POSITIVELYAWARE.COM JULY + AUGUST 2012
GETTING PrEP’d: ARE YOU READY? LEATHER, PORN,
AND KINK. PLAYING IT SAFE TREATMENT STRATEGIES:
WHAT’S RIGHT FOR YOU
Following his run on TV’s “The Voice,” Jamar Rogers takes to the stage again —to share his story of life with HIV
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.
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 2012 06/12 28PRZ12036
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: May 2012
JULY+AUGUST 2012 VOLUME 24 NUMBER 5
D E PA R T M E N T S
6 IN BOX 6 READERS’ POLL 7
Wish HIV away.
Hepatitis C treatment without interferon. Activists issue report on cure research. Trending on Twitter.
23 CULTURE CLUB
Remembering where we’ve been.
44 ASK THE HIV SPECIALIST
How safe is safe?
45 SALIENT RAMBLINGS
“It‘s so strange the way things turn.”
24 Jamar’s voice
After his run on TV’s “The Voice,” Jamar Rogers takes to the stage for more than singing.
F E AT U R E S
19 Treatment strategies
As therapies improve, how to choose what’s right for you.
DIGITAL EDITION READ THE PRINT VERSION OF POSITIVELY AWARE ON YOUR COMPUTER OR TABLET.
34 PrEP’ing Are you ready? Doctors and advocates gear up to bring Truvada PrEP to those who are at greatest risk of infection.
39 Leather, porn, and kink They’re actually safer than you might think.
ON THE COVER AND ON THIS PAGE JAMAR ROGERS PHOTOGRAPHED BY MATTHEW GARSTECK. MAKEUP: JACKIE MGIDO. JAMAR ROGERS’ ASSISTANT: MICHELLE ROGERS. JAMAR ROGERS’ MANAGER: SALLY COLÓN. STYLIST: KENZIE CROSLEY. CLOTHING PROVIDED BY KITSON IN BEVERLY HILLS, CA.
J U LY+AUGUST 2012
P OS I T I V E LYAWA R E .CO M
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EDITOR-IN-CHIEF Jeff Berry
www.positivelyaware.com Jamar in full
ASSOCIATE EDITOR Enid Vázquez COPY EDITOR
PROOFREADER Jason Lancaster WEB MASTER Joshua Thorne CREATIVE DIRECTOR
Listen to the audio or read the full interview with Jamar Rogers. www.positivelyaware.com/jamar
How the Supreme Court’s ruling will affect health care. www.positivelyaware.com/2012/12_05/aca.shtml
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© 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. 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. 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.
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READERS’ POLL IN THE MAY+JUNE ISSUE, WE ASKED READERS
Sharing and educating
What do you think is the best way to provide HIV testing in prisons?
I JUST OPENED THE 2012 PA DRUG GUIDE AND CURLED UP
for a cover-to-cover read. I didn’t get past the editor’s note. Like always, Jeff’s open sharing was moving, and caused me to pause. No one talks so bluntly about switching, the shifting paradigms of treatment, and/or aging. No one else lays it all out there with honesty, conviction, and gentleness. I don’t know why his ideas get me all choked up. Maybe there is a trace of provider’s guilt. I used to worry 24 hours a day, when I was practicing. I wondered if I made the right decisions, were the guidelines making the right call, were the available regimens a one-size-fits-all. There were so many choices, I have come to see, that could have been better. Let me phrase it differently. There are so many aspects of treatment that have gotten better! One of those is the improved side effect profiles. Also, initiating treatment early…in the good way. Not the “hit it hard; hit it early” way. Maybe I just get moved by hearing that there is another voice out there fighting the same fight, and looking at the same ideas, like switching as an option. Like Jeff said, when we know better, we do better. It has been a journey. Thanks to Jeff for sharing his. Thanks to PA for being a part of mine. —Name withheld by request The response from Dr. Bick in the May+June “Ask the Specialist” column was not accurate. The writer asked about her brother getting treatment for HIV while in prison and Dr. Bick said he has a right to it. Actually, while you may have that right, you do not necessarily get treatment when in jail. I had to serve two weeks in jail. Before I went in, the judge was informed of
my illness and I handed all my meds over after sentencing. I went to jail, my meds were shelved, and I was given no access to them. Before entering jail my T-cell count was stable and I was healthy. After leaving, my T-cells were below 200, I had lost a lot of weight, and I had AIDS. So please don’t misinform people about rights that are not given, even by the judges. I will never be free of the anger I have for these people. —KS
Correction In the May+June issue, in the article about The Normal Heart, the executive producer at Arena Stage was referred to as Edgar Obie. His name is actually Edgar Dobie. Also, this production is actually not the first regional one, but rather the first D.C.-area professional production. The photo caption should read “Jim Parsons and Lee Pace in the 2011 Broadway production of The Normal Heart.” We apologize for the errors and thank Arena Stage for bringing them to our attention.
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.
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J U LY+AUGUST 2012
“Test as requested—and provide education. Make condoms and lube available so that when sex happens, it’s lower risk.”
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“As a transgender woman who was in prison and infected with HIV, I feel it should be offered to all inmates.” “Testing positive in jail or prison has a negative impact on a person’s life, so inmates should be able to choose. Testing should be offered only where immediate access to quality care and treatment is available.” “We test upon intake, then in 120 days and again upon release. Mandatory testing should be done in all correctional facilities. That way we can get them into treatment and try to keep them in treatment when released.” THIS ISSUE’S POLL QUESTION:
Before you tested HIV-positive, did you think you were at risk? n No n Didn’t even think about it n Yes, but low risk n Yes, but didn’t care n Yes, practiced safer sex CAST YOUR VOTE AT
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EDITOR’S NOTE JEFF BERRY @PAEDITOR ON TWITTER
Wish HIV away
RUTH IS A FUNNY THING. IT HAS A WAY OF SNEAKING
sweep it under the rug, erroneously believing it can’t happen to them, attaching shame and stigma to simply having a virus. We need to stop wishing HIV away, and it has to begin with us. I know for some of us the fear of losing our jobs, and hence our health insurance, is a very real, palpable fear. But we need to start by speaking and owning our own truth, if only in the mirror. In this issue, Jamar Rogers speaks very openly and honestly about his own struggles, and the power of speaking his own truth regarding his HIV status. However, there are some of us who continue to hide, or live in denial, because it’s more comfortable, or it’s easier, or we are afraid of the unknown. But it might be that we could have a real impact by coming out about our status, if only to ourselves. HIV is nothing to be ashamed of. The only stigma attached to HIV is that which we allow. It has no power to dictate our actions, our feelings, or our beliefs, other than the power that we choose to let it have over us. Let’s stop the fantasy. Let’s stop pretending that HIV can be wished away. Until there is a cure, HIV is unfortunately here to stay. Just like that uninvited guest at the party, it can either be shunned, merely tolerated, or it can be embraced. Remember, you are the host, and it’s your party— what happens is up to you. So shine your light brightly, hold your head up high, don’t be ashamed, and refuse to live in fear. It’s only when we finally decide to embrace and rejoice in our own truth, that we can begin to see the truth and light in others. And by joining together, we create a force and a light so bright, so strong, that its presence is undeniable and it cannot be extinguished or ignored.
PHOTO: CHRIS KNIGHT
up on you when you least expect it, like a guest who shows up at a party, uninvited.
Wish Me Away is the name of a song by country music singer Chely Wright, and is also the title of her recently released documentary film, which chronicles her struggles coming out as a lesbian to her fans, the country music industry, and the world at large. It’s a touching, sometimes sad, often intense, and ultimately empowering film that tells her truth, as she has lived it, in the hopes that it might help others who may also be struggling. During the film’s opening, Chely states that she is just trying to live her own life openly and honestly, because not doing so is nearly killing her. She knew from a very early age that she was different, that she was gay, and for decades she swore to herself that she would take that secret to her grave. Years ago, I made a similar vow to myself—that I would take to the grave my own secret that I had been sexually abused as a child by my father. I have no doubt that a similar conviction exists for countless others when it comes to their HIV status. We live in fear—fear of losing our jobs, our family, our friends, our very safety. So we wish HIV away. We take our pills in hiding, so others won’t ask questions. If there is a blood drive at the office, we call in sick, rather than have to explain why we can’t donate. We drive hours to visit a doctor or clinic in another town, rather than be recognized at “that clinic” at home. We wish HIV away. I’m sure we all have that one friend who has never been tested, and refuses to, because they would just rather not know. They wish HIV away by pretending it doesn’t even exist. There is the family who hides the cause of death of their son or daughter by saying they died of cancer. The church that preaches that AIDS is God’s punishment for being gay. The legislators who slash budgets and funding and deny lifesaving medications to people with HIV. They all wish HIV away, and
P OS I T I VELYAWARE.COM
We need to stop wishing HIV away, and it has to begin with us. We need to start by speaking and owning our own truth, if only in the mirror.
Take care of yourself, and each other.
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WITH HIV Take your best shot against HIV. Positive or negative, we’re all affected by HIV. Join us in the effort to change minds and open hearts by sharing the stories and faces of people living with HIV, their loved ones, and their friends. On September 21, wherever you are, take a photo of a moment of your day that shows how you live with HIV, and help to defeat HIV stigma and discrimination. Photos will appear in our online gallery, and selected images in the November+December issue of PA. Get in the picture!
It’s time for a Plan B. It’s time that the HIV/AIDS community joined all other people living with illness and injury. It’s time we refused to settle for less than single-payer, universal healthcare for all. 25 years ago, ACT UP taught us how to change the status quo. We need to remember. Join us on the National Mall. Show up. Speak out. Make history.
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Join us as TPAN commemorates a quarter-century of service to Chicago’s HIV community.
CHICAGO CULTURAL CENTER OCTOBER 4, 2012 5:30–8:30 PM
TICKETS AVAILABLE AT WWW.TPAN.COM
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The Quad goes before the FDA
PHOTO: JOSHUA THORNE
An FDA advisory committee voted 13–1 to recommend that the FDA approve a new once-daily HIV drug known as the Quad. The FDA usually follows the recommendations of its advisory committee and is scheduled to consider approval of the Quad by August 27. If approved, it becomes the third single-tablet HIV regimen on the market, along with Atripla and Complera. As its nickname implies, the Quad is made up of four different medications. These are the new integrase inhibitor elvitegravir (brand name not yet available), plus Viread and Emtriva (tenofovir and emtricitabine—available both separately as well as together under the brand name Truvada), and cobicistat. This fourth drug is not an HIV medication, but a booster agent to improve the bioavailability of elvitegravir. Currently, Norvir (ritonavir) is the only such booster agent available. Elvitegravir would join the only HIV integrase inhibitor currently on the market, Isentress. For more information on the Quad, go to www.positivelyaware.com/quad.
