to save on your out-of-pocket expenses. Subject to eligibility. Restrictions apply.
EvEn wIth hIv,
i never stop fighting.” “When I was first diagnosed with HIV, I didn’t know what each day would bring or how the virus would affect my body over time. But at some point, I realized I had to take control. So I worked on my body. My mind. And my attitude. Since then, I’ve dedicated my life to fighting HIV with everything in me. My meds help a lot. About a year ago, my doctor told me about EPZICOM. In combination with other medications, it’s been shown to help keep HIV from making more copies of itself and infecting healthy cells. 68% of patients taking a regimen with EPZICOM had their viral load become undetectable in less than one year. Plus, patients saw a 93% increase in their T-cell counts.* So I started taking it as part of my combination therapy. Turns out that was a good thing. My viral load is undetectable. And me? I just keep fighting on.” † †
Not an actual patient testimonial. Based on collection of real patient experiences. Individual results may vary.
* HEAT study of 688 patients defines undetectable as a viral load less than 50 copies/mL. Baseline median T-cell count for patients receiving EPZICOM was 214 cells/mm3 and at 48 weeks, patients saw a median increase of 201 cells/mm3 in their T-cell count.
Ask your healthcare provider if epzIcom is right for you. Learn more at www.epzicomForYou.com
EPZICOM® (abacavir sulfate and lamivudine) Tablets MEDICATIOn GuIDE EPZICOM® (ep′ zih com) Tablets Generic name: abacavir (uH-BACK-ah-veer) sulfate and lamivudine (la-MIV-yoo-deen) Read the Medication Guide that comes with EPZICOM before you start taking it and each time you get a refill because there may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. Be sure to carry your EPZICOM Warning Card with you at all times. What is the most important information I should know about EPZICOM? • Serious Allergic Reaction to Abacavir. EPZICOM contains abacavir (also contained in ZIAGEN® and TRIZIVIR®). Patients taking EPZICOM may have a serious allergic reaction (hypersensitivity reaction) that can cause death. Your risk of this allergic reaction is much higher if you have a gene variation called HLA-B*5701 than if you do not. Your doctor can determine with a blood test if you have this gene variation. If you get a symptom from 2 or more of the following groups while taking EPZICOM, call your doctor right away to determine if you should stop taking this medicine.
Group 1 Group 2 Group 3 Group 4 Group 5
Symptom(s) Fever Rash nausea, vomiting, diarrhea, abdominal (stomach area) pain Generally ill feeling, extreme tiredness, or achiness Shortness of breath, cough, sore throat
A list of these symptoms is on the Warning Card your pharmacist gives you. Carry this Warning Card with you. If you stop EPZICOM because of an allergic reaction, nEVER take EPZICOM (abacavir sulfate and lamivudine) or any other abacavir-containing medicine (ZIAGEn and TRIZIVIR) again. If you take EPZICOM or any other abacavir-containing medicine again after you have had an allergic reaction, WITHIn HOuRS you may get life-threatening symptoms that may include very low blood pressure or death. If you stop EPZICOM for any other reason, even for a few days, and you are not allergic to EPZICOM, talk with your doctor before taking it again. Taking EPZICOM again can cause a serious allergic or life-threatening reaction, even if you never had an allergic reaction to it before. If your doctor tells you that you can take EPZICOM again, start taking it when you are around medical help or people who can call a doctor if you need one. • Lactic Acidosis. Some human immunodeficiency virus (HIV) medicines, including EPZICOM, can cause a rare but serious condition called lactic acidosis with liver enlargement (hepatomegaly). Nausea and tiredness that don’t get better may be symptoms of lactic acidosis. In some cases this condition can cause death. Women, overweight people, and people who have taken HIV medicines like EPZICOM for a long time have a higher chance of getting lactic acidosis and liver enlargement. Lactic acidosis is a medical emergency and must be treated in the hospital. • Worsening of hepatitis B virus (HBV) infection. Patients with HBV infection, who take EPZICOM and then stop it, may get “flare-ups” of their hepatitis. “Flare-up” is when the disease suddenly returns in a worse way than before. If you have HBV infection, your doctor should closely monitor your liver function for several months after stopping EPZICOM. You may need to take anti-HBV medicines. • use with interferon- and ribavirin-based regimens. Worsening of liver disease (sometimes resulting in death) has occurred in patients infected with both HIV and hepatitis C virus who are taking anti-HIV medicines and are also being treated for hepatitis C with interferon with or without ribavirin. If you are taking EPZICOM as well as interferon with or without ribavirin and you experience side effects, be sure to tell your doctor. EPZICOM can have other serious side effects. Be sure to read the section below entitled “What are the possible side effects of EPZICOM?” What is EPZICOM? EPZICOM is a prescription medicine used to treat HIV infection. EPZICOM includes 2 medicines: abacavir (ZIAGEN) and lamivudine or 3TC (EPIVIR®). See the end of this Medication Guide for a complete list of ingredients in EPZICOM. Both of these medicines are called nucleoside analogue reverse transcriptase inhibitors (NRTIs). When used together, they help lower the amount of HIV in your blood. This helps to keep your immune system as healthy as possible so that it can help fight infection. Different combinations of medicines are used to treat HIV infection. You and your doctor should discuss which combination of medicines is best for you. • EPZICOM does not cure HIV infection or AIDS. We do not know if EPZICOM will help you live longer or have fewer of the medical problems that people get with HIV or AIDS. It is very important that you see your doctor regularly while you are taking EPZICOM. • EPZICOM does not lower the risk 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 safe sex by using a latex or polyurethane condom or other barrier method to lower the chance of sexual contact with semen, vaginal secretions, or blood. Never use or share dirty needles. Who should not take EPZICOM? Do not take EPZICOM if you: • have ever had a serious allergic reaction (a hypersensitivity reaction) to EPZICOM or any other medicine that has abacavir as one of its ingredients (TRIZIVIR and ZIAGEn). See the end of this Medication Guide for a complete list of ingredients in EPZICOM. • have a liver that does not function properly. • are less than 18 years of age. Before starting EPZICOM tell your doctor about all of your medical conditions, including if you: • have been tested and know whether or not you have a particular gene variation called HLA-B*5701. • are pregnant or planning to become pregnant. We do not know if EPZICOM will harm your unborn child. You and your doctor will need to decide if EPZICOM is right for you. If you use EPZICOM while you are pregnant, talk to your doctor about how you can be on the Antiviral Pregnancy Registry for EPZICOM. • are breastfeeding. Some of the ingredients in EPZICOM can be passed to your baby in your breast milk. It is not known if they could harm your baby. Also, mothers with HIV should not breastfeed because HIV can be passed to the baby in the breast milk. • have liver problems including hepatitis B virus infection. • have kidney problems. • have heart problems, smoke, or suffer from diseases that increase your risk of heart disease such as high blood pressure, high cholesterol, or diabetes. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take any of the following medicines*: • methadone • HIVID® (zalcitabine, ddC) • EPIVIR or EPIVIR-HBV® (lamivudine, 3TC), ZIAGEn (abacavir sulfate), COMBIVIR® (lamivudine and zidovudine), or TRIZIVIR (abacavir sulfate, lamivudine, and zidovudine).
How should I take EPZICOM? • Take EPZICOM by mouth exactly as your doctor prescribes it. The usual dose is 1 tablet once a day. Do not skip doses. • You can take EPZICOM with or without food. • If you miss a dose of EPZICOM, take the missed dose right away. Then, take the next dose at the usual time. • Do not let your EPZICOM run out. • Starting EPZICOM again can cause a serious allergic or life-threatening reaction, even if you never had an allergic reaction to it before. If you run out of EPZICOM even for a few days, you must ask your doctor if you can start EPZICOM again. If your doctor tells you that you can take EPZICOM again, start taking it when you are around medical help or people who can call a doctor if you need one. • If you stop your anti-HIV drugs, even for a short time, the amount of virus in your blood may increase and the virus may become harder to treat. • If you take too much EPZICOM, call your doctor or poison control center right away. What should I avoid while taking EPZICOM? • Do not take EPIVIR (lamivudine, 3TC), COMBIVIR (lamivudine and zidovudine), ZIAGEN (abacavir sulfate), or TRIZIVIR (abacavir sulfate, lamivudine, and zidovudine) while taking EPZICOM. Some of these medicines are already in EPZICOM. • Do not take zalcitabine (HIVID, ddC) while taking EPZICOM. Avoid doing things that can spread HIV infection, as EPZICOM does not stop you from passing the HIV infection to others. • Do not share needles or other injection equipment. • Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades. • Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom or other barrier method to lower the chance of sexual contact with semen, vaginal secretions, or blood. • Do not breastfeed. EPZICOM can be passed to babies in breast milk and could harm the baby. Also, mothers with HIV should not breastfeed because HIV can be passed to the baby in the breast milk. What are the possible side effects of EPZICOM? EPZICOM can cause the following serious side effects: • Serious allergic reaction that can cause death. (See “What is the most important information I should know about EPZICOM?” at the beginning of this Medication Guide.) • Lactic acidosis with liver enlargement (hepatomegaly) that can cause death. (See “What is the most important information I should know about EPZICOM?” at the beginning of this Medication Guide.) • Worsening of HBV infection. (See “What is the most important information I should know about EPZICOM?” at the beginning of this Medication Guide.) • Changes in immune system. When you start taking HIV medicines, your immune system may get stronger and could begin to fight infections that have been hidden in your body, such as pneumonia, herpes virus, or tuberculosis. If you have new symptoms after starting your HIV medicines, be sure to tell your doctor. • Changes in body fat. These changes have happened in patients taking antiretroviral medicines like EPZICOM. The changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the back, chest, and stomach area. 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. Some HIV medicines including EPZICOM may increase your risk of heart attack. If you have heart problems, smoke, or suffer from diseases that increase your risk of heart disease such as high blood pressure, high cholesterol, or diabetes, tell your doctor. The most common side effects with EPZICOM are trouble sleeping, depression, headache, tiredness, dizziness, nausea, diarrhea, rash, fever, stomach pain, abnormal dreams, and anxiety. Most of these side effects did not cause people to stop taking EPZICOM. This list of side effects is not complete. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store EPZICOM? • Store EPZICOM at room temperature between 59º to 86ºF (15º to 30ºC). • Keep EPZICOM and all medicines out of the reach of children. General information for safe and effective use of EPZICOM Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not use EPZICOM for a condition for which it was not prescribed. Do not give EPZICOM to other people, even if they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about EPZICOM. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for the information that is written for healthcare professionals or call 1-888-825-5249. What are the ingredients in EPZICOM? Active ingredients: abacavir sulfate and lamivudine Inactive ingredients: Each film-coated EPZICOM Tablet contains the inactive ingredients magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablets are coated with a film (OPADRY® orange YS-1-13065-A) that is made of FD&C Yellow No. 6, hypromellose, polyethylene glycol 400, polysorbate 80, and titanium dioxide. COMBIVIR, EPIVIR, EPZICOM, TRIZIVIR, and ZIAGEN are registered trademarks of GlaxoSmithKline. * The brands listed are trademarks of their respective owners and are not trademarks of GlaxoSmithKline. The makers of these brands are not affiliated with and do not endorse GlaxoSmithKline or its products. This Medication Guide has been approved by the US Food and Drug Administration.
Lamivudine is manufactured under agreement from Shire Pharmaceuticals Group plc, Basingstoke, UK ©2009, GlaxoSmithKline. All rights reserved. March 2009 EPZ:2MG ©2010 ViiV Healthcare Group of Companies All rights reserved. Printed in USA.
TABLE OF CONTENTS JULY / AUGUST 2011
STATUS SYMBOLS 6 PLAYING DEFENSE Protecting NYC’s low-income HIVers is a 16-year battle that continues to rage on.
8 make yourself comfortable A padded undergarment earns rave reviews from lipoatrophy sufferers.
9 movin’ on up The nation’s oldest AIDS service organization finds a new home.
10 LIZ’S LEGACY Elizabeth Taylor dedicated decades to fighting HIV. Here are some highlights.
H-EYE-V 11 life ball The city of Vienna hosts one of the biggest HIV/AIDS charity events in the world.
HAART BEATS 36 too good to be true The government goes after unregulated drugs claiming to treat HIV and herpes.
38 PrEP-ping for Disappointment A new study dims hopes of Truvada’s efficacy in preventing HIV infection.
43 Couples Therapy Antiretrovirals may help keep your HIVnegative partner uninfected.
43 evolution revolution clock wise from top: Alfred Gescheidt; julie turkewitz; Martin Barraud
20 Doctor who
As HIV becomes easier to live with, experts say it’s time for primary care physicians to care for more HIVers. Is it time to your downsize your doctors?
24 LeVar Burton’s Next Generation
The Roots and Star Trek actor helps the AIDS Research Alliance boldly go where few have gone before in its search to find a cure for HIV.
