Positive Women: Making decisions, creating policy, and improving lives. Also this issue: News from the International AIDS Conference, a tour of the National Institutes of Health, and facing up to lipoatrophy.
positivelyaware.com September+OCTOBER 2012 CURE NEWS FROM AIDS 2012 facing up to lipoatrophy POSITIVE Women Making decisions, creating policy, and improving lives ABOUT PREZISTA ® PREZISTA® is always taken with and at the same time as ritonavir (Norvir ®), in combination with other HIV medicines for the treatment of HIV infection in adults. PREZISTA® should also be taken with food. • The use of other medicines active against HIV in combination with PREZISTA®/ritonavir (Norvir ®) may increase your ability to ﬁght HIV. Your healthcare professional will work with you to ﬁnd the right combination of HIV medicines • It is important that you remain under the care of your healthcare professional during treatment with PREZISTA® PREZISTA® does not cure HIV infection or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using PREZISTA.® Please read Important Safety Information below, and talk to your healthcare professional to learn if PREZISTA® is right for you. IMPORTANT SAFETY INFORMATION What is the most important information I should know about PREZISTA®? • PREZISTA® can interact with other medicines and cause serious side effects. See “Who should not take PREZISTA®?” • PREZISTA® may cause liver problems. Some people taking PREZISTA,® together with Norvir ® (ritonavir), have developed liver problems which may be life-threatening. Your healthcare professional should do blood tests before and during your combination treatment with PREZISTA.® If you have chronic hepatitis B or C infection, your healthcare professional should check your blood tests more often because you have an increased chance of developing liver problems • Tell your healthcare professional if you have any of these signs and symptoms of liver problems: dark (tea-colored) urine, yellowing of your skin or whites of your eyes, pale-colored stools (bowel movements), nausea, vomiting, pain or tenderness on your right side below your ribs, or loss of appetite • PREZISTA® may cause a severe or life-threatening skin reaction or rash. Sometimes these skin reactions and skin rashes can become severe and require treatment in a hospital. You should call your healthcare professional immediately if you develop a rash. However, stop taking PREZISTA® and ritonavir combination treatment and call your healthcare professional immediately if you develop any skin changes with these symptoms: fever, tiredness, muscle or joint pain, blisters or skin lesions, mouth sores or ulcers, red or inflamed eyes, like “pink eye.” Rash occurred more often in patients taking PREZISTA® and raltegravir together than with either drug separately, but was generally mild Who should not take PREZISTA®? • Do not take PREZISTA® if you are taking the following medicines: alfuzosin (Uroxatral®), dihydroergotamine (D.H.E.45,® Embolex,® Migranal®), ergonovine, ergotamine (Cafergot,® Ergomar ®), methylergonovine, cisapride (Propulsid®), pimozide (Orap®), oral midazolam, triazolam (Halcion®), the herbal supplement 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, indinavir (Crixivan®), lopinavir/ ritonavir (Kaletra®), saquinavir (Invirase®), boceprevir (Victrelis™), or telaprevir (Incivek™) • Before taking PREZISTA,® tell your healthcare professional if you are taking sildenaﬁl (Viagra,® Revatio®), vardenafil (Levitra,® Staxyn®), tadalafil (Cialis,® Adcirca®), atorvastatin (Lipitor ®), rosuvastatin (Crestor ®), pravastatin (Pravachol®), or colchicine (Colcrys,® Col-Probenecid®). Tell your healthcare professional 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 condoms This is not a complete list of medicines. Be sure to tell your healthcare professional about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements. What should I tell my doctor before I take PREZISTA®? • Before taking PREZISTA,® tell your healthcare professional if you have any medical conditions, including liver problems (including hepatitis B or C), allergy to sulfa medicines, diabetes, or hemophilia • Tell your healthcare professional if you are pregnant or planning to become pregnant, or are breastfeeding — The effects of PREZISTA® on pregnant women or their unborn babies are not known. You and your healthcare professional will need to decide if taking PREZISTA® is right for you — Do not breastfeed. It is not known if PREZISTA® can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV should not breastfeed because HIV can be passed to your baby in the breast milk What are the possible side effects of PREZISTA®? • High blood sugar, diabetes or worsening of diabetes, and increased bleeding in people with hemophilia have been reported in patients taking protease inhibitor medicines, including PREZISTA® • Changes in body fat have been seen in some patients taking HIV medicines, including PREZISTA.® The cause and long-term health effects of these conditions are not known at this time • Changes in your immune system can happen when you start taking HIV medicines. Your immune system may get stronger and begin to ﬁght infections that have been hidden • The most common side effects related to taking PREZISTA® include diarrhea, nausea, rash, headache, stomach pain, and vomiting. This is not a complete list of all possible side effects. If you experience these or other side effects, talk to your healthcare professional. Do not stop taking PREZISTA® or any other medicines without ﬁrst talking to your healthcare professional 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 refer to the ritonavir (Norvir ®) Product Information (PI and PPI) for additional information on precautionary measures. Please read accompanying Patient Information for PREZISTA® and discuss any questions you have with your doctor. 28PRZDTC0288R8 PREZISTA® (darunavir) is a prescription medicine. It is one treatment option in the class of HIV (human immunodeficiency virus) medicines known as protease inhibitors. IS THE PREZISTA ® EXPERIENCE RIGHT FOR YOU? There is no other person in the world who is exactly like you. And no HIV treatments are exactly alike, either. That’s why you should ask your healthcare professional about PREZISTA® (darunavir). Once-Daily PREZISTA® taken with ritonavir and in combination with other HIV medications can help lower your viral load and keep your HIV under control over the long term. In a clinical study* of almost 4 years (192 weeks), 7 out of 10 adults who had never taken HIV medications before maintained undetectable† viral loads with PREZISTA® plus ritonavir and Truvada.® Find out if the PREZISTA® EXPERIENCE is right for you. Ask your healthcare professional and learn more at DiscoverPREZISTA.com Please read the Important Safety Information and Patient Information on adjacent pages. Snap a quick pic of our logo to show your doctor and get the conversation started. *A randomized open label Phase 3 trial comparing PREZISTA®/ritonavir 800/100 mg once daily (n=343) vs. Kaletra®/ritonavir 800/200 mg/day (n=346). †Undetectable was defined as a viral load of less than 50 copies per mL. Registered trademarks are the property of their respective owners. Janssen Therapeutics, Division of Janssen Products, LP © Janssen Therapeutics, Division of Janssen Products, LP 2012 06/12 28PRZ12036G IMPORTANT PATIENT INFORMATION PREZISTA (pre-ZIS-ta) (darunavir) Oral Suspension PREZISTA (pre-ZIS-ta) (darunavir) Tablets 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 healthcare provider about your medical condition or your treatment. Also read the Patient Information leaflet for NORVIR® (ritonavir). What is the most important information I should know about PREZISTA? • PREZISTA can interact with other medicines and cause serious side effects. It is important to know the medicines that should not be taken with PREZISTA. See the section “Who should not take PREZISTA?” • PREZISTA may cause liver problems. Some people taking PREZISTA in combination with NORVIR® (ritonavir) have developed liver problems which may be life-threatening. Your healthcare provider should do blood tests before and during your combination treatment with 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. • Tell your healthcare provider if you have any of the below signs and symptoms of liver problems. • Dark (tea colored) urine • yellowing of your skin or whites of your eyes • pale colored stools (bowel movements) • nausea • vomiting • pain or tenderness on your right side below your ribs • loss of appetite PREZISTA may cause severe or life-threatening skin reactions or rash. Sometimes these skin reactions and skin rashes can become severe and require treatment in a hospital. You should call your healthcare provider immediately if you develop a rash. However, stop taking PREZISTA and ritonavir combination treatment and call your healthcare provider immediately if you develop any skin changes with symptoms below: • fever • tiredness • muscle or joint pain • blisters or skin lesions • mouth sores or ulcers • red or inflamed eyes, like “pink eye” (conjunctivitis) Rash occurred more often in patients taking PREZISTA and raltegravir together than with either drug separately, but was generally mild. See “What are the possible side effects of PREZISTA?” for more information about side effects. What is PREZISTA? PREZISTA is a prescription anti-HIV medicine used with ritonavir and other anti-HIV medicines to treat adults with human immunodeficiency virus (HIV-1) infection. PREZISTA is a type of anti-HIV medicine called a protease inhibitor. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). When used with other HIV medicines, PREZISTA may help to reduce the amount of HIV in your blood (called “viral load”). PREZISTA may also help to increase the number of white blood cells called CD4 (T) cell which help fight off other infections. Reducing the amount of HIV and increasing the CD4 (T) cell count may improve your immune system. This may reduce your risk of death or infections that can happen when your immune system is weak (opportunistic infections). PREZISTA does not cure HIV infection or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using PREZISTA. Avoid doing things that can spread HIV-1 infection. • 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. • D o not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood. Ask your healthcare provider if you have any questions on how to prevent passing HIV to other people. Who should not take PREZISTA? Do not take PREZISTA with any of the following medicines: • alfuzosin (Uroxatral®) • dihydroergotamine (D.H.E. 45®, Embolex®, Migranal®), ergonovine, ergotamine (Cafergot®, Ergomar®) methylergonovine • cisapride • pimozide (Orap®) • oral midazolam, triazolam (Halcion®) • the herbal supplement St. John’s Wort (Hypericum perforatum) • the cholesterol lowering medicines lovastatin (Mevacor®, Altoprev®, Advicor®) or simvastatin (Zocor®, Simcor®, Vytorin®) • rifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®) • sildenafil (Revatio®) only when used for the treatment of pulmonary arterial hypertension. Serious problems can happen if you take any of these medicines with PREZISTA. What should I tell my doctor before I take PREZISTA? PREZISTA may not be right for you. Before taking PREZISTA, tell your healthcare provider if you: • have liver problems, including hepatitis B or hepatitis C • are allergic to sulfa medicines • have high blood sugar (diabetes) • have hemophilia • are pregnant or planning to become pregnant. It is not known if PREZISTA will harm your unborn baby. Pregnancy Registry: 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. The purpose of the registry is follow the health of you and your baby. • are breastfeeding or plan to breastfeed. Do not breastfeed. We do not know if PREZISTA can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk. Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Using PREZISTA and certain other medicines may affect each other causing serious side effects. PREZISTA may affect the way other medicines work and other medicines may affect how PREZISTA works. Especially tell your healthcare provider if you take: • medicine to treat HIV • 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. • medicine for your heart such as bepridil, lidocaine (Xylocaine Viscous®), quinidine (Nuedexta®), amiodarone (Pacerone®, Cardarone®), digoxin (Lanoxin ®), flecainide (Tambocor ®), propafenone (Rythmol®) • warfarin (Coumadin®, Jantoven®) • medicine for seizures such as carbamazepine (Carbatrol®, Equetro®, Tegretol®, Epitol®), phenobarbital, phenytoin (Dilantin®, Phenytek®) • medicine for depression such as trazadone and desipramine (Norpramin®) • clarithromycin (Prevpac®, Biaxin®) • medicine for fungal infections such as ketoconazole (Nizoral®), itraconazole (Sporanox®, Onmel®), voriconazole (VFend®) • colchicine (Colcrys®, Col-Probenecid®) • rifabutin (Mycobutin®) • medicine used to treat blood pressure, a heart attack, heart failure, or to lower pressure in the eye such as metoprolol (Lopressor®, Toprol-XL®), timolol (Cosopt®, Betimol®, Timoptic®, Isatolol®, Combigan®) • midazolam administered by injection • medicine for heart disease such as felodipine (Plendil®), nifedipine (Procardia®, Adalat CC®, Afeditab CR®), nicardipine (Cardene®) IMPORTANT PATIENT INFORMATION • s teroids such as dexamethasone, fluticasone (Advair Diskus®, Veramyst®, Flovent®, Flonase®) • bosentan (Tracleer®) • medicine to treat chronic hepatitis C such as boceprevir (VictrelisTM), telaprevir (IncivekTM) • medicine for cholesterol such as pravastatin (Pravachol®), atorvastatin (Lipitor®), rosuvastatin (Crestor®) • medicine to prevent organ transplant failure such as cyclosporine (Gengraf®, Sandimmune®, Neoral®), tacrolimus (Prograf®), sirolimus (Rapamune®) • salmeterol (Advair®, Serevent®) • medicine for narcotic withdrawal such as methadone (Methadose®, Dolophine Hydrochloride), buprenorphine (Butrans®, Buprenex®, Subutex®), buprenorphine/naloxone (Suboxone®) • medicine to treat schizophrenia such as risperidone (Risperdal®), thioridazine • medicine to treat erectile dysfunction or pulmonary hypertension such as sildenafil (Viagra®, Revatio®), vardenafil (Levitra®, Staxyn®), tadalafil (Cialis®, Adcirca®) • medicine to treat anxiety, depression or panic disorder such as sertraline (Zoloft®), paroxetine (Paxil®) This is not a complete list of medicines that you should tell your healthcare provider that you are taking. Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine. Do not start any new medicines while you are taking PREZISTA without first talking with your healthcare provider. How should I take PREZISTA? • Take PREZISTA 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. If you have difficulty swallowing PREZISTA tablets, PREZISTA oral suspension is also available. Your health care provider will help determine whether PREZISTA tablets or oral suspension is right for you. • PREZISTA oral suspension should be given with the supplied oral dosing syringe. Shake the suspension well before each usage. • If you take too much PREZISTA, call your healthcare provider or go to the nearest hospital emergency room right away. What should I do if I miss a dose? People who take PREZISTA one time a day: • If you miss a dose of PREZISTA by less than 12 hours, take your missed dose of PREZISTA right away. Then take your next dose of PREZISTA at your regularly scheduled time. • If you miss a dose of PREZISTA by more than 12 hours, wait and then take the next dose of PREZISTA at your regularly scheduled time. People who take PREZISTA two times a day • If you miss a dose of PREZISTA by less than 6 hours, take your missed dose of PREZISTA right away. Then take your next dose of PREZISTA at your regularly scheduled time. • If you miss a dose of PREZISTA by more than 6 hours, wait and then take the next dose of PREZISTA at your regularly scheduled time. If a dose of PREZISTA is skipped, do not double the next dose. Do not take more or less than your prescribed dose of PREZISTA at any one time. What are the possible side effects of PREZISTA? PREZISTA can cause side effects including: • See “What is the most important information I should know about PREZISTA?” • Diabetes and high blood sugar (hyperglycemia). Some people who take protease inhibitors including PREZISTA can get high blood sugar, develop diabetes, or your diabetes can get worse. Tell your healthcare provider if you notice an increase in thirst or urinate often while taking PREZISTA. • Changes in body fat. These changes can happen in people who take antiretroviral therapy. 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 exact cause and longterm health effects of these conditions are not known. • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Call your healthcare provider right away if you start having new symptoms after starting your HIV medicine. • Increased bleeding for hemophiliacs. Some people with hemophilia have increased bleeding with protease inhibitors including PREZISTA. The most common side effects of PREZISTA include: • diarrhea • headache • nausea • abdominal pain • rash • vomiting Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of PREZISTA. For more information, ask your health care provider. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. How should I store PREZISTA? • Store PREZISTA oral suspension and tablets at room temperature [77°F (25°C)]. • Do not refrigerate or freeze PREZISTA oral suspension. • Keep PREZISTA away from high heat. • PREZISTA oral suspension should be stored in the original container. Keep PREZISTA and all medicines out of the reach of children. General information about PREZISTA Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use PREZISTA for a condition for which it was not prescribed. Do not give PREZISTA to other people even if they have the same condition you have. It may harm them. This leaflet summarizes the most important information about PREZISTA. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about PREZISTA that is written for health professionals. For more information, call 1-800-526-7736. What are the ingredients in PREZISTA? Active ingredient: darunavir Inactive ingredients: PREZISTA Oral Suspension: hydroxypropyl cellulose, microcrystalline cellulose, sodium carboxymethylcellulose, methylparaben sodium, citric acid monohydrate, sucralose, masking flavor, strawberry cream flavor, hydrochloric acid (for pH adjustment), purified water. PREZISTA 75 mg and 150 mg Tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose. The film coating contains: OPADRY® White (polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide). PREZISTA 400 mg and 600 mg Tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose. The film coating contains: OPADRY® Orange (FD&C Yellow No. 6, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide). This Patient Information has been approved by the U.S Food and Drug Administration. Manufactured by: PREZISTA Oral Suspension Janssen Pharmaceutica, N.V. Beerse, Belgium PREZISTA Tablets Janssen Ortho LLC, Gurabo, PR 00778 Manufactured for: Janssen Therapeutics, Division of Janssen Products, LP, Titusville NJ 08560 NORVIR® is a registered trademark of its respective owner. PREZISTA® is a registered trademark of Janssen Pharmaceuticals © Janssen Pharmaceuticals, Inc. 2006 Revised: June 2012 986588P 5537 N. Broadway St. Chicago, IL 60640 phone: (773) 989–9400 fax: (773) 989–9494 email: email@example.com www.positivelyaware.com editor-in-Chief Jeff Berry associate editor Enid Vázquez Sue Saltmarsh, Jason Lancaster Web Master Joshua Thorne Creative director Rick Guasco copy Editors EXCLUSIVELY ON www.positivelyaware.com contributing writers Keith R. Green, Liz Highleyman, Sal Iacopelli, Laura Jones, Jim Pickett, Matt Sharp photographers Chris Knight, Joshua Thorne Surface vs. substance A website—and app—that encourages truth in Internet dating www.positivelyaware.com/2012/12_06/mister.shtml Additional conference coverage from AIDS 2012 www.positivelyaware.com/2012/12_06/aids2012.shtml Medical advisors Daniel S. Berger, MD Gary Bucher, MD Michael Cristofano, PA Joel Gallant, MD Swarup Mehta, PharmD advertising inquiries Lorraine Hayes firstname.lastname@example.org distribution Manager Bradley P Mazzie Follow us on Facebook and on TwitteR (@posaware) We read you comment on our articles at POSITIVELYAWARE.COM © 2012. Positively Aware (ISSN: 1523-2883) is published bi-monthly by Test Positive Aware Network (TPAN), 5537 N. Broadway St, Chicago, IL 60640. TPAN is an Illinois not-for-profit corporation, providing information and support to anyone concerned with HIV and AIDS issues. Positively Aware is a registered trademark of TPAN. All rights reserved. Circulation: 100,000. For reprint permission, contact Sue Saltmarsh. Six issues mailed bulk rate for $30 donation; mailed free to those living with HIV or those unable to contribute. We accept contribution of articles covering medical or personal aspects of HIV/AIDS. We reserve the right to edit or decline submitted articles. When published, the articles become the property of TPAN and its assigns. You may use your actual name or a pseudonym for publication, but please include your name and phone number. email@example.com Although Positively Aware takes great care to ensure the accuracy of all the information that it presents, Positively Aware staff and volunteers, TPAN, or the institutions and personnel who provide us with information cannot be held responsible for any damages, direct or consequential, that arise from use of this material or due to errors contained herein. Opinions expressed in Positively Aware are not necessarily those of staff or TPAN, its supporters and sponsors, or distributing agencies. Information, resources, and advertising in Positively Aware do not constitute endorsement or recommendation of any medical treatment or product. TPAN recommends that all medical treatments or products be discussed thoroughly and frankly with a licensed and fully HIV-informed medical practitioner, preferably a personal physician. POSITIVELY AWARE IS PUBLISHED BY A model, photographer, or author’s HIV status should not be assumed based on their appearance in Positively Aware, association with TPAN, or contributions to this journal. Distribution of Positively Aware is supported in part through an unrestricted grant from ViiV Healthcare. 4 S E PTE MB E R +O C TO B ER 201 2 P os i t iv e lyAware .com SEP+OCT 2012 VOLUME 24 NUMBER 6 D e pa r t m e n t s 6 In Box 6 Readers’ poll 7 editor’s Note What is a woman? 13 Briefly FDA approves Truvada for HIV prevention. Rapid home HIV test approved. Initial study results find dolutegravir/Epzicom is superior to Atripla. 34 Conference Update News from the XIX International AIDS Conference in Washington, D.C. 44 ask the HIV specialist Safe sex is for seniors, too. 45 WHOLISTIC PICTURE Battle of the sexes? c o v e r F e at u r e s 22 Securing care for HIV-positive women Challenges and solutions for women living with HIV. 26 Black women, society, and HIV An expert talks about the context of infection. 28 ‘Everyone needs a support system’ How one therapist helps HIV-positive women learn to take care of themselves. 30 Nine months to birth day HIV and pregnancy—keeping yourself and your baby healthy. F e at u r e 41 The mirror has two faces A personal account of using facial filler for lipoatrophy. On the cover and this page: Tamara wilson, HIV-Positive since 1999, photographed by chris Knight P osi t i velyAware.com S E P T E MB E R+ OC TOB E R 2 01 2 5 In Box join the conversation: firstname.lastname@example.org and @posaware In the JULY+AUGUST issue, we asked HIV testing in prison? First let me say this is strictly my opinion in answer to your reader’s poll question concerning HIV testing in prison. I believe it should be required upon entering and leaving prison. Prior to my incarceration, I worked at Prevention Point Philadelphia (a needle exchange program), the Gay & Lesbian AIDS Education Initiative, and I spoke at various events about HIV/AIDS in the prison system. I’ve been positive for 18 years and for the last 11 years I’ve been trying to get as many people tested as possible. At present, I have three and a half years left on my sentence. During my incarceration, I have been a Peer Educator teaching a class called Positive Voices behind the Walls (a little plug never hurts!) and an advocate for testing. I’m open about my HIV status, so HIV can have a “face” that defies the expectations of some of the men in here. After taking my class for 16 weeks, I have seen men’s attitudes change completely because they see me living healthy, happy, with a loving family, and looking forward to a long life. So, yes, testing should be mandatory, along with education and good information about prevention. —Larry White Deer, Pennsylvania You’re not the only one Finally, I’ve found relief! On May 21st, I read my first ever issue of Positively Aware—the March+April Drug Guide. Readers’ poll Before you tested HIV-positive, did you think you were at risk? I had no idea that anyone has the same problems as me. The issue touched me deeply. Simply knowing you’re there, that I can reach out to someone for information seems to make everything a little bit better. I’m not sure how to receive future issues, but put me on your mailing list if at all possible! —Dwayne E. No. 8% I didn’t think about it. 16% Yes, but I practiced safer sex. 24% Yes, but I thought I was at low risk. Yes, but I didn’t care. 33% 19% Florida Good wishes Your comments: Comment on July+August Editor’s Note: Thank you for the uplifting article, “Wish HIV Away.” Though easier said than done, I know that I’ll be able to pick my head up in the morning and continue on with a positive outlook on the day. I’m not at the stage yet where people can know, only because I’m just two months into this disease, but I know I will get there (fingers crossed). —Steven “I barebacked all the way after my first encounter—I have no one to blame but myself and my lack of self-esteem.” via thebody.com Hidden no more I have to let you guys know how much I appreciated the article, “The Hidden People,” in your January+February 2012 issue. I would love to have the Muslim brothers come to Memphis to speak in the very near future. My southern hat goes off to the writer Sue Saltmarsh for the article. And love to Karim Rush, Shadeed Jenkins, and Iman Boyd. Great job, POSITIVELY AWARE! You guys rock! —Anthony Hardaway via the Internet “After I found out, I wanted to kill myself— my partner never told me he had HIV.” “Before I tested positive, I always practiced safe sex. But I also remember feeling like no matter how much of a good boy I was, HIV was going to get me.” “I practiced safer sex until depression and drugs got in my way.” “I never thought about it. I suspect I was infected in 1986. At that time, there wasn’t much information available about infection and I had no idea what behavior was risky and what wasn’t.” “I thought those who caught HIV led reckless lives, taking drugs and having many anonymous partners and unprotected sex. I was naïve to believe I would be OK if I limited myself to one casual partner every few months.” Do the write thinG. Positively Aware treats all communications (letters, e-mail, etc.) as letters to the editor unless otherwise instructed. We reserve the right to edit for length, style, or clarity. Unless you tell us not to, we will use your name and city. Positively aware We read you. 5537 N. Broadway St. Chicago, IL 60640 SHare your comments about our articles at POSITIVELYAWARE.COM email@example.com 6 S E PTE M B E R +O C TO B ER 201 2 this issue’s poll question: Who is more stigmatized because of HIV? cast your vote at positivelyaware.com P os it iv e lyAware .com Editor’s NOTE Jeff Berry @PAeditor What is a woman? PHOTO: Chris Knight I’ve had many teachers in life, including women up of mostly women, HIV-positive who have taught me particularly important lessons about educator and activist Linda Scruggs said it best by stating she wasn’t courage, strength, resilience, caring, and compassion. going to ask for anything, because women have been asking to be Cindy, the oldest of my three sisters, realized at an counted in for the last two decades. “Today I stand here early age that it was her job to help look after the other to give you some directions. We’ve decided to stop askfour kids in the Berry clan. My sister Barb became a ing, and maybe you just need the recipe.” veterinarian, the first doctor in our family. The one who Scruggs called for meaningful involvement of women was closest to me in age, Wendy, became my best friend at every level, from the government to local communities growing up. My mother Norma went back to work when and organizations, and also made it clear that women are I started preschool in the early 1960’s, and continued not just asking for male-run organizations that “tolerate” a working as a schoolteacher and elementary school prinwomen’s program. “We need the support and resources… cipal until she retired. And my grandmother, Ruby, lived to give us the power to heal our sisters, to change our to be 101, and would often recount to us colorful stories men. We are the mothers of the earth.” from her life, such as the one about traveling all day in In her talk, Scruggs also shared part of what she says a covered wagon to see the Wright Brothers perform got her to the stage that day. She learned she was HIVbreathtaking feats in their amazing flying machines. positive while visiting a perinatal clinic and was 13-weeks All these women and others demonstrated to me pregnant, and had to decide whether to terminate the wonderful qualities that I respected and admired, and pregnancy and live five years, or have the baby and possought to emulate and incorporate into my own sense sibly live three. She says she’s glad that day the doctor of values and ideals. There are countless examples in was wrong, and her son, Isaiah, was born free of HIV, our culture of strong, courageous women and their and he just recently turned 21. many accomplishments and contributions to the world. “I could’ve made the decision to have an abortion. So why is it that so many women who are in positions An abortion would not have been the first one I had had, of power and leadership appear threatening to so many but I had an experience with God. I had an experience who live in our male-dominated society? that…made me really look and reflect about women. A recurring theme at this year’s International AIDS After all, what is a woman who thinks she’s ugly? What Conference was the role of women in ending the is a woman who feels she has no self-value? What is a epidemic. In her address at the conference opening woman who allows not one, but two men to rape her in plenary, Secretary of State Hillary Clinton talked about silence? What is a woman who allows an uncle to molest the essential role of communities, especially people livher and others and still be silent?... What is a woman ing with HIV, in turning the tide on the epidemic. “And it who feels that she’s been broken and voiceless? What is will come as no surprise to you,” Clinton told the packed a woman who’s afraid of understanding herself? What audience, “that I would like to highlight the particular is a woman who spent a lifetime trying to be someone role that women play.” other than herself? Clinton pointed out that in Sub-Saharan Africa “I’ll tell you, that cold November day, that woman women account for 60% of people living with HIV. was me, but it was through the support of this commu“Women want to protect themselves, and they want nity that I was able to find a voice and a place, that adequate health care, and we need to answer their call,” I could be just who I say I am. I am a woman.” said Clinton. “Every woman should be able to decide when and whether to have children. This is true if she is Take care of yourself, and each other. HIV-positive or not. Women need and deserve a voice in the decisions that affect their lives.” In a lively morning plenary session by a panel made P osi t i velyAware.com There are countless examples in our culture of strong, courageous women and their many accomplishments and contributions to the world. So why is it that so many women who are in positions of power and leadership appear threatening to so many who live in our maledominated society? S E P T E MB E R+ OC TOB E R 2 01 2 7 Please turn past this page; it has intentionally been left blank. POSITIVELY AWARE âž¤ Please turn past this page; it has intentionally been left blank. POSITIVELY AWARE âž¤ Please turn past this page; it has intentionally been left blank. POSITIVELY AWARE âž¤ Please turn past this page; it has intentionally been left blank. POSITIVELY AWARE âž¤ Please turn past this page; it has intentionally been left blank. POSITIVELY AWARE âž¤ BRIEFLY Enid Vázquez Photo: Joshua Thorne FDA approves Truvada for PrEP The Food and Drug Administration (FDA) in July approved Truvada as the first medication to help prevent HIV infection. As expected, the approval came with restrictions. Truvada, a combination of tenofovir (Viread) and emtricitabine (Emtriva), is one of the most prescribed medications for HIV in this country. For HIV prevention, the use of Truvada is called “PrEP,” for “pre-exposure prophylaxis.” “[We] commend the FDA’s approval of [Truvada] for the use of [PrEP] to prevent HIV transmission. This approach can prevent many new infections and could dramatically impact HIV transmission worldwide,” said Kenneth H. Mayer, MD, Medical Research Director and Co-chair of The Fenway Institute at Fenway Health. “My colleagues and I are delighted to have helped to demonstrate the utility of this promising approach for HIV prevention.” David Ernesto Munar, President/CEO of the AIDS Foundation of Chicago, said, “Our challenge now is to implement PrEP as strategically as possible, and to ensure the people who need it most, those who are most at risk for HIV, have access.” “This is an enormous turning point, a real game changer, in the fight against HIV,” said Jim Pickett, AFC’s Director of Prevention Advocacy and Gay Men’s Health. “The toolbox we have now has Truvada as PrEP. We can look forward to more sex acts being protected, especially among individuals who have already chosen, for whatever reason, to not use condoms consistently.” According to a press release from the FDA, “Truvada is to be used for [PrEP] in combination with safer sex practices to prevent sexually-acquired HIV infection in adults at high risk.” The FDA said Truvada for PrEP should be used as part of a comprehensive HIV prevention plan that includes risk P osi t i velyAware.com reduction counseling, consistent and correct condom use, regular HIV testing, and screening for and treatment of other sexually-transmitted infections, stating that “Truvada is not a substitute for safer sex practices.” Truvada now carries a Boxed Warning on its drug label alerting health care professionals and uninfected individuals that Truvada for PrEP must only be used by people confirmed to be HIV-negative before being prescribed the drug and tested at least every three months during use to reduce the risk of developing drug resistance. Both the antiviral and the PrEP dose is one pill taken once daily. Truvada maker Gilead Sciences worked with the FDA to create a Risk Evaluation and Mitigation Strategy (REMS) for Truvada PrEP. The REMS focuses on a prescriber training and education program in counseling and managing individuals who are taking or considering Truvada for PrEP. The REMS looks at the elements of a comprehensive HIV prevention strategy, the importance of adhering to the recommended daily dosing regimen, and the serious risks of taking Truvada for PrEP if already infected with HIV or of becoming infected while taking it. According to the press release, “Truvada’s safety and efficacy for PrEP were demonstrated in two large, randomized, double-blind, placebo-controlled clinical trials. The iPrEx trial evaluated Truvada in 2,499 HIV-negative men or transgender women who have sex with men and with evidence of high risk behavior for HIV infection... Results showed Truvada was effective in reducing the risk of HIV infection by 42% compared with placebo in this population. Efficacy was strongly correlated with drug adherence in this trial.” It was also shown in iPrEX that there was a 92% reduction of risk for HIV in participants who took Truvada in the prescribed oncedaily dose. “The Partners PrEP trial was conducted in 4,758 heterosexual couples, where one partner was HIV-infected and the other was not (serodiscordant couples),” the press release continued. “The trial evaluated the efficacy and safety of [both] Truvada and [Viread] tenofovir versus placebo in preventing HIV infection in the uninfected male or female partner. Results showed Truvada reduced the risk of becoming infected by 75% compared with placebo. “No new side effects were identified in the clinical trials evaluating Truvada for the PrEP indication. The most common side effects reported with Truvada include diarrhea, nausea, abdominal pain, headache, and weight loss. Serious adverse events in general, as well as those specifically related to kidney or bone toxicity, were uncommon.” As a condition of approval, Gilead Sciences is required to collect and analyze samples from individuals who become infected with HIV while taking Truvada to see if they’ve developed drug resistance. The company is also required to collect data on women who become pregnant while taking Truvada for PrEP and to conduct other research. “Today’s decision is the culmination of almost 20 years of research involving investigators, academic and medical institutions, funding agencies, and nearly 20,000 trial participants around the world, and Gilead is proud to have been a partner in this effort,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. >> S E P T E MB E R+ OC TOB E R 201 2 13 BRIEFLY Enid Vázquez Moises Agosto in the greatest expansion of HIV prevention tools than at any other time in the history of this epidemic. Coupled with the reforms included in the Patient Protection and Affordable Care Act, as well as the National HIV/AIDS Strategy, we are in a position for the first time in over three decades to finally end this epidemic. Today’s decision is another important step in realizing that goal.” Dolutegravir/Epzicom superior to Atripla? >> The following is from a statement from Moises Agosto, Director of Treatment Education, Adherence, and Mobilization for the National Minority AIDS Council (NMAC): “While PrEP shows substantial promise as a supplement to current HIV prevention efforts, it is by no means a panacea and is only effective when used in conjunction with traditional prevention and risk reduction strategies, such as condom usage. “Anti-retroviral medications, like Truvada, are extremely powerful drugs with the potential for serious side effects. As such, PrEP should only be used by individuals who are highly vulnerable to HIV infection, including those in sero-discordant couples, sex workers, and gay men. Its efficacy is also directly related to an individual’s adherence to a regimen, and should only be used by those who can commit to taking it regularly. Finally, use of PrEP by individuals who may already be HIV-positive could increase the risk of drug resistance. “In recent years, there have been a number of promising developments in biomedical interventions—from treatment as prevention and pre-exposure prophylaxis to microbicides and vaccine research. These advances have resulted 14 S EP TE M B E R +O C TO BER 201 2 Shionogi-ViiV Healthcare LLC announced that initial results from its Phase 3 study SINGLE (ING114467) show superiority of its investigational HIV medication dolutegravir plus Epzicom over Atripla, one of the most widely prescribed antiviral medications in the country. At 48 weeks, 88% of study participants on the dolutegravir regimen achieved undetectable viral load (less than 50 copies/mL) vs. 81% of those on Atripla, a statistically significant difference. The company said the difference was primarily driven by a higher rate of discontinuation due to adverse events in the Atripla arm. All individuals in the study were taking antiviral therapy for the first time, a group that does the best in HIV treatment. There were 414 