HIV patients often drop out of care
HIV prevention pill recommended
Only one in five HIV patients maintained a high level of medical care based on three criteria, according to an analysis of 12 clinics in the U.S. The study, published in the April 23 edition of Journal of Acquired Immune Deficiency Syndrome (JAIDS), was based on the medical records of more than 22,000 people receiving care between 2001 and 2009. In looking at the three criteria—establishment of care (a follow-up appointment six or more months after first engaging with care); retention in care (two or more follow-up appointments at least 90 days apart in each year of care); and loss to follow-up (no visit for more than twelve months without return)—the researchers found that: 21.7% of these patients never established HIV care after their first visit; 57.4% did not meet retention criteria; and 34.9% were lost to follow-up. 20.4% of patients established and retained care under the definitions of the study. “For optimal clinical benefit, HIVinfected patients should receive periodic outpatient care indefinitely,” the researchers stated. “These data highlight the need to improve establishment and retention in HIV care.”
An advisory committee of the FDA recommended that the agency approve the use of the HIV medication Truvada for HIV-negative people to prevent infection with the virus (see story on page 34). The FDA was scheduled to consider the new indication for Truvada in September, as POSITIVELY AWARE went to press. An actual indication for prevention on the drug label would make it easier for medical providers to prescribe it and insurers to pay for it.
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HIV the musical: Living with Henry Living with Henry is the title of a new Canadian musical that explores present day issues of living with HIV such as stigma, disclosure, and interpersonal relationships. The musical will be premiering in New York City this summer from July 23–29 as part of the New York Musical Theatre Festival. “It has become apparent that there are few, if any, theatrical productions that discuss HIV in the ‘now’ context,” says writer and director Christopher Wilson, who is himself HIV-positive. “Living With Henry is a contemporary theatrical view of HIV/AIDS, framing it as a chronic illness rather than a death sentence.” For more information go to www. LivingWithHenry.com; Living With Henry tickets are $25 and can be purchased online at www.nymf.org or by calling (212) 352-3101. —JEFF BERRY Ryan Kelly (left) and Dale Miller star in Living with Henry.
Another home HIV test Another FDA advisory committee recommended that the agency approve the OraQuick In-Home HIV Test. Unlike other over-the-counter HIV tests available from Home Access, in which people mail in samples on a swab and get their results over the phone, the OraQuick test results would be available in 20 minutes and can be read right at home, as with home pregnancy tests. An oral swab is used. J U LY + AU G U ST 2 01 2
BRIEFLY ENID VÁZQUEZ
Breast milk antibodies help neutralize HIV Antibodies that help to stop HIV from replicating have been found in breast milk. Researchers at Duke University Medical Center isolated the antibodies from immune cells, called B cells, in the breast milk of infected mothers in Malawi. HIV-1 can be transmitted from mother to child via breastfeeding, but only one in 10 HIV-positive nursing mothers is known to pass the virus to their infants. Research showed that the B cells in breast milk can generate neutralizing antibodies that may inhibit the virus. The discovery of the two antibodies in breast milk may also help researchers with new investigations into adult-toadult transmission, as well as to motherto-child transmission. “This is important work that seeks to understand what a vaccine must do to protect babies from mucosal transmission during breastfeeding,” said Barton Haynes, MD, co-author and director of the Center for HIV/AIDS Vaccine Immunology (CHAVI), as well as director of the Duke Human Vaccine Institute (DHVI). “The antibodies isolated are the first HIV antibodies isolated from breast milk that react with the HIV-1 envelope, and it is important to understand how they work to attack HIV-1.” The Centers for Disease Control and Prevention (CDC) recommend against breastfeeding if a mother has HIV-1, because baby formula is a safe alternative for U.S.-born infants. The World Health Organization, however, encourages HIVpositive nursing mothers in resource-poor regions to breastfeed while mother and/ or baby take antiretroviral drugs to prevent the infection in the infant. Without the nutrients and immune factors in mothers’ milk, many more babies would die from other diseases. The study was published May 18 in PLoS One. —SUE SALTMARSH 14
J ULY+AUGUST 2012
Treatment for hep C without interferon Boehringer Ingelheim (BI) issued a press release on 12-week data with two investigational compounds for the treatment of hepatitis C, BI 201335 and BI 207127. Although not yet studied in people with HIV, it’s a beginning for a new treatment option that can be expected to help people co-infected with HIV and hepatitis C (HCV) in the future. The two drugs were used together, along with ribavirin, but importantly, without interferon, a drug that is very difficult to tolerate, but is currently part of every hep C treatment regimen. “Eliminating interferon from HCV treatment is an urgent need,” said Stefan Zeuzem, MD. He is Chief of the Department of Medicine and Professor of Medicine at the Johann Wolfgang Goethe University Hospital in Frankfurt, Germany, and lead investigator of the study. The planned interim results showed that 68% of study participants achieved a sustained viral response (SVR) against their hep C. SVR at 12 weeks has been independently correlated to SVR at week 24, which is considered a cure. The participants (less than 100 of them) had genotype 1, the most difficult type of hep C to treat. The results were presented at the European Association of the Study of the Liver (EASL) conference, held in Barcelona in April.
Clue found to Ziagen and Epzicom hypersensitivity According to a press release from the FDA issued in May, “A team of researchers led by the U.S. Food and Drug Administration has discovered a new mechanism for identifying and understanding drug-related autoimmune reactions. “In an article published in the journal AIDS, the team describes that in certain at-risk patients, the anti-HIV drug Ziagen (abacavir) causes the immune system to ‘see’ a patient’s own healthy tissues and proteins as a foreign invader. The affect is similar to what happens when the immune system recognizes a viral or bacterial protein during an infection.” The agency said the “latest discovery will advance the FDA’s ability to approve therapies that are personalized for safety.” Ziagen is also found in the two-drug combination pill Epzicom. Both medications can cause allergic reactions that can be serious and even fatal, but the risk has been virtually eliminated by an easy and inexpensive test for the gene HLAB*5701, which makes people susceptible to the reaction. Ziagen and Epzicom are rather rarely used in the U.S., with competitor Truvada probably being the number one selling HIV drug in the country.
Activists issue report on HIV cure research Activists from the AIDS Treatment Activists Coalition (ATAC), Project Inform (in San Francisco), and the Treatment Action Group (TAG, in New York City) issued a report summarizing the talks presented at the Community HIV Cure Workshop, which took place in March in Seattle before CROI. The report received funding support from Bionor Pharma, Gilead Sciences, and Merck. “A cure for HIV will be essential to ending the AIDS pandemic, but science that is focused directly on a cure is still in early stages and will likely require the support of multiple stakeholders to proceed at the fastest pace,” the report begins. “Among recent signs of progress, researchers have contributed new insights into where and why HIV persists despite potent ARV therapy.” Read the 10-page report at www.positivelyaware.com.
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Nickelodeon seeks positive youth Trending HIV/AIDS on Twitter Six HIV/AIDS activists are urging Twitterers to use the hashtags #HIV, #AIDS, or #IAC during the International AIDS Conference, being held July 22–27 in Washington, D.C. The suggestion will help to “trend” HIV/AIDS on Twitter, meaning that instead of Kim Kardashian being one of the most talked about topics on Twitter, it could be HIV and AIDS at the top of the list instead. “Together, through this campaign, we (the global community) can, we must, make #HIV and #AIDS a trend. This is a huge opportunity to bring much-needed awareness to the HIV/AIDS global epidemic. To achieve success, we must all make a conscious effort to tweet our little fingers off!” writes activist Kevin Maloney in a recent blog on TheBody.com. “#HIV: Let’s Trend until the End will redefine how HIV, AIDS, and hepatitis C (along with other sexually transmitted infections) awareness, prevention, outreach, activism, and much more are put into action in areas that are in desperate need of support.” To participate, RSVP on the campaign’s Facebook event page, and click on “going,” or go to twitter.com/hashtaghiv.
Mallory Kydd, from Nick News with Linda Ellerbee, is looking for youth ages 11-17 to share their stories of living with HIV for a documentary to be aired on World AIDS Day, December 1. “We are primarily looking for stories that have a lot of depth. For example, the recent news piece about the 13-year-old boy who had his admission rejected at a private school in Pennsylvania,” said Kydd in an email sent to AIDS service organizations. Anyone interested should contact Kydd at Mallory@LDP.com or 1-212-463-0029.
Justice Dept. settles HIV bias lawsuits The Justice Department has reached two settlements resolving claims that health care providers refused to serve people with HIV in violation of the Americans with Disabilities Act (ADA). The first complaint was filed by a man with HIV who went to the Mercy Medical Group Midtown Clinic in Sacramento and was incorrectly told by the podiatrist seeing him that surgery was not an option because of the risk of the surgeon contracting HIV from him. The second complaint was filed by a man with HIV who went to the Knoxville Chiropractic Clinic North for chiropractic treatment following an automobile accident, where a doctor determined that he needed 24 appointments to treat his injuries. However, he was informed on his third visit that the clinic could not treat people “like him.” The Justice Department determined that the Knoxville Chiropractic Centers had a blanket policy of refusing treatment to people with HIV in violation of the ADA. “It is critical that people with disabilities, including HIV, not be denied equal access to goods and services, especially to health care services. The Civil Rights Division takes discrimination based on unfounded fears and stereotypes about HIV very seriously,” said Thomas E. Perez, Assistant Attorney General for the Civil Rights Division. The settlement agreements require the entities to develop and implement a non-discrimination policy and to train staff on the requirements of the ADA. In addition, Mercy Medical Group and CHW Medical Foundation are required to pay $60,000 to the complainant and $25,000 as a civil penalty, and Knoxville Chiropractic Centers is required to pay $10,000 as a civil penalty. Announcement of the settlements was made in May.
Combivir, Viramune go generic
Isentress drug label update
The FDA has approved generic formulations of the HIV medications Viramune (nevirapine) and Combivir, a combination of Epivir (lamivudine) and Retrovir (zidovudine or AZT). The approvals mean that these generic formulations can be marketed in the United States. The availability of these generics could be problematic for HIV treatment, since in an effort to save money, people could be forced to switch to the cheaper generics from other, more tolerable antiretrovirals. A comprehensive list of the approved generic HIV therapeutic drug products is available on the FDA’s HIV web site.
In May, the FDA approved of a labeling update for Isentress, an HIV integrase inhibitor. The three-year data (156 weeks, from a planned five-year study) showed that 76% of participants given Isentress had reached the goal of viral load less than 50 copies/mL, compared to 68% of the Sustiva group. Moreover, the average CD4+ T-cell increase seen with Isentress was 281 compared to 241 for Sustiva. This study looked at 600 people taking HIV treatment for the first time, a group that is expected to achieve the best results with therapy.