26 On the Front Lines
A monkey vaccine trial may lead scientists closer to vaccinating humans.
COLUMNS 44 MIND + MOOD Have you ever considered that living with HIV can be a spiritual experience?
We’re constantly reporting on the newest breakthroughs in drugs and medications, but who are the people being tested in these pivotal studies?
46 LIVING THE QUESTIONS
28 SCARRED BY STIGMA
ALSO 48 ASK & TELL: Mike Ruiz
On her journey to Mississippi, photographer Julie Turkewitz captures the faces of people bringing integrity to living with HIV in the Deep South.
Tyler Helms makes a case for compassion for those new to living with HIV.
COVER: George Marks/Hulton Archive
Matthew Breen Gieseke creative director Scott McPherson Senior Editor Neal Broverman associate Editor Michelle Garcia digital Editor Ross von Metzke Editorial assistant Charles Culbert contributing editor Michael Matson Editor in chief
managing Editor Winston
vice president, integrated marketing
Senior manager, marketing &
Mark Umbach Robert Hébert integrated marketing coordinator Robert Imes advertising sales coordinator Shamila Siddiqui Director of circulation Jeff Lettiere fulfillment manager Argus Galindo corporate communications interactive art director
Christopher Harrity Dave Johnson Webmaster Peter Di Maso Web Production Coordinator Joe Okonkwo online production manager
Stephen P. Jarchow Paul Colichman cfo Tony Shyngle executive vice president Stephen Macias senior vice president & group publisher Joe Landry senior vice presidents Christin Dennis, Alex Paul, Bernard Rook, Josh Rosenzweig vice presidents Brian Goldman, John Knoebel, Joe Valentino chairman
Power to the (Young) People
Young activist Logan Voxx takes his message of safe sex to billboards in places where such a conversation may not be runof-the-mill.
HIV Plus Columnists
Check back regularly for new columns with HIV Plus writers Robert Levithan (The New 60) and Tyler Helms (Living the Questions).
digital media art director
Aimee Leinhardt Kevin Roff Advertising Production Manager Heidi Medina Production Manager
digital imaging technician
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4 | H I V P L U S j u ly/a u g u st 2 0 1 1
HIV Plus (ISSN 1522-3086) is published bimonthly by Here Publishing Inc., 10990 Wilshire Blvd., Penthouse Suite, Los Angeles, CA 90024. HIV Plus is a registered trademark of Here Media Inc. Entire contents © 2011 by Here Publishing Inc. All rights reserved. Printed in the USA.
voxx: courtesy subjec t
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6 | H I V P L U S J U LY/A U G U S T 2 0 1 1
Michael Bloomberg’s attempt to slash funding is thwarted by Housing Works.
ge t t y images
Protecting New York City’s low-income HIVers is a 16-year battle that continues to rage on
derrick mitchell was once drugaddicted and homeless, barely getting by on the streets of New York City. At a syringe exchange, he was introduced to New York’s HIV/AIDS Services Administration, a public program that connects low-income HIVers with medications, health services, job programs, food stamps, and housing. Mitchell wouldn’t start utilizing the program until after a drug-related arrest, but he’s thankful he did—he’s now sober and healthy, and he has his own apartment. “I was able to have a place to live that was clean and safe and afforded me the time to sit back and assess what I was doing with my life,” Mitchell says. “All that came from contact with HASA and my HASA worker.” The HASA program, as valuable as it is, is under attack by New York City bureaucrats, specifically Mayor Michael Bloomberg, who wants to prune the agency’s staff in an effort to balance the budget. Bloomberg’s proposal included the elimination of one third of HASA’s case managers; he unsuccessfully proposed the same cuts last year. HASA is just one of dozens of AIDS programs that have become vulnerable in these days of government penny-pinching, but a reprieve for New York’s low-income HIV-positive population has come from a federal judge who stopped the city from slashing HASA’s payroll and ordered Bloomberg’s proposal to be taken off the table. Attorneys for the HIV Law Project and Housing Works, a group that works to keep low-income people with HIV from living on the street, have been fighting for years to keep HASA from being whittled away, and the organizations have law on their side. When Mayor Rudy Giuliani cut HASA funding soon after assuming office in 1994, Housing Works filed suit. Finally, in 2001, a
court ruled that the agency’s reduced staff was failing its clients, violating the Americans With Disabilities Act, and leading to “devastating consequences.” A federal court order was issued that demanded the agency maintain adequate case managers, specifically a ratio of 34 clients to one manager. After he came to power in January 2002, Bloomberg appealed the court order to the U.S. Supreme Court, but the judges refused to hear the case and the order stood. Likely anticipating further legal challenges, New York’s progressive-leaning city council passed a law that essentially says the same thing as the order—HASA must employ enough case managers to keep a 34-to-1 ratio. Bloomberg’s more recent assaults on HASA started last year, when his budget proposal called for a chop of 246 case managers. Housing Works and the HIV Law Project filed suit and the proposed cuts were withdrawn. This year’s budget likewise called for slashing HASA’s case managers, this time by 254. Housing Works went to court to stop these reductions from going forward and was successful—the judge called the mayor’s budget proposal “illegal,” prompting applause in the Brooklyn courtroom. “Our folks live with wasting, dementia, neuropathy, immobility,” says Armen Merjian, a senior staff attorney for Housing Works. Of the need for HASA, Merjian says, “It’s very difficult to go to 15 different disease-ridden waiting rooms to wait for different benefits; it’s difficult to fill out paperwork.” Even though “we’re living in this starvethe-beast-and-break-the-social-contract age,” Merjian says he and Housing Works will continue fighting for low-income people with HIV. ✜
J U LY/A U G U S T 2 0 1 1 H I V P L U S
Lights, Camera, Take Action A Texas filmmaker turns her lens on African-American ministers and their relationship to HIV
Make Yourself Comfortable A padded undergarment earns rave reviews from lipoatrophy sufferers thrilled to return to a life without sitting pain
after two decades of living with HIV, Terry Delonas found himself smuggling a cushion into the board meetings he attended for the various AIDS service organizations with which he worked. One of the side effects of his 20 years’ worth of medication was severe lipoatrophy—loss of fat tissue— in the thighs and buttocks, which made sitting down for long stretches extremely painful, even in the nicest chairs. If only there was a cushion you could wear, he thought. When a search turned up no such product, Delonas decided to create his own. The result was SitRelief Shorts, a medically designed padded undergarment that combines a comfortable polyester-andspandex shorts with highly resilient foam. Featuring tapered pads with infinity edges on all sides (ensuring that there is no telltale bulge where the pad begins and ends), the cushioning goes from the waistband all the way down to mid-thigh. The smart, realistic design provided an added benefit, which Delonas says came out in the clinical trials. Not only did the shorts allow HIVers discreet relief from their suffering, the pads boosted wearers’ confidence. The added contour and shape made pants fit better, which made them less self-conscious about their wasting appearance.
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For the trials, Delonas, a Southern California resident, sought the help of four local HIV doctors, who enrolled 40 patients of various ages, all of whom were experiencing either mild, moderate, or severe lipoatrophy in the buttocks and thighs. The results were astounding: The average patient went from an ability to sit for 12 minutes without the shorts to a vastly improved 187 minutes with them. The doctors were just as enthusiastic as the patients, saying the shorts prevented the fragile tissue and veins in the legs and buttocks from being crushed while protecting the patient’s bones. And by allowing people to go to movies or to classes or seminars, the product greatly improved their quality of life. To date, LipoWear, Delonas’s year-old Orange County, Calif.–based company, has sold about 1,000 pairs of SitRelief shorts, which come in six sizes for men and five for women. While Delonas says his biggest obstacle is the fact that the people who need his product the most are often the ones least able to afford it, his goal is to get Medicare approval so patients can get them by prescription. Meanwhile, his greatest rewards are the amazing letters he receives from grateful customers. “People say this has really changed their lives. And as a daily user, I can underscore that. It has changed mine as well.” LipoWear.com
AIDS activists have many tools: placards, bullhorns, the Internet. For Dona Gassaway Mitchell, a video camera gets her message out. Through her films, Mitchell attempts to change perceptions of HIV among the influential ministers of black churches. Mitchell’s first film, Why the Black Church Prayed, is a 30-minute work depicting a minister slowly realizing the impact HIV has on his congregation. Mitchell, the children’s and youth drama director at Dallas’s Concord Missionary Baptist Church, plays a news reporter in the movie, which she also wrote and coproduced. Filmed in March with a borrowed camera and volunteer actors, the project was a labor of love and passion for Mitchell. “It’s 30 years of this AIDS crisis, and it’s been on the rise in the black community for the past 10,” says Mitchell, who has also produced plays that tackled African-Americans and HIV. “We need a social attitude change and the way to get that is through the pastors—80% to 90% of the black community goes to church. It’s our tradition.” Though Mitchell’s film was received warmly when screened at the South Dallas Cultural Center and the Black Men’s Film Festival this past spring, getting it made was a different story. Numerous churches turned Mitchell down when she asked to film in their facilities. “We ended up shooting at a funeral home because the churches rejected us,” Mitchell says. “That really shows you the problem we have.” Mitchell hopes her films— her next movie, Seven Minutes, is a collection of life-affirming sermons by seven ministers in seven minutes, now in production—encourage ministers to exert their influence by hosting HIV forums and preaching about self-worth. “The films are my way to re-sound the alarm in the black community,” Mitchell says. “We need to break the silence about HIV and let the pastors know they have a role in this.”
Movin’ on Up
New York-based GMHC, the nation’s oldest AIDS service organization, finds a new home for its expanded services which has the potential to serve more people with a 20% larger kitchen and brandnew equipment. For clients wishing to prepare food at home, the new space offers an expanded food pantry, named for late artist Keith Haring in recognition of the Keith Haring Foundation’s $250,000 gift for the program. Other services moving to the new headquarters include health and nutrition education; legal, housing, and mental health support; vocational training; and case management. A second space, scheduled at press time to open in June, will house HIV prevention and testing services, continuing at the 24th Street location until then. The new Center for HIV Prevention, at 224 W. 29th St., will also be home to a new program offering educational and career guidance to people aged 13-18, regardless of HIV status. It’s aimed at fostering the self-esteem that will help HIV-positive youths have better lives and help HIV-negative ones stay negative, Hill says. “What helps a person use a condom is self-confidence, resiliency, selfesteem,” she says.
A program for medical professionals to combat the aggressive bacterial infection with small steps like constant screening has led to a 65% decline in diagnoses among HIVers in Veterans Affairs hospitals.
opposite page (from top): Image Source , thinkstockphotos.com; this page: krishna stone
in the 30th year of the AIDS epidemic and its 30th year of existence, Gay Men’s Health Crisis still sees high demand for its services—and the agency’s leaders say a move to bigger and better office space will help them continue to meet that demand. “In those 30 years we’ve only moved four times, and each time we’ve moved, it’s been to better serve people with HIV and AIDS,” says Marjorie Hill, CEO of New York City–based GMHC, the nation’s oldest AIDS service provider. GMHC’s latest move, in April, took it to 165,000 square feet of space at 446 W. 33rd St. in Manhattan. The location has several advantages over the old one, about 10 blocks away at 119 W. 24th St., where GMHC faced a 30% rent increase, Hill says. It has 45,000 more feet of usable space, spread over just two floors instead of the previous 12, allowing for improved service coordination for the agency’s 11,000 clients, she says. While some activists, such as GMHC cofounder Larry Kramer, raised concerns about clients losing access to the hot meals served on 24th Street, Hill says the meal program will continue at the new location,
A Better MRSA Plan
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In the long run, glamorous movie star Elizabeth Taylor, who died of heart failure in March, may be better remembered for her work battling AIDS than for her Oscar-winning performances. Though she had seven husbands (and eight marriages), her real passion was activism. She dedicated decades of her life to fighting HIV and the stigma attached to it. Here are some highlights of her philanthropy:
• Taylor has helped raise approximately $100 million to fight AIDS. • In 1984, Taylor coordinated and hosted the first fund-raiser for AIDS Project Los Angeles. • Soon after her friend Rock Hudson died of AIDS-related causes in 1985, Taylor founded the American Foundation for AIDS Research (amfAR). “I am on a crusade against AIDS and I’ll battle forever even after a cure is found,” she said at the time. “Making people aware of the disease, and comforting and embracing sufferers, has been my greatest role off screen.” • Since its inception, amfAR has funded 2,000 HIV and AIDS research teams worldwide. • Thirty years after she wowed the public with her Edith Head–designed gown at the 1969 Oscars, Taylor auctioned it off, netting $167,500 for amfAR. • Taylor testified before Congress for the Ryan White bill in 1986. When the legislation was finally passed in 1993, it helped fund emergency AIDS care in needy areas. • Ronald Reagan, heavily criticized for remaining mum on the subject of AIDS for much of his presidency, spoke at a 1987 amfAR fund-raising dinner after Taylor invited him. • Taylor founded the Elizabeth Taylor AIDS Foundation in 1991 to “focus on funding AIDS-based service organizations that deliver direct care to people with HIV and provide public education efforts,” according to the organization’s website. The foundation has given grants to 311 HIV-related organizations.