individuals put on dolutegravir and 419 put on Atripla. Overall, 2% of those on the dolutegravir-based regimen discontinued due to adverse events vs. 10% of those receiving the Atripla regimen. The most common adverse events while on Atripla were neurological (reported by 41% of Atripla recipients vs. 15% of participants receiving the dolutegravir), while the most common drug-related adverse events with dolutegravir were in the gastrointestinal system (reported by 22% of people on dolutegravir vs. 22% of those given Atripla). Dolutegravir is an investigational integrase inhibitor (INSTI), the same class as Isentress, the only INSTI currently on the market. Rapid home HIV test approved In June, the Food and Drug Administration (FDA) approved the OraQuick In-Home HIV Test, an HIV self-test kit that does not require sending a sample to a laboratory for analysis. The kit, which tests a swab from your mouth, is approved for sale in stores and online to anyone age 17 and older. (Although HIV is not found in saliva, evidence of exposure to the virus—called HIV antibodies—is found in the mouth and indicates infection.) A positive result at home must then be followed up with a confirmatory blood test from a laboratory. The FDA said the test can be falsely negative for reasons that include the occurrence of HIV infection within three months before testing. People who engage in behaviors that put them at increased risk of getting HIV—including having unprotected sex with new partners, or injecting illegal drugs—should be re-tested on a regular basis. They should not interpret a negative test to indicate that engaging in high risk behavior is safe. P os it iv e lyAware .com E-NEWS | From the Weekly E-News Website offers access to HIV meds for uninsured HarborPath, a new non-profit organization, has been established to create a program that offers a single place where uninsured HIV-positive people who otherwise qualify for manufacturersponsored patient assistance programs (PAPs) can apply for and receive their medications. The “one stop shop” portal will provide a streamlined, online process to qualify individuals and deliver the donated medications through a mailorder pharmacy. HarborPath will pilot the program in states with high need, including Alabama, Texas, and Virginia. To create the portal, HarborPath worked closely with the National Alliance of State and Territorial AIDS Directors (NASTAD) and the Clinton Health Access Initiative (CHAI), which provided the seed funding for the organization. On World AIDS Day 2011, President Bill Clinton noted the need to fight HIV/AIDS in the U.S. “I am proud that my foundation is partnering with NASTAD and other pharmaceutical manufacturers to make sure Americans living with HIV have access to the life-saving medications they need,” said President Clinton. “This P osi t i velyAware.com Sign up for the weekly email newsletter of positively aware. go to positivelyaware.com is an important step forward in our fight against the disease.” ViiV Healthcare is the first pharmaceutical company to support the program with HIV/AIDS medications and funding. The goal of HarborPath is to get all HIV/AIDS medications into the program and serve uninsured individuals with: n n n n n An easy-to-use website with a single portal to determine eligibility for the program and to fill prescriptions for participating companies’ HIV/AIDS medications. Automatic notifications for both the individual and the case manager of qualification for the program. A pharmacy that ships a 3-month supply of all participating medications in one package within two business days of final approval and confirms delivery of the medications. Renewal reminders to individuals and case managers to improve medication adherence. A fully automated portal that case managers can access at any time for up-to-the-minute status of an individual’s application or shipment. If needed, live support is also available through a toll-free call center. Murray Penner, Deputy Executive Director at NASTAD, said, “Under the current PAP process, an individual or their case manager has to apply separately to each company’s program for these medications, which can be complex and time-consuming. Missing doses or failing to fill prescriptions because of complications sometimes associated with these processes may result in serious health consequences, or even death, in addition to increased transmission of the virus. HarborPath is designed to address this urgent need in the U.S.” Studies find once-daily ‘Quad’ is safe and effective The findings of two large international randomized studies published in The Lancet medical journal indicate that the new once-daily pill combining three antiretrovirals and a booster molecule is a safe and effective alternative to two widely used drug regimens for newly diagnosed HIV-positive adults who have had no previous treatment. The study results also indicate that the new “Quad” pill is faster acting, doesn’t have the neuropsychiatric side effects associated with other combinations, and could improve compliance with treatment. “Patient adherence to medication is vital, especially for patients with HIV, where missed doses can quickly lead to the virus becoming resistant to medication. Older HIV treatment regimens involve taking several pills multiple times a day,” explains Paul Sax from Brigham and Women’s Hospital, Harvard Medical School, lead author of the first study. “Our results provide an additional highly potent, well-tolerated treatment option, and highlight the simplicity of treatment resulting from combining several antiretrovirals in a single pill. Studies have shown that single pill treatments improve both adherence and patient satisfaction, and help prevent prescription errors, thereby reducing the likelihood of treatment failure and drug resistance.” The first study randomly assigned 700 patients from centers across North America to start treatment with two different single tablet regimens—either the Quad, combining the new integrase inhibitor elvitegravir (EVG) boosted with cobicistat (a new pharmacoenhancer; COBI) plus emtricitabine/tenofovir (Emtriva/Viread), or Atripla (efavirenz/ emtricitabine/tenofovir), the current gold standard regimen approved by the FDA in 2006. After 48 weeks of treatment, 88% >> S E P T E MB E R+ OC TOB E R 201 2 15 BRIEFLY Enid Vázquez of patients given the Quad had suppressed viral loads (less than 50 copies/ mL), compared with 84% in the Atripla group. Adverse events that led to patients discontinuing treatment were infrequent and similar in both groups. Mild nausea was more common with the Quad, but patients were less likely to have dizziness, abnormal dreams, insomnia, and rash compared with the Atripla regimen. The second trial included 708 treatment-naïve adults from 146 medical centers across Australia, Europe, North America, and Thailand. Patients were randomly assigned to receive a once-daily Quad or a popular and recommended twice-daily combination of Norvirboosted Reyataz (atazanavir/ritonavir) plus Truvada (emtricitabine/tenofovir). The primary endpoint, to achieve viral levels below 50 copies/mL by week 48, was reached by 90% of people in the Quad group compared with 87% in the atazanavir/ritonavir/emtricitabine/tenofovir group. The safety of the two regimens was also similar. PA’s editor debuts blog on HuffPo first conference to be held in the U.S. since President Obama lifted the travel ban on HIV-positive people, his anticipation of such events as displays of the AIDS Memorial Quilt, a planned march and demonstration, the performance of the Tony Award-winning play The Normal Heart, as well as the many global leaders in AIDS policy, advocacy, and treatment advances that presented at the conference. Positively Aware editor Jeff Berry has joined other AIDS activists and journalists such as The Body’s Kellee Turrell, the AIDS Foundation of Chicago’s David Ernesto Munar, and others in becoming a blogger published by The Huffington Post. In advance of the upcoming AIDS 2012 World AIDS Conference, Berry wrote “Reflections from an Epidemic: Carrying the Torch to AIDS 2012.” In it, he talks about the significance of this being the Did he get infected? In the July+August issue of Positively Aware, a young man in Chicago, Chris, was anxiously awaiting the results of his HIV tests following a potential exposure through sex (“PrEPing,” July+August). Two months later, he remains HIV-negative. Simplify your life. Turn your assorted prescription medicine bottles into single-dose packs. Easy to remember. Easy to take. Each pack contains all the pills of a single dose. Free FedEx shipping anywhere in the continental U.S. J Discount Pharmacy Call to place your first order: (773) 278-5337 16 S E P TE M B E R +O C TO BER 201 2 P os i t iv e lyAware .com TPAN, publisher of Positively Aware, is commemorating 25 years of service to Chicago’s HIV community. Join Jamar Rogers, of NBC’s “The Voice,” for a special performance. October 4, 2012 5:30–8:30 PM | Chicago Cultural center Tickets available at Photo: Matthew Garsteck Event sponsors www.tpan.com ANNIVERSARY PARTNERS $100,000 AND ABOVE Alphawood Foundation Bristol-Myers Squibb $50,000 AND ABOVE Janssen Therapeutics $25,000 AND ABOVE Abbott Virology EMD Serono Lloyd A. Fry Foundation ViiV Healthcare Walgreens $10,000 AND ABOVE AIDS Foundation of Chicago Blue Cross and Blue Shield of Illinois Cheetah Gyms Gilead Sciences, Inc. Macy’s MillerCoors Steamworks COMPLERA (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) is a prescription medicine used as a complete single-tablet regimen to treat HIV-1 in adults who have never taken HIV medicines before. COMPLERA does not cure HIV or AIDS or help prevent passing HIV to others. The one for me Patient model. Pill shown is not actual size. INDICATION COMPLERA (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg) is a prescription HIV medicine that contains 3 medicines, EMTRIVA® (emtricitabine), EDURANT™ (rilpivirine), and VIREAD® (tenofovir disoproxil fumarate) combined in one pill. COMPLERA is used as a complete single-tablet regimen to treat HIV-1 infection in adults (age 18 and older) who have never taken HIV medicines before. ® COMPLERA does not cure HIV and has not been shown to prevent passing HIV to others. It is important to always practice safer sex, use latex or polyurethane condoms to lower the chance of sexual contact with any body fluids, and to never re-use or share needles. Do not stop taking COMPLERA unless directed by your healthcare provider. See your healthcare provider regularly. IMPORTANT SAFETY INFORMATION Contact your healthcare provider right away if you get the following side effects or conditions while taking COMPLERA: • Nausea, vomiting, unusual muscle pain, and/or weakness. These may be signs of a buildup of acid in the blood (lactic acidosis), which is a serious medical condition • Light-colored stools, dark-colored urine, and/or if your skin or the whites of your eyes turn yellow. These may be signs of serious liver problems (hepatotoxicity), with liver enlargement (hepatomegaly), and fat in the liver (steatosis) • If you have HIV-1 and hepatitis B virus (HBV), your liver disease may suddenly get worse if you stop taking COMPLERA. Do not stop taking COMPLERA without ﬁrst talking to your healthcare provider. Your healthcare provider will monitor your condition COMPLERA may affect the way other medicines work, and other medicines may affect how COMPLERA works, and may cause serious side effects. Do not take COMPLERA if you are taking the following medicines: • other HIV medicines (COMPLERA provides a complete treatment for HIV infection.) • the anti-seizure medicines carbamazepine (Carbatrol®, Equetro®, Tegretol®, Tegretol-XR®, Teril®, Epitol®), oxcarbazepine (Trileptal®), phenobarbital (Luminal®), phenytoin (Dilantin®, Dilantin-125®, Phenytek®) • the anti-tuberculosis medicines rifabutin (Mycobutin), rifampin (Rifater®, Rifamate®, Rimactane®, Rifadin®) and rifapentine (Priftin®) • a proton pump inhibitor medicine for certain stomach or intestinal problems, including esomeprazole (Nexium®, Vimovo®), lansoprazole (Prevacid®), omeprazole (Prilosec®), pantoprazole sodium (Protonix®), rabeprazole (Aciphex®) • more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate • St. John’s wort (Hypericum perforatum) • other medicines that contain tenofovir (VIREAD®, TRUVADA®, ATRIPLA®) • other medicines that contain emtricitabine or lamivudine (EMTRIVA®, Combivir®, Epivir® or Epivir-HBV®, Epzicom®, Trizivir®) • rilpivirine (Edurant™) • adefovir (HEPSERA®) In addition, also tell your healthcare provider if you take: • an antacid medicine that contains aluminum, magnesium hydroxide, or calcium carbonate. Take antacids at least 2 hours before or at least 4 hours after you take COMPLERA • a histamine-2 blocker medicine, including famotidine (Pepcid®), cimetidine (Tagamet®), nizatidine (Axid®), or ranitidine hydrochloride (Zantac®). Take these medicines at least 12 hours before or at least 4 hours after you take COMPLERA • the antibiotic medicines clarithromycin (Biaxin®), erythromycin (E-Mycin®, Eryc®, Ery-Tab®, PCE®, Pediazole®, Ilosone®), and troleandomycin (TAO®) • an antifungal medicine by mouth, including fluconazole (Diflucan®), itraconazole (Sporanox®), ketoconazole (Nizoral®), posaconazole (Noxafil®), voriconazole (Vfend®) • methadone (Dolophine®) This list of medicines is not complete. Discuss with your healthcare provider all prescription and nonprescription medicines, vitamins, or herbal supplements you are taking or plan to take. Save up to 200 $ per month COMPLERA. You may be able to save on the co-pay for your COMPLERA prescription with a Gilead HIV Co-pay Assistance Card. Call 1-877-505-6986 for more information or visit www.COMPLERA.com.* A complete HIV treatment in only 1 pill a day. Ask your healthcare provider if it’s the one for you. Before taking COMPLERA, tell your healthcare provider if you: • have liver problems, including hepatitis B or C virus infection • have kidney problems • have ever had a mental health problem • have bone problems • are pregnant or plan to become pregnant. It is not known if COMPLERA can harm your unborn child • are breastfeeding; women with HIV should not breast-feed because they can pass HIV through their milk to the baby Contact your healthcare provider right away if you experience any of the following serious or common side effects: Serious side effects associated with COMPLERA: • New or worse kidney problems can happen in some people who take COMPLERA. If you have had kidney problems in the past or take other medicines that can cause kidney problems, your healthcare provider may need to do blood tests to check your kidneys during your treatment with COMPLERA • Depression or mood changes can happen in some people who take COMPLERA. Tell your healthcare provider right away if you have any of the following symptoms: feeling sad or hopeless, feeling anxious or restless, or if you have thoughts of hurting yourself (suicide) or have tried to hurt yourself • Bone problems can happen in some people who take COMPLERA. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do additional tests to check your bones • Changes in body fat can happen in people taking HIV medicine. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms and face may also happen. The cause and long-term health effect of these conditions are not known • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new symptoms after starting your HIV medicine Common side effects associated with COMPLERA: • trouble sleeping (insomnia), abnormal dreams, headache, dizziness, diarrhea, nausea, rash, tiredness, and depression Other side effects associated with COMPLERA: • vomiting, stomach pain or discomfort, skin discoloration (small spots or freckles), and pain Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of COMPLERA. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. 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. Take COMPLERA exactly as your healthcare provider tells you to take it • Always take COMPLERA with a meal. Taking COMPLERA with a meal is important to help get the right amount of medicine in your body. A protein drink does not replace a meal • Stay under the care of your healthcare provider during treatment with COMPLERA and see your healthcare provider regularly Please see Patient Information for COMPLERA on the following pages. *The co-pay program covers up to $200 per month for 1 year from card activation or until the card expires, up to $2400 in a calendar year. The program is subject to change or cancellation at any time. Learn more at www.COMPLERA.com FDA-Approved Patient Labeling Patient Information COMPLERA® (kom-PLEH-rah) (emtricitabine, rilpivirine and tenofovir disoproxil fumarate) Tablets COMPLERA may help: • Reduce the amount of HIV in your blood. This is called your “viral load”. • Increase the number of white blood cells called CD4+ (T) cells that help fight off other infections. Important: Ask your doctor or pharmacist about medicines that should not be taken with COMPLERA. For more information, see the section “What should I tell my healthcare provider before taking COMPLERA?” Reducing the amount of HIV and increasing the CD4+ (T) cell count may improve your immune system. This may reduce your risk of death or infections that can happen when your immune system is weak (opportunistic infections). Read this Patient Information before you start taking COMPLERA and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about COMPLERA? COMPLERA does not cure HIV infections or AIDS. • Always practice safer sex. • Use latex or polyurethane condoms 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 about how to prevent passing COMPLERA can cause serious side effects, including: 1. Build-up of an acid in your blood (lactic acidosis). Lactic acidosis can happen in HIV to other people. some people who take COMPLERA or similar (nucleoside analogs) medicines. Lactic Who should not take COMPLERA? acidosis is a serious medical emergency that can lead to death. • Do not take COMPLERA if your HIV infection has been previously treated with Lactic acidosis can be hard to identify early, because the symptoms could seem like HIV medicines. symptoms of other health problems. Call your healthcare provider right away if you • Do not take COMPLERA if you are taking certain other medicines. For more get any of the following symptoms which could be signs of lactic acidosis: information about medicines that must not be taken with COMPLERA, see “What • feeling very weak or tired should I tell my healthcare provider before taking COMPLERA?” • have unusual (not normal) muscle pain • have trouble breathing What should I tell my healthcare provider before taking COMPLERA? • have stomach pain with Before you take COMPLERA, tell your healthcare provider if you: - nausea (feel sick to your stomach) • have liver problems, including hepatitis B or C virus infection - vomiting • have kidney problems ��� feel cold, especially in your arms and legs • have ever had a mental health problem • feel dizzy or lightheaded • have bone problems • have a fast or irregular heartbeat • are pregnant or plan to become pregnant. It is not known if COMPLERA can harm your unborn child Pregnancy Registry. There is a pregnancy registry for women who take antiviral medicines during pregnancy. Its purpose is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry. Call your healthcare provider right away if you have any of the following symptoms • are breast-feeding or plan to breast-feed. The Centers for Disease Control and of liver problems: Prevention recommends that mothers with HIV not breastfeed because they can pass • your skin or the white part of your eyes turns yellow (jaundice). the HIV through their milk to the baby. It is not known if COMPLERA can pass through • dark “tea-colored” urine your breast milk and harm your baby. Talk to your healthcare provider about the best • light-colored bowel movements (stools) way to feed your baby. • loss of appetite for several days or longer Tell your healthcare provider about all the medicines you take, including prescription • nausea and nonprescription medicines, vitamins, and