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J U LY + AU G U ST 2 01 2
INDICATIONS ISENTRESS (raltegravir) is a prescription HIV-1 medicine used with other HIV medicines to treat adults with human immunodeficiency virus (HIV-1) infection. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). The use of other medicines active against HIV-1 in combination with ISENTRESS may increase your ability to fight HIV. ISENTRESS does not cure HIV Infections or AIDS. Patients must stay on continuous HIV therapy to control infection and decrease HIV-related illnesses.
IMPORTANT RISK INFORMATION Severe, potentially life-threatening, and fatal skin reactions and allergic reactions have been reported in some patients taking ISENTRESS. If you develop a rash with any of the following symptoms, stop using ISENTRESS and contact your doctor right away: fever, generally ill feeling, extreme tiredness, muscle or joint aches, blisters or sores in mouth, blisters or peeling of skin, redness or swelling of the eyes, swelling of the mouth or face, problems breathing. Sometimes allergic reactions can affect body organs, like the liver. Contact your doctor right away if you have any of the following signs or symptoms of liver problems: yellowing of the skin or whites of the eyes, dark or tea-colored urine, pale-colored stools/bowel movements, nausea/vomiting, loss of appetite, pain, aching or tenderness on the right side below the ribs. 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 doctor right away if you start having new symptoms after starting your HIV medicine. People taking ISENTRESS may still develop infections or other conditions associated with HIV infections. The most common side effects of ISENTRESS include: headache, trouble sleeping, nausea, and tiredness. Less common side effects include: weakness, stomach pain, dizziness, depression, and suicidal thoughts and actions.
I am ambitious. I am driven. I am a business owner. I am HIV positive. You are special, unique, and different from anyone else. And so is your path to managing HIV. When you’re ready to start HIV therapy, talk to your doctor about a medication that may fit your needs and lifestyle. In a clinical study lasting 156 weeks, patients being treated with HIV medication for the first time who took ISENTRESS (raltegravir) plus Truvada: Had a low rate of side effects — The most common side effects of moderate to severe intensity (that interfered with or kept patients from performing daily activities) were insomnia (4%), headache (4%), nausea (3%), and tiredness (2%) At week 144, cholesterol was measured and patients who took ISENTRESS plus Truvada experienced less effect on LDL cholesterol (“bad” cholesterol): — Cholesterol increased an average of 7 mg/dL with ISENTRESS plus Truvada versus 22 mg/dL with Sustiva plus Truvada — When they began the study, the average LDL cholesterol of patients on ISENTRESS plus Truvada was 97 mg/dL versus 92 mg/dL for those on Sustiva plus Truvada
Ask your doctor about ISENTRESS. Not sure where to start? Visit isentress.com/questions Tell your doctor right away if you get unexplained muscle pain, tenderness, or weakness while taking ISENTRESS. This may be a sign of a rare but serious muscle problem that can lead to kidney problems. Rash occurred more often in patients taking ISENTRESS and darunavir/ritonavir (Prezista) together, than with either drug separately, but was generally mild. Tell your doctor about all your medical conditions, including if you are pregnant or plan to become pregnant. It is not known if ISENTRESS can harm your unborn baby. Also tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed if you have HIV because of the risk of passing HIV to your baby. Tell your doctor about all the medicines you take, including prescription medicines like rifampin (a medicine used to treat infections such as tuberculosis), non-prescription medicines, vitamins, and herbal supplements. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please read the Patient Information on the adjacent page for more detailed information.
Need help paying for ISENTRESS? Call 1-866-350-9232 Copyright © 2012 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. INFC-1038369-0000 05/12 Sustiva is a registered trademark of Bristol-Myers Squibb Brands mentioned are the trademarks of their respective owners.
Patient Information ISENTRESS ® (eye sen tris) (raltegravir) Film-Coated Tablets ISENTRESS ® (eye sen tris) (raltegravir) Chewable Tablets Read this Patient Information before you start taking ISENTRESS and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. What is ISENTRESS? ISENTRESS is a prescription HIV medicine used with other HIV medicines to treat adults and children 2 years of age and older with human immunodeficiency virus (HIV-1) infection. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). When used with other HIV medicines, ISENTRESS may reduce the amount of HIV in your blood (called “viral load”). ISENTRESS may also help to increase the number of CD4 (T) cells in your blood 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). It is not known if ISENTRESS is safe and effective in children under 2 years of age. ISENTRESS does not cure HIV infection or AIDS. People taking ISENTRESS may still develop infections or other conditions associated with HIV infection. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infections. Patients must stay on continuous HIV therapy to control infection and decrease HIV-related illnesses. Avoid doing things that can spread HIV-1 infection to others: • Do not share needles or other injection equipment. • Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades. • Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood. Ask your doctor if you have any questions on how to prevent passing HIV to other people. What should I tell my doctor before taking ISENTRESS? Before taking ISENTRESS, tell your doctor if you: • have liver problems. • have phenylketonuria (PKU). ISENTRESS Chewable Tablets contain phenylalanine as part of the artificial sweetener, aspartame. The artificial sweetener may be harmful to people with PKU. • have any other medical conditions. • are pregnant or plan to become pregnant. It is not known if ISENTRESS can harm your unborn baby. Pregnancy Registry: You and your doctor will need to decide if taking ISENTRESS is right for you. If you take ISENTRESS while you are pregnant, talk to your doctor about how you can be included in the Antiretroviral Pregnancy Registry. The purpose of the registry is to follow the health of you and your baby. • are breastfeeding or plan to breastfeed. - Do not breastfeed if you are taking ISENTRESS. You should not breastfeed if you have HIV because of the risk of passing HIV to your baby. - Talk with your doctor about the best way to feed your baby. Tell your doctor about all the medicines you take, including: prescription and nonprescription medicines, vitamins, and herbal supplements. Taking ISENTRESS and certain other medicines may affect each other causing serious side effects. ISENTRESS may affect the way other medicines work and other medicines may affect how ISENTRESS works. Especially tell your doctor if you take: • rifampin (Rifadin, Rifamate, Rifater, Rimactane), a medicine commonly used to treat tuberculosis. Ask your doctor or pharmacist if you are not sure whether any of your medicines are included in the list above. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. Do not start any new medicines while you are taking ISENTRESS without first talking with your doctor. How should I take ISENTRESS? • Take ISENTRESS exactly as prescribed by your doctor. • You should stay under the care of your doctor while taking ISENTRESS. • Do not change your dose of ISENTRESS, switch between the film-coated tablet and the chewable tablet or stop your treatment without talking with your doctor first. • Take ISENTRESS by mouth, with or without food. • If your child is taking ISENTRESS, your child’s doctor will decide the right dose based on your child’s age and weight. • ISENTRESS Chewable Tablets may be chewed or swallowed whole. • ISENTRESS Film-Coated Tablets must be swallowed whole. • If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not double your next dose or take more than your prescribed dose. • If you take too much ISENTRESS, call your doctor or go to the nearest emergency room right away. • Do not run out of ISENTRESS. Get your ISENTRESS refilled from your doctor or pharmacy before you run out. What are the possible side effects of ISENTRESS? ISENTRESS can cause serious side effects including: • Serious skin reactions and allergic reactions. Severe, potentially life-threatening and fatal skin reactions and allergic reactions have been reported in some patients taking ISENTRESS. If you develop a rash with any of the following symptoms, stop using ISENTRESS and contact your doctor right away: ° fever ° muscle or joint aches ° redness or swelling of the eyes ° generally ill feeling ° blisters or sores in mouth ° swelling of the mouth or face extreme tiredness blisters or peeling of the skin ° ° ° problems breathing
Sometimes allergic reactions can affect body organs, like the liver. Contact your doctor right away if you have any of the following signs or symptoms of liver problems: ° yellowing of the skin or whites of the eyes ° dark or tea colored urine ° pale colored stools/bowel movements ° nausea/vomiting ° loss of appetite ° pain, aching or tenderness on the right side below the ribs • 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 doctor right away if you start having new symptoms after starting your HIV medicine. • Phenylketonuria (PKU). ISENTRESS Chewable Tablets contain phenylalanine as part of the artificial sweetener, aspartame. The artificial sweetener may be harmful to people with PKU. The most common side effects of ISENTRESS include: • headache • nausea • trouble sleeping • tiredness Less common side effects include: • weakness • depression • stomach pain • suicidal thoughts and actions • dizziness Tell your doctor right away if you get unexplained muscle pain, tenderness, or weakness while taking ISENTRESS. This may be a sign of a rare but serious muscle problem that can lead to kidney problems. Rash occurred more often in patients taking ISENTRESS and darunavir/ritonavir together than with either drug separately, but was generally mild. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of ISENTRESS. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store ISENTRESS? Film-Coated Tablets: • Store ISENTRESS Film-Coated Tablets at room temperature between 68°F to 77°F (20°C to 25°C). Chewable Tablets: • Store ISENTRESS Chewable Tablets at room temperature between 68°F to 77°F (20°C to 25°C). • Store ISENTRESS Chewable Tablets in the original package with the bottle tightly closed. • Keep the drying agent (desiccant) in the bottle to protect from moisture. Keep ISENTRESS and all medicines out of the reach of children. General information about ISENTRESS Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information Leaflets. Do not use ISENTRESS for a condition for which it was not prescribed. Do not give ISENTRESS to other people, even if they have the same symptoms you have. It may harm them. This leaflet gives you the most important information about ISENTRESS. If you would like to know more, talk with your doctor. You can ask your doctor or pharmacist for information about ISENTRESS that is written for health professionals. For more information go to www.ISENTRESS.com or call 1-800-622-4477. What are the ingredients in ISENTRESS? ISENTRESS Film-Coated Tablets: Active ingredient: raltegravir Inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium phosphate dibasic anhydrous, hypromellose 2208, poloxamer 407 (contains 0.01% butylated hydroxytoluene as antioxidant), sodium stearyl fumarate, magnesium stearate. The film coating contains: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, red iron oxide and black iron oxide. ISENTRESS Chewable Tablets: Active ingredient: raltegravir Inactive ingredients: hydroxypropyl cellulose, sucralose, saccharin sodium, sodium citrate dihydrate, mannitol, red iron oxide (100 mg tablet only), yellow iron oxide, monoammonium glycyrrhizinate, sorbitol, fructose, natural and artificial flavors (orange, banana, and masking that contains aspartame), crospovidone, magnesium stearate, sodium stearyl fumarate, ethylcellulose 20 cP, ammonium hydroxide, medium chain triglycerides, oleic acid, hypromellose 2910/6cP, PEG 400. This Patient Information has been approved by the U.S. Food and Drug Administration. Distributed by: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA Revised April 2012 USPPI-T-05181204R018 Copyright © 2007, 2009, 2011 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. INFC-1038369-0000 05/12 U.S. Patent Nos. US 7,169,780
As therapies improve, how to choose what’s right for you BY ROSS SLOTTEN, MD, MPH
ILLUSTRATION © MICHAEL POWERS
EFORE THE MID-1990S, HIV INFECTION WAS A DEATH SENTENCE.