• Taylor’s foundation dispatched a $500,000 mobile medical unit to help HIV-positive New Orleanians affected by 2005’s devastating Hurricane Katrina.
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BERTRAND LANGLOIS/AFP/Gett y Images
Paris: French artist Anandha Seethanen performs in a production of the musical Hair at
the Théâtre du Gymnase March 18. This version of the Broadway hit promotes safe sex, and one third of its profits will benefit Sidaction, a French association that raises money for AIDSrelated causes.
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PREZISTA IMPORTANT SAFETY INFORMATION AND INDICATION Talk to your healthcare ABOUT PREZISTA professional about the ® PREZISTA (darunavir) is a signs and symptoms of liver prescription medicine. It is one problems. These may include treatment option in the class of yellowing of your skin or whites HIV (human immunodeficiency of your eyes, dark (tea-colored) virus) medicines known as urine, pale-colored stools protease inhibitors. (bowel movements), nausea, PREZISTA is always taken with vomiting, loss of appetite, and at the same time as ritonavir or pain, aching or sensitivity on (Norvir®), in combination with other your right side below your ribs HIV medicines for the treatment of • In a small number of patients, HIV infection in adults. PREZISTA PREZISTA has been reported should also be taken with food. to cause a severe or life• The use of other medicines active threatening rash. Contact against HIV in combination with your healthcare professional PREZISTA/ritonavir (Norvir®) may immediately if you develop increase your ability to fight HIV. a rash. Your healthcare professional will Can PREZISTA be taken with work with you to find the right other medications? combination of HIV medicines • Taking PREZISTA with • It is important that you remain certain medicines could under the care of your healthcare cause serious and/or lifeprofessional during treatment with threatening side effects PREZISTA or may result in loss of its effectiveness. Do not take PREZISTA does not cure HIV PREZISTA if you are taking infection or AIDS, and does not the following medicines: prevent passing HIV to others. alfuzosin (Uroxatral®), dihydroergotamine (D.H.E.45®, Please read Important Safety ® Migranal ), ergonovine, Information below, and talk to ergotamine (Wigraine®, your healthcare professional Ergostat®, Cafergot®, Ergomar®), to learn if PREZISTA is right methylergonovine, cisapride for you. (Propulsid®), pimozide (Orap®), oral midazolam, triazolam IMPORTANT SAFETY (Halcion®), rifampin (Rifadin®, INFORMATION Rifater®, Rifamate®), sildenafil (Revatio®) when used to treat What is the most important pulmonary arterial hypertension, information I should know indinavir (Crixivan®), lopinavir/ about PREZISTA? ritonavir (Kaletra®), saquinavir • PREZISTA, together with (Invirase®), lovastatin (Mevacor®, Norvir®, has been observed Altoprev®, Advicor®), pravastatin in a small number of (Pravachol®), simvastatin (Zocor®, patients to cause liver Simcor®, Vytorin®), salmeterol problems which may be life(Serevent®), or products threatening. Your healthcare containing St. John’s wort professional should do • Before taking PREZISTA, tell your blood tests prior to starting healthcare professional if you combination treatment are taking sildenafil (Viagra®), including PREZISTA. If you vardenafil (Levitra®), tadalafil have chronic hepatitis B or (Cialis®, Adcirca®), atorvastatin C infection, your healthcare (Lipitor®), atorvastatin/amlodipine professional should check (Caduet®), rosuvastatin (Crestor®), your blood tests more or colchicine (Colcrys®). This often because you have is not a complete list of an increased chance of medicines. Be sure to tell developing liver problems
your healthcare professional about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements
• As with other protease inhibitors, taking PREZISTA may strengthen the body’s immune response, enabling it to begin to fight infections that have been hidden. Patients may experience signs and symptoms of inflammation that can include swelling, tenderness, or redness • Tell your healthcare professional if you are taking estrogen-based • The most common side effects contraceptives (birth control). related to taking PREZISTA include PREZISTA might reduce the diarrhea, nausea, rash, headache, effectiveness of estrogen-based stomach pain, and vomiting. Other contraceptives. You must take important severe side effects additional precautions for birth include inflammation of the liver control, such as condoms or pancreas and increased blood fat levels. What should I tell my • This is not a complete list of healthcare professional all possible side effects. If you experience these or other side before I take PREZISTA? effects, talk to your healthcare • Before taking PREZISTA, tell your professional. Do not stop taking healthcare professional if you have PREZISTA or any other medicines any medical conditions, including without first talking to your allergy to sulfa medicines, healthcare professional diabetes, liver problems (including You are encouraged to report hepatitis B or C), or hemophilia negative side effects of • Tell your healthcare professional prescription drugs to the FDA. if you are pregnant or planning Visit www.fda.gov/medwatch, to become pregnant, or are or call 1-800-FDA-1088 breastfeeding Please refer to the ritonavir (Norvir®) - The effects of PREZISTA on Product Information (PI and PPI) pregnant women or their unborn for additional information on babies are not known. You and precautionary measures. your healthcare professional Dosing Information: will need to decide if taking PREZISTA is right for you For adults taking HIV meds for the first time and for many - Do not breastfeed if you are adults who have taken HIV meds taking PREZISTA. You should in the past: PREZISTA 800 mg not breastfeed if you have (two 400-mg tablets) must be taken HIV because of the chance of at the same time with 100 mg passing HIV to your baby Norvir® once daily every day. PREZISTA must be taken with food. What are the possible side For some adults who have taken effects of PREZISTA? HIV meds in the past: • High blood sugar, diabetes or PREZISTA 600 mg/Norvir® 100 mg worsening of diabetes, and must be taken twice daily at the increased bleeding in people with same time every day with food. hemophilia have been reported in Your healthcare professional can patients taking protease inhibitor determine which dose is right for you. medicines, including PREZISTA Please see Important Patient • Changes in body fat have been Information on the next page seen in some patients taking HIV for more information, or visit medicines, including PREZISTA. www.PREZISTA.com. The cause and long-term health effects of these conditions are not If you or someone you know needs help paying for medicine, call known at this time 1-888-4PPA-NOW (1-888-4772669) or go to www.pparx.org.
www.PREZISTA.com Distributed by: Tibotec Therapeutics/Division of Centocor Ortho Biotech Products, L.P., Titusville, NJ 08560
©2011 Tibotec Therapeutics
EXPANDED ONCE-DAILY DOSING FOR PREZISTA For adults who have not taken HIV medications before and ALSO for many adults who have taken HIV medications in the past Once-Daily PREZISTA 800 mg (two 400-mg tablets) must be taken with Norvir速 100 mg and food at the same time every day, as part of combination HIV therapy. Talk to your healthcare professional about your HIV treatment options and ask if Once-Daily PREZISTA is right for you. Please read Important Safety Information and dosing information on adjacent page.
www.PREZISTA.com Registered trademarks are the property of their respective owners.
IMPORTANT PATIENT INFORMATION PREZISTA (pre-ZIS-ta) Darunavir ALERT: Find out about medicines that should Not be taken with PREZISTA. Please also read the section “Who should not take PREZISTA?”. Read this Patient Information before you start taking PREZISTA and each time you get a refill. There may be new information.This information does not take the place of talking to your doctor or healthcare provider about your medical condition or your treatment. What is the most important information I should know about PREZISTA? PREZISTA, together with NORVIR® (ritonavir), has been observed in a small number of patients to cause liver problems which may be life-threatening. Your healthcare provider should do blood tests prior to initiating combination treatment including PREZISTA. If you have chronic hepatitis B or C infection, your healthcare provider should check your blood tests more often because you have an increased chance of developing liver problems. Talk to your healthcare provider 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. In a small number of patients, PREZISTA has been reported to cause a severe or life-threatening rash. Contact your healthcare provider immediately if you develop a rash. Please also read the section “What are the possible side effects of PREZISTA?” What is PREZISTA? PREZISTA is a prescription anti-HIV medicine used with other anti-HIV medicines used to treat adults. PREZISTA is a type of anti-HIV medicine called a protease (PRO-tee-ase) inhibitor. PREZISTA is used with ritonavir and other anti-HIV medicines to treat people with human immunodeficiency virus (HIV-1) infection. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). 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. Some of these conditions are pneumonia, herpes virus infection, and Mycobacterium avium complex (MAC) infections. Because of this, it is very important for you to remain under the care of a healthcare provider. 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 healthcare provider if you have any questions on how to prevent passing HIV to other people. What should I tell my doctor before I take PREZISTA? PREZISTA may not be right for you. Before taking PREZISTA, tell your doctor or healthcare provider if you: • are allergic to sulfa medicines.
• h ave diabetes. 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 healthcare provider will need to decide if taking PREZISTA is right for you. If you take PREZISTA while you are pregnant, talk to your healthcare provider 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 healthcare provider about the best way to feed your baby. The Centers for Disease Control and Prevention (CDC) recommends that HIV-infected mothers not breastfeed to avoid the risk of passing HIV infection to your baby. Who should not take PREZISTA?** Together with your healthcare provider, 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 healthcare provider 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 healthcare provider 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 healthcare provider 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 healthcare provider 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®)
IMPORTANT PATIENT INFORMATION – dexamethasone, fluticasone (Advair Diskus®, Cutivate®, Flonase®, Flovent Diskus®) – bosentan (Tracleer®) – atorvastatin (Lipitor®), pravastatin (Pravachol®), rosuvastatin (Crestor®) – cyclosporine (Sandimmune®, Neoral®), tacrolimus (Prograf®), sirolimus (Rapamune®) – salmeterol (Serevent®) – Methadone, buprenorphine, buprenorphine/naloxone – risperidone (Risperdal®, Risperdal® Consta®, Risperdal® M-TAB®), thioridazine – sildenafil (Viagra®), vardenafil (Levitra®), tadalafil (Cialis®) – tadalafil (Adcirca®) – paroxetine (Paxil®), sertraline (Zoloft®) Tell your healthcare provider 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 healthcare provider 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 healthcare providers and pharmacists any time you get a new medicine. Both your healthcare provider 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 healthcare provider or pharmacist. You can ask your healthcare provider 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 healthcare provider. You must take ritonavir (NORVIR®) at the same time as PREZISTA. • Do not change your dose of PREZISTA or stop treatment without talking to your healthcare provider first. • Take PREZISTA and ritonavir (NORVIR®) with food. • Swallow PREZISTA tablets whole with a drink. What should I do if I miss a dose? People who take PREZISTA one time a day: • 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 your 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®) right away. Then take your next dose of PREZISTA and ritonavir (NORVIR®) at your regularly scheduled time. People who take PREZISTA two times a day • 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 your 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®) right away. Then take your next dose of PREZISTA and ritonavir (NORVIR®) at your regularly scheduled time. 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? 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 antiHIV medicines. Do not rely on this leaflet alone for information about side effects. Your healthcare provider can discuss with you a more complete list of side effects. PREZISTA, together with NORVIR® (ritonavir), has been observed in a small number of patients to cause liver problems which may be life-threatening. Your healthcare provider should do blood tests prior to initiating combination treatment including PREZISTA. If you have chronic hepatitis B or C infection, your healthcare provider should check your blood tests more often because you have an increased chance of developing liver problems. Talk to your healthcare provider 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 a small number of patients, PREZISTA has been reported to cause a severe or life-threatening rash. Contact your healthcare provider immediately if you develop a rash. Other relevant severe side effects were inflammation of the liver or pancreas, increased blood fat levels, diabetes, and changes in body fat. The most common side effects include diarrhea, nausea, rash, headache, abdominal pain and vomiting. Other side effects of PREZISTA include the following: • 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. Tell your healthcare provider 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 healthcare provider. 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
Manufactured for Tibotec, Inc. by: JOLLC, Gurabo, Puerto Rico Distributed by: Tibotec Therapeutics, Division of Centocor Ortho Biotech Products, L.P., Raritan NJ 08869 NORVIR® is a registered trademark of its respective owner. PREZISTA® is a registered trademark of Tibotec Pharmaceuticals © Tibotec, Inc. 2006
Revised: December 2010
PRAKASH MATHEMA/AFP/Gett y Images
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from top: Todd Williamson/WireImage; STEPHANE DE SAKUTIN/AFP/Ge t t y Images; following page: lifeball.org
West Hollywood: (top) Glee’s Darren Criss performs at new hot spot the Office as part of a benefit for AIDS Project
Los Angeles March 26.