herbal supplements. • stomach pain 2. Severe liver problems. Severe liver problems can happen in people who take COMPLERA or similar medicines. In some cases these liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis) when you take COMPLERA. You may be more likely to get lactic acidosis or severe liver problems if you are COMPLERA may affect the way other medicines work, and other medicines may female, very overweight (obese), or have been taking COMPLERA or a similar affect how COMPLERA works, and may cause serious side effects. If you take certain medicines with COMPLERA, the amount of COMPLERA in your body may be too low and medicine containing nucleoside analogs for a long time. it may not work to help control your HIV infection. The HIV virus in your body may become 3. Worsening of Hepatitis B infection. If you also have hepatitis B virus (HBV) infection resistant to COMPLERA or other HIV medicines that are like it. and you stop taking COMPLERA, your HBV infection may become worse (flare-up). A “flare-up” is when your HBV infection suddenly returns in a worse way than before. Do not take COMPLERA if you also take these medicines: COMPLERA is not approved for the treatment of HBV, so you must discuss your HBV • COMPLERA provides a complete treatment for HIV infection. Do not take other HIV medicines with COMPLERA. therapy with your healthcare provider. • the anti-seizure medicines carbamazepine (CARBATROL®, EQUETRO®, TEGRETOL®, • Do not let your COMPLERA run out. Refill your prescription or talk to your healthcare TEGRETOL-XR®, TERIL®, EPITOL®), oxcarbazepine (TRILEPTAL®), phenobarbital provider before your COMPLERA is all gone. (LUMINAL®), phenytoin (DILANTIN®, DILANTIN-125®, PHENYTEK®) • Do not stop taking COMPLERA without first talking to your healthcare provider. ® ® • If you stop taking COMPLERA, your healthcare provider will need to check your health • the anti-tuberculosis medicines rifabutin (MYCOBUTIN ), rifampin (RIFATER , RIFAMATE®, RIMACTANE®, RIFADIN®) and rifapentine (PRIFTIN®) often and do regular blood tests to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking • a proton pump inhibitor medicine for certain stomach or intestinal problems, including esomeprazole (NEXIUM®, VIMOVO®), lansoprazole (PREVACID®), omeprazole COMPLERA. (PRILOSEC®), pantoprazole sodium (PROTONIX®), rabeprazole (ACIPHEX®) • more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium What is COMPLERA? COMPLERA is a prescription HIV (Human Immunodeficiency Virus) medicine that: phosphate • is used to treat HIV-1 in adults who have never taken HIV medicines before. HIV is the • St. John’s wort (Hypericum perforatum) virus that causes AIDS (Acquired Immunodeficiency Syndrome). If you are taking COMPLERA, you should not take: • contains 3 medicines, (rilpivirine, emtricitabine, tenofovir disoproxil fumarate) • other medicines that contain tenofovir (VIREAD®, TRUVADA®, ATRIPLA®) combined in one tablet. EMTRIVA and VIREAD are HIV-1 (human immunodeficiency • other medicines that contain emtricitabine or lamivudine (EMTRIVA®, COMBIVIR®, virus) nucleoside analog reverse transcriptase inhibitors (NRTIs) and EDURANT is an EPIVIR® or EPIVIR-HBV®, EPZICOM®, TRIZIVIR®) HIV-1 non-nucleoside analog reverse transcriptase inhibitor (NNRTI). • rilpivirine (EDURANT™) It is not known if COMPLERA is safe and effective in children under the age of 18 years. • adefovir (HEPSERA®) Also tell your healthcare provider if you take: The most common side effects of COMPLERA include: an antacid medicine that contains aluminum, magnesium hydroxide, or calcium • trouble sleeping (insomnia) carbonate. Take antacids at least 2 hours before or at least 4 hours after you take • abnormal dreams COMPLERA. • headache • a histamine-2 blocker medicine, including famotidine (PEPCID®), cimetidine • dizziness (TAGAMET®), nizatidine (AXID®), or ranitidine hydrochloride (ZANTAC®). Take these • diarrhea medicines at least 12 hours before or at least 4 hours after you take COMPLERA. • nausea • the antibiotic medicines clarithromycin (BIAXIN®), erythromycin (E-MYCIN®, ERYC®, • rash ERY-TAB®, PCE®, PEDIAZOLE®, ILOSONE®), and troleandomycin (TAO®) • tiredness • an antifungal medicine by mouth, including fluconazole (DIFLUCAN®), itraconazole (SPORANOX®), ketoconazole (NIZORAL®), posaconazole (NOXAFIL®), voriconazole • depression (VFEND®) Additional common side effects include: • methadone (DOLOPHINE®) • vomiting Ask your healthcare provider or pharmacist if you are not sure if your medicine is • stomach pain or discomfort • skin discoloration (small spots or freckles) one that is listed above. Know the medicines you take. Keep a list of your medicines and show it to your • pain • healthcare provider and pharmacist when you get a new medicine. Your healthcare provider and your pharmacist can tell you if you can take these medicines with COMPLERA. Do not start any new medicines while you are taking COMPLERA 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 COMPLERA. How should I take COMPLERA? Stay under the care of your healthcare provider during treatment with COMPLERA. • Take COMPLERA exactly as your healthcare provider tells you to take it. • Always take COMPLERA with a meal. Taking COMPLERA with a meal is important to help get the right amount of medicine in your body. A protein drink does not replace a meal. • Do not change your dose or stop taking COMPLERA without first talking with your healthcare provider. See your healthcare provider regularly while taking COMPLERA. • If you miss a dose of COMPLERA within 12 hours of the time you usually take it, take your dose of COMPLERA with a meal as soon as possible. Then, take your next dose of COMPLERA at the regularly scheduled time. If you miss a dose of COMPLERA by more than 12 hours of the time you usually take it, wait and then take the next dose of COMPLERA at the regularly scheduled time. • Do not take more than your prescribed dose to make up for a missed dose. • When your COMPLERA supply starts to run low, get more from your healthcare provider or pharmacy. It is very important not to run out of COMPLERA. The amount of virus in your blood may increase if the medicine is stopped for even a short time. • If you take too much COMPLERA, contact your local poison control center or go to the nearest hospital emergency room right away. • What are the possible side effects of COMPLERA? COMPLERA may cause the following serious side effects, including: • See “What is the most important information I should know about COMPLERA?” • New or worse kidney problems can happen in some people who take COMPLERA. If you have had kidney problems in the past or take other medicines that can cause kidney problems, your healthcare provider may need to do blood tests to check your kidneys during your treatment with COMPLERA. • Depression or mood changes. Tell your healthcare provider right away if you have any of the following symptoms: - feeling sad or hopeless - feeling anxious or restless - have thoughts of hurting yourself (suicide) or have tried to hurt yourself • Bone problems can happen in some people who take COMPLERA. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do additional tests to check your bones. • Changes in body fat can happen in people taking HIV medicine. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms and face may also happen. The cause and long term health effect of these conditions are not known. • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new symptoms after starting your HIV medicine. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of COMPLERA. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088). How do I store COMPLERA? • Store COMPLERA at room temperature 77 °F (25 °C). • Keep COMPLERA in its original container and keep the container tightly closed. • Do not use COMPLERA if the seal over the bottle opening is broken or missing. Keep COMPLERA and all other medicines out of reach of children. General information about COMPLERA: Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use COMPLERA for a condition for which it was not prescribed. Do not give COMPLERA to other people, even if they have the same symptoms you have. It may harm them. This leaflet summarizes the most important information about COMPLERA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about COMPLERA that is written for health professionals. For more information, call (1-800-445-3235) or go to www.COMPLERA.com. What are the ingredients of COMPLERA? Active ingredients: emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate Inactive ingredients: pregelatinized starch, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, povidone, polysorbate 20. The tablet film coating contains polyethylene glycol, hypromellose, lactose monohydrate, triacetin, titanium dioxide, iron oxide red, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake. This Patient Information has been approved by the U.S. Food and Drug Administration Manufactured and distributed by: Gilead Sciences, Inc. Foster City, CA 94404 Issued: August 2011 COMPLERA, the COMPLERA Logo, EMTRIVA, HEPSERA, TRUVADA, VIREAD, GILEAD, and the GILEAD Logo are trademarks of Gilead Sciences, Inc. or its related companies. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other trademarks referenced herein are the property of their respective owners. © 2012 Gilead Sciences, Inc. All rights reserved. 202123-GS-000 02AUG2011 CON12383 3/12 Securing care for Women living with HIV Challenges and solutions for HIV-positive women by Naina Khanna F In the U.S., the HIV epidemic looks very different. Women comprise over a quarter of the estimated 1.2 million people living with HIV in the U.S.—not including transgender women, for whom no accurate data are available. In 1984, women represented only 8% of HIV infections in the U.S. Thus, even at a national level, the trend is troubling. Data from 2012 show that in the District of Columbia, rates of new HIV diagnosis among black women have doubled. In Maryland, 35% of all AIDS diagnoses are among women, and in the U.S. Virgin Islands, 36.4% of people with an AIDS diagnosis were women in 2009. And when you drill down further, particularly in the U.S. South, in some counties, HIV infection rates among females may be even higher. Let’s be clear: this is not a numbers game anyone wants to win. Of even more concern, in the United States, HIV acquisition among women is correlated with race, poverty, experience of trauma, mental illness, substance use, and vulnerability to assorted social stigmas—the same factors that reduce likelihood of positive health outcomes in 22 S E P TE M B E R +O C TO BER 201 2 people living with HIV. That is, these socioeconomic factors increase vulnerability to poor health outcomes, with or without an HIV diagnosis. U.S. women living with HIV are disproportionately likely to be women of color (over 80%), especially black and Latina, and living in poverty, compared to men living with HIV. According to the HIV Cost Services and Utilization Study (HCSUS), 64% of HIV-positive women in ongoing medical care had annual incomes under $10,000, compared with 41% of HIV-positive men in care. More than twice as many HIV-positive women (76%) as HIV-positive men (34%) are living with and caring for at least one child under the age of 18. Thus, care systems for HIV-positive women must account for caretaking responsibilities, including provisions for minor children. Alarmingly, data show that adherence to anti-retroviral therapy tends to decrease among women living with HIV as the number of children under 18 living in the home increases. This is no real surprise. As women, we tend to prioritize caring for others over ourselves. Sometimes Photo: © IAS/Steve Shapiro-Commercialimage.net ive years ago, women had the dubious distinction of surpassing men as the majority of people in the world living with HIV. And in some countries, including Cambodia, Mozambique, and Rwanda, women now comprise nearly two-thirds of people living with the virus. Organizing Principal: Megaphone in hand, it’s a matter of practicality—we only have so many dollars to go around and hours in the day and bus vouchers. Sometimes it’s a matter of stigma—we don’t want others to see us taking our meds or going to medical appointments. And frequently it’s a reflection of how we value ourselves, especially as poor women, women of P os i t iv e lyAware .com Naina Khanna, Director of Policy and Community Organizing, WORLD, rallies demonstrators at the International AIDS Conference in July. color, women living with HIV. We have internalized that our health, our wellness, our wellbeing is too often not a priority for our society and political leadersâ€”so why should we make it a priority for us? Transgender women are especially likely to live in extreme poverty, to face exceptional barriers to safe housing, P osi t i velyAware.com employment, and access to quality health care, and, if HIV-positive, are less likely than other populations to receive antiretroviral therapy and more likely to experience negative interactions with health care providers. Transgender women are also disproportionately likely to face violence in their communities. Although researchers within the U.S. and internationally have known for years that women who have experienced violence and trauma are at elevated risk of acquiring HIV (even in non-conflict settings), new data released in 2012 show that women with HIV in the U.S. are twice as likely to have been victims of S E P T E MB E R+ OC TOB E R 201 2 23 Women’s bodies are not only about making babies. Fully upholding our human rights includes upholding our right to be sexual beings who experience joy and erotic pleasure. intimate partner violence and suffer posttraumatic stress disorder at a rate five times greater than HIV-negative women. Rates of violence faced by transgender women are likely to be even higher—data released in 2011 by the National Coalition of Anti-Violence Programs showed that transwomen comprised 44% of all LGBTQ murder victims. The same study found that over half of LGBTQ violence survivors did not even report attacks, with the highest rates of non-reporting being among transgender women of color. Not that surprising, given that transwomen also face disproportionate sexual, physical, and verbal harassment at the hands of police, according to Injustice at Every Turn—A Report of the National Transgender Discrimination Study. Research shows that women, including transwomen, who have experienced trauma are less likely to be adherent to medication and are more likely to face multiple barriers to care overall. Systemic violence against women also persists. Women living with HIV in the U.S. continue to report significant reproductive rights violations, despite medical progress and research and treatment advances that clearly demonstrate HIV-positive people can live a long and healthy life, avoid passing the virus to children with appropriate care and treatment, and even avoid passing the virus to their sexual partners, when viral load is suppressed and other factors that increase vulnerability (such as genital sores or ulcers) are not present. Importantly, for many women living with HIV, motherhood may be one of the only socially valued identities available to them. As described by Michelle Berger in Workable Sisterhood, many women living with HIV in the U.S. already exist at the intersection of race, class, and gender oppression, in addition to societal stigma about any behaviors they engage in, or life experiences they have had—even prior to HIV diagnosis. “When they became HIVpositive all the positions they occupied— drug user, sex worker, poor woman, were 24 S EP TE MB E R +O C TO BER 201 2 already concentrated, or saturated, with a set of representations and assumptions about those positions.” Thus, HIV becomes just another one of several stigmatizing social markers. Yet having a socially valued identity may impact HIV-positive women’s feelings about themselves and may inspire them to take better care of themselves. In one study, HIV-positive women reported that pregnancy and childrearing provided them a socially sanctified feeling of being important and valued. Motherhood became a highly valued identity that helped mitigate regret related to HIV acquisition and other life circumstances. One study, published in AIDS Patient Care and STDs in May 2010, demonstrated that of 181 predominantly African American HIV-positive women in care in two urban HIV medical clinics, only 31% reported a personalized discussion with their HIV provider about their own fertility desires and intentions. Of those 31%, 64% had initiated the conversation themselves with their providers. The same study found that age was a strong predictor of provider-patient communication about pregnancy, with women under the age of 30 being six times more likely to have had a general conversation about pregnancy with their providers. Another study of 118 HIV-positive women conducted at the University of Rochester found that 54% of participants in that study had been sterilized. The study found high rates of “tubal regret” among participants, and pointed to a need to counsel women living with HIV about reversible methods of contraception. And research conducted by the U.S. Positive Women’s Network found that women living with HIV self-reported high rates of coerced abortion, tubal ligation, and sterilization. When HIV-positive women do have conversations with providers about their fertility plans, some health care providers perceive the pregnancyrelated needs of women living with HIV to be limited exclusively to the prevention of vertical transmission. In addition, data collected by the U.S. Positive Women’s Network suggest that HIV criminalization laws, currently on the books in 36 states and U.S. territories, may deter women from HIV testing, from accessing care, and may intimidate them with regard to disclosing sexual behavior to providers. Despite the fact that there are many other diseases and genetic disorders with higher risk of parent to child transmission, and that assisted reproduction is not only permitted but often encouraged in such cases, HIV status has been used as a special reason to deny HIV-positive women the right to conceive naturally or with assistance; the right to comprehensive family planning and counseling service; and the right to retain custody of their children. Given last year’s HPTN 052 data, which demonstrated a 96% reduction in HIV transmission among heterosexual serodiscordant partners when viral load was suppressed, people living with HIV and/ or their partners who want to conceive should be counseled about a range of options, including natural conception and now pre-exposure prophylaxis (PrEP) for the negative partner. Prevention justice demands that a range of HIV prevention options be available, including options that are controlled by women. But women’s bodies are not only about making babies. Fully upholding our human rights includes upholding our right to be sexual beings who experience joy and erotic pleasure. And for some of us, that means not using condoms, with our partner’s knowledge and consent. This will require a conscious effort of providers counseling patients who have experienced stigma, sometimes multiple concurrent stigmas, to provide accurate information about risk. Despite the significant epidemic among U.S. women—it is estimated that 300,000 women are living with HIV in the U.S., and 25% is no minor proportion—the National HIV/AIDS Strategy, released in July 2010, failed to articulate a single goal specifically for women. It does not detail how to P os it iv e lyAware .com HIV care is more than just medical care. It must be coupled with services designed to uphold sexual and reproductive rights and to address the impact of violence and trauma in women’s lives. reduce new HIV infections among women, to increase access to care, or a strategy to improve women’s health outcomes. The Strategy similarly failed to articulate the relationship between violence or trauma and HIV for women. And nowhere in the Strategy was the need to strengthen sexual health and reproductive choice for women living with HIV even mentioned. And just this year, although the President’s proposed domestic HIV budget for FY 2013 was relatively good, the Part D program was the only part of Ryan White for which a decrease was proposed. Part D is the only program within Ryan White specifically designed to meet the needs of women, youth, and families. This is indicative of an alarming trend away from women-centered care and supportive services when they are more critical than ever. Thus, not only are we faced with a well-documented social and political “war on women” from the far right, with all women’s rights and body sovereignty being utilized as a political football in the 2012 election cycle—but women living with HIV are literally facing disproportionate wars: violence, and a battle for their lives, health, and dignity in their own communities, neighborhoods, and homes. And in the midst of all this, somewhere along the way we lost our will to address the gender nuances of the domestic HIV epidemic. 