And almost worse than the prognosis itself was the disease course: suffocation from pneumonia, blindness, dementia, hideous purple skin lesions engulfing limbs and internal organs, and incurable cancers, to name a few. No disease that I can think of is as merciless and mean-spirited as HIV/AIDS. TREATMENT STRATEGY HISTORY Strategies for the treatment of HIV/AIDS have evolved since the introduction of AZT P OS I T I VELYAWARE.COM
(Retrovir) in the late 1980s. AZT alone was a failure. At most, it extended life by only a few months. Dual therapy with AZT and
didanosine (ddI) or lamivudine (3TC), or stavudine (d4T) and ddI or 3TC was better, succeeding in a third of those treated; the other two-thirds died. Real progress came in 1996, with the development of potent triple-drug therapies. In that banner year, the mantra became “hit early and hit hard.” But hitting early and hitting hard had its drawbacks. Some of the side effects— especially the so-called “Crixivan belly,” buffalo hump, wasting of facial and limb fat, and “AZT butt”—were so alarming that J U LY + AU G U ST 2 01 2
NO ONE KNOWS WHAT KIND OF SIDE EFFECTS MIGHT OCCUR AFTER TAKING ANTIRETROVIRAL THERAPY FOR 30 TO 40 YEARS OR MORE... [BUT] THE FEAR OF LONG-TERM EFFECTS, THOUGH UNDERSTANDABLE, IS NOT A REASON TO AVOID TREATMENT.
patients and their advocates asked why therapy could not be delayed until absolutely necessary. Those of us who treated people with HIV reluctantly agreed. As a result, until recently, most HIV-infected individuals weren’t offered treatment until their CD4 counts approached 250. Now that we have simpler regimens with fewer disturbing side effects, there are once again whispers of “hit early, hit hard.”
WHAT TO DO You’re newly diagnosed with HIV infection and told that your CD4 count is 510 and your viral load is 7,000. What should you do? The prospect of treatment still terrifies many people with HIV, sometimes more than the infection itself. For some of us over 40, the disfigurement of body shape changes has been a disturbing experience, whether for ourselves or our friends, partners, or relatives who took early HIV therapies. It’s true that those people would not be alive today without those therapies, but the emotional and physical cost has been high. Even changing to newer regimens doesn’t reverse the disfigurement. Unfortunately, despite extensive research, the cause remains a mystery and there’s no effective solution in sight. Today, we can assure people that if they never take AZT or d4T, they’re unlikely to develop the so-called lipodystrophy syndrome. I haven’t seen a new case in more than a decade. Moreover, no one knows what kind of side effects might occur after taking antiretroviral therapy for 30 to 40 years or more. Yes, that’s how long most people will be taking these medications, since the treatment of HIV is so successful that many, if not most people in the developed world can expect to live normal life spans, as long as they don’t stop their therapy, ever. And a cure is unlikely soon; maybe none will ever be found. A vaccine, if one can be developed, will prevent disease, 20
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but it’s unlikely to help those already infected. There are potential side effects of anti-HIV medications—cardiovascular disease, osteoporosis, kidney and liver disease, even cancers. But let’s put this disease in perspective: Untreated HIV infection is fatal in more than 95% of those infected. Only rabies is more lethal. No current HIV therapy will ever approach that kind of mortality rate. The fear of long-term effects, though understandable, is not a reason to avoid treatment.
THE GUIDELINES Now that we agree that the majority of people with HIV infection should be treated at some point, the question is, when should we start therapy? Since the early part of the last decade, a panel of experts under the auspices of the Department of Health and Human Services has issued a series of guidelines for the use of antiretroviral agents in HIV-1 infected adults and adolescents. These guidelines are based on the latest scientific evidence and the expert opinions of the panelists themselves when that evidence is scanty. The primary goal of treatment, of course, is to reduce the morbidity and mortality of HIV infection. Morbidity means the development of diseases that are both directly and indirectly related to the AIDS virus. Diseases such as pneumocystis pneumonia, cytomegaloviral retinitis, cryptococcal meningitis, and cryptosporidial diarrhea are direct consequences of advancing disease, when the immune system is so severely impaired that usually harmless organisms cause dreadful illness. Indirect consequences are related to T-cell activation, CD4 cell depletion, and inflammation, all of which increase the risks for heart attacks, cognitive impairment (dementia), and every type of cancer. The panel recommends antiretroviral therapy for all people, regardless of CD4 count, who
are pregnant, have a history of an AIDSdefining illness, have HIV-related kidney disease, or are co-infected with hepatitis B. In all four conditions, randomized, controlled studies have proven beyond doubt that the benefits of therapy far outweigh the negatives. Randomized, controlled trials have also proven that treatment is beneficial for those individuals with CD4 counts of less than 350 but who do not have an AIDS-defining illness and appear perfectly healthy. Non-randomized or observational trials also support the initiation of therapy in people with CD4 counts between 350 and 500. Such trials are considered less scientifically rigorous, since they sometimes lack a control arm and are not randomized, potentially introducing bias into the results. One study, HIV-CAUSAL, a collaborative study between U.S. and European sites, included some 8,300 antiretroviralnaïve (that is, untreated) patients with initial CD4 counts over 500 who then experienced drops below 500 cells. Those individuals whose treatment was delayed until their counts dropped below 350 had a higher risk of an AIDS-defining illness or death than those who started treatment when their counts were greater than 350 but less than 500. Another study from Europe, Australia, and Canada, called CASCADE, showed similar outcomes. As a result, the expert panel recommends therapy for patients with CD4 counts between 350 and 500. The evidence is weaker for the initiation of therapy in people with CD4 counts greater than 500, in part because it may take a decade or more to know about the benefits (or harms) of early treatment. Because trials are ongoing, are not randomized or controlled, or are observational only, the panel’s recommendation for treatment is moderate, rather than strong. Nevertheless, many of the experts would offer treatment to those in the earliest phases of HIV infection. This makes sense—for no other treatable infectious disease do we opt to delay therapy. If you had syphilis, you wouldn’t wait six months P OS I T I V E LYAWAR E .CO M
TOO OFTEN, WE FORGET THAT OLDER PEOPLE ARE SEXUALLY ACTIVE. IN FACT, 70% OF MEN AND MORE THAN 50% OF WOMEN OVER THE AGE OF 60 ARE STILL HAVING SEX. to get a shot of penicillin. You’d treat it at the time of diagnosis. This past year, the panel added a secondary goal of antiretroviral therapy: public health considerations. Although studies long ago demonstrated that treating pregnant women prevented perinatal transmission of HIV, it was not until recently that studies showed a similar benefit in serodiscordant couples. In a multi-continental trial of 1,700 HIV-discordant heterosexual couples, half of the HIV-infected partners were randomized to receive antiretroviral treatment immediately, the other half delayed therapy until their CD4 counts dropped to 250. All were counseled about safe sex practices. In the delayed arm, there were 28 new infections; in the immediate treatment arm, only one infection. There was therefore a 96% reduction in rate of transmission from the HIV-positive partner to the uninfected one. The panel now recommends that the HIV-positive partner in a sero-discordant couple, straight or gay, be treated, regardless of CD4 count or viral load. One can make a case for advising the treatment of any HIVpositive person who has multiple sex partners, some of whom may be HIV-negative.
WHICH WILL IT BE? Once we’ve decided when to treat, we need to know what treatment to initiate. As of 2012, there are 30 FDA approved antiretroviral agents in six different classes: nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), fusion inhibitors (FIs) CCR5 antagonists, and integrase inhibitors (INSTIs). The decision of which combination of drugs to use is based on at least nine factors: n
The presence of cardiovascular disease, chemical dependency, liver or kidney disease, psychiatric illness, or tuberculosis n Potential adverse effects n Potential interactions with other medications P OS I T I VELYAWARE.COM
The presence of resistance to one (or more) antiretroviral agent Gender and pre-treatment CD4 count if considering Viramune (nevirapine) The presence of HLA-B*5701 if considering Ziagen (abacavir) or the coformulation Epzicom Co-receptor tropism if considering Selzentry (maraviroc) Patient adherence issues Pill burden
Assuming that none of those nine factors is a concern, the panel recommends one of four regimens based on the results of randomized, controlled trials: n
Atripla (efavirenz/tenofovir/ emtricitabine) n Boosted Reyataz (atazanavir + ritonavir) and Truvada (tenofovir/ emtricitabine) n Boosted Prezista (darunavir + ritonavir) and Truvada n Isentress (raltegravir) and Truvada That’s relatively easy. But what if one or more of those nine factors are concerns?
THE OLDER CROWD It’s beyond the scope of this article to examine every possible reason for prescribing alternative regimens to those recommended above. The expert panel addresses in painstaking detail the pros and cons of various drug combinations in a variety of settings. However, for the first time the guidelines acknowledge a reality of the HIV/AIDS epidemic in the United States and other developed countries: More than a third of people living with HIV/ AIDS are older than 50. In another decade, that number will be more than half of all cases. Most trials focus on younger patients. Data for older patients, especially those in the 60- to 80-year-old age group, are limited. In pharmaceutical trials,
drug developers control for a number of variables, like gender and race, but they don’t want people in their trials who take medications that may interfere with the drug they’re testing. Their goal is to get their particular drug to market. Diabetics, or people on blood thinners, or those with kidney and liver disease—in short, many elderly individuals—may be excluded from a study because their treatments or disease states may muddy the outcome of the study. Second, the panelists rightly urge health care providers to take a good sexual history. Too often, we forget that older people are sexually active. In fact, 70% of men and more than 50% of women over the age of 60 are still having sex. Many of these seniors don’t view themselves at high risk for HIV infection. Postmenopausal vaginal dryness, the failure of heterosexual couples to use a condom because pregnancy is no longer an issue, and the availability of drugs for erectile dysfunction all increase the risk of sexually transmitted diseases. And third, for those individuals over 50 who are taking antiretroviral agents, it’s essential to monitor bone, kidney, cardiovascular, metabolic, and liver health. This is true for younger patients too, but co-morbid conditions and “polypharmacy”—that is, taking medications for other diseases as well as HIV—are more common in the over-50 group.