KwaZulu-Natal, South Africa: (above) High school students wait outside a mobile HIV clinic March 8. Only a handful of organizations offer HIV tests in schools in South Africa, a country in which 9% of people younger than 20 have HIV. Kathmandu, Nepal: On behalf of the CNN Freedom Project, which works to eliminate human trafficking and sex
slavery, actress Demi Moore joins Anuradha Koirala, founder of the Maiti Nepal orphanage and rehabilitation home, April 7 at the home, which provides refuge for survivors of trafficking, including HIV-affected women and children.
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ď ´ Vienna:
City Hall shines at the 19th annual Life Ball, one of the biggest HIV/AIDS charity events in the world. Hosted by the nonprofit organization AIDS Life, the benefit, which took place May 21, attracted the likes of Brooke Shields, Janet Jackson, Vivienne Westwood, Natasha Bedingfield, and former president Bill Clinton. j u ly/a u g u s t 2 0 1 1 H I V P L U S
DOCTOR WHO As HIV becomes easier to live with, experts urge more primary care physicians to treat HIVers. Is it time to downsize your doctors? BY NEAL BROVERMAN
ustin Goforth, positive for 18 years, once received treatment at an HIV clinic sponsored by the National Institutes of Health. The NIH eventually closed the clinic, Goforth says, because the patients, all on antiretroviral regimens, showed no signs of illness. And sick people were what doctorsin-training came to the NIH to study. “The medical fellows that came to NIH to learn infectious disease specialty care weren’t getting that experience,” Goforth says. “Once you get people on a regimen, then it’s just about primary care and not about the infectious disease care anymore.” Goforth, a nurse and a director of several programs at Washington, D.C.’s WhitmanWalker health center, now gets his medical needs met through his internist. It’s been 30 years since AIDS was first diagnosed in the United States, and in that time much has changed—prevention, treatment, life expectancy. But the relationship
between doctor and HIV patient may not have evolved along with treatment of the disease. Some experts are now calling for a shift: Where infectious disease specialists once cared for HIVers, now primary care physicians are being called upon to take over treatment. This issue came to the forefront after an Institute of Medicine report in March documented a shortage of HIV specialists (due largely to the fact that this field often pays less than other specialties, so fewer doctors enter this area) and asserted the problem will only worsen. Weeks later, the Los Angeles County Department of Health Services director, Mitchell Katz, MD, wrote in Archives of Internal Medicine that HIV is a chronic, treatable disease that can and should be handled by more general practitioners. Frank Spinelli, MD, a Manhattan internist who treats many HIV-positive patients and previously served as the clinical director
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not an infectious disease specialist, his internist is especially knowledgeable about HIV—something that needs to start becoming the rule instead of the exception. “My doctor says he can train a primary care physician in about two days on how to provide HIV care,” Goforth says. “But that two days of training is very necessary. Going to a doctor who has no history of serving that population is risky.” Exposure to more HIV-positive patients during medical school and residency programs will help ensure a wider breadth of HIV knowledge for primary care physicians, Spinelli says. That will be necessary, as a reversal of the shortage in HIV specialists is unlikely. The fact of the matter, say both Spinelli and Cunningham, is that infectious disease doctors who specialize in HIV care typically have more work and complications—and makes less money—than an obstetrician, for example. A love for the work is what pushes people into treating AIDS, says Spinelli, who trained in the 1980s at places such as New York’s St. Vincent’s Hospital, a huge center for AIDS care at the time. Back then, people were dying at alarming rates, and the passion to save them led many to get into the field. Now that the disease is manageable, working with HIV is less of a passion project. “When I go to HIV meetings every year, I look behind me and there’s no one younger than me,” Spinelli says. “I’m looking for the next generation and I don’t see them. There’s a shortage of HIV doctors even though the number of HIV-positive people is going up.” That’s why the shift to primary care doctors treating HIV-positive patients must begin in earnest, Spinelli says. It’s not only important, but like once-aday regimens, having one doctor who fulfills all your needs brings a little more normality to lives of HIVers. “I can go see an infectious disease specialist and a primary doctor, but that would be a pain in my rear end,” Goforth says. “I’m a very busy man.” ✜
Certain HIV-related issues do warrant seeking an infectious disease specialist, according to William Cunningham, MD, MPH, a professor at the University of California, Los Angeles, School of Medicine. “Pretty much any cancer-related complication like Kaposi’s sarcoma” requires someone highly educated on the subject of HIV, Cunningham says. “Lymphoma or any of the blood-related disorders as well.” For those in rural areas where HIV and infectious disease doctors are scarce, Spinelli suggests seeking out university medical centers, located in almost every state, when they need specialized care. But if you’re in generally good health and live outside of an area with many options for physicians, a general practitioner may be the most practical choice. Nevertheless, everyone must be vigilant with his or her own care. There are specific questions HIVers should ask their doctors to assure the best care. Anyone seeking a new doctor should first ask if he or she is comfortable treating HIV. “Even in New York, a lot of doctors don’t want to do [HIV care],” Spinelli says. “It’s complicated; people are scared of it. You’d have to say, ‘I’m HIV-positive—how comfortable are you treating HIV? What is your experience? How many patients do you treat with HIV? Are you involved with any research? Where do you get your information? Do you attend conferences?’ ” Coming from a place of anxiety, though, is not helpful, Cunningham says. This new treatment paradigm offers benefits as well as concerns. “As people with HIV get older, just like other people they’re more likely to develop conditions like diabetes, heart disease, arthritis, kidney disease, and hypertension,” Cunningham says. “Those conditions are best managed by a primary care doctor who can put together the whole picture and treat all the conditions at the same time.” For an HIV patient like Goforth, a doctor who considers his overall health in an effort to lead him toward a long life is crucial, he says. Though
of HIV services at New York City’s Cabrini Medical Center, agrees with many of Katz’s points but offers some caveats. Keeping up with advances in the disease takes a lot of time, he says, and if your doctor isn’t making an effort in that regard, you can suffer. “I’m constantly going to meetings about HIV,” he says. “I’m involved in clinical trials where I learn about the new advances. I think if I was an internist in a small town, I wouldn’t necessarily know this stuff.” Spinelli compares the situation to that of a primary care physician reading an electrocardiogram, something usually done by a cardiologist—an internist like Spinelli could read the EKG, but if something didn’t look normal, the expertise of a heart doctor would be needed. “The same thing happens when an HIV-positive patient does not become routine, where something might change or get worse or abnormal,” Spinelli says. “I’m scared to think that a primary care doctor may not have the capacity to actually take care of those changes.” Self-education is imperative for primary care physicians who are relatively new to treating HIV-positive people, Spinelli says. Reading up on HIV reports and journals and staying on top of the newest medications is a must. “It would be an injustice to you if you had HIV and your doctor was prescribing something to you that’s ancient,” he says. While Spinelli does believe most HIVers who adhere to their regimens aren’t substantially more or less healthy than people without the virus (“Now we tell HIV-positive patients that you’re probably going to die from what everybody else is going to die from—a heart attack”), there are still conditions specific to HIV that all doctors must be aware of. Preventive measures like male Pap smears—helpful because of the prevalence of anal cancer among HIV-positive men—and vitamins to fight meds-related bone weakening are things any good doctor should suggest to HIV-positive patients.
LeVar Burton’s Next Generation LeVar Burton helps the AIDS Research Alliance boldly go where few have gone before in its search to find a cure for HIV for 25 years levar burton served as the executive producer and host of PBS’s Reading Rainbow, sharing a love of books and reading with kids—and teaching them a thing or two about social advancements and important historical moments in the process. The actor, best known for his award-nominated performances in Roots and Star Trek: The Next Generation, has spent his career using his talents for a greater good. Now, as the spokesman for the AIDS Research Alliance, Burton is dedicated to a new cause—eradicating HIV/AIDS.
So much of the focus among AIDS charities right now is on underdeveloped countries, but the ARA is concentrating the bulk of its resources on the United States. Why was that important to you? Because that’s where the population of those infected is growing the fastest. And we still need to do a better job of educating our young. I get the impression that here in the United States, the prevailing attitude is, Oh, we’ve got that licked. AIDS is pretty much over, right? Nothing could be further from the truth, especially in terms of the population of young African-American men and women. It’s growing at an alarming rate in sub-Saharan Africa. It’s growing at an alarming rate in China. Really, we’re talking about the future of the human species, when you break it all the way down. You have been involved in numerous projects over the years that have taken a place in the history books.
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From Roots to Reading Rainbow to the wide variety of charitable efforts you’ve participated in, why do you gravitate toward projects with educational significance? It doesn’t make sense to not use the celebrity to a good end. I’ve believed for a long time that this communications grid that we have blanketed the planet with is, without question, is the most powerful tool ever created for social growth and change. We are a global village, and to not use the opportunity to speak out for what’s right doesn’t make sense. I was raised in a family where one’s life was supposed to be about giving back. You’ve been in this business for more than 30 years, so I can imagine AIDS touched your life on a personal level very early on. In the early ’80s, I saw a lot of colleagues being taken, and we have certainly gone through a process of education in this business. I remember very, very clearly when Rock Hudson came out, and the ripple that sent through the town. There was, at that time, still very much a stigma. No one wanted to deal with it or address it. Then show business really educated itself. But then again we have a whole new generation of people who seem to have lost their minds, running around having unprotected sex. You just wonder, What are you thinking?
You’re involved in an audio book project, Nelson Mandela’s Favorite African Folktales, to benefit people living with HIV/AIDS in South Africa. How did that project come about? Through [actress] Alfre Woodard. When Alfre calls, you don’t say no. She is always involved with something really delicious and incredibly meaningful. She’s one of those people. It was a no-brainer. To what extent do you plan on getting involved in the work being done by the AIDS Research Alliance? Initially, my role is being available to do outreach and speak to outlets like this. There are some events we have planned over the next few months. Right now, whatever they need for me to do, I’m up for it. Not that I could ever hope to fill her shoes, but I think the death of Elizabeth Taylor leaves a real void, and when ARA came to me, they said, “Look, we need help.” When I went in and sat down with them and heard the story and how committed they are to finding a cure, I thought, Whatever I can do, I’m in. Burton is updating Reading Rainbow and developing it for new audiences—look for a new take on the show later in the year. To learn more about the AIDS Research Alliance, visit AIDSResearch.org. ✜
courtesy subjec t
So many organizations out there are focused on treatment. The AIDS Research Alliance has made finding a cure its focus. Why was that appealing to you? Treatment is the norm in this pandemic, but there’s really no organization out there raising money to find a cure. So when they asked, after sitting down and hearing from them the story of the ARA and what their intentions are and the work they’re doing, I thought I would have to be soulless or dead to refuse.
The Thirty Years’ War As AIDS enters its fourth decade, we look back at the events that changed the course of history
From top left, clockwise: AIDS quilt, ribbon, Dianne Feinstein, Larry Kramer, Michael Callen, Freddy Mercury, Parting Glances, Elizabeth Taylor, Act Up, Fire In My Belly
It’s not a birthday to celebrate, but the 30th year of AIDS does remind us to appreciate how far we’ve come. From the early days of panic and paranoia to today’s promise, the world has seen monumental advances in not only prevention and treatment but also acceptance and tolerance. A diverse group, including scientists, politicians, and reality stars, helped contribute to these sweeping changes and increased the odds of AIDS not living to 40. Here are some of the people and moments that brought us to now...
the thirty years’ war
June: The CDC reports that there have been several cases of a syndrome involving PCP, Kaposi’s, and other opportunistic infections among gay men in California’s Los Angeles and Orange counties. This suggests the infectious agent may be sexually transmitted. Scientists apply various names to the syndrome, including gayrelated immune deficiency, gay compromise syndrome, and community-acquired immune dysfunction. July: By the beginning of the month, 452 cases of the syndrome, from 23 states, have been reported to the CDC. Later that month, with reports surfacing of cases among hemophiliacs and Haitians (making it clear that it’s not an exclusively gay disease), doctors and researchers settle on the name— acquired immune deficiency syndrome, or AIDS.
Cases of AIDS are now being reported worldwide. In November, the World Health Organization holds a meeting to address the situation. By year’s end, the United States has seen 3,064 reported AIDS cases; 1,292 of these people have died. January: The Red Cross and other blood banks reject a proposed ban on blood donations from gay men. In 1984, however, the U.S. government will bar gay men from donating. May: San Francisco mayor Dianne Feinstein (below) declares the month’s first week AIDS Awareness Week. August: Activist Michael Callen (below, left) and others testify at the first congressional hearing on AIDS. September: The ACLU brings attention to an “AIDS Alert,” a list of people with AIDS circulated among Seattle police. The list was eventually destroyed after an order from the police chief.
February: The Reagan administration proposes rejecting immigrants who test positive for HIV. February: A witty look at gay life in 1980s New York, the low-budget but much-loved Parting Glances features Steve Buscemi as an unrepentant rock star losing his battle with AIDS. June: The federal government commits $100 million over five years to evaluate promising AIDS medications.