2011’s HPTN 052 results demonstrated that achieving viral suppression in people living with HIV can effectively reduce onward transmission of HIV. Thus, ensuring high-quality care and access to voluntary treatment for people living with HIV should be one of our primary goals as an HIV community—to achieve the National HIV/AIDS Strategy’s prevention and care goals. In July, the International AIDS Conference (AIDS 2012) returned to the U.S. after a 22-year absence. The theme of AIDS 2012 was Turning the Tide Together— meaning that we have the science to end new HIV infections and to keep people P osi t i velyAware.com living with HIV healthy. Now we have to muster the political will and resources to make this possibility a reality. Just last June, the Supreme Court of the United States upheld the Affordable Care Act (ACA)—a piece of legislation that holds great promise for all women, and especially for women living with HIV. But HIV care and treatment is more than just medication and more than just medical care, especially for women. It must be coupled with services designed to uphold sexual and reproductive rights and to address the impact of violence and trauma in women’s lives. Women living with HIV still face unique vulnerabilities in 2012 and turning the tide on the epidemic for women will require a gender-sensitive response. Because women’s access to health care and ability to adhere to medication is related in large part to other life factors, including our physical, psychological, and emotional safety, addressing logistical barriers to care and promoting safety for women is central to achieving the National HIV/AIDS Strategy’s goals and to achieving the promise of the Affordable Care Act for women. Through ACA implementation, we must also keep in place services that facilitate access to care for women living with HIV, including but not limited to psychosocial support, peer-based services, transportation, and childcare. Thankfully, President Obama’s March 30 release of a memorandum establishing a federal interagency working group to address the intersection of HIV/AIDS, violence against women and girls, and gender-related health disparities presents a new opportunity to align the domestic HIV response with international standards and to rectify some of these serious oversights. The workgroup is charged with, among other things: n Integrating sexual and reproductive health services, gender-based violence services, and HIV/AIDS services, where research demonstrates that doing so will result in improved and sustained health outcomes. n Promoting research to better understand the intersection of the biological, behavioral, and social science bases for the relationship between increased HIV/AIDS risk, domestic violence, and gender-related health disparities. 2012 marks a critical moment in the global HIV response. It’s time we truly commit to upholding women’s rights and the rights of all people living with and disproportionately impacted by HIV as an essential component to turning the tide of the epidemic. This must include: n Meaningful and visible leadership of women living with HIV in all aspects of decision-making. n Research on and funding for womencontrolled prevention options—tools which a woman can use without the consent or even the knowledge of her partner, and which uphold our full rights to sexual pleasure and sexual and reproductive health. n Bold action, including a plan and a timeline from the White House Office of National AIDS Policy to address the intersections of violence against women, HIV, sexual and reproductive rights, and women’s health. Naina Khanna is the policy director at Women Organized to Respond to Lifethreatening Disease (WORLD) in Oakland, California and coordinates the U.S. Positive Women’s Network (PWN). She was appointed to President Obama’s Advisory Council on HIV/AIDS (PACHA) in 2010. She has presented and advised on women’s rights and achieving gender-sensitive, human rights-grounded policies informed by people living with HIV. Ms. Khanna was diagnosed with HIV in 2002. S E P T E MB E R+ OC TOB E R 201 2 25 black women, Society, and HIV An expert talks about the context of infection Taken from an interview with Adaora A. Adimora, MD, MPH I n the mid-1900s, there was Editor’s note: Adaora A. Adimora, MD, MPH, received her medical degree from Yale University School of Medicine and Master’s in Public Health in epidemiology (the study of how disease spreads among people) from the University of North Carolina at Chapel Hill (UNC). Dr. Adimora’s work as both a physician and an epidemiologist has focused on infectious disease, particularly HIV and its disproportionate effect on minority populations. Her groundbreaking research includes the publishing of the first national data on concurrent sexual partnerships in women and analysis of the contextual (social, economic, and environmental) factors that promote concurrent sexual partnerships among African Americans in the United States. She has testified before a Congressional committee on the HIV epidemic and, for World AIDS Day in 2010, was invited to the White House to speak in a panel discussion. The following is taken from an interview with Dr. Adimora. —Enid Vázquez 26 S EP TE M B E R +O C TO BER 201 2 the rise of so-called “risk factor epidemiology.” People became much more focused on individual determinants, the individual behaviors and characteristics of people that put them at risk for disease. And these things are important. But it turns out there’s increasing evidence that in order to really make headway with the HIV epidemic in this country, and in the world, there’s going to need to be more attention paid to some of the social factors that drive people’s behavior and also set them up to acquire infection. P os i t iv e lyAware .com Tamara wilson, HIV-Positive since 1999, volunteers at chicago women’s aiDS project. She credits her mother with helping her to manage her HIV, and TPAN for helping to save her life. Photograph by chris knight has been found to put people at greater risk for HIV than serial monogamy, even if people in both groups have had the same number of partners over the same period of time. T he thing that It appears, for example, that the connections between black people in the U.S. differ to some extent compared to the connections among white people in the sense that there are more disassortative relationships, or relationships between people with different risk factors. There’s more of a tendency for African Americans to have relationships with people who have much greater risk for HIV than they themselves do. There’s also the issue of partnerships that overlap in time, or sexual concurrency. In addition, they tend to find partners within their communities, which are often segregated. Sexual concurrency P osi t i velyAware.com is really, really important is the observation that it is the social context of life in the United States that really contributes to those partnership patterns. It’s pretty clear that black people as a whole tend to live under very different circumstances in the United States than white people do. And some of these characteristics that we have been studying, like incarceration for example, not only contribute to HIV, but they’re also emblematic of the oppression that minority populations are living under in the United States. A history of incarceration, for example, which is experienced by black men more than any other group, primarily as a result of the war on drugs, lowers the possibility of employment and increases the risk of poverty, while at the same time disrupting the stability of longterm partnerships. Incarceration and death due to violence and disease in black men lead more black women to enter into relationships with men who have greater risk factors for HIV than they do. This doesn’t mean that each and every minority, each and every African American, in the United States is poor and oppressed. But as a whole, it is these types of factors that contribute to the spread of HIV, STDs, and in fact different rates of other diseases, such as diabetes and heart disease. Black people are at greater risk of acquiring HIV infection independent of their own low-risk behavior compared to other groups. I would also emphasize that we do have personal responsibility for our behavior. However, I think some people tend to look at this work and say, “Oh, they’re just blaming the environment, blaming the majority population.” That’s really not exactly it. While we do have personal responsibility for our behavior, I think it’s very critically important to realize that black people have substantially increased risks than other populations, even with the same behavior. And this has been demonstrated. This is true for black gay men as well as for black heterosexual men and women. I would say to black women living with HIV, keep the faith. Teach your sons and daughters all the lessons you’ve learned. You have a wealth of experience, and certainly resiliency. We need to work in whatever ways we can to change the social and economic factors that are putting our people at risk, and putting our children at risk. It would help if everyone in the United States had health care. It’s astonishing to me that, apparently, health care is not a right. It remains an open question in the United States that people should have health coverage, even though it’s clearly most cost effective for the nation as a whole. This is a civil rights issue. That’s what I mean by working to change the economic factors that put people at risk. Health care availability, affordability for all, would make a huge difference in terms of transmission of HIV, and also in terms of the personal health of people who are living with HIV. go to positivelyaware.com to read published studies and abstracts. S E P T E MB E R+ OC TOB E R 201 2 27 ‘Everyone Needs a Support How one therapist helps HIV-positive women learn to take care of themselves by Enid Vázquez F or more than 10 years, “The HIV-positive women I work with have the same types of issues, but it’s even more important that they address emotional and life concerns because their health depends on it,” says Burch. While women often focus on interpersonal problems and family stress, improved health is always an underlying goal of Burch’s work at CWAP. “Stress that comes from emotional and psychological problems can be a threat to a woman with HIV,” she says, pointing out that stress and depression are known to increase mortality for positive women. Nevertheless, she finds that many women worry about their lovers and families more than they do about themselves, even in the face of HIV. “Women in our society are rewarded for taking care of other people,” Burch said. “We often don’t think about taking care of ourselves independent of someone helping us with that or coaching us through it. We may not be socialized to be assertive. And of course, all of that really comes through in thinking about how to 28 S EP TE M B E R +O C TO BER 201 2 P os i t iv e lyAware .com Photo: ProELLEments Photography psychotherapist Kesha Burch, LCPC, has counseled HIV-positive women at the Chicago Women’s AIDS Project (CWAP). Whether positive or negative, the women she counsels face similar problems, she says, with health being an added and important concern for those living with HIV or any other chronic illness. System’ negotiate safe sex practices and so on and so forth. “You don’t want to get away from all the nurturing,” she notes, “but how do you take care of other people and take care of yourself as well? There has to be some balance. Hopefully, counseling helps women achieve greater balance. It’s about feeling empowered enough to be themselves and to pursue things that they’re worthy of having in their lives,” says Burch. Instead, she finds that many women settle for less than they deserve, which can begin a cycle of more unhappiness in their lives. Others have problems establishing healthy relationships and may have negative coping skills, experiencing difficulty with attachment (including having many sexual partners) and figuring out who is worthy of being with them. These women often feel that they have to accept bad behavior in order to be in a relationship or are confused about what they have to do to be in one. “There are also issues around disclosure and that relates back to self-esteem and self-worth. It’s important for them to communicate with partners for their own health and also so that they can be truly known and accepted and loved,” she said. “This is similar to the things that other people are dealing with, being true to themselves.” Once a woman has a healthier relationship with herself, her other relationships are healthier too. Burch cites support groups and support buddies as being important for positive women, along with caring friends, family members, and supportive partners. “We were created to be in relationships with each other. It’s not just about romantic relationships, but about learning how to be a good parent and how to have a healthy friendship…all kinds of relationships that are essential to human existence,” she says. “Everyone needs a support system, and the healthier your support system, the better off you are. It’s about the people in your life who are for you and support you. That helps P osi t i velyAware.com anybody’s mental health and physiological health as well. It helps anybody to become more resilient and do better.” What’s different for people living with a chronic illness like HIV, she says, is that the same skills they use for creating healthy relationships also work in managing their health care. “Sometimes negative issues can seep into their attitudes towards their health, their health care, and their provider. When I talk to them about using skills in a relationship, I recognize that those assertiveness skills can help them ask for what they need from their medical provider so they don’t just think that they go to their doctor and are told what to do, but report things that are of concern to them and ask, can we check into this?” Burch said. “Sometimes I rehearse with them. ‘What would you like to say when you go to the doctor?’ I had a client who felt that her doctor wasn’t listening to her. There were some things that she thought needed to be addressed, but she was complaining about it to other people and not taking it back to the doctor to say ‘this really worries me’ or ‘I wish that at my last appointment we could have talked about this.’ “So I helped her narrow down her complaints and her concerns to three things per visit, because there’s some reality there too. The doctor cannot spend 90 minutes on a visit. The alternative was for her to feel consistently frustrated with her experience with the doctor,” Burch said. “She didn’t realize she could ask for what she wants. For the first item on her list, she was able to get a referral to a specialist. That also then reduced her anxiety and worry about what was going on with her.” She notes that not being able to communicate with a provider or understand what was being asked of them could lead some people to not take their medication correctly. Burch pointed to other practical things people can do to support their self-worth and value. “It could be as simple as putting on make-up. It could be signing up to take a class or to stop talking to someone who is not doing right by them—any behavioral steps that reinforce the message that they’re of value.” Going for counseling, she believes, is one big step towards self-care. “When you show up to therapy, that’s just in and of itself an affirmation that you’re worthy of a better life and this is part of what you are going to do about it,” Burch says. “There’s always some kind of spark I see that pulls women in, something I can’t describe that gives them just a little bit of hope that things could be different. Especially for the women who are dealing with addiction, it’s that little piece of themselves that helps to pull them out, to show up on the doorstep of a detox or drug treatment program. There’s a ton of internal strength and resiliency there, and that’s something that I reflect back to them sometimes. ‘Look at all that you’ve been through to get to this point.’ “When you see that spark, that’s the essence of who that person really is,” says Burch. “The trick is to get them to see it, despite their circumstances.” She sometimes suggests that people make positive affirmations, keep a journal, and read certain books or authors. While she can help weed out negative beliefs people have about themselves that they may not even be aware of, these activities can keep people focused on messages that are the opposite of the negative beliefs and feelings. “It’s about changing that message,” she said. She sometimes has clients take time to just relax and sit silently. Many people are often too busy running around doing everything they have to do to give themselves time for reflection and hearing what’s inside them, she said. Perhaps the most important part of her work, she believes, is treating people with kindness and respect. “That’s really at the core of the Chicago Women’s AIDS Project,” she notes. “The mission statement is about empowering women, seeing the value in each and every woman.” S E P T E MB E R+ OC TOB E R 2012 29 Nine Months to BIRTH HIV and pregnancy—keeping yourself and your baby healthy by John Verna, MS, PA-C W ell, as you suspected, your pregnancy test is positive. Congratulations! Pregnancy can be an exciting time, and a really wonderful experience. Of course, now that you’re expecting, you probably have lots of questions, some of which relate to how your HIV-positive status will impact your pregnancy and your baby. The goal in every pregnancy is to keep both mom and baby healthy—and I’m happy to say that this is a goal that’s well within your reach. Just because you have HIV does not mean you can’t have a happy, healthy pregnancy, and a happy, healthy baby. Basically, the same things that keep you healthy will keep your baby healthy. Risks of transmitting the virus to your baby decrease as your own viral load decreases. In fact, if you are on HIV medication and take the medications as prescribed, there’s only a 1% chance of passing HIV to your baby. In my 11 years as an HIV specialist, and having seen over 150 pregnant patients with HIV, I have never had a patient pass HIV to her baby. However, if you’re not on HIV meds, or don’t take them like you’re supposed to, there’s a 25% chance (basically a one in four chance) that you will pass HIV to the baby. Even medication at the last minute, at the time of labor, cuts the risk and some states have laws about testing mothers during labor if an HIV test result is not on file for the pregnancy. So let’s talk about what you need to do to keep both you and your little one healthy. Many women wonder how HIV can be transmitted to the baby. HIV can be transmitted during pregnancy, during 30 S EP TE M B E R +O C TO BER 201 2 labor and delivery, or by breastfeeding. We’ll talk about what you can do during pregnancy, during labor, and after your baby is born to decrease the chances of transmitting the virus. How to reduce the risk of transmitting HIV to your baby during pregnancy K eeping your viral load low is important during pregnancy to reduce the risk of transmission. Regardless of what is recommended based solely on your CD4+ and VL levels, you may want to start taking HIV meds as soon as you learn you are pregnant. Yes, there are guidelines from the Department of Health and Human Services (DHHS) that recommend when to start treatment based on CD4+ and VL, but there are groups of people for which treatment is recommended no matter what. Pregnant women are one of those groups. We are trying to prevent your baby from becoming infected. Earlier initiation of therapy may be more effective in reducing in utero transmission. In fact, a 2010 study conducted in France found that “early and sustained control of HIV viral replication is associated with decreased residual risk of transmission and favors initiating HAART drugs as early in pregnancy as possible for all women.” In other words, starting HAART (highly active antiretroviral therapy) drugs early to control the viral load as much as possible decreased the chances that the virus would be transmitted to the baby. In fact, we know that having an undetectable viral load substantially lowers the risk of transmission of HIV to the fetus and lessens the need for consideration of cesarean delivery (C-section). That’s why I have always suggested that my patients start HAART immediately after learning about their pregnancy. So, if you are not currently taking HIV medications (whether you are treatmentnaïve or have taken them in the past), tell your HIV specialist about what medications you’ve taken in the past and provide all laboratory tests (genotypes, phenotypes, HLA B*5701) and be honest about any adherence issues that you’ve had in the past. Also talk about any tolerability issues and drug allergies you have had with any old regimen(s). As soon as you learn that you’re pregnant, you should contact your HIV specialist to discuss your options for medication and to review what you’re currently taking to make sure your medications are safe for the baby. If you are taking HIV medication, like HAART, your clinician will likely continue your treatment. However, if you are taking a regimen that contains efavirenz (Sustiva, which is also a component of Atripla), you’ll need to make a change. Efavirenz is a Pregnancy Category D medication, meaning it should not be taken P os i t iv e lyAware .com IRTH DAY P osi t i velyAware.com Photo ÂŠ Jani Bryson while pregnant, especially during the first trimester of your pregnancy. Itâ€™s reassuring, however, to know that of 14 studies with 1,345 pregnant women on efavirenz published in the journal AIDS two years ago, there was only one infant born with a birth defect, a rate no different from the general population of pregnant women. Many women wonder if HIV medications are going to harm their babies or themselves. Several HIV medications have been found to be safe for pregnant women and babies. As a matter of fact, there is an international registry (the Antiretroviral Pregnancy Registry) that monitors for potential birth defects in infants exposed to HIV medications in utero. The Department of Health and Human Services (DHHS) currently recommends Kaletra and Combivir taken twice a day. Ask your HIV specialist what is going to be best for you and keep in mind that results of any past or current S E P T E MB E R+ OC TOB E R 201 2 31 You should have discussions with both your obstetrician and HIV specialist to help determine what is best for you and your baby. If you don’t have a specialist, now might be a good time to seek one out. genotype test will also be considered. If you have a viral load of more than 1,000 copies, your provider will order a genotype before starting you on medications. Any drug resistance found by the test may limit your treatment options. So there is a lot to consider here, and you should have discussions with both your obstetrician and HIV specialist to help determine what is best for you and your baby. Assuming that you have an HIV specialist, your specialist will refer you to an obstetrician who has experience with HIV-positive mothers. If you don’t have a specialist, now might be a good time to seek one out. You can visit the websites of the American Academy of HIV Medicine (www.aahivm.org) and the Gay and Lesbian Medical Association (http:// glma.org), or call the National AIDS Hotline (open 24 hours a day every day of the year) at 1-800-CDC-INFO (232-4636). The right doctor and the right tests I t can be very helpful to have an obstetrician with experience treating HIV-positive women, in part because the decisions regarding whether to use certain “invasive” genetic tests can be difficult. Many pregnant women undergo a variety of screening tests. During the first trimester these tests include a fetal ultrasound and a blood test for mom. This screening process can help determine the risk of the fetus having certain birth defects (Down syndrome, trisomy 18, or trisomy 13). Second trimester prenatal screening may include additional blood testing (of mom) called Multiple Markers. These include alpha-fetoprotein (AFP), hCG, estriol, and inhibin. These markers provide information about a woman’s risk of having a baby with genetic conditions or birth defects. This screening is usually performed between the 15th and 20th weeks of pregnancy. If the results of these tests are 32 S EP TE M B E R +O C TO BER 201 2 abnormal, genetic counseling is recommended. Additional testing may be needed for an accurate diagnosis. These tests include chorionic villus sampling (CVS) and amniocentesis, both of which are considered “invasive.” During amniocentesis, a small amount of amniotic fluid is removed by inserting a long, thin needle through your belly and into the womb. In CVS, chorionic villi cells are removed from the placenta, either in the same way amniocentesis is performed or through the cervix using a catheter and gentle suction. Because these tests are invasive, they involve at least a theoretical increased risk of transmitting the virus to the baby. To date, there have been 159 reported invasive procedures on HIV-positive moms with no transmission of HIV to the baby. In all cases, women were on HAART with undetectable viral loads and though no transmissions of HIV have occurred, a small increase in risk can’t be ruled out. Therefore, any HIV-positive woman undergoing any invasive procedure should be on HAART and have an undetectable viral load at the time of the procedure. Some experts consider CVS too risky to offer to their HIV-positive patients and recommend limiting invasive procedures to amniocentesis only, but existing data on transmission risk associated with these procedures are limited. Invasive testing procedures should be discussed thoroughly with your OB and between you and your partner. Your OB (or genetic counselor) will discuss the pros and cons of invasive testing with you. But ultimately, whether to test (or not to test) is a personal decision. Lowering the risk during labor and delivery A gain, the goal is to limit the baby’s exposure to the virus. So it’s probably not surprising that your options for labor and delivery depend upon your viral load (another important reason to take your HIV meds as prescribed). The American College of Obstetricians and Gynecologists (ACOG) has recommended considering a scheduled C-section delivery for HIV-positive women since 1999. A scheduled C-section is recommended for women with a viral load that’s greater than 1,000 copies/mL near the time of delivery (36 weeks’ gestation) and for any woman with an unknown viral load. It is also recommended for women who did not receive HIV medication during pregnancy. In these situations, ACOG recommends a scheduled C-section at 38 weeks’ gestation in order to decrease the likelihood of onset of labor or rupture of membranes before delivery. For women with a viral load that’s less than 1,000 copies/mL near time of delivery, a scheduled C-section is not routinely recommended. So, if your viral load is less than 1,000 copies/mL near the time of delivery, your choices for labor and delivery are essentially the same as a woman who doesn’t have the virus, and you can have a vaginal delivery. The risk of perinatal transmission of HIV in women with an undetectable viral load (at 36 weeks gestation) is 1% or less, even with a vaginal delivery. No evidence is available to show that this risk can be lowered further by performing a scheduled C-section. Remember, a C-section is major surgery and has its own risk of complications, compared with vaginal delivery. Under new DHHS guidelines, only women with viral loads of more than 400 copies/mL should be given IV zidovudine (AZT) continuously, even if your genotype shows resistance for this drug. The use of AZT is recommended because of its unique characteristics and its proven record in reducing transmission. To help prevent transmission, your baby will be given liquid AZT immediately after birth and this will be continued (by you at home) twice a day for six weeks. P os it iv e lyAware .com Women in the U.S. with HIV should not breastfeed their babies due to increased risk of transmitting the virus. Baby formula is a safe and healthy alternative. Unfortunately, women in the U.S. with HIV should not breastfeed their babies due to increased risk of transmitting the virus. Baby formula is a safe and healthy alternative to breast milk and there are many brands and options that are available to you. Also, while the risk is very low, HIV can also be transmitted to a baby through food that was pre-chewed by an HIV-positive mother (or caretaker). To be completely safe, babies should not be fed pre-chewed food. Does the baby have HIV? T here are two types of tests that will be performed on your baby to find out if he or she has HIV. The first is the HIV antibody test. All babies born to a mom with HIV will test positive for the first several Again, just because you have HIV does not mean you can’t have a healthy pregnancy and baby. In fact, just this past year I had an HIV-positive patient who followed her regimen and had a healthy pregnancy, and an uncomplicated vaginal birth. She and her husband welcomed a healthy HIV-negative baby into the world. It can be done, and it is done by lots of women just like you every day. So, again, congratulations! months of their lives. This does not mean that they have HIV. Rather, it means that the baby has simply been exposed to his/ her mother’s HIV. The second test, PCR testing, looks for the virus and not just the antibodies to the virus. It is this test that can tell whether the baby has HIV or not. This test will be done during the first few days of his/her life. The PCR test will be repeated several times on your baby. To know for certain that your baby is not infected with HIV, the baby must not be breastfeeding and must have two negative PCR tests, the first at one month (or older) and the second at four months (or older). Many experts confirm the HIV-negative status of the baby with an HIV antibody test at age 12 to 18 months. To be diagnosed with HIV, a baby must have two positive PCR tests. John Verna has spent his entire profes- sional career providing health care to individuals with HIV. For the past three years, he has worked at Access Community Health Network in Chicago. John knows just how special (and scary) pregnancy can be, as he and his wife recently welcomed their first child. Are you Aware? Get Positively Aware. ❑ 1-year subscription: $30 donation. Six bi-monthly issues every year. Subscriptions are mailed free of charge within the U.S. to those who are HIV-positive. ❑ Bulk copies (U.S. only): Available free of charge; however, a donation is requested to cover shipping. No international bulk orders. Minimum order 10 copies, shipped via UPS (No P.O. Box addresses): ______ copies ❑ Back issues: $3 per copy. Enclosed is my payment. ______ copies: July+August 2012 ______ copies: May+June 2012 ______ copies: March+April 2012 (HIV Drug Guide) ______ copies: January+February 2012 ❑ Sign me up for the E-News, PA’s weekly email newsletter: Bill to: Card Number Expires Name on Card Signature (required) Charge my: ❑ Visa ❑ MasterCard ❑ American Express total amount: $___________ Charges will appear on your credit card statement as TPA Network. Test Positive Aware Network (TPAN) is a not-for-profit organization dedicated to providing support and information to all people affected by HIV. Ship to: Name Agency (if applicable) email address Address ❑ Enclosed is my donation of ❑ $25 ❑ $50 ❑ $100 ❑ $250 ❑ $500 ❑ $_______ Your contribution helps provide subscriptions to people who can’t afford them. All donations are tax-deductible to the full extent allowed by law. P osi t i velyAware.com City Phone Mail to: State Zip e-mail Positively Aware 5537 N. Broadway St. S E P T E MB E R+ OC TOB E R Chicago, IL 60640 2012 33 CONFERENCE UPDATE AIDS 2012 WASHI N GTO N , D . C . After a 22-year absence, the International AIDS Conference returned to the U.S. following President Obama’s lifting of the federal immigration and travel ban against people from outside the U.S. with HIV/AIDS. An estimated 22,000 activists, advocates, clinicians, and others converged on Washington, D.C. in July. For conference webcasts and transcripts go to www.aids2012.org. IAS cure workshop highlights advances and challenges By Jeff Berry At this year’s conference we heard about exciting advances in cure research, as well as the launch of the International AIDS Society’s (IAS) “Towards an HIV Cure” global scientific strategy. A two-day pre-conference workshop brought together researchers and community advocates to preview some of these advances and provide insight into work 34 S E P TE M B E R +O C TO BER 201 2 being done in the seven different areas of research that the agenda has identified as highest priority. The workshop, cochaired by Steven Deeks, MD, University of California, San Francisco, and IAS president and Nobel laureate Françoise Barré-Sinoussi, Pasteur Institute, Paris, was opened by Dr. Anthony S. Fauci, Director of the National Institute of Allergy and Infectious Diseases, NIH. In his opening remarks, Fauci stated that a cure that only benefits 0.01% of the population is not going to excite anyone—it has to be scalable. During the community literacy session Australian researcher Sharon Lewin, MD, PhD, gave an overview presentation addressing major barriers to a cure, including what actually defines a cure and potential targets and mechanisms, as well as underscoring the importance of assays for future research and the need for these tests to undergo rigorous standardization with labs before going into wider use. Activist and Positively Aware contributor Matt Sharp talked about his experiences as a cure research study participant, and the challenges that lie ahead, including ethical study design, Analytical Treatment Interruptions (ATI), and informed consent. Sharp noted that some cure research may be quite risky, with little chance for benefit. He asked what the “reasonable” risks are for HIVpositive individuals who will be participating in early and potentially dangerous cure studies, and how can we best protect them? Developing guidelines for determining when potentially risky treatment interruptions are appropriate is a critical next step, said Sharp, and community input and community advisory boards are essential in ensuring ethical, patientoriented studies. An elegant presentation given by Robert Siliciano, MD, PhD, Johns Hopkins University School of Medicine, was perhaps one of the clearest and most concise presentations I’ve ever seen on the basics of immunology, HIV infection, P os i t iv e lyAware .com Photos: ©IAS/Steve Shapiro-Commercialimage.net Cure caucus: (above, from left) Sharon Lewin, MD, PhD; Rowena Johnston, vice president of research, amfAR; Steven Deeks, MD, University of California San Francisco; Françoise Barré-Sinoussi, new president of the International AIDS Society; Mark Harrington, Treatment Action Group; and UNAIDS executive director Michel Sidibé review developments in HIV cure research. and the multiple molecular mechanisms which maintain HIV latency. HIV is not completely eradicated from the body by standard antiretroviral therapy because some of it lies resting in memory CD4+Tcells, which can proliferate for an average of 73.4 years in the human body. However, if you stop taking therapy, the virus typically comes roaring back within a matter of weeks. One eradication approach would be to remain on standard ARV therapy to keep the virus suppressed, while at the same time purging these latent reservoirs and blocking them from infecting new cells, so that they would have nowhere to go and eventually die off, ridding the body of HIV. But it’s complicated—the number of latently infected cells may be much higher than previously thought, by as much as 50-fold, according to Siliciano. Sarah Palmer, PhD, Swedish Institute for Communicable Disease Control and Karolinska Institute, gave a presentation on measuring persistent HIV infection, including an excellent slide outlining some of the advantages and disadvantages of the four currently available assays which measure persistence. In concluding her talk, Palmer emphasized that “looking ahead, to determine the effectiveness of curative strategies, our field will need to develop a more standardized assay system which is sensitive, efficient, less costly, and adaptable in local settings.” Other presentations covered recent advances in the development of accurate P osi t i velyAware.com animal models for use in future cure research, vaccine and immune-based therapies and the role of immune activation and inflammation in viral persistence. The conference ended with a slightly unorthodox, yet immensely informative and entertaining presentation by Fred Verdult of Amsterdam on the psychosocial benefits of a cure for Sharp turn: PA contributor Matt HIV. Verdult, after Sharp talks about his experiences as a finding out he had HIV cure research study participant. in 1998, started Volle Maan, an organization that conducts studies of future infection. The survey and communication projects also asked about disadvanon health and disease to tages of living with HIV—the encourage people to live full risk of experiencing health and worthwhile lives. Volle problems in the future was conducted a survey of 458 the number one answer, while individuals in the Netherlands psychosocial effects such as asking how important to them stigma and the risk of infecta cure for HIV is, why a cure is ing someone else were also important, and which type of highly ranked. cure is preferred. Deeks closed the twoThe majority of the survey day workshop by declaring respondents indicated they Verdult’s presentation the were in good health, with “highlight of the meeting,” only 14% stating that their and remarking on the spirit health was poor. Seventy-two of collaboration among the percent said that it was very attendees. Barré-Sinoussi said important to them to be cured that next steps include the of HIV, while another 22% said efforts of the working groups, it was somewhat important. including a newly added Yet when asked about how a social sciences research team cure might look, participants and an ethics working group, had varying responses. 