THE COST What’s also new is that the panel has compiled a list of the Average Wholesale Price (AWP) of individual antiretroviral agents and co-formulations like Atripla, Complera, Truvada, and Epzicom. I’m not sure what purpose this serves except to satisfy our curiosity. Everyone knows that treating HIV is crazy expensive. The wholesale monthly cost of Atripla is $2,080.97; the wholesale monthly cost of Prezista, Norvir, J U LY + AU G U ST 2 01 2
SELECTING THE OPTIMAL TREATMENT MAY BE TRICKY, BUT NO UNDERLYING DISEASE STATE, EXCEPT THE DIAGNOSIS OF A TERMINAL ILLNESS, SHOULD PREVENT SOMEONE FROM BEING TREATED.
and Truvada is $2,930.25. The difference between generic lamivudine and the brand Epivir is only $48 per month. Most people don’t pay for their medications anyway, although some have substantial co-pays, especially those on multiple drug regimens. I’m not aware that insurers have bothered to look at treatment guidelines to determine what co-pay should be charged to a patient. In my experience, the costs to patients are going up, not down. But as more antiretroviral agents go generic, perhaps those co-pays will go down.
FINDING THE ANSWER Let’s return to the problem of what a newly diagnosed person should do. I agree with many on the expert panel that most people with HIV should be treated, no matter what their CD4 count is. I’ve seen too many people die to feel otherwise. I’m also concerned about transmission to an uninfected sexual partner. Although this imaginary individual has a normal CD4 count and not a terribly high viral load, he’s not an elite controller (that is, he doesn’t have an undetectable viral load without treatment) and he’s unlikely to be a long-term non-progressor (generally, someone with an average viral load less than 2,000 copies). After doing a resistance profile (genotype) and determining that this individual did not have underlying resistance to one or more medications in our armament, I would most likely offer a single treatment regimen (Atripla) rather than a multi-drug regimen. That’s a personal preference because of concerns about compliance, not because I feel that the other regimens are inferior. If this individual were a female of childbearing age, or was pregnant or trying to conceive, a regimen containing Sustiva (efavirenz) should be avoided, especially in the first trimester when toxic effects on the fetus are greatest. In general, a 22
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protease inhibitor-based regimen has been proven safer. AZT, no longer a preferred agent for most people, may even be considered as one of the components of therapy because of its proven efficacy in preventing mother-to-child transmission. Atripla (and possibly Complera, though Complera is new and still considered an alternative to the preferred regimens) could be a good choice for an elderly patient on multiple medications. Drugdrug interactions are fewer than in those on boosted protease inhibitor regimens. However, if that individual suffered from underlying kidney disease, I would not recommend Atripla or Complera since they both contain tenofovir, which can exacerbate kidney disease. In that case, I might recommend Sustiva and Epzicom (abacavir and lamivudine). Abacavir, however, must be used with caution, especially in individuals with a known risk of cardiovascular disease, and a test must be performed to rule out potential hypersensitivity (severe allergy) to that drug. Ah, the complexities of treating HIV! Having so many choices—and taking so many things into consideration—can make one’s head spin. Once a person begins an antiretroviral regimen, he or she needs to be monitored periodically. The treatment goal is viral suppression to levels of less than 75 or 20 copies/milliliter of blood, depending on the assay used for monitoring. It may take up to 16 weeks for viral levels to fall below detectability, but dramatic drops in viral load are generally seen within two to four weeks of starting therapy. According to the expert guidelines, a viral level should be measured no later than eight weeks after beginning treatment to prevent further resistance to medications if the response to treatment is suboptimal. Thereafter, it should be measured every three to four months. A person is considered to have failed antiretroviral therapy if his or her viral level is persistently greater
than 200 copies. Occasionally, after being on therapy for years, a person might experience a “blip”—that is, a rare instance in which the virus is detectable, usually at very low levels (between 76 and 199 copies). It’s not necessary to change therapy or try to perform resistance testing when a blip occurs. The vast majority of the time, viral levels will be undetectable at the next monitoring visit. In general, a poor CD4 response to therapy is not a reason to change regimens. Those individuals who begin treatment when their CD4 counts are very low (under 200 cells) sometimes do not have as robust a response to therapy as those with higher CD4 counts at the initiation of therapy. The viral load is the best measure of treatment success. The main concern about CD4 counts remaining under 200 is the risk of opportunistic infections, like pneumocystis pneumonia, so it’s necessary to continue prophylaxis (prevention) against these infections until counts rise to safer levels.
CONCLUSION To conclude, although HIV is not curable, it’s treatable. And more than that, if started early, the treatment is usually well tolerated and has fewer side effects, especially the newer regimens developed in the past decade. Selecting the optimal treatment may be tricky, depending on the underlying health of the HIV-positive person. Elderly patients, pregnant women, people with a history of substance abuse, and those also infected with hepatitis B or C, or tuberculosis present great challenges to clinicians. But no underlying disease state, except the diagnosis of a terminal illness, should prevent someone from being treated. Treatment means a longer life and better quality of life, perhaps a normal life span. No treatment, when treatment is warranted, means certain death.
ROSS SLOTTEN, MD, MPH, is a family prac-
titioner in private practice in Chicago. He has treated people with HIV for 29 years. P OS I T I V E LYAWA R E .CO M
Remembering where we’ve been
An award-winning documentary looks back at the arrival and impact of AIDS in San Francisco BY JEFF BERRY
R PHOTO: RICK GERHARTER
ECENTLY A PRESS RELEASE
came across my desk promoting the documentary film We Were Here, which I had wanted to see for some time. I sat down on a Friday afternoon to view the film at home, alone. I really had no preconceived notions about the film other than that it was about the early days of the AIDS epidemic in San Francisco. I was woefully unprepared for the experience of the next 90 minutes, and the effect and hold the film would have over me for the next few weeks. According to the press release, “We Were Here revisits the beginning of the AIDS crisis in America through the eyes of five individuals who lived in San Francisco prior to the epidemic. From their different vantage points as caregivers, activists, researchers, friends and lovers of the afflicted, and people with AIDS themselves, the interviewees share stories which are not only intensely personal, but illuminate the much larger themes of that era: the political and sexual complexities, P OS I T I VELYAWARE.COM
the terrible emotional toll, and the role of women—particularly lesbians—in caring and fighting for their gay brothers.” The movie takes you back to a specific time and place in history, and does it extremely well. I remember my very first visit to San Francisco, in 1983—I was still quite young (24) and yet somehow seemingly oblivious to the horror and devastation that the epidemic had already inflicted upon the inhabitants of the gay mecca. As Paul Boneberg states in the film, it’s estimated that by 1977, 10% of the gay men in San Francisco were already infected. By the time the first cases were seen in 1981, 20% were infected, and by the time they had a test for HIV (in 1985), 50% were infected. This progression of the epidemic in the City by the Bay as depicted in the film is, in the words of Armistead Maupin, “absolutely electrifying.” Director David Weissman, who lived in San Francisco at the time, says that the movie reflects his own personal experience and view, through the
juxtaposition of normalcy and insanity. “It was very important that the story be told by someone who had lived through it,” says Weismann in a bonus feature on the DVD, “rather than be told by someone who was learning about it from the outside.” The film’s editor and co-director Bill Weber, who lived in New York and then moved to San Francisco in the 1980s, noted the differences between activists in New York, who wore their black ACT UP t-shirts, and those in San Francisco, some of whom would be a little more daring in their outfits. He recounts an instance when cops donned rubber gloves while arresting activists during a protest, and the activists chanted, “Your gloves don’t match your shoes, you’ll see it on the news!” It was important, say the directors, that the story be told in a way that was not too heavy-handed or overwhelming, so there are moments of humor and periods in the film when you are intentionally given a break from the emotional rollercoaster. But in the end, the movie is uplifting and inspirational and a beautiful tribute to a bygone era. I highly recommend it not only to those who lived through that period, but also for anyone wanting to learn more about what it was really like, having only heard about it through friends’ stories or news clippings. Says Weiss, “I’m hoping that it empowers those of us who have lived through it to realize that we have become richer, more beautiful people because of what we lived through…and not feel any shame or hesitation in sharing that part of ourselves. That we can be mentors, and teachers, and examples…” “And that we’re sexy, too,” says Weber, with a chuckle.
WE WERE HERE is now
available on DVD in stores, at www.amazon.com, and for rent or purchase through the iTunes Store. J U LY + AU G U ST 2 01 2
JAMAR’S VOI After his standout performance on TV’s “The Voice,” Jamar Rogers takes to the stage again—to share his story of life with HIV INTERVIEW BY JEFF BERRY
P H O T O G R A P H Y B Y M AT T H E W G A R S T E C K
N THIS YEAR’S SECOND SEASON OF NBC’S HIT REALITY TALENT SHOW
“The Voice,” we were introduced to the vibrant and effusive Jamar Rogers, whose cover of Bon Jovi’s “It’s My Life” was named Best Performance on The Voice by Rolling Stone magazine, which called his performance “simply electrifying.” PA spoke with Rogers just a few weeks after he lost out to Juliet Simms in the semi-finals and was eliminated. But Rogers’ story doesn’t end there, and he has a bit of a different take on the final outcome of the competition. His journey of facing adversity, overcoming despair, and finding redemption and healing, is one that will resonate with many, and can inspire us all. I’ve been following you and the show. You sharing your experience and coming out as HIV-positive was very emotional for me, and I’m sure a lot of
others watching the show, too. First of all, Jeff, hats off to you, brother. It’s just crazy how the world is
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changing. My experience on the show has given me faith that society is in a good place right now, where we all can receive this as a story, and maybe in our lifetime, stigma and prejudice will go away, once and for all.
I completely rebelled. I had had enough of my parents’ rules, and I started dabbling in drugs, I ended up running away from home at the age of 17 and was basically strung out from the ages of 18–23 on crystal meth—was just partying all the time, all I ever really wanted to do was party. Once I decided to actually get off of meth, a couple of months later I found out I was HIV-positive. I’ve been off of meth for
Absolutely. I agree. So, tell us about yourself. You grew up in Oklahoma, right?
I’m from all over the place, I don’t really have a hometown. New York is the tenth state that I’ve lived in in my lifetime because my parents moved around a lot. I was raised in a very, very strict Christian household, and when I turned 17,
seven years this month, so I found out I was positive about 6½ years ago. I got really, really sick. I had like
P OS I T I V E LYAWAR E .CO M
CE five T-cells, and I had Kaposi’s sarcoma, pneumonia, and thrush in my mouth. I had been getting sick while I was using meth, and I just thought that the meth didn’t agree with my body. I continued getting sick after I stopped using meth and I went to the emergency
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room. When the doctor first came in and told me that I was positive, I don’t know what others’ experiences are, I just know that at that moment, I felt the biggest peace wash over me. I can’t believe how at ease and peaceful I felt. I was actually very calm, and I suddenly
felt, I’m going to be alright, I’m going to be okay, I’m going to get through this. Contracting HIV was a lifechanger, obviously, but it was sort of better for me because I settled down. I began to learn so much about myself, and my own defensive behavior, and started seeking counseling, and my relationship with God flourished. I began to see God as a partner, as a loving Father, and not as someone who was waiting for me to screw up. That changed my whole perspective on how I viewed myself. I’m no longer married now, but the girl I was married to then helped save my life. She went to all my doctor’s appointments with me, did all of the research for me, and when I first started taking Atripla, she took care of me for those first couple of weeks when I was all woozy. By the grace of God, I’ve been undetectable for five years, and I’m very healthy. When I moved to New York to pursue music full-time about three years ago, I was not comfortable sharing my HIV status.