March: ACT UP is formed in New York; the FDA approves the first AIDS drug, AZT, marketed as Retrovir. October: Congress overwhelmingly passes the Helms Amendment, which forbids federal funding for any AIDS programs that promote homosexuality. October: During the largest gay rights march in the nation’s history, activist Cleve Jones’s NAMES Project Memorial Quilt is unveiled to commemorate those lost to AIDS.
March: The U.S. Food and Drug Administration licenses the first blood test for HIV antibodies. April: The Normal Heart, Larry Kramer’s semiautobiographical play about the AIDS epidemic, premieres at New York City’s offBroadway Public Theater. July: Ann-Margret and Los Angeles mayor Tom Bradley participate in the city’s first AIDS Walk. September: The American Foundation for AIDS research is formed with Elizabeth Taylor (left) as founding chairman. In its first 25 years the foundation will invest $325 million in its mission. October: Rock Hudson, 59, dies of AIDS complications at his Beverly Hills home.
June: Due to reports of unusual outbreaks of pneumocystis carinii pneumonia (PCP) and the rare cancer Kaposi’s sarcoma among gay men in New York City and Los Angeles, the Centers for Disease Control and Prevention establishes a task force on Kaposi’s sarcoma and opportunistic infections. Later, the outbreaks will be seen as the first identified cases of AIDS. September: From his Manhattan apartment, activist Larry Kramer begins to mobilize gay New Yorkers with Kaposi’s sarcoma.
In the spring, French and American researchers both report the discovery of a virus they believe to be the cause of AIDS. The virus will later become known as human immunodeficiency virus, or HIV. October: In an effort to stop the spread of AIDS, the city of San Francisco shuts down gay bathhouses. In three years, 817 cases of AIDS had been reported in San Francisco. December: Ryan White, a 13-year-old hemophiliac in Kokomo, Ind., is diagnosed with AIDS, having contracted HIV through tainted blood. The community’s harassment of White and his family makes national news, and the family eventually moves away.
February: Artist Keith Haring dies of AIDSrelated complications at age 31. May: Longtime Companion becomes one of the first American films to focus almost solely on AIDS. August: Congress passes the Ryan White Comprehensive AIDS Resources Emergency Act, funding a variety of AIDS-related services.
November: A study indicates that AZT can cut mother-to-child transmission of HIV by two thirds. November: The Real World: San Francisco follows the trials of HIV-positive AIDS activist Pedro Zamora. The 22-year-old dies of AIDS-related complications on November 11, one day after the last episode of his series airs. President Bill Clinton would later publicly thank Zamora for putting a brave face on the disease.
May: The Centers for Disease Control and Surgeon General Koop distribute the pamphlet “Understanding AIDS” to each of the 107 million homes in America. August: Presidential candidate George H.W. Bush endorses protections against discrimination for people with HIV/AIDS. October: Congress passes an $800 million AIDS research package, with a provision from Sen. Jesse Helms requiring that testing confidentiality be dropped.
January: To prevent the spread of HIV, the Los Angeles Unified School District approves the distribution of condoms in high schools. August: Mary Fisher, an HIVpositive woman, addresses the Republican National Convention. December: The Bush White House allows the Food and Drug Administration to fast-track experimental anti-HIV drugs.
June: President Clinton establishes the Presidential Advisory Council on HIV/AIDS by executive order. December: The FDA approves saquinavir (brand name Invirase), the first in a new class of drugs called protease inhibitors, whose use with other drugs becomes known colloquially as a “cocktail.”
May: Tony Kushner’s Angels in America: Millennium Approaches, the first part of his AIDS epic, opens on Broadway. It wins a Tony award for Best Play and the Pulitzer Prize for Drama. The second part, Perestroika, premieres in November and also wins the Tony. September: HBO’s dramatization of Randy Shilts’s groundbreaking book And the Band Played On premieres. December: The film Philadelphia tells the story of a gay lawyer (Tom Hanks, right, in an Oscar-winning role) who sues his former firm after he’s fired for having AIDS.
March: Three thousand AIDS demonstrators storm New York’s City Hall to draw attention to the problems within the city’s hospital system. April: President George H.W. Bush is heckled for his inaction on AIDS at a nationally televised speech on the bicentennial of George Washington’s inauguration. September: The AIDS charity album Red Hot + Blue (above) is released, featuring reworked Cole Porter classics sung by artists including Annie Lennox, Tom Waits, and Debbie Harry. It was one of the first projects of the Red Hot Organization, which continues to raise money for HIV causes through additional album releases.
June: Jeremy Irons is the first celebrity to wear the red AIDS awareness ribbon publicly, at the 1991 Tony Awards. The Red Ribbon Project was conceived by New York’s Visual AIDS Artists Caucus. August: A major research study indicates that AZT can slow progression to AIDS in asymptomatic HIV-positive people. Protests over the cost of the drug—up to $7,000 a year for one person—lead manufacturer Burroughs Wellcome to reduce the price by 20% in September. October: A second anti-HIV drug receives FDA approval—didanosine, sold under the brand name Videx. November: Freddie Mercury (left), the flamboyant lead singer of Queen, is the latest celebrity to die of AIDS-related causes. He was 45.
February: The American version of the British drama Queer as Folk introduces Robert Gant’s (below) Ben Bruckner as an HIV-positive love interest to Hal Sparks’s HIV-negative Michael Novotny. April: The World Health Organization outlines steps to make antiretroviral drugs more accessible to people in poor nations. November: The FDA approves an HIV test than can provide results within 20 minutes.
February: Scientists announce that they detected HIV in an African man’s blood sample preserved from 1959, making it the oldest documented case of HIV infection. June: The FDA approves the first human trial of an AIDS vaccine, to involve 5,000 volunteers throughout the United States. November: The Joint United Nations AIDS Programme announces that HIV infections worldwide rose 10% over the past year, with great increases among women and youths.
July: Hopeful news emerges from the international AIDS conference in Vancouver. Scientists report that new drug combinations have dramatically improved the health of many people with AIDS. Some say the “cocktails” may transform the disease from a terminal one into “a chronic, manageable disorder like diabetes.” September: On ER, heterosexual physician assistant Jeanie Boulet (played by Gloria Reuben, right) learns she has HIV.
January: New York City health officials report the first documented drop in AIDS deaths—the number of city residents dying of the disease declined 30% from 1995 to 1996. February: CDC officials say there were 13% fewer deaths in the first half of 1996 than in the same period in 1995. The trend is attributed to the new drug therapies. June: The New York Times reports post-exposure prophylaxis, or PEP, medication is being offered to those who may have been exposed to the virus but have not tested positive for infection.
January: The CDC announces that 1998 marked the first time there were more AIDS diagnoses among black and Latino gay men than among white gay men. February: New research indicates AIDS may have originated as far back as 1930. November: The World Health Organization reports that new HIV infections rose during the year, but the infection rate stabilized in sub-Saharan Africa for the first time.
February: Results from a study involving six large U.S. cities indicate that 30% of young black gay men are HIV-positive. June: On the 20th anniversary of the epidemic, the United Nations devotes a special session to HIV and AIDS, the first for a public health issue. All 189 member countries sign a Declaration of Commitment on HIV and AIDS, which includes pledges to reduce HIV prevalence among young people by 25% in the hardest-hit nations by 2005, and to reduce it by 25% globally by 2010.
February: New York City health officials announce that a study of young gay men in the city shows 12% of them are infected with HIV. The highest infection rates are among African-American and mixedrace men. May: The World Health Organization’s annual report says AIDS has become the fourth leading cause of death worldwide. August: The CDC reports that deaths from AIDS continue to drop, but at a lower rate than they did immediately after the introduction of drug cocktails. U.S. AIDS deaths declined 42% from 1996 to 1997, but only 20% from 1997 to 1998. Federal officials say the performance of the new drugs has caused people to become complacent about preventing HIV transmission.
January: President George W. Bush outlines what will become PEPFAR—the President’s Emergency Plan for AIDS Relief, aimed at fighting AIDS in developing countries. November: Results from a trial of the AidsVax vaccine show it failed to prevent HIV transmission. The trial was conducted among injection-drug users in Thailand. December: On World AIDS Day, the WHO announces its “3 by 5” plan, to have 3 million people in resource-poor countries on antiretroviral drugs by 2005.
2004-2011 2007 February: The first PEPFAR funds are distributed—$350 million to 14 countries, a month after congressional approval. July: The Bill and Melinda Gates Foundation announces a $50 million donation to the Global Fund to Fight AIDS, Tuberculosis, and Malaria. December: Designers Against AIDS launches with the mission of using pop culture components to raise media awareness of HIV/AIDS.
July: The FDA approves Atripla (below), the first once-daily single-tablet regimen. From Bristol-Myers Squibb and Gilead Sciences, it combines efavirenz, emtricitabine, and tenofovir. December: Results are in from two African studies that indicate male circumcision can help prevent HIV transmission, although there are fears that some populations may not accept the procedure and that it could lead to a lax approach to prevention.
September: GlaxoSmithKline’s patent on Retrovir (AZT) expires, meaning any company can produce generic versions without paying royalties, and the FDA approves four generics. November: The WHO announces that the 3 by 5 plan is far short of its goal, but it estimates that expanded access to treatment saved between 250,000 and 350,000 lives during the year.
August: The annual report from UNAIDS notes AIDS deaths worldwide dropped from 2.2 million in 2005 to 2 million in 2007, and that there were 33 million people living with HIV globally at the end of 2007. November: German doctors announce that they have essentially cured an American patient of HIV through a bone marrow transplant given to treat his leukemia two years earlier. The man has been off antiretroviral drugs since the transplant and still shows no traces of the virus.
January: Barack Obama is inaugurated as U.S. president. He immediately lifts an executive order that had denied U.S. aid to international family planning organizations, some of them active in HIV prevention, if they provided abortion services. He also promises to lift the U.S. ban on HIV-positive immigrants and visitors. March: Pope Benedict XVI (left) reiterates the Roman Catholic Church’s opposition to condom use, saying it may actually contribute to the spread of HIV.
March: U.N. secretary-general Ban Ki-moon releases a report urging world leaders to take bold action against the AIDS epidemic, warning that recent progress is fragile. Some 7,000 people worldwide become infected each day—two for each person beginning antiretroviral treatment—and 1,000 of those infected are children. March: Elizabeth Taylor dies of congestive heart failure at age 79. April: Larry Kramer’s (below) landmark 1985 AIDS play The Normal Heart gets its first Broadway production.
August: State and federal budget crises threaten AIDS Drug Assistance Programs in several states. Several drug companies, including BristolMyers Squibb, step up to provide temporary assistance to the programs. September: Project Runway contestant Mondo Guerra reveals that a design he created—featuring oversize plus signs—was inspired by his HIVpositive status. November: The secretary of the Smithsonian, G. Wayne Clough, withdraws an edited version of A Fire in My Belly (below), a silent film by artist David Wojnarowicz (who died of AIDS complications in 1992) from the exhibit “Hide/Seek: Difference and Desire in American Portraiture” after complaints from the Catholic League.
January: A large-scale trial of a vaginal microbicide is stopped because the product is not preventing HIV and may even be enabling it. March: Due to the studies released the preceding December, WHO endorses male circumcision as part of a comprehensive AIDS prevention strategy. April: WHO reports that 2,000,000 people in low- and middle-income countries are receiving HIV drugs— only 28% of those who need such treatment.
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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:
•Are breastfeeding: Women with HIV should not breastfeed because they can pass HIV through their milk to the baby. Also, ATRIPLA may pass through breast milk and cause serious harm to the baby. •Have liver problems, including hepatitis B or C virus infection.
ATRIPLA is one of several treatment options your doctor may consider.