95% as well as a call for more cure thought that a total cure research funding and collabowithout any risk of future ration. The next IAS Towards transmission or infection very an HIV Cure workshop is desirable, while only 41% conscheduled for immediately sidered it desirable to have a prior to the 2013 international cure that had no risk of future conference in Kuala Lumpur, transmission but carried a risk Malaysia. Other news on the cure front A group of patients in France who became infected with HIV and then started on antiretroviral therapy (ART) early in the post-infection period have shown no signs of a resurgence of their HIV infection seven years after being taken off therapy. “These results suggest that…antiretroviral treatment should be started very early after infection,” said Charline Bacchus, lead researcher of the study at the French National Agency for Research on AIDS and Viral Hepatitis (ANRS). The patients in the ANRS EP47 VISCONTI cohort (known as the Visconti Cohort) have an extremely low reservoir of HIV in their cells similar to that of “HIV controller” patients. HIV controllers are those who are able to control their HIV infection without the use of ART for an extended period of time, and represent about one out of every 300 people who have HIV. In the study, 12 patients started therapy within 10 weeks of infection, were on therapy for an average of three years, and were able to control HIV after an average of seven years off therapy. At a press conference Asier Saez-Cirión, one of the study investigators, said they were interested in finding out whether HIV controller status could be induced. He estimated that 5–15% of those treated early could eventually control HIV off therapy. But don’t stop those HIV meds S E P T E MB E R+ OC TOB E R 2012 35 CONFERENCE UPDATE AIDS 2012 WASHI N GTO N , D . C . just yet—not only would we need to figure out how to identify who would have this type of response to early treatment, but also get those individuals onto treatment immediately following infection. The other question one might ask is, could some of those in the study already have been HIV controllers to begin with? While the genetic alleles commonly associated with HIV controllers was not found in these patients there may be other factors playing a role, which researchers now are trying to uncover. Another study looked at two men who had been infected with HIV for many years, on suppressive antiretroviral therapy (ART), and who underwent treatment of lymphoma via an allogenic (meaning foreign, or from another donor) stem cell transplantation. Both patients received a milder form of chemotherapy, known as the conditioning regimen, prior to transplant, which allowed them to stay on their ART during and after the transplant. One patient was on Atripla, the other on Isentress/ Truvada. HIV was detectable in their cells immediately after the transplant, but the transplanted donor cells replaced the patients’ own lymphocytes over time. The amount of HIV DNA in their blood cells decreased and became undetectable, for up to two years now in one patient and three-and-a-half years in the other. CD4s declined in both patients initially, followed by a robust CD4 increase in one patient, and the stabilization 36 S EP TE MB E R +O C TO BER 201 2 and no further decline of CD4s in the other. Unlike Timothy Ray Brown, the “Berlin” patient, who received cells that were resistant to HIV because they lacked the CCR5 receptor, these patients received cells that were CCR5+. It is believed that the antiretroviral treatment protected the donor cells from becoming infected, leading one researcher to refer to it as “a form of PrEP [preexposure prophylaxis] at the cellular level.” Further tissue sampling and analytic treatment interruption will need to be conducted to assess the full extent of the reduction of HIV in the reservoir. At a press conference held the same day these two studies were presented, David Margolis, MD, University of North Carolina at Chapel Hill, was asked by a reporter about the media’s role in reporting on cure advances responsibly and accurately, while at the same time not giving too much hope or creating complacency. “That’s your job,” said Margolis. “We are very careful about what we say [as researchers], and we’ve defined cure several different ways. Different kinds of cure and eradication mean different things to different people, and have different levels of value. Perhaps we should come up with a word, like ‘complicated-eradicationchemo-immunotherapy,’ to slow people down. But you can’t argue with the goal and you can’t get there without working on it—and I can’t say how long it will take.” Drug updates by Enid Vázquez Complera, the newest single tablet regimen (STR), comprised of rilpivirine (Edurant) plus emtricitabine/tenofovir (Truvada), continues to hold its own. Previously, it had been shown to be non-inferior to Atripla, another STR, made of efavirenz (Sustiva) plus emtricitabine/tenofovir. This time, however, it has been shown to maintain an undetectable viral load (of less than 50 copies/mL) in people who were switching from a Norvir-boosted protease inhibitor (PI) combination. These were 24-week results in nearly 500 individuals, of whom two-thirds were switched to Complera and the rest maintained on their PI regimen. Overall total cholesterol, LDL (“bad cholesterol”), and triglycerides decreased to a greater extent among those switched than on those maintained on their PI. The differences were statistically significant. “We all know that regimen simplification improves quality of life,” said Frank Palella, MD, of Northwestern University when he presented these results from the SPIRIT study. Also continuing to do well: the still investigational elvitegravir and dolutegravir, both integrase inhibitor medications (INSTIs). In 96-week results from Study 145, elvitegravir continued to be noninferior (as it was in earlier 48-week results) to Isentress, the only INSTI currently on the market. Development of INSTI drug resistance was low (about 7%) and similar with both medications. The 700 participants in this study were treatment-experienced, so they were less likely to achieve undetectable viral load. Overall, 47.6% of the 351 participants on dolutegravir had undetectable viral loads, compared to 45% of those on Isentress. In 48-week results from the SPRING-2 study, dolutegravir was as effective as Isentress, with 88% vs. 85% of participants in the two groups achieving undetectable viral load. The participants were treatment-naïve (first time on HIV therapy), See more dolutegravir news in Briefly. Getting a boost The investigational drug cobicistat (COBI), which boosts drug levels (a “pharmacoenhancer”), was given with Reyataz plus Truvada and compared to Norvir-boosted Reyataz plus Truvada, a preferred regimen under U.S. treatment guidelines. In Phase 3 study results after 48 weeks, cobicistat-boosted Reyataz was non-inferior to Norvir-boosted Reyataz, with high rates of virologic success (viral loads of less than 50 copies per mL) and similar safety and tolerability. Nearly 700 individuals participated in Study 114. “Cobicistat appears to be an effective drug for boosting P os it iv e lyAware .com protease inhibitor levels, with greater potential for coformulation,” said presenter Joel Gallant, MD, MPH of Johns Hopkins University School of Medicine. He noted the various co-formulations of cobicistat with protease inhibitors that are in development. Moreover, he pointed out that, “[Norvir]-boosted Reyataz is known to be a lipid-friendly regimen and cobicistat is no different.” “This is all good news,” said session co-facilitator Christine Katlama, MD, of Hospitalier Pitie-Salpetriere in Paris, “because all the drugs work and when they don’t work there is no resistance.” Photo: © IAS/Ryan Rayburn-Commercialimage.net Risky business for sex workers Several sessions looked at abuses that put sex workers at risk for HIV—and we’re not talking sex. Instead, it’s police actions around the world—including here in the United States—to confiscate condoms and to use them as evidence of prostitution that puts sex workers at risk for HIV. Advocates P osi t i velyAware.com said the situation is such that many sex workers are afraid to carry condoms because of the police harassment this can cause. In fact, even outreach workers have been followed by the police so that sex workers can be arrested when they take the condoms offered. As advocates My body, my business: Discussing sex workers’ issues. pointed out, it is not illegal to carry condoms. Rather, Risen, MD, MPH, PhD, of Save “rescue and save” sex workconfiscation serves as another the Children, said, “Violence ers should be called “arrest avenue of illegal detention against female sex workers and abuse.” and intimidation. spreads far beyond individual In the session titled “The Moreover, criminalization incidents and factually is genOldest Profession: Is Sex of consensual sex work keeps der-based violence.” Among Work Work?,” Naomi Akers workers under dangerous conother recommendations, Save said equating sex work with ditions. In the “Criminalizing the Children in Bangladesh human trafficking is insulting Condoms and Sex Work” says behavioral change camand hurts both sex workers, session, Acasia Shields, author paigns should be aimed at who are targeted by raids, of Criminalizing Condoms, a changing community percepand victims of trafficking, report from the Open Society tions and creating acceptance who aren’t helped at all. Foundation, said, “Police of sex workers in mainstream “When you’re doing sex work, routinely search sex workers society, and that maternal and of course you see it as work. to confiscate and destroy conchild services should focus It buys you food and helps doms. This affects their ability more on issues related to sex you take care of your family,” to practice safe sex and they workers. she said, calling trafficking know it.” Darby Hickey of the Los “horrible.” Of the U.S. sex workers Angeles chapter of SWOP Deanna Kerrigan of the surveyed, 52% said they (Sex Workers Outreach Johns Hopkins Bloomberg were afraid to carry condoms Project), said, “We think School of Public Health in because of fear of police sometimes that countries like Baltimore detailed findings harassment. Shields said the United States are a world of higher HIV risk among sex other abuses include apart from countries like workers around the world, and threats of arrest to Bangladesh, but unfortunatesaid support for sex workers’ exhort sex, ly, we face the same issues. groups, as well as human and and beating It is about law and about health rights is critical for all or raping sex policy change, but also about sex workers, including men workers. how police operate outside and transgender people. Discussing the range of law. So we need Labor rights, the focus of the the findings to change policies, holdsession, would help to elimifrom the first ing police accountable, and nate stigma and discrimination national congress address the wider societal and increase HIV prevention of sex workers in indifference and downright efforts for this group of workBangladesh, Simon hostility.” She said efforts to ers, she said. Richard Howard S E P T E MB E R+ OC TOB E R 201 2 37 CONFERENCE UPDATE AIDS 2012 WASHI N GTO N , D . C . of the International Labour Office (ILO) said, “Decent work [as outlined by ILO] should exist for all human beings, regardless of whether it’s legal or not, whether it takes place in a formal or informal environment.” Underscoring the human rights issues affecting sex workers were protests against the U.S. Consulate for denying them visas to attend the conference. In the final analysis, the sex workers movement advocates for decriminalization of sex work as the most important way of protecting their human rights. “The epidemic is not driven by the lack of a pill or a gadget, the epidemic is driven by repression,” said plenary speaker Cheryl Overs, Senior Research Fellow at the Michael Kirby Centre for Public Health and Human Rights at Monash University in Melbourne. She founded a sex workers’ rights organization in Australia in the ‘80s and the Global Network of Sex Work Projects in the ‘90s. She has worked in HIV policy and programming for male, female, and transgender sex workers in more than 20 developing countries. “And that brings me to law and policy,” she continued. “Sex workers from Sweden to Singapore to Swaziland all say that the greatest threat to their health and human rights is the law that makes it impossible to find safe places to work, and prevents them from having the same protections as other workers and other citizens.” 38 S E P TE MB E R +O C TO BER 201 2 At the center of research A look behind the National Institutes of Health Story and photographs by rick Guasco With an annual budget approaching $31 billion, the National Institutes of Health (NIH) is the medical research agency of the federal government and the largest source of funding in the world for medical research. The NIH is also a driving force behind AIDS and HIV vaccine research; 10% of the agency’s budget —$3 billion—goes toward HIV/AIDS, funding research conducted at academic, commercial, and private labs, as well as at NIH headquarters in Bethesda, Maryland. Some 75 buildings are scattered throughout the 312-acre NIH campus. During the International AIDS Conference, the agency hosted a press tour of two of those buildings, offering a closer look at the role the NIH plays in clinical research and treatment. The vaccine center Opened in 2000, the Vaccine Research Center is a five-story facility where research is done to find vaccines not only for HIV, but for influenza, Ebola virus, and other diseases that pose global health risks. Gary J. Nabel, MD, PhD, director of the Vaccine Research Center, opened the tour, explaining how the facility serves as an “intellectual hub” by putting all the stages of vaccine research and development under one roof. Basic research is first conducted to find a promising vaccine candidate. A vaccine is of little use, however, if it can’t be efficiently and safely mass-produced, so it undergoes test production for good manufacturing practices and quality control. From there, a successful candidate then goes to clinical trials to determine how safe it is for patient use. Results from the trials are reviewed in a series of assessments. If the vaccine candidate doesn’t pass this process with flying colors, it goes back to basic research, Vaccine chief: The NIH’s Vaccine and the cycle begins Research Center is headed by again. The three-phase cycle can take 10–18 years Dr. Gary J. Nabel. for a would-be vaccine to complete. search for an HIV vaccine. Nabel said that the search Although it took 17 years to for a vaccine has been develop a vaccine against elusive, because, “HIV is conhepatitis B, he pointed out stantly mutating, changing its that a polio vaccine took genetic make-up and protein 45 years. structure.” “A vaccine is at least 10 “HIV is a sugar-coated years into our future,” Nabel virus,” Nabel explained. said. “What we’ve learned is Sugars produced by the body that HIV is a very crafty virus.” are converted into proteins by While one or two vaccine the virus. “This makes it inviscandidates look promising, it ible to the body’s immune will be at least until mid-2013 system, which does not perbefore an assessment can be ceive the virus as a threat.” made, and a little longer to However, Nabel offered evaluate more mature data, some perspective on the Nabel said. Even if a vaccine P os it iv e lyAware .com were discovered today, it would take at least four years of additional testing and evaluation before it could become publicly available. The Clinical Research Center Next stop on the tour was the Mark O. Hatfield Clinical Research Center, a hospital where 1,500 clinical trials for a variety of illnesses (including HIV/AIDS) are conducted. Opened in 2005, the Hatfield Clinical Research Center is connected to the Warren Grant Magnuson Clinical Center, built in 1953, to form the largest hospital in the U.S. dedicated to clinical research. The Clinical Research Center has spawned numerous treatments, from the first pediatric chemotherapy to development of AZT, the first anti-HIV drug. The center houses an HIV clinic that treats 500 patients, only one or two of whom are ever in-patients. Dr. Henry Masur is the research center’s Director of Critical Care Medicine, but has focused the major part of his career on HIV and its associated complications. Although a research institution, Masur said the clinic recognizes the importance of keeping HIVpositive patients connected to care. That’s why while half the clinic’s nursing staff is in research, the other half of the nurses are also case managers. Hepatitis C is a major concern for people who are HIVpositive, Masur said. There are 3–5 million people who P osi t i velyAware.com have hep C out of 314 million Americans. While the current standard of care for hepatitis C can sometimes be difficult to tolerate and only helps to clear the virus in about onethird to one-half of patients, recent advances have raised the cure rate to 75% and higher. Masur said advances in treatment look even more promising, comparing them to the advent of protease inhibitors and combination therapy for HIV that came in 1995. As people are now living longer with HIV, Masur said the research center is beginning to look at aging and other complications. “We’ll soon be examining neurocognitive issues,” he said. “Beyond anecdotally, does it happen, and if so, what can we do to reverse it?” “Knowledge is bi-directional,” Masur said. “What we learn in the lab will help patients. But there is a lot we can learn from patients and put to use.” Clinical Care: Dr. Henry Masur (above) introduces Senora Mitchell, a medical clerk who has been with the Hatfield Clinical Research Center’s HIV clinic since 1987. “I love my work,” Mitchell said. “I get to make a difference every day.” Modest accommodations: You might expect that an examination room in the most prominent medical research hospital in the country, if not the world, would look better than this. But Masur noted that taxpayers pay for NIH facilities, so the exam room looks the same as at any other doctor’s office. S E P T E MB E R+ OC TOB E R 2012 39 Scenes from a week that was words & images by Rick Guasco B eyond the headline- making sessions of the International AIDS Conference, there was much to see and do inside and away from Washington, D.C.’s convention center. “What would an AIDS conference be without a little protesting?” said an unflappable Secretary of State Hilary Clinton as a small group of demonstrators rose and chanted when she took the stage on opening day. During a panel discussion addressing the efficiency of overseas anti-AIDS efforts, Bill Gates spoke candidly: “The amount of money we have [now] is not enough to treat everyone. We’re in a period of incredible uncertainty about how much this funding will stay strong. Even the uncertainty creates instability in how the investment ahead will be made. The voices of the AIDS community are going to have to be louder than ever.” The week of the conference offered opportunities to honor the fallen and plea for the living. Visitors to the AIDS Memorial Quilt, displayed on the Mall, could not only see the panels, but also recite the names of those memorialized by the Quilt. In the streets, approximately 1,000 marchers took their messages to the White House. Discordant voices—demonstrating for sex workers’ rights, against Wall Street, opposing HIV criminalization laws—were united by one refrain, “cure AIDS now.” 40 S EP TE M B E R +O C TO BER 201 2 P os i t iv e lyAware .com The mirror has Two Faces A personal account of using facial filler for lipoatrophy By Jeff Berry E ver since it first began appearing with some regularity in people with HIV in the mid 1990’s, lipoatrophy has earned its well deserved reputation as the Scarlet Letter of HIV, also known as “the look.” Lipoatrophy is the loss of subcutaneous fat under the skin, most notably in the face, but also in the butt, arms, and legs, and is thought to be part of a larger syndrome called lipodystrophy, which is the redistribution of fat in the body and can include buffalo hump, enlarged breasts, and visceral fat in the abdomen. It can sometimes be extremely disfiguring, and almost always causes some level of emotional distress, even depression, and oftentimes self-imposed isolation in those who suffer from its stigmatizing effects. It can also affect adherence to HIV medications, and deter people from starting treatment in the first place. The cause of lipoatrophy has been linked to certain HIV medications, most notably d4T (Zerit, stavudine) and to a lesser extent AZT (Retrovir, zidovudine) and ddI (Videx, didanosine); other HIV meds, including some protease inhibitors; and it has also been linked to HIV itself. D4T is rarely prescribed in the U.S. anymore, but is still widely used in many developing countries due to its availability and low cost. While we