MAKEUP: JACKIE MGIDO. JAMAR ROGERS’ ASSISTANT: MICHELLE ROGERS. JAMAR ROGERS’ MANAGER: SALLY COLÓN. STYLIST: KENZIE CROSLEY. CLOTHING PROVIDED BY KITSON IN BEVERLY HILLS.
J U LY + AU G U ST 2 01 2
I decided a while ago to
live for something greater
than myself... I wanted to make an impact on the world, and I wanted to really help people. My close family and friends knew, but that was just a handful of people. I still carried so much stigma and shame, and so much embarrassment. I was very open and candid about my drug use in the past [including during auditions for seasons eight and nine of American Idol], but I didn’t feel that I was ready to discuss my HIV status. Over the course of [The Voice] audition, I knew it was time to talk about this, for two reasons. One, because I decided a while ago to live for something greater than myself—me just being famous for the sake of being famous wasn’t enough. I wanted to make an impact on the world, and I wanted to really help people. Two, I thought that maybe I could use this as a way to change people’s minds, to maybe show people that HIV comes in all shapes, sizes, colors, creeds, races, and maybe if I put a modern, human face on it, it wouldn’t be this thing that we whispered about, that maybe we could talk about it out loud. Honestly, Jeff, I’m so glad that I did it. I’m so glad that I overcame the fear that I had, because I can’t even begin to tell you the number of messages I received from people saying I’m the first person they’ve ever told they were HIV-positive. And because I was able to share my story, they now feel empowered to tell their families or their loved ones. I just feel like, no matter what place I got on the show, I won. I definitely won, because I overcame so much fear, and I really think I was on the path of changing people’s minds. You do talk very openly about your crystal meth addiction, so how did you get sober, and at what point did you realize, or start to think, that maybe you had a decent shot at life again? It was a series of events that made me realize I was just done with meth. For one thing, I was just getting more and more depressed and suicidal. It was only a matter of time before I was just not going to be here anymore, I really believe that. Two, none of my friends would let me stay 26
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with them anymore because I was stealing from them, so that was part of my “rock bottom.” And three, I was engaged at the time, and even though she was pregnant [with another man’s] child, we agreed to raise the baby together as our own. The day of the delivery, I went into the bathroom and shot up and I got really high, I remember I was so geeked that I couldn’t cut the baby’s cord, and that was kind of my a-ha moment. I remember thinking, how are you going to take care of this child when you can’t even cut the cord, you can’t even take care of yourself? The very next day I said to my fiancée at the time, let’s get out of Atlanta, I really want to make a change, and she was really happy, she had been so supportive of me. So we moved to Milwaukee where my mom was, and I didn’t know anyone there, and I didn’t know how to get any meth, and that was the beginning of my recovery. It was a few months after I
made that decision that I found out I was HIV-positive. I know some people might have gone backwards, but if anything, it just kind of encouraged me to keep doing what I was doing in my recovery, because I wanted to live more than ever, and if meth was going to kill me, then obviously I needed to cut that out of my life. During auditions your mom said that she saw you through life’s darkest hour, but now you’re a shining example to others. How much does that mean to you, having that kind of support from your family? It means so much, because when I ran away, my relationship with my mom really suffered, and for two years while I was out there, she had no idea where I was. Christmases went by, and she didn’t get a phone call from me. The true miracle of my recovery is the reconciliation of me and my mom. People look at us and they think, oh, P OS I T I V E LYAWAR E .CO M
good. I wasn’t really even nervous, I was more excited than anything. You have to understand, I had been waiting 10 years to shake CeeLo [Green’s] hand, and even if he didn’t turn around for me [and want me on his team], I was going to shake his hand [laughs]. I was so excited to just let him know how much he meant to me, and how much his artistry meant to me, so I was stoked. Right after the audition, CeeLo told you to stop and listen to the love, and the audience kind of roared, for a nice long ovation, and you got really emotional. Can you describe that moment, what that meant to you?
you guys are so close, but they don’t know that we’ve gone to hell and back together. My mom was the first person I called when I found out I was positive, so that right there shows that we definitely repaired what we had broken. It’s a beautiful thing, it’s a very affirming pat on the back. I want to talk a little bit about “The Voice” and that experience. You were the first person to do the blind auditions on “The Voice” [even though it didn’t appear that way on the show], were you more nervous having to go first, or were you just glad to get it out of the way? I was glad to get it out of the way. We had been auditioning for months before that blind audition, so I was like, I’m ready to do this. In fact, I was actually relieved to be going first, because that meant I didn’t have to wait around, and get in my head. I went out there, and I just felt P OS I T I VELYAWARE.COM
Growing up, I was just a weird kid, you know? When I did live in Oklahoma, I didn’t fit in with the black kids, I didn’t fit in with the white kids. I was just kind of there, and I was into what people would consider a weird type of music, and I always dressed kind of weird. I’ve never really been the popular guy. I think at that moment I realized that people liked me, and I had genuinely been myself, there were no secrets, everything was out there in the open, and people didn’t care. They liked me in spite of it, and that was what touched me. I had such a low opinion of myself for so many years and I’d just begun building up my self-esteem a few years ago, so to have it rewarded in such a way, it still strikes me emotionally sometimes. That moment, I’ll never forget that moment, it was a beautiful thing. I respect CeeLo as a songwriter, as a rapper, as a singer, I respect everything that he does, and to hear him give me accolades—hell, not even just him, all of the coaches. I had Christina Aguilera’s and Maroon Five’s first albums, and to hear these people that I listen to tell me that they think I’m great, I mean, that’s just a good feeling! That’s why I tell people all the time that I won. I won that show, as far as I’m concerned. I won in so many different ways…yeah, I won [laughs].
CeeLo has been so supportive of you from the start of the show… And that hasn’t ended, it hasn’t stopped. On the show you performed “It’s My Life” by Bon Jovi and you’ve said it was the favorite performance of yours from the show. Would you say that the song is kind of an anthem for you, now, or perhaps a reflection of where you are? Absolutely. It’s so funny, because I was not a big fan of the original. I had never gotten into the words. When CeeLo first suggested that I sing it, every instinct inside of me was like, hell no, I am not singing that song. Together we came up with that rendition that everyone heard, and he said, I just need you to listen to the words. Once I listened to the words, I was like this song is so perfect, for everything that I believe in, everything that I stand for. I’m all about never giving up, I’m all about chasing life, and savoring life, and tasting life, instead of just merely tolerating life. I’m about living life with passion, and I’m also about being the exception to the rule, and telling people don’t let society dictate your personality, your self-esteem, and definitely don’t let your past dictate that. I really believe that song embodies everything that I feel. In fact, I’ve been invited to sing a lot of places since my elimination, and that’s the song that everyone wants to hear. HIV stigma is still such a huge barrier to people getting into and staying in care and on treatment. Your courage and openness about your HIV status really serves as a role model to those struggling with stigma and denial, but also as an example to others who continue to perpetuate the stigma through their own ignorance and fear. What future role do you see yourself playing to help educate others about HIV? I have planned on doing activism work for years now. I really wasn’t doing hardcore J U LY + AU G U ST 2 01 2
I need to make music.
I think that’ll be the best activism I can do.
activism work in New York, I was just volunteering at a few community organizations, but I did have some plans for things that I wanted to do. Now that I have this platform, I definitely am attacking it with passion. In addition to joining the POZ Army, I’ll be doing some stuff in D.C. at the International AIDS Conference. And I’ll be there… Yay! I better get to meet you face to face! I would like that! I just recorded this amazing [CDC] campaign yesterday that I think will be unveiled nationwide [during the week of the conference], but I don’t think it would be nearly enough for me to just go around giving speeches, even though that would help. I think I need to make music. I think that’ll be the best activism I can do, by showing, here’s this artist that’s relevant today, his music’s played on the radio, I see his music videos, and no one cares that he’s HIV-positive. If I can make HIV normal or mainstream, in a way, then it begins to change people’s perspective. I believe that I’ve made a little headway, but there’s still so much work to get done. So, in addition to the speeches, and the Public Service Announcement, my number one goal and focus is to make the best music possible, because everyone receives music. Black, white, old, young, music can be a healer, it can be a uniter, and it can definitely bring people together. What I’m hoping is that my music is so good, that I won’t be the HIV guy, but I’ll just be this amazing artist who happens to have HIV.
your life, and you probably regret some of the choices you’ve made. We’re no different. I’ve made some bad choices and this is who I am today. My message is get up… get up, and keep running. It doesn’t matter what you’ve been through, whether it was an addiction, a bad relationship, or an eating disorder, whatever has happened, whether you willingly put yourself there, or you were there unwillingly, there is a tomorrow that’s waiting, so get with it, snap out of it, we’ve got work to do. I’m totally with you there. So you said you’re going to be speaking in D.C., do you know what you’re going to be talking about, and will you be performing as well? I think that they want me to perform, I have no idea. Usually, whenever I give speeches, I just give myself a theme, and I just go up there and wing it, and it always works for me [laughs]. What people don’t know about me is I like to speak as much as I like to sing, especially about something I’m extremely passionate about. I’m just honored, because last year at this time I was just doing some work for God’s Love We Deliver, and trying to start an AIDS outreach at my church, and now I get to actually speak to the world…oh man, I get chills just thinking about it, I think it’s so crazy.
That’s a great way of looking at it— HIV does not define me, it’s just a part of who I am.
Volunteering is such an important part of the success of many AIDS organizations, POSITIVELY AWARE is published by TPAN in Chicago, and we provide support, education, testing, and referrals to people with HIV or at risk. I started out as a volunteer here 20 years ago, so we all understand how important it is. How did you come to volunteer at God’s Love We Deliver, and how important has giving back been to you?