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 of suicide, and a few have actually committed suicide. These problems may occur more often in patients who have had mental illness. IMPORTANT SAFETY INFORMATION Contact your healthcare provider right away if you get the following •Kidney problems (including decline or failure of kidney function). If you have had kidney problems, or take other medicines that may side effects or conditions associated with ATRIPLA: • Nausea, vomiting, unusual muscle pain, and/or weakness. These cause kidney problems, your healthcare provider should do regular blood tests. Symptoms that may be related to kidney problems include may be signs of a buildup of acid in the blood (lactic acidosis), a high volume of urine, thirst, muscle pain, and muscle weakness. which is a serious medical condition. • Light-colored stools, dark-colored urine, and/or if your skin or the •Other serious liver problems. Some patients have experienced serious liver problems, including liver failure resulting in transplantation whites of your eyes turn yellow. These may be signs of serious or death. Most of these serious side effects occurred in patients with a liver problems. chronic liver disease such as hepatitis infection, but there have also • If you have HIV-1 and hepatitis B virus (HBV), your liver disease been a few reports in patients without any existing liver disease. may suddenly get worse if you stop taking ATRIPLA. •Bone changes. Lab tests show changes in the bones of patients treated Do not take ATRIPLA if you are taking the following medicines with tenofovir DF, a component of ATRIPLA. Some HIV patients treated because serious and life-threatening side effects may occur when with tenofovir DF developed thinning of the bones (osteopenia), which taken together: Vascor® (bepridil), Propulsid® (cisapride), could lead to fractures. Also, bone pain and softening of the bone Versed® (midazolam), Orap® (pimozide), Halcion® (triazolam), (which may lead to fractures) may occur as a consequence of kidney or ergot medications (for example, Wigraine® and Cafergot®). problems. If you have had bone problems in the past, your healthcare In addition, ATRIPLA should not be taken with: provider may want to check your bones. ® ® ® Combivir (lamivudine/zidovudine), EMTRIVA (emtricitabine), Epivir Common side effects: or Epivir-HBV® (lamivudine), Epzicom® (abacavir sulfate/lamivudine), SUSTIVA® (efavirenz), Trizivir® (abacavir sulfate/lamivudine/zidovudine), •Dizziness, headache, trouble sleeping, drowsiness, trouble TRUVADA® (emtricitabine/tenofovir DF), or VIREAD® (tenofovir DF), concentrating, and/or unusual dreams. These side effects tend to go because they contain the same or similar active ingredients as ATRIPLA. away after taking ATRIPLA for a few weeks. These symptoms may be ® ATRIPLA should not be used with HEPSERA (adefovir dipivoxil). more severe with the use of alcohol and/or mood-altering (street) drugs. If you are dizzy, have trouble concentrating, and/or are drowsy, Vfend® (voriconazole) or REYATAZ® (atazanavir sulfate) with or without avoid activities that may be dangerous, such as driving or operating Norvir® (ritonavir) should not be taken with ATRIPLA since they may lose their effect and may also increase the chance of having side effects machinery. from ATRIPLA. Fortovase® or Invirase® (saquinavir) should not be used •Rash is a common side effect that usually goes away without any as the only protease inhibitor in combination with ATRIPLA. change in treatment, but may be serious in a small number of patients. Taking ATRIPLA with St. John’s wort or products containing St. John’s wort •Other common side effects include: tiredness, upset stomach, vomiting, is not recommended as it may cause decreased levels of ATRIPLA, gas, and diarrhea. increased viral load, and possible resistance to ATRIPLA or Other possible side effects: cross-resistance to other anti-HIV drugs. This list of medicines is not complete. Discuss with your healthcare •Changes in body fat have been seen in some people taking anti-HIV-1 medicines. The cause and long-term health effects are not known. provider all prescription and nonprescription medicines, vitamins, or herbal supplements you are taking or plan to take. •Skin discoloration (small spots or freckles) may also happen. Tell your healthcare provider if you: •If you notice any symptoms of infection, contact your healthcare provider right away. •Are pregnant: Women should not become pregnant while taking ATRIPLA and for 12 weeks after stopping ATRIPLA. Serious birth defects •Additional side effects are inflammation of the pancreas, allergic have been seen in children of women treated during pregnancy with reaction (including swelling of the face, lips, tongue, or throat), one of the medicines in ATRIPLA. Women must use a reliable form of shortness of breath, pain, stomach pain, weakness, and indigestion. barrier contraception, such as a condom or diaphragm, even if they also use other methods of birth control, while on ATRIPLA and for 12 weeks You should take ATRIPLA once daily on an empty stomach. Taking ATRIPLA at bedtime may make some side effects less bothersome. after stopping ATRIPLA.
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.
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. 697US09AB07063/TR8944 06/10
“My entire HIV regimen in one pill daily. For me, that’s great.” Phill ip
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
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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. • 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.
Job number: 697US09AB07063
Trim size 7.3125 x 10.5
ATRIPLA® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) 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. 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.
ATRIPLA® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) • 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 breastfeeding. 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. • 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.
ATRIPLA® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) 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.
On the Front Lines Medical breakthroughs come fast and furious these days, but who are the people being tested in the pivotal studies that make these advances possible? By Michelle Garcia
as the whole HIV/AIDS thing goes,” he says. “But I knew I could do my part to help others as well.” After Banko threw his hat into the ring he was subject to several rounds of paperwork, blood work, screening, and interviews. Michele Vertucci, the clinic manager at the AIDS Research Alliance in Los Angeles, says potential participants must first share their medical background and lifestyle habits during a telephone interview. Once advancing past that round, candidates come in
to the clinic for a screening appointment, which involves the signing of an extensive consent form. Then Vertucci or another administrator meets with the candidates individually to outline everything they face during the trial, including the length of the study and the basics of vaccine or treatment trials. Vaccine trials, like the one Banko has entered, typically last three to five years, while trials for treatment drugs like Merck’s Isentress, which the ARA evaluated, last up to two martin barraud
after a few moments of perusing status updates and photos of friends on Facebook, an ad caught Michael Banko’s eye. The ad sought participants in a study for an HIV vaccine. This wasn’t Banko first association with HIV awareness, research, and prevention. In 2006 he raised money to run the National AIDS Marathon. But becoming a vaccine volunteer, he decided, was his duty. “I consider myself a fairly healthy gay male, and I’ve been lucky as far
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years. In either case, it’s a substantial commitment, and research organizations like the ARA want to make sure that participants are dedicated to checking in regularly and staying on top of their health. During the testing phase, volunteers are given either a placebo or the real drug or vaccine. They’re then expected to report regularly on their health and to be screened for changes in their condition. The ARA’s current vaccine study has only 55 people enrolled. Vertucci acknowledges that some potential candidates for the study don’t even consider participating in the HIV vaccine trials due to the fear that they might contract the virus or because society’s view of HIV has changed. “Back in 1998 we tested the first
[HIV] vaccine study in the U.S.,” she says. “At that time we first screened 400 people and enrolled 200 into the study. In 1998 there was a shared knowledge among the community that we needed a vaccination. And I think, with this current vaccine study, it’s been more difficult in some ways to recruit people than it was in 1998. It’s a different atmosphere. Now it’s no longer viewed as a fatal disease. Young people now just don’t think they’ll get infected, or others have a fatalistic approach.” As for becoming infected via a vaccine, Vertucci says that shouldn’t be a concern. “If we were doing something like a hepatitis B study, people wouldn’t have the same fears or concerns,” Vertucci says. “The HIV is manmade in a lab, so a person can’t get
HIV from the vaccine, and you can’t give it to a partner. It’s not a live virus. Once people hear that, then they’re like, ‘Oh, OK, yeah, I can do this.’ It’s just like when you were a kid and you got a polio vaccination.” Some study participants agree to be in trials for the small compensation. Others take the opportunity to try treatments that have not been released to the market but could still help ease disease symptoms or treatment side effects, such as diarrhea or lipodystrophy. Testers like Banko do it because he knows it could help pave the way for a world without AIDS. “My friends who are HIV-positive seem to be thankful,” he says. “Even though it won’t be helping them, unfortunately, they understand why this is so necessary.” ✜
J U LY/A U G U S T 2 0 1 1 H I V P L U S
VICTORIA, 30 | jackson
Victoria was abandoned by both parents at a young age and grew up in foster care. When she discovered she had HIV, she convinced herself it was a punishment she deserved for time spent doing drugs. She’s been sober since 2008 but has not told family members she is HIV-positive. “They’d bury me before my time,” she says. “People here don’t want to hear about HIV/ AIDS. The stigma is so bad, people feel like, ‘If I touch you, I’m gonna get this.’ Or ‘If I’m gonna eat after you, I’m gonna get this.’ And I feel like the government needs to step up and help us more than they are.”
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SCARRED BY STIGMA
On her journey to Mississippi, photographer Julie Turkewitz captures the faces of people bringing integrity to living with HIV in the Deep South
new york–based reporter and photographer Julie Turkewitz jumps at the opportunity to talk to HIV-positive people and AIDS activists outside the Big Apple. While HIV is a serious affliction wherever it exists, many New Yorkers with the virus have better access to care and support than those in some other parts of the country, who are often isolated and sometimes lack access to basic medications. So when she met members of AIDS Action in Mississippi, an organization working to break down stigma and lobby the state for better funding of care programs, she was moved to capture their faces and stories. What most inspires Turkewitz about the subjects of her photo series “Scarred by Stigma” is their tenacity in their work as activists and in their lives, despite the hurdles they face. “They are really saying, ‘This is a part of me, but it’s not who I am,’ ” says Turkewitz, a staff writer for the AIDS and poverty activist group Housing Works. Mississippi is far from a paradise where health is concerned. For the past two decades, the state has been consistently been ranked as one of the least healthy in the country by insurance company United Health. HIV-positive Mississippians face a high poverty rate, housing discrimination, and a lack of
access to medical care, all spurred by institutionalized prejudices, according to an extensive report on the topic released in March by Human Rights Watch. And these findings don’t even touch on the rampant stigma and discrimination that HIVers experience on a day-to-day basis at home, at the office, or even among friends. In fact, Turkewitz says that speaking to the group of Mississippians made her think of the early days of AIDS, when people acted out of fear of a mysterious virus. “When people started telling me their stories, it felt like I was hearing all of these things that came about in the 1980s when no one knew anything about HIV/AIDS,” she says. With this series, Turkewitz hopes to put a real face on the epidemic by showing people that they have HIV-positive coworkers, friends, and family members. The goal is to reduce stigma, to humanize the disease, and to make tangible the struggles of marginalized HIVers. Government decision-makers and community leaders are a target audience as well. “The government is the leader,” Turkewitz says. “They set the tone. If they treat people with HIV without respect, other people are going to treat them the same way.” —Michelle Garcia
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Earnest, 51 | HATTIESBURG
Earnest fought in Desert Storm in 1990 and 1991. After his HIV diagnosis, he attempted suicide and was in a coma for several months. The lip-like scar on his cheek and the lengthy gash on his arm are a result of the attempt. Life continues to be a struggle. “I can take the blood, the bullets, the bombs, but I can’t take it when people look me in the face and say, ‘You’ve got that thang.’ You don’t know how many times in the last two, three years I’ve heard that.”
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DAVID , 42 | BILOXI
David’s mother kicked him out of his house because he has HIV. “She wouldn’t even hug me for a long time,” he says. David is a triplet, and his brother Daniel died of AIDS in 2002. Daniel never sought care and hid his HIV status from most people.
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jackie, 30 | jackson
Jackie has not found a way to explain HIV to her daughter Iyanla. “She’s my baby, I will have to, but I just don’t how yet. She’ll go to school, run her mouth. There’s a lot of discrimination.”