don’t see as many new cases of lipoatrophy here in the U.S. with those who have since initiated therapy using newer and less-toxic antiretrovirals, it is still prevalent among those using d4T in developing P osi t i velyAware.com countries, although d4T continues to fall out of favor with providers and is used less and less as more and newer drugs become available in those regions. For those who have been treated with some of these older, more toxic drugs (when that was all that was available), many have developed the sunken cheeks, veiny arms and legs, and loss of fat in the butt to the point where it is uncomfortable to sit for more than a short period of time. Once you discontinue taking a drug like d4T, you can sometimes stop the lipoatrophy from progressing any further, but it can take a long time to see any reversal of its effects, if ever, so some people will turn to using facial fillers to replace the fat in the face that has been lost. I have written several articles in the past, for both Positively Aware and TheBody.com, about my experiences dealing with the physical and emotional aspects of having lipoatrophy and its stigmatizing effects, as well as my experience using a facial filler, Sculptra (known then as New-Fill) back in 2001. The results I saw in 2001 were only moderate, and disappeared within about six months to a year, mainly due to the fact that I only received two treatments because that was all that I could afford. I n the fall of last year, I decided to revisit the idea of receiving another round of facial filler treatments, and I went to see Dr. Dan Berger of Northstar Medical Center in Chicago for a consultation. Dr. Berger, who also writes for Positively Aware, and has over 12 years of experience providing Sculptra, recommended that I undergo five or six “sessions” due to the level of facial lipoatrophy that I had. Facial lipoatrophy is graded on a scale of 1 to 5, with 1 being mild, and 5 being severe—mine was severe, between grade 4 and 5. During each session, I was to receive injections of two vials, or one “kit” of Sculptra, one vial for each side of my face. Sculptra, or injectable poly-L-lactic acid, is one of only two FDA approved treatments in the U.S. for HIV-associated facial lipoatrophy, the other being Radiesse. Both of these injectables work by being absorbed into the body and stimulating the growth of the body’s own collagen, so they are not permanent fillers. There are other fillers available (see table, page 43) that are also used for S E P T E MB E R+ OC TOB E R 201 2 41 facial lipoatrophy, but they are permanent and can sometimes cause serious side effects and allergic reactions (as can both Sculptra and Radiesse). Only one is FDA approved (Silikon 1000) and none are approved for use in HIV. Anecdotally, I’ve heard of people who have used them and are pleased with their results, but personally I did not want to use something that was going to be permanent. I felt comfortable using Sculptra because I had used it before and I already knew what to expect, but also because I would be getting six treatments instead of two, so I was hoping to experience better results this time around. Plus, as Dr. Berger explained it, after getting six treatments, my face would never go back to the way it was before receiving Sculptra, and I would only require a “touchup” session once a year. The cost of Sculptra is expensive, running about $1,700 for one kit (two vials), or $850 per 367.5 mg vial, which also includes the cost for the session—doctor, time, and procedure. Most insurance companies still consider its use to be a cosmetic treatment and are therefore likely to refuse to cover the drug as well as the procedure. However, if you are initially denied, you should appeal and see if you can get them to recognize it as a medical necessity (which it really is). Recognizing 42 S E P TE MB E R +O C TO BER 201 2 the high cost and lack of coverage by most plans, and the great need of those who have this condition, the manufacturer created a patient assistance program (PAP) for people with HIV that assists in helping to pay for Sculptra. However, a new company (Valeant) recently took over the PAP, and it now only covers those with up to $61,940 in annual income, and provides just two kits plus one follow up kit after a two-year period. Under the PAP Sculptra is free for those with an annual income less than 200% of the Federal Povery Level ($22,340 for an individual, slightly higher based on family size and in Alaska and Hawaii), and then on a sliding scale above this amount and up to $61,940. The staff at Northstar was very helpful in getting me set up with the PAP, and in November of 2011 I received my first treatment. I t is very important that the physician who is performing the procedure be trained specifically in the use of Sculptra and how to properly inject it, which requires a certain threading, or tunneling, technique. According to the package label, “during the first injection session with Sculptra, only a limited correction should be made. The contour deficiency should be under-corrected, never fully corrected or overcorrected (overfilled) during any injection session. Re-evaluate the patient no sooner than two weeks after the injection session to determine if additional correction is needed.” Each session only takes around 40-45 minutes, and it would begin with Dr. Berger marking my face with a white pencil to guide him while injecting the Sculptra. Starting with ice packs on my face to minimize the swelling, and then a local anesthetic to numb my face, he would begin injecting the filler into different areas of my face, using his hands to help “move” the filler into place once it was injected. Even with the local anesthetic, I experienced a good deal of discomfort when the needles went in and he tunneled, especially during the first couple of sessions when there was little fat in my face for him to work with. But the discomfort was only temporary, and when the session was over, I was left with some temporary swelling, a few marks, and on occasion, some slight bruising, but the swelling went down in a few hours and any marks or bruising were gone within a day or two. Following each session, and according to the package label, I was to “massage in a circular fashion the treated areas for five minutes, five times per day for five days,” in an effort to stimulate collagen growth and “even out” the facial filler under my P os it iv e lyAware .com “After” Photo: Chris Knight FACE ON: Berry before his initial treatment, and three months after the sixth and last session. FACE OFF: Commonly used options for HIV-related facial lipoatrophy SOURCE: FACIALWASTING.ORG Product Type/Sessions Approved? Cost Sculptra Poly-L-lactic acid Non-permanent; 3–7 or more sessions needed. FDA approved. Patient Assistance for product only (under $61,940 yearly income): www.needymeds.org/papforms/ sculpt1039.pdf. Labor cost average $400 per session. Full price: $1,100 per session for product. Radiesse Calcium hydroxylapatite (CaHA) microspheres Non-permanent; 2–3 or more sessions needed. FDA approved. Patient Assistance available: www. radiesse-fl.com/Physician-section/ Patient-access-program/ Full price: $1,200 per session. Silikon 1000 Microdroplets Permanent; 4–6 or more sessions needed. Off-label use; FDA approved for intraocular injections to treat CMV-related retinal detachment. No Patient Assistance Program. $400–800 per session, depending on the physician. Bioalcamid Polyalkylimide gel Permanent; 1–2 sessions needed. Not FDA approved. Available in Canada, Mexico, and Europe. $4,500 average total. Two sessions. Infections reported after 3–4 years. PMMA Polymethylmethacrylate Permanent; 1–2 sessions needed. Not FDA approved. Available in Mexico and Brazil. American version Artefil is too expensive for the amount required. $2,000 average cost for total reconstruction. Patient assistance in Tijuana: www.MedicalPMMA.com skin. I went back for five more sessions, one every four weeks. P atients are advised that after the initial treatment and within a week the effects will completely disappear, and the contour of the face returns to how it was before. With each subsequent session, however, you begin to see the cumulative benefit of each successive treatment, and the effects are more noticeable and last longer. By the third or fourth treatment, I was really looking more and more like my old self, and couldn’t wait for each following treatment, pain or no pain! Treatment advocate Nelson Vergel warns that not everyone experiences the same level of results. “Some people in my online discussion group, especially those with moderate to more advanced cases of facial lipoatrophy, have complained of poor response with Sculptra after spending a few thousand dollars for several sessions that did not end up restoring their faces.” Vergel, founder of FacialWasting.org and pozhealth at yahoogroups.com, says that some of them end up getting silicone microdroplets in the U.S. or flying to Mexico to get permanent options like PMMA (see table, above). P osi t i velyAware.com Of course, nothing is perfect, and there are side effects associated with Sculptra. The most common side effects reported in studies are bruising, swelling, discomfort, and rash, but these typically resolve within a few days to a few weeks. There is a “device-related adverse event” called an injection site subcutaneous papule, which is a small lump or bump under the skin, the onset of which can occur anywhere from a few weeks to a few years afterward. I experienced several of these lumps, one under my left eye, and two under my right temple (sometimes if you get these papules you can feel them under your skin, but they are barely noticeable—other times they can be more visible). There are also more serious adverse events that can potentially occur, so be sure to read the full package label. I n the end, for me the few small lumps, the cost of treatment, and the pain were all a small price to pay for what it has ultimately done for my self-esteem. I feel better about myself overall, because I look healthier. The effect for me was subtle, most people didn’t really notice or say anything, other than “you look rested” or “you look really great!” I realize that I am very lucky to have a decent-paying job that has afforded me the ability to benefit from this treatment, and that many others are not as fortunate. I also realize that even though the HIV treatments available today are much less likely to cause facial lipoatrophy (if at all), the fear of developing facial lipoatrophy still may deter some people from ever starting treatment, or may cause those who are on treatment to be less than fully adherent to their regimen. While Medicare finally agreed to cover the procedure a few years ago, the amount that they reimburse is well below what providers charge. That is why I plan to continue to advocate for insurance companies, Medicare, and Medicaid to cover this procedure at a reasonable amount, much in the same way that breast reconstruction is provided to women with breast cancer who have undergone a mastectomy. The benefit of these treatments is vital to the psychological well-being and quality of life for so many people living with HIV who are affected by this condition. Go to www.sculptra.us for more information. For a list of providers trained in the use of Sculptra, visit www.sculptraaesthetic.com. S E P T E MB E R+ OC TOB E R 2012 43 Ask the HIV specialist Helen C. Koenig, MD, MPH Safe sex is for seniors, too Finding an HIV Specialist™ is easy with AAHIVM’s Referral Link: www.aahivm.org. Enter your ZIP code on the home page, and click on the “Go” button for a list of HIV Specialists™ near you. 44 Q: I am a 65-year-old woman. I lost my husband six years ago and have finally decided to enter the dating world again. My friends have convinced me to go on a cruise especially for single seniors, but my daughter is giving me all kinds of warnings about sexually transmitted diseases and HIV. HIV didn’t even exist back when I first became sexually active. Seriously, how great is my risk of contracting such diseases? After all, we are all going to be senior citizens and I’m not going on this cruise intending to “hook up” (as they say). Is all this safe sex stuff really necessary? n A: As you head for the sun, the all-you-can-eat buffets, and the cruise festivities, don’t forget to pack some condoms with your sun block. While the risk of bringing home HIV or another sexually transmitted infection (STI) is not high, it’s not zero either. You are joining a growing population of women who are sexually active in their 60s and 70s and, unfortunately seeing a higher rate of STIs than ever before. What really is your risk of acquiring an STI? This depends entirely on the partner or partners with whom you choose to be sexually active, what type of sex you choose to have (oral, vaginal, or anal) and whether you choose to use protection or not. You have no way of knowing the sexual history of the men you’ll meet or their risk of having an STI. Studies have shown that even doctors, after taking a complete sexual history in a medical setting, are still terrible at predicting whether someone has HIV. Your prospective partners may not know they have STIs, as many can be present for months or years without symptoms, including HIV. Women who have been in a monogamous relationship for the last 20 or 30 years, or for whom sex hasn’t been an issue, may find it difficult to think about buying and asking their partner to use condoms. But here are some good reasons to brave that aisle at the drug store before you hit the high seas, as well as empowering yourself enough to make sure they’re used: S EP TE M B E R +O C TO BER 201 2 3,500 women over age 45 were diagnosed with AIDS in 2009. People over the age of 50 now account for 15% of new HIV/AIDS diagnoses, and over 35% of all deaths from AIDS. n The highest percentage of trichomoniasis (a parasitic infection, considered the most common curable STI) is now actually in women over 50. Also on the menu are syphilis, gonorrhea, chlamydia, hepatitis B and C, herpes, and human papilloma virus. n Postmenopausal women are at a particularly high risk of acquiring HIV and other STIs because the vaginal wall is thinner as a result of lower estrogen levels and the immune system is not as strong as it used to be. You can’t control the risk of STIs in your partners, but you can control the risk of bringing one home yourself with correct condom use. Perhaps you think it’s “the man’s job” to come prepared with protection, but I encourage you to bring your own as backup! Chances are, the condom colors, flavors, and textures out there have changed a bit since you last looked. Lubricants now also come in wider varieties and are important if you experience vaginal dryness, both for your own comfort and to prevent condoms from tearing. So pack some protection and enjoy the festivities ahead! P os it iv e lyAware .com Illustration © karlkotasinc Search for an HIV Specialist™ Wholistic picturE Sue Saltmarsh Battle of the sexes? With all the evidence that there is indeed and the problem is not in getting people to go against those natural leanings, but in the rest of us accepting whatever choices they make. As a former girl, I can tell you that there is nothing on Earth that could’ve induced me to become a scientist, engineer, or mathematician. Why should I have been forced into a field I had no interest in? Why should any boy be forced to take Home Ec over Shop, to play the flute instead of football, or vice versa against his own interest? Throughout history, there have been courageous activists of both sexes fighting for things that were good for everybody. Without Elizabeth Cady Stanton and Susan B. Anthony, the issue of women voting might never have come to the forefront, but it took 56 men in Congress to pass the amendment that gave women the right to vote. Rosa Parks and Martin Luther King were both crucial to the civil rights movement, but it was Lyndon Johnson, a white guy from Texas, who made it the law of the land. We need to stop putting each other in neat little boxes. People—every sex, every race, every religion, every size, every age, with every illness—have to decide for themselves what’s worth fighting for in this lifetime. Since 2009, we’ve had a lot of people, many who call themselves Christians and/or Republicans, deciding that the only thing worth fighting for is whatever goes against everyone who doesn’t look, believe, or act like them. But now we also have more, including some Christians/Republicans, waking up, shaking off complacency, and standing together in all their glorious varieties to fight for justice, equality, and the things that are best for the Whole. “Men should be advocates for all and not just their own gender!” feminists stridently shout. Shouldn’t women? Shouldn’t we all? Regardless of the composition of our chromosomes, we are all human. None of us would be here without the contributions of both male and female. So I propose we stop being “feminists” or “masculinists” (See? not even a word for it!) and do our best to become humanists. Photo: CHeryl Mann a “war on women” being waged by “conservatives,” it’s hard not to feel a “feministic” response. I am not a feminist. But I am also not in favor of any woman being forced to have a child she cannot support financially, emotionally, physically, or spiritually, just as no man should be forced into fatherhood that he doesn’t want and can’t do well. But I digress. Some feminists have been heard to say that no man would be here without his mother’s body having created him. I have to wonder how they could have missed the fact that a man (the sperm had to come from one of them, after all) was also involved in that creation. But then, I thought, couldn’t such biological criteria be used to argue the case for the opposite side of every agenda? Women have testosterone too and yet the number of female-only causes far outweighs male-only ones. At this stage of human history, I doubt that there is any black or white person who doesn’t carry a gene inherited from an ancestor of the other color and yet we have racism from both sides. And, as I’ve said before, aren’t people who develop cancer after years of chain smoking just as deserving of the medical care and treatment they need to survive as people who acquire HIV after years of unprotected sex with multiple partners? When feminists angrily accuse me of misogyny, I stand by my belief that BOTH sexes are as valuable and as worthy of living as the other. And yet, if a man published a calendar called “How is a jar of Vaseline better than a woman?” I’ve no doubt he would be verbally castrated by the very women who publish “How is a cucumber better than a man?” And, by the way, the word for the female equivalent of misogyny, misandry, rarely sees the light of day, though both obviously exist in full force. I have frequently been amazed by the number of commercials on PBS and other progressive media sources that tout the urgent need to get more girls to become scientists, engineers, and mathematicians. What about the boys who are truly, innately passionate about math and science? And where are the commercials urging more boys to become nurses, teachers, and dancers? Fact is that each sex has natural tendencies P osi t i velyAware.com We need to stop putting each other in neat little boxes. Regardless of the composition of our chromosomes, we are all human. Breathe deep. Live Long. S E P T E MB E R+ OC TOB E R 2012 45 On September 21, take your best shot against HIV. A Day with hiv Whether weâ€™re positive or negative, we are all affected by HIV. Take your best shot against HIV/AIDSâ€”take part in A Day with HIV, the HIV awareness and anti-stigma campaign presented by Positively Aware. On Sept. 21, use your smartphone or digital camera and take a snapshot of a moment of your life. Upload your picture and story to ADaywithHIV.com or email them to firstname.lastname@example.org. Select pictures will appear in a special section of the November+December issue of Positively Aware. Additional pictures will be featured on ADayWithHIV.com. Get in the picture. ADayWithHIV.com