Absolutely, and my message to people who are HIV-negative is maybe you can’t relate to every angle of my story, but you’ve definitely made bad decisions in
I was going to this amazing church in New York, which was really into a lot of social outreaches, and I knew that it would kind of be within the church’s message if
J ULY+AUGUST 2012
P OS I T I V E LYAWAR E .CO M
What I’m hoping is that my music is so good, I won’t be the HIV guy, but
I’ll just be this amazing artist who happens to have HIV.
we started an HIV outreach. So I started doing some research and volunteer work at a bunch of agencies in New York, and I really clicked with God’s Love We Deliver, so I just continued volunteering there throughout the summer and the fall, until things on “The Voice” picked up for me. What it did for me personally was reduce my own stigma and my own prejudice that was making me feel so ashamed and dirty about myself. Before I knew it, I was meeting these amazing people and they were opening my eyes to so many things, and I was learning so much, and I now see the hand of God throughout it all. Because if I hadn’t been doing that volunteer work, I don’t know if I would have been ready and willing to talk about it on “The Voice.” So now I have some plans to start some organizations of my own. I am all about preventative measures and teaching younger people the facts so that they’re knowledgeable, but my passion really lies with helping people that are living with HIV. What are we doing when someone has just found out they’re positive? I’m about dealing with the psychology of the matter—let’s treat what this is really about, let’s get them some counseling, let’s help them get their GED, some job training skills. I just know the programs that helped me when I first moved to New York, and I want to do that. This approach is from a holistic standpoint, and from a spiritual standpoint. Let’s see if we can equip some more soldiers to go out there, and get rid of this stigma and prejudice. No one person can do it, it’s going to take a large number of us banding together, and saying, this is what it is, but we’re not going to lie down and die. We’re going to actually show people that we’re here, and we have something to live for, and we have something to say. It must feel sometimes like you are being pulled in a million different directions,
with a lot of people making so many requests and demands for your time and energies. How do you handle that, and how do pace yourself? Oh, I love it! You have to understand, I’ve made these guardrails, which are my own personal boundaries that I’ve set for myself. What I mean is, I know what my vision is, and I don’t like the term celebrity, but I’m embracing it if it means I can use my celebrity for good. So what I’ve done is define what celebrity means to me. If there are requests for my appearances, or for interviews, and it has nothing to do with what fits in with my own personal goals or boundaries, then I just say no to those kinds of things. I have a very clear and concise message right now, and I don’t want to get off message. So no, it’s not difficult at all—obviously I’m going to talk to POSITIVELY AWARE, because that goes along with my message [both laugh]. Well, that’s good to know! Thanks! So, what’s the one thing about Jamar Rogers that people don’t know, that you’d want them to know? That I’m a pretty prolific writer. Yeah, that’s why I think it’s really funny that the night before I got eliminated, CeeLo said that if I were to write a book about my life, it would be a best seller. I actually have plans to write several books. So what’s ahead for you? Besides the activism work, I’m still in L.A., and I’ve been in the studio almost every day recording, and I’ve been in some talks with some people, I don’t know if I’m at liberty to say who just yet. The show has helped me in a way that…it has basically fast-tracked me, and I’m just so grateful for it, I am so grateful for “The Voice.”
GO TO WWW.POSITIVELYAWARE.COM/JAMAR TO LISTEN TO THE AUDIO OR FOR A TRANSCRIPT OF THE COMPLETE 30-MINUTE INTERVIEW. P OS I T I VELYAWARE.COM
J U LY + AU G U ST 2 01 2
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.
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 $
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
PrEP’ing Are you ready? Doctors and advocates are gearing up to bring Truvada PrEP to people at greatest risk of infection BY ENID VÁZQUEZ
OVE IT OR HATE IT, IT’S
coming: HIV prevention with the use of one pill, taken once a day.
In May, the use of the HIV drug Truvada by HIV-negative people to prevent infection with the virus was recommended for FDA approval by the agency’s Antiviral Drugs Advisory Committee (AVDAC). “Today is an exciting day for HIV prevention,” said Kenneth H. Mayer, MD, Medical Research Director and Co-Chair of The Fenway Institute at Fenway Health in Boston, about the recommendation. “Although [Truvada] for PrEP [pre-exposure prophylaxis, or prevention] is not a panacea, this approach can prevent many new infections and could dramatically impact HIV transmission worldwide.” But for all of its promise, and all of its advocates, HIV prevention with Truvada has some concerned that it could be used incorrectly, creating a new set of potentially serious problems. Many also worry that people on PrEP may stop using condoms or increase their 34
J ULY+AUGUST 2012
risk in other ways, such as having sex with more partners. Doing so may negate the good that PrEP can do. As well-intentioned as these people may be, they may be overlooking problems with condoms and HIV treatment, both of which if used and used correctly, are highly effective in preventing HIV transmission. Yet few come out against condoms or HIV therapy because of their potential for misuse and harm. Even sex with condoms can be risky, and the promise of prevention for partners with HIV treatment is often unfulfilled due to lack of access—the Centers for Disease Control and Prevention (CDC) estimates that only one in three people with HIV in the U.S. have controlled, or “undetectable,” virus, and further, that one in five don’t even know they’re infected. People with HIV may also choose not to be on antiviral therapy for any number of reasons, and so remain more infectious to their sexual partners than if they were on treatment, especially in the absence of condoms. Never mind that those with undetectable virus in their blood may still be infectious.
AT RISK The week that the advisory committee made its decision, a young man in Chicago struggled with the symptoms of seroconverting, including nausea, diarrhea, and nightsweats, after having three episodes of unprotected sex with a presumably HIVnegative man in another city. Chris had chatted with this man for months over the Internet, but it wasn’t until after they had sex that he told Chris, “You know, there are some people out there who say that they’re HIV-negative but they’re positive and they’re spreading the virus. My ex-boyfriend in L.A. is one of those guys.” “He even had a word for it, ‘pozzing.’ I never heard of that,” said Chris. Would taking Truvada every day have helped Chris, who was now in a state of panic? “I definitely would be somebody who would take something like that,” said Chris. “It sounds almost like a miracle drug, especially after all I’ve been through with my friends, watching some of them get infected and some of them die. I think the drug is exciting.” P OS I T I V E LYAWA R E .CO M
PHOTO: JOSHUA THORNE
WHEN SAFER SEX ISN’T When Mark (not his real name) worked in HIV services in Chicago more than a decade ago, he heard from several gay men that they were infected when their sex partner took his condom off while they were having sex, usually without their knowledge. He began spreading the word about this danger in his outreach and heard back from many men who told him, “That’s my story.” “I would always tell people to reach around and feel to see that the condom was still on,” said Mark. “People were shocked.” He remembers most distinctly a handsome young man who stood up during one of his talks and tearfully thanked him. “He was angry at his infector,” said Mark, “but I remember even more his anger and hurt at friends who didn’t believe that this had happened to him.” In some cases, gay men who were “tops,” or insertive anal sex partners, thought they were virtually risk-free. But while they were at lower risk than the “bottom” (receptive) partner, many of them became infected nonetheless. He’s also haunted by the experience of P OS I T I VELYAWARE.COM
testing two young men who were a couple. The first boyfriend tested HIV-negative, but the second one tested positive. “Right in front of me out in the lobby, he said, ‘I’m negative, let’s go home.’ And there was nothing I could do about it. They had to send me home that day because I was going out of my mind.” Afterwards he made it a point to tell people to ask to be in the same room when their partner gets an HIV test result, and that it’s a red flag if the person refuses. Like Chris and many other gay men, Mark struggled with the deception practiced on the Internet. “I don’t know how many times guys told me, ‘Oh my God, you’re the first person to tell me you’re positive’ or ‘You’re the first person I’ve met who’s positive.’ No, I’m just probably the first guy who was honest. Others [who were HIV-positive] either lie or they don’t know they’re positive. If you put your life and your care in someone else’s hands based on their word, you’re putting yourself at risk.” Even gay men who thought they were in safe, monogamous relationships became infected by the partner they trusted, he said. Mark says that if PrEP protects one or two people, it’s worth it. “I’m on the side of using all the options we can get.”
SEXUAL ASSAULT Eight years ago, Vince (not his real name) went home with a man he’d just met. They made out, but Vince, drunk, fell asleep. He woke up with the man inside him. He fought back and got the guy off him, but there was no condom, which mystified him, since “the guy didn’t know me.” Having always practiced protected anal sex, Vince knows that this sexual assault is how he became infected. He had only had unprotected sex one other time—and he thought it was protected. “I know he had on a condom, I helped him put it on. But he let it come off inside me.” Vince wondered what happened to the condom when he didn’t see it after sex. Thinking back on that night in a bathhouse, he says he should have asked about it. (The condom came out later when he used the bathroom.) Vince waited six months to test for HIV (the recommendation at the time) and he was negative. He says he was lucky. But that was then and this is now.
Today once-daily prevention with Truvada is an option that can be added to condom use with an off-label prescription and is already available, even without official FDA approval. “I absolutely would have taken it, even though I always played safe. You never know when something like that is going to happen. You do everything you can to prevent it and then you make one mistake and it changes your life forever. It sucks,” said Vince. He says he would take Truvada PrEP today in a heartbeat, if he was still HIV-negative and at risk, knowing what he knows now. “Having been through that [first] experience, it would have helped when I got infected,” Vince said.
RISK PERCEPTION Realizing that you may be at risk, however, is one of the hurdles for PrEP usage. Surveys of people at high risk of becoming HIV-positive have repeatedly found that many report they were at low or no risk of infection, but after testing, many were in fact already positive. This was raised as one of the possible reasons for the disappointing results of Truvada PrEP in women in the FEMPrEP study. The women who became infected (an equal number in both the placebo—fake pill—and Truvada groups) had indicated that they were at low risk for acquiring HIV. Did the women given Truvada not take it because of that belief? Their blood work showed little or no evidence of the drug being in their system. Largely thanks to PrEP research, “risk perception” is now an important consideration in prevention. Yet, the large Partners PrEP study showed that Truvada did protect women against HIV. So did a CDC study in Botswana. All of which goes to show the potential value of PrEP. Undoubtedly, sex can be complicated, and as the stories above show, often easier done than said (or discussed).
WHAT YOU DON’T KNOW Ironically, Chris could have used another medication intervention that’s long been available, called PEP, for post-exposure prophylaxis. If certain HIV medications are taken for 28 days, beginning within J U LY + AU G U ST 2 01 2
Truvada is not a morning-after pill as some believe. 72 hours after sexual exposure, they can prevent infection from taking place. It’s something he didn’t think about because he wasn’t aware of it. Researchers have written about the lack of awareness among gay men of the availability of both PEP and PrEP. When there is awareness, it sometimes goes along with misunderstanding or downright misinformation. Truvada is not, for example, a morning-after pill as some believe.
If Truvada is approved for use in HIVnegative individuals, the lack of awareness around its prevention power should change drastically, with education becoming possible by its manufacturer, clinics, and community organizations.