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Too Good to Be True
Ikon Images/Andy Baker
The U.S. government goes after companies with unregulated drugs that claim to treat—and in some cases cure—HIV and herpes when the economy is fragile and money is tight, people with HIV and other infections may look to the Internet or retail stores for treatment options that are less expensive than the meds prescribed by their doctors. But the U.S. Food and Drug Administration is warning consumers not to trust drugs that were never evaluated or approved by the federal government, specifically those claiming to cure HIV, herpes, and other incurable infections. Eleven manufacturers were issued letters on April 28 by the FDA and the Federal Trade Commission to stop making unproven claims with regards to their products. Among those manufacturers were Masterpeace Inc., which sells Disintegrate Formula and Detox Formula, claiming that its products treat HIV. Other drugs, such as Medavir, Herpaflor, Viruxo, C-Cure, and Never an Outbreak, are promoted as treatments or cures for herpes, but their claims have not been verified by the FDA. The companies were given 15 days to notify the agencies of their plans to take the necessary steps to come into compliance with the laws. If they fail to communicate these steps during that period, they may face legal action including seizure injunction or criminal prosecution. FDA public relations specialist Shelly Burgess says the government agencies will continue to monitor and investigate the trade of these drugs as well as enact regulations to stop the distribution of unapproved products. “It is expected that the announcement will send a strong message that profiting through health fraud and endangering public health will not be tolerated,” Burgess says. It is unknown exactly how many people
have purchased these products, but Brandon Macsata, CEO of the AIDS Drug Assistance Program (ADAP) Advocacy Association, says that this situation presents a clear example of why more could be done to regulate drug sales in the country. “We could say that the United States has the most strict regulations for prescription drugs, and there’s a reason,” he says. “We want to make sure people are getting the medication they’re supposed to be getting. We want to make sure it’s a legitimate product that will combat the disease or infection that they have.” Burgess suggests that people seeking treatment see a medical professional who can prescribe regulated, FDA-approved treatment. Macsata says he understands the economic hardships that many currently grapple with, which may keep people from paying for prescription medication and legitimate health care. “We’re facing the ADAP crisis, where there’s 8,000 people on waiting list to get medications, while government officials are parading around saying they’re getting help from pharmaceutical programs,” he says. “Still, we don’t know how many people are falling through the cracks. You have to look at it from the patient’s perspective. If you don’t have insurance and the one program you rely on says it can’t afford to serve you, you’re going to do what you can to get access to some medication.” Nonetheless, Macsata suggests finding other programs, charities, and other methods of finding sanctioned drugs. “My advice to any patient is if it sounds too good to be true, it probably is,” he says. “If you’re looking for a drug that costs $35 a day and you find it for $8, there’s probably a reason.” ✜
j u ly/a u g u s t 2 0 1 1 H I V P L U S
PrEP-ping for Disappointment A 2010 breakthrough paved a path for stopping the spread of HIV, but another study indicates it won’t be as broadly helpful as hoped
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New Brain Studies Provide Relief New data suggests that the effects of HIV on the brain may not be as severe as previously suspected while brain-function impairment and dementia brought on by HIV have long been a concern among doctors and people living with the virus, recent studies suggests that HIVers might be at a much lower risk for these complications than studies have previously suggested. Two years ago the results of a large study presented in Cape Town, South Africa, rattled the HIV community by revealing that 53% of the 1,555 HIV-positive people tested had at least a mild impairment of brain function. While in most cases the impairment was slight, it nonetheless raised concerns about the long-term effects of HIV on the brain. However, two new studies presented at the 17th annual conference of the British HIV Association in April offered less worrisome findings, indicating that brain impairment wasn’t much more common in people with HIV than in those without the virus. The first study examined 101 HIV-positive adults (average age 53) with no previous symptoms of brain problems. The rate of impairment found in this group was 19%, which is not only considerably lower than the 53% found in the previous study, it’s
only three percentage points above the rate of impairment found in the general population. The second study focused on 31 people between the ages of 16 and 25. Comparing their brain function with that of 14 of their HIV-negative brothers and sisters (making sure to match age, ethnicity, and gender), the results of two separate tests showed no more impairment in the HIVpositive youths than was found in their HIV-negative siblings. A third test, which focused on the effects of distress on memory and thinking problems, did yield higher instances of impairment in the group with HIV, but researchers suggest that these results could be affected by the level of depression and anxiety commonly found in people with the disease. Brain impairment can lead to loss of memory, concentration, or motor skills as well as cause behavioral changes and, in severe cases, dementia. While more research will need to be done in this area to determine specifically how HIV affects the brain, the new data provides hope for people concerned about the level of cognitive damage caused by the virus.
truvada: courtesy gilead sciencesw; ge t t y images
Headlines on HIV treatment and prevention news don’t get much bigger than one from last November, when researchers concluded that pre-exposure prophylaxis (PrEP)— antiretroviral medication taken prior to HIV exposure—dramatically reduced infection rates among gay men and transgender women. Those who took Truvada 90% of the time reported a 73% lower rate of infection, according to the study— lauded by one United Nations agency chief as “a breakthrough that will accelerate the prevention revolution.” Even sporadic Truvada users still had significantly lower risk of infection. However, one subsequent study this year has dimmed prospects that Truvada’s efficacy in preventing HIV infection spans all demographics, specifically females. On April 18 the FEM-PrEP study of HIV-negative women in Tanzania, Kenya, and South Africa was halted after its sponsor, global health organization FHI, determined that it “was highly unlikely to be able to demonstrate the effectiveness of Truvada…in preventing HIV infection in the study population, even if it continued to its originally planned conclusion,” FHI officials said. The reason for Truvada’s (a combination of tenofovir and emtricitabine) lack of success in the Phase III clinical trial—be it nonadherence to the regimen or a true difference in how the drug works in heterosexual women versus gay men—had yet to be explained as of press time. Researchers called the preliminary results “surprising and disappointing.” “When available, the final results from FEM-PrEP will make a strong contribution to our understanding of the use of antiretrovirals for HIV prevention,” FHI said in a news release.
INDICATIONS ISENTRESS is an anti-HIV medicine used for the treatment of HIV. ISENTRESS must be used with other anti-HIV medicines, which may increase the likelihood of response to treatment. The safety and effectiveness of ISENTRESS in children has not been studied. It is important that you remain under your doctorâ€™s care. ISENTRESS will NOT cure HIV infection or reduce your chance of passing HIV to others through sexual contact, sharing needles, or being exposed to your blood.
IMPORTANT RISK INFORMATION A condition called Immune Reconstitution Syndrome can happen in some patients with advanced HIV infection (AIDS) when anti-HIV treatment is started. Signs and symptoms of inflammation from opportunistic infections may occur as the medicines work to treat the HIV infection and strengthen the immune system. Call your doctor right away if you notice any signs or symptoms of an infection after starting ISENTRESS. Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness while taking ISENTRESS. This is because on rare occasions muscle problems can be serious and can lead to kidney damage. When ISENTRESS has been given with other anti-HIV drugs, side effects included nausea, headache, tiredness, weakness, trouble sleeping, stomach pain, dizziness, depression, and suicidal thoughts and actions. Mild rash occurred more often in patients taking ISENTRESS plus Prezista than with either drug alone.
You are special, unique, and different from anyone else. And so is your path to managing HIV. When you’re ready to start HIV therapy, talk to your doctor about a medication that may fit your needs and lifestyle. In clinical studies lasting 96 weeks, patients being treated with HIV medication for the first time who took ISENTRESS plus Truvada: Had a low rate of side effects — The most common side effect of moderate to severe intensity (that interfered with or kept patients from performing daily activities) was trouble sleeping — This side effect occurred more often in patients taking ISENTRESS plus Truvada (4%) versus Sustiva plus Truvada (3%) Experienced less effect on LDL cholesterol (“bad” cholesterol) — Cholesterol increased an average of 7 mg/dL with ISENTRESS plus Truvada versus 21 mg/dL with Sustiva plus Truvada — When they began the study, the average LDL cholesterol of patients on ISENTRESS plus Truvada was 96 mg/dL versus 93 mg/dL for those on Sustiva plus Truvada
Ask your doctor about ISENTRESS. Not sure where to start? Visit isentress.com/questions People taking ISENTRESS may still develop infections, including opportunistic infections or other conditions that occur with HIV infection. Tell your doctor about all of your medical conditions, including if you have any allergies, are pregnant or plan to become pregnant, or are breast-feeding or plan to breast-feed. ISENTRESS is not recommended for use during pregnancy. Women with HIV should not breast-feed because their babies could be infected with HIV through their breast milk. Tell your doctor about all the medicines you take, including prescription medicines like rifampin (a medicine used to treat infections such as tuberculosis), non-prescription medicines, vitamins, and herbal supplements. 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 more information about ISENTRESS, please read the Patient Information on the following page.
Need help paying for ISENTRESS? Call 1-866-350-9232 Copyright © 2011 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. INFC-1005193-0000-06/11(112) Sustiva is a registered trademark of Bristol-Myers Squibb Truvada is a registered trademark of Gilead Sciences, Inc. Prezista is a registered trademark of Tibotec, Inc.
Patient Information ISENTRESS ® (eye sen tris) (raltegravir) Tablets Read the patient information that comes with ISENTRESS1 before you start taking it and each time you get a refill. There may be new information. This leaflet is a summary of the information for patients. Your doctor or pharmacist can give you additional information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment. What is ISENTRESS? • ISENTRESS is an anti-HIV (antiretroviral) medicine used for the treatment of HIV. The term HIV stands for Human Immunodeficiency Virus. It is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). ISENTRESS is used along with other anti-HIV medicines. ISENTRESS will NOT cure HIV infection. • People taking ISENTRESS may still develop infections, including opportunistic infections or other conditions that happen with HIV infection. • Stay under the care of your doctor during treatment with ISENTRESS. • The safety and effectiveness of ISENTRESS in children has not been studied. ISENTRESS must be used with other anti-HIV medicines. How does ISENTRESS work? • ISENTRESS blocks an enzyme which the virus (HIV) needs in order to make more virus. The enzyme that ISENTRESS blocks is called HIV integrase. • When used with other anti-HIV medicines, ISENTRESS may do two things: 1. Reduce the amount of HIV in your blood. This is called your “viral load”. 2. Increase the number of white blood cells called CD4 (T) cells. • ISENTRESS may not have these effects in all patients. Does ISENTRESS lower the chance of passing HIV to other people? No. ISENTRESS does not reduce the chance of passing HIV to others through sexual contact, sharing needles, or being exposed to your blood. • Continue to practice safer sex. • Use latex or polyurethane condoms or other barrier methods to lower the chance of sexual contact with any body fluids. This includes semen from a man, vaginal secretions from a woman, or blood. • Never re-use or share needles. Ask your doctor if you have any questions about safer sex or how to prevent passing HIV to other people. What should I tell my doctor before and during treatment with ISENTRESS? Tell your doctor about all of your medical conditions. Include any of the following that applies to you: • You have any allergies. • You are pregnant or plan to become pregnant. - ISENTRESS is not recommended for use during pregnancy. ISENTRESS has not been studied in pregnant women. If you take ISENTRESS while you are pregnant, talk to your doctor about how you can be included in the Antiretroviral Pregnancy Registry. • You are breast-feeding or plan to breast-feed. - It is recommended that HIV-infected women should not breast-feed their infants. This is because their babies could be infected with HIV through their breast milk. - Talk with your doctor about the best way to feed your baby. Tell your doctor about all the medicines you take. Include the following: • prescription medicines, including rifampin (a medicine used to treat some infections such as tuberculosis) • non-prescription medicines • vitamins • herbal supplements Know the medicines you take. • Keep a list of your medicines. Show the list to your doctor and pharmacist when you get a new medicine. How should I take ISENTRESS? Take ISENTRESS exactly as your doctor has prescribed. The recommended dose is as follows: • Take only one 400-mg tablet at a time. • Take it twice a day. • Take it by mouth. • Take it with or without food. Do not change your dose or stop taking ISENTRESS or your other anti-HIV medicines without first talking with your doctor.
If you fail to take ISENTRESS the way you should, here’s what to do: • If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do NOT take two tablets of ISENTRESS at the same time. In other words, do NOT take a double dose. • If you take too much ISENTRESS, call your doctor or local Poison Control Center. Be sure to keep a supply of your anti-HIV medicines. • When your ISENTRESS supply starts to run low, get more from your doctor or pharmacy. • Do not wait until your medicine runs out to get more. What are the possible side effects of ISENTRESS? When ISENTRESS has been given with other anti-HIV drugs, side effects included: • nausea • headache • tiredness • weakness • trouble sleeping • stomach pain • dizziness • depression • suicidal thoughts and actions Other side effects include: rash, severe skin reactions, feeling anxious, paranoia, low blood platelet count, diarrhea, liver failure. A condition called Immune Reconstitution Syndrome can happen in some patients with advanced HIV infection (AIDS) when combination antiretroviral treatment is started. Signs and symptoms of inflammation from opportunistic infections that a person has or had may occur as the medicines work to treat the HIV infection and help to strengthen the immune system. Call your doctor right away if you notice any signs or symptoms of an infection after starting ISENTRESS with other anti-HIV medicines. Contact your doctor promptly if you experience unexplained muscle pain, tenderness, or weakness while taking ISENTRESS. This is because on rare occasions, muscle problems can be serious and can lead to kidney damage. Rash occurred more often in patients taking ISENTRESS and darunavir together than with either drug separately, but was generally mild. Tell your doctor if you have any side effects that bother you. These are not all the side effects of ISENTRESS. For more information, ask your doctor or pharmacist. How should I store ISENTRESS? • Store ISENTRESS at room temperature (68 to 77°F). • Keep ISENTRESS and all medicines out of the reach of children. General information about the use of ISENTRESS Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. • Do not use ISENTRESS for a condition for which it was not prescribed. • Do not give ISENTRESS to other people, even if they have the same symptoms you have. It may harm them. This leaflet gives you the most important information about ISENTRESS. • If you would like to know more, talk with your doctor. • You can ask your doctor or pharmacist for additional information about ISENTRESS that is written for health professionals. • For more information go to www.ISENTRESS.com or call 1-800-622-4477. What are the ingredients in ISENTRESS? Active ingredient: Each film-coated tablet contains 400 mg of raltegravir. Inactive ingredients: Microcrystalline cellulose, lactose monohydrate, calcium phosphate dibasic anhydrous, hypromellose 2208, poloxamer 407 (contains 0.01% butylated hydroxytoluene as antioxidant), sodium stearyl fumarate, magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, red iron oxide and black iron oxide.
IMPORTANT: Take ISENTRESS exactly as your doctor prescribed and at the right times of day because if you don’t: • The amount of virus (HIV) in your blood may increase if the medicine is stopped for even a short period of time. • The virus may develop resistance to ISENTRESS and become harder to treat. • Your medicines may stop working to fight HIV. • The activity of ISENTRESS may be reduced (due to resistance).
Distributed by: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA
Registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Copyright © 2007, 2009 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved.
Revised February 2011 9795112 U.S. Patent Nos. US 7,169,780 INFC-1005193-0000-06/11(112)
A new study confirms that early antiretroviral use may be the best medicine for keeping your HIV-negative partner uninfected
ge t t y images (2)
hiv-positive people with healthy immune systems who started taking oral antiretroviral medicine soon after becoming infected reduced the risk of transmitting the virus to their HIV-negative sexual partners by 96%, according to findings announced by the National Institute of Allergy and Infectious Diseases in May. NIAID director Anthony S. Fauci, MD, said previous data about using antiretrovirals to make HIVers less infectious to their sexual partners came largely from observational and epidemiological studies. “This new finding convincingly demonstrates that treating the infected individual— and doing so sooner rather than later—can have a major impact on reducing HIV transmission,” he said. The study, monitoring 1,762 couples, was begun in April 2005 by Myron Cohen, MD,
director of the Institute for Global Health and Infectious Diseases at the University of North Carolina at Chapel Hill. Ninety-seven percent of the couples participating in the global study were heterosexual. Before they entered the study, the HIVpositive partners’ CD4 counts had to be between 350 and 550 cells per cubic millimeter. The HIV-negative partners were tested to ensure that did not have the virus. The couples were split into two groups. The HIV-infected partner in the first group immediately started taking a combination of three antiretroviral drugs. HIV-positive partners in the other group did not start taking antiretroviral medications until their CD4 counts dropped below 250 cells per cubic millimeter. During the study, couples received treatment for any HIV-related complications,
A monkey vaccine trial may take scientists one step closer to finding an HIV vaccine for humans a new vaccine to immunize against simian immunodeficiency virus, which appears in African primates and is similar to HIV, has proven to be effective in about half of its test subjects who were later exposed to the virus, according to a new study published in the journal Nature. Lead researcher Louis Picker, MD, of Oregon Health and Science University, says the breakthrough came after 10 years of developing an SIV vaccine as a means to discover an HIV vaccine. Rhesus macaque monkeys from the Oregon National Primate Research Center were the subject of this trial. Of the monkeys who were vaccinated and then exposed to SIV, half were able to maintain long-term control of the virus. However, the unvaccinated animals that were exposed to the virus developed simian AIDS.
counseling on safe sex practices, STI treatment, and frequent medical monitoring. The trial was supposed to end in 2015, but NIAID released the findings early after an interim evaluation revealed the 96% reduction in risk.
Researchers chose the cytomegalovirus, or CMV, as the delivery system, or vector, for the vaccine. CMV is a benign virus to those without compromised immune systems. Between 50% and 80% of American adults are infected with CMV, which is related to the herpesvirus and may remain in the body for life. The vaccine it carries would build and maintain a resistance to HIV by programming certain T cells to remain on constant alert for the virus. Picker said that while the results of the study are groundbreaking, it could be years before scientists test the vaccine in humans. “Imagine if you’re looking at a very high, seemingly unscalable cliff,” he said. “And so far efforts to climb it have not reached the top. What this work basically does is show a path. We still have to climb the cliff, but we now have a path, which we can follow. We have a response that we know that’s protective of a highly aggressive virus that is similar to HIV, and we have a vector that generates those responses, so it should translate, but we still have to put on the climbing gear and climb the path.”
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MIND + MOOD
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Gary McClain, Ph.D.
Spiritual Self-Care Have you ever considered that living with HIV can be a spiritual experience?
a client i’ll call jen talked with me soon after receiving the news that she was HIV-positive. “I can’t help but ask why this happened to me, even though I’m not really expecting to find an answer. I just know that I want my life to have some kind of meaning beyond an HIV diagnosis. Having that focus is going to help me to get through this.” Another client, whom I’ll call Alex, has been living with HIV for many years and recently changed regimens. “I came home from my doctor’s appointment and I couldn’t help but think that I was being given yet another chance at life. I put on my favorite music and it sounded different than it has ever sounded before, almost as if I was hearing it for the first time. I felt connected to the world in a new way.” Living with HIV forces us to look at our basic beliefs about life, to face the reality of life. It can make us experience what it means to put love into action, beginning with loving ourselves. These challenges and the lessons they teach can be the launching pad for a spiritual awakening, which in turn contributes to overall emotional health. Want to explore your spiritual side? Here are some ideas for building more spirituality into your life. Practice mindfulness. We are only guaranteed this moment in time, no more and no less. Are you making the most of each moment, in the now, or are you focused on what already happened or what might happen? Mindfulness helps you to wake up to what’s real—and possible—right now. Meditate, contemplate, or pray. You might find it helpful to develop a regular meditation routine every day,
even for a few minutes, to relax the bang-banging going on in your head and let yourself just be. This is the foundation for mindfulness. Or spend some time focusing your mind on the meaning of your life, or on a positive idea or image. Most religions encourage some form of prayer as a way of communicating with a higher power, expressing appreciation, seeking guidance, and asking for help for ourselves and others. Read for inspiration. Spend some time reading an inspirational book, even just a page or two, to give you a hand in maintaining an optimistic attitude. Or find some spiritual resources on the Web. Build in a few minutes first thing in the morning or at the end of the day (or better yet, both). Enjoy what you most enjoy. It’s easy to fall into letting life happen around us or running on that treadmill of work and more work and forgetting to honor ourselves by doing the things we most enjoy. A medical condition can be a wake-up call to add more balance to life—including recreation and fun.
sounds of birds chirping or children playing in the park. Or hit the beach and listen to what the waves have to tell you. Embrace compassion. Accept yourself for who you are and celebrate your personal strengths as well as all the evidence that you are human and not superhuman. And then be sure to do the same for the other people in your life. Replace judgment with acceptance. Don’t forget—we are all in this world together. Share, care, volunteer. Put your compassion to work by doing something for someone in need. Help out a friend, a family member, or a stranger in need by offering just a few words of encouragement. Lend someone a listening ear. Put in an hour or two helping out with a cause that’s important to you.
Join a spiritual community. Joining a church, synagogue, temple, or other spiritual community brings you into contact with people who share your spiritual values, who can help you to deepen your day-to-day experience of spirituality and provide emotional support.
Joys—along with disappointments and sorrows—are a part of life. Having spiritual support for the road ahead can make all the difference in terms of coping with the inevitable challenges that spring up along the way as well as maintaining a hopeful and optimistic attitude. Spiritual self-care strengthens your foundation. It helps you to survive and thrive—and makes you a lot less likely to lose your balance when you hit the next bump in the road. You’re treating your HIV. But what are you doing for your spirit?
Experience nature. The natural world around us is a constant reminder that we are a part of something larger than our daily experiences. It’s still summer. Take quiet walks, sit outside and enjoy the sun, the breeze, the
McClain is a counselor in New York City with a specialty in coping with chronic health conditions. His books include The Complete Idiot’s Guide to Breaking Bad Habits and Empowering Your Life With Joy.
J u ly/A u g u s t 2 0 1 1 H I V P L U S
LIVING THE QUESTIONS
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What the World Needs Now
Thinking back on the time he discovered his status, our columnist makes a case for compassion for those new to living with HIV being diagnosed with HIV creates a weird emotional conflict. First you are told you have this horrible disease, and then five seconds later you’re being told to think positively because “you will live longer than anyone else ever has!” At least that’s what my doctor said in a chipper voice the day I was diagnosed. I remember crying and smiling at the time because I was worried he would think I didn’t hear him. But the smile disappeared. I found myself disgusted by my own body. I cringed at the sight of my urine. My own blood was jarring to me. Even though I was by all accounts perfectly healthy, I soon found the mental impact of this experience to be more than I could handle. One day, I was so paralyzed by my thoughts I couldn’t even muster the energy to get out of bed. That was the first time I ever missed work. I was constantly trying to make sense of an issue it seemed the rest of the world had long ago figured out. I watched HIV-positive friends date and form great outlooks on the world. I tried, but I only grew sadder each day. I would wake up feeling drunk and nauseous each morning due to my medication. Each day was becoming more unproductive than the previous. I was exhausted. I once had run seven miles a day, and now I barely went to the gym. My personality was gone. Once outgoing and assertive, I was now withdrawn and unhappy. I didn’t know how to fix it. Mind tired, body weary, spirit a void, I hit rock bottom. I don’t recall much from one particular Friday night, but what I do remember is waking up barely dressed, my apartment in shambles, with the sickening realization that it was now Sunday morning. The floor was littered with broken glasses from my kitchen, the AIDS-related book my sister had made me
ripped to pieces. An open bottle of Ambien lay under the bed. It was clear my intention had been to not wake up. I am thankful every day since then that I did wake up. The human mind is so complex in the way it processes feelings and the actions that follow. But I do think we can’t overlook the need to globally add a layer of emotional care to any treatment plan for HIV and AIDS. How? Well, it requires everyday people to take everyday actions. I think back and wish someone had simply asked me how I was doing. I would later find out another friend of mine had had a similar experience after diagnosis, and I wish he had shared it early on. It’s not as much the disease that affects the soul and spirit, but rather how we react to it, how we hide it, how we ignore it. People who are uninfected must force themselves to develop a new understanding and compassion for those living with the virus. And every step helps. Even mundane tasks like updating your online profiles, asking each person about their status before sex, or simply getting an HIV test are tasks that remind people HIV is not only very real, but it’s also OK. In these moments we have the power to help others be OK with themselves. Imagine the impact if there were a few less bruised souls and a few more caring spirits. Perhaps it starts by simply remembering that though we as individuals are responsible for our own journeys to happiness, it’s OK—and perhaps even our unspoken duty—to care about someone else’s. Tyler Helms is a former television journalist and advertising executive. He was diagnosed with HIV in 2007 and came out as positive on World AIDS Day, 2009.
j u ly/a u g u s t 2 0 1 1 H I V P L U S
STATUS SYMBOLS ASK + TELL
a campaign to help raise awareness. Very few people—I’m told only about 30% of the population in New York City—are aware that if you’ve been exposed to HIV you have 36 hours to embark on a course of treatment that can help eradicate it. It’s post-exposure prophylaxis [PEP]. How is the campaign doing? It’s doing well—it’s very grass roots at this point. The whole point is to try and take the fear and stigma out of being infected. Some of these shock and awe commercials for HIV are terrifying. For some people who are wired a certain way, it might make them aware and make them think, Wow, this is pretty scary shit—I better take care of myself. But for a lot of people, it just pushes them further into denial. The goal is to make people more apt to get tested and to follow through with treatment.
in addition to being a celebrity photographer, music video director, and star of the Logo network’s gay “housewives”-esque reality show, The A-List: New York, Mike Ruiz has long been involved in charitable causes. He recently hosted a kickoff event for AIDS Walk New York and continues to lend his time—and art—to raising money and awareness for HIV causes. How did you get involved with the AIDS Walk? [Event sponsor] GMHC (GMHC.org) contacted me last November asking me to participate in their Fashion Forward event, so I donated [photographs] for their silent auction. And since then I’ve been doing whatever I can to raise awareness for them. When they asked me to be a guest bartender at the kickoff event for the AIDS Walk, I said yes. We raised a nice chunk of change, and I had a great time. Why is it so important for you to give back to the community? I grew up gay in a very blue-collar suburban environment and overcame a lot of challenges to find my way to New York City, where I made a great
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life for myself. And after waking up one day feeling incredibly grateful and fortunate, I began to notice that there were many heartbreaking things needing attention. I felt like I had to do something. It was involuntary. And now it’s ingrained in my identity. I would really feel empty if I weren’t doing as much as I’m doing. You shot the image for the Men’s Sexual Health Program’s “36:00” campaign. How did that come about? My friend Dr. Demetre Daskalakis, who works at the NYU School of Medicine in infectious diseases, mounted a program in which they go into bathhouses and clubs and do actual HIV testing on site. I shot
When were you first impacted by HIV or AIDS? I’d been hearing stories about it since high school, but my first roommate in Miami in 1992 had HIV, and he later succumbed to it. After I moved away from Miami, we would talk on the phone, and over the course of a couple years his voice started changing. He never told me he was infected, and when I got the call that he was gone, it just knocked the wind out of me. Will we see any of your AIDS activism on the upcoming season of The A-List: New York? I hope so, but I don’t have much control over what people see. I’ve learned that you have to put a certain spin on things to get them to include it on the show, because at the end of the day it’s a reality show and it’s meant to be entertaining. But I don’t ever want to trivialize anything I’m doing just to get it on TV. ✜
Keeping It Real
You do a lot of work with gay youth. What observations have you made about the younger generation’s perceptions of HIV versus your own generation’s? My generation grew up thinking HIV was a death sentence, so we have a completely different mindset from those who seem to view this as a manageable disease. Dr. Daskalakis educated me a lot on the statistics, and it turns out there’s a rise of infection among young people, which can be attributed to the fact that they don’t seem to have the sense of urgency my generation did.
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