TO BE YOUNG “We see PrEP for youth not as a lifelong medication but as a stopgap measure,” said psychologist Sybil Hosek, PhD, of
What you should know before PrEP n
You need to test HIV-negative before going on PrEP (pre-exposure prophylaxis or prevention). This may require multiple testing (for example, testing HIV-negative three months in a row). You must also be tested for hepatitis B before getting Truvada. Your kidney function and serum phosphorus levels (for evidence of bone weakness) should be measured. It takes about three doses (three days) for Truvada to reach adequate levels in your body for protection against HIV. Adherence, or taking PrEP correctly and daily, is required. PrEP must be monitored with continued testing for HIV and other sexually transmitted infections and review of any side effects that may occur. Monitoring may be required every three or four months. Side effect monitoring includes laboratory tests (blood draws) for potential kidney toxicity. It’s widely believed that PrEP should include the use of condoms and behavioral modification (finding ways to lessen the risk of infection). It is possible that not using condoms along with PrEP may allow for the
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risk of infection, possibly negating the effects of PrEP altogether. Other serious infections can occur without a condom and are epidemic in the gay community: hepatitis C, syphilis, and gonorrhea. (Remember that gonorrhea is also spread through oral sex.) People who become HIV-positive while on Truvada PrEP risk the development of drug resistance. In studies, the only risk of drug resistance seen was in individuals who were already positive at the time of starting PrEP but didn’t know it or people who were infected with an already drug-resistant strain of HIV. Health care providers might consider supplementing vitamin D and calcium in PrEP patients. Some patients may also benefit from DEXA bone scans before and during treatment. Research continues to investigate the best uses of PrEP, such as the possibility of less than daily usage and the use of other medications besides Truvada. Other biological prevention methods such as microbicides are also being studied.
READ THE CDC’S INTERIM GUIDELINES:
www.cdc.gov/mmwr/preview/ mmwrhtml/mm6003a1.htm?s_ cid=mm6003a1_w.
Stroger Hospital of Cook County, the Chicago site for the Adolescent Trials Network (ATN) for HIV/AIDS Interventions. “We know that adolescence is a risky time,” said Hosek. “There’s a lot of impulsivity and a lot of behavior changes—hormonal, psychological, and emotional—that put people in vulnerable positions when it comes to HIV. And so we feel that PrEP may be a great option during that maturation period.” The ATN points to CDC statistics showing that among adolescents and young adults (ages 13 to 25), the estimated percentage of HIV infections resulting from male-to-male contact increased from 57% in 2005 to 68% in 2008, while infections resulting from heterosexual contact or injection drug use decreased. For black youth, however, the increase was 73% in that time period. ATN’s Project PrEPare has two studies looking at PrEP effectiveness now that its initial research has shown that youth would accept and use PrEP (feasibility). These two studies are scheduled to enroll 300 youth at the network’s 14 sites across the country, including Chicago. Visit www. projectpare.net. Like other PrEP research, Project PrEPare provides condoms and counseling along with medication. As to the argument that money should be used for treatment of actual HIV infection rather than prevention, Hosek said they’re both part of the same package, with PrEP expected to increase HIV testing levels and awareness of previously unknown infection with the need for access to treatment. Moreover, she said it would help providers talk to their patients about getting HIV-positive partners into care and treatment. Like many advocates, she also points to the fact that Truvada PrEP—especially for short-term use—costs less than a lifetime of HIV therapy. “I think it would help people to remember their own youth,” said Hosek. “It’s a time of exploration. It’s a time of emotional energy and risk taking, of cognitive development. Their brains are maturing. Pleasure often takes precedence over planning. P OS I T I V E LYAWAR E .CO M
PrEP could be the ‘game changer’ needed to more effectively fight HIV. Saying ‘just use a condom’ is not working. “Not that condoms aren’t a great option,” she continued, “but some people just aren’t going to use them. So I think the more options we have for youth, the better.”
TURNING THE TIDE In February, Boston’s Fenway Institute issued a 59-page report in which it stated that, based on initial study results, “PrEP could be the ‘game changer’ needed to more effectively fight HIV.” The institute, one of two U.S. sites involved in iPrEx, urged the FDA to approve Truvada PrEP. It continues to conduct PrEP research through HPTN 069 (NEXT PrEP), and is also involved in HPTN 061 (the BROTHERS study), a multiplecomponent intervention for black MSM. HPTN (HIV Prevention Trials Network) hailed the Truvada PrEP decision as “a milestone for HIV prevention” and a webinar announcement referred to PrEP as “a bridge to the end of AIDS.” With flat funding for the AIDS Drug
SAN FRANCISCO JOINS MIAMI
Assistance Program and cuts to Medicaid that are becoming more common in the states, more and more people may find themselves without access to treatment, let alone prevention. There is free access to Truvada PrEP through the iPrEx study which has expanded (iPrEx OLE) with three U.S. sites (Chicago, Boston, and San Francisco). There may also be patient assistance or co-pay assistance programs available if PrEP is FDA approved. Earlier, in August of 2011, six organizations from around the country devoted to HIV/AIDS work and services (the AIDS Foundation of Chicago, AVAC, the Black AIDS Institute, the National Minority AIDS Council, Project Inform, and the San Francisco AIDS Foundation) urged the Department of Health & Human Services (DHHS) to establish so-called “demonstration projects” to examine PrEP effectiveness out in the real world, especially among the hardest-hit MSM of color. A year later, few demonstration projects are underway.
San Francisco and Miami, two cities that have traditionally had some of the highest rates of HIV infection in the country, have teamed up for a PrEP demonstration project funded by the National Institutes of Health (NIH). Stephanie Cohen, MD, MPH, medical director of the City Clinic for sexually transmitted infections (STIs) for the San Francisco Department of Public Health, said individuals accessing care from the clinic who are at risk of HIV infection will be offered Truvada PrEP. In addition, the Magnet gay men’s health clinic in the Castro will refer men to the program. “We are looking at uptake in PrEP— who’s interested in it, who’s not, and why,” said Cohen. “We plan to develop marketing and education messages from what we learn in our, and other, demonstration projects.” The goal is to enroll 300 MSM in San Francisco and 200 in Miami. A
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“It’s an historic moment in HIV prevention and there’s a lot of work to be done in learning how to use this new prevention tool.”
demonstration project is also in the works for New York City, she said. “Does it work? Yes, we know it does, but how do we get it out there?” said Cohen. The California HIV/AIDS Research Program (CHRP) of the University of California is also conducting a PrEP demonstration project, in cities throughout the state (including Oakland, San Diego, and Long Beach), focusing on high-risk MSM of color “who lack resources for testing and counseling.” The program will also look at the use of TLC+ (testing and linkage to care plus treatment) in men who become infected. “It’s an historic moment in HIV prevention,” said Cohen, “and there’s a lot of work to be done in learning how to use this new prevention tool.”
CHICAGO In Chicago, Howard Brown Health Center (HBHC), which serves the LGBT (lesbian, gay, bisexual, and transgender) community, does not have a demonstration project per se. Rather, the center is making PrEP part of its primary care services. It has created a protocol for staff training so that everyone can be on the same page about who makes a good candidate for PrEP, said Kristin Keglovitz, PA, HBHC’s medical director. She said the clinic’s PrEP protocol will be a multidisciplinary model involving the services of counselors in addition to prescribers. HBHC has already prescribed PrEP and even participated in the iPrEx study, she said. Last year she prescribed PEP twice to a woman with an HIV-positive partner before telling the patient she might be better off on PrEP. It’s a strategy that’s backed by research showing that people taking multiple courses of PEP often go on to become infected, because they are at continuing risk for the virus. “As an organization, and for myself as a provider, we definitely support PrEP,” 38
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said Keglovitz. “It’s a big milestone for prevention.” She said the strategy is “obviously not for everybody,” and not a replacement for condoms. “Prevention messages will be crucial,” she said.
WHAT NOW? The FDA advisory committee recommended that PrEP be approved for three specific risk groups—men who have sex with men, HIV-negative partners of HIVpositive people, and others at high risk of acquiring HIV through sex. It noted that “regular HIV testing, adherence, and behavioral counseling on safer sex practices, including condom use, are essential components of healthcare delivery around PrEP.” All advocates are beating the drum for using condoms along with PrEP. Whether PrEP users out in the real world do or not remains to be seen. But with all the unknowns surrounding PrEP, there is perhaps one true take-home message from studies and advocates alike: PrEP doesn’t work if you don’t take it. Sitting on the FDA advisory committee and voting to recommend Truvada PrEP for approval, community representative Daniel Raymond of the Harm Reduction Coalition in New York City eloquently reminded everyone that, “This is the 25th anniversary of the AIDS Coalition to Unleash Power [ACT UP] and part of the legacy of that movement is empowering patients about learning and mastering the science and sharing it within our respective communities. I think that PrEP gives us the opportunity to do that all over again…just as responsibly as we’ve been trying to do for the last 25 years.” Clearly, community awareness is as crucial as ever. SPECIAL THANKS TO DR. JOEL GALLANT of Johns Hopkins University
for reviewing this article and sidebar.
LEATHER, They’re actually not as risky BY ENID VÁZQUEZ
HILE HIV PRE-
vention in the U.S. focuses on men who have sex with men (MSM), it’s clear that anyone can pick up HIV. Hence, precautions are taken in certain communities that revolve around sexual activity. ADULT FILMS On January 17, 2012, Los Angeles Mayor Antonio Villaraigosa signed an ordinance stating that adult film actors working within Los Angeles must wear condoms. California’s occupational safety and health P OS I T I V E LYAWAR E .CO M
PHOTO © FERRAN TRAITE SOLER
PORN, AND KINK as you might think agency already has rules stating that porn performers must wear condoms during filming. “Since 2004, nobody has contracted HIV on set,” says Diane Duke, executive director of the Free Speech Coalition (FSC), located in southern California. FSC oversees health and safety services for the adult film industry. Duke said there are approximately 1,000 performers filming each year and the fact is, condom-free porn sells best. “We’ve developed a bloodwork pathogen plan that we believe is very effective in protecting the health of the performers,” she said, “and they support it.” Before filming begins, performers must have a certificate of results from a recent (that week) PCR RNA (HIV viral load) test, P OS I T I VELYAWARE.COM
which can find actual HIV in the blood within 9 to 11 days after exposure. They must also test monthly for gonorrhea and Chlamydia, and yearly for syphilis. The Los Angeles County Department of Public Health reported in 2010 that four cases of HIV have occurred since 2004 in the porn industry during production. Duke points to a recent Los Angeles County report looking at HIV risk factors and how to manage them. Not once in the 162-page report does it refer to the industry.
LEATHER The leather community, which focuses on S/M sexuality, does not necessarily revolve around sexual intercourse. Gregory Bear Abbott, a gay leatherman for more than 20 years, says, “We play.
That doesn’t mean somebody gets penetrated. It usually means somebody gets marked up [whipped, flogged, etc.].” He said he was “very impressed” with the evidence of safer sex he saw in May at the Cleveland Leather Awareness Weekend (CLAW). On the other hand, he’s heard the phrase “if you’re undetectable, you’re uncatchable.” “I’m sorry, but undetectable means 50 copies [of HIV per mL of blood]. That could mean there were still 49. You’re still at risk,” he said. He points to other infections, like gonorrhea and syphilis, that can be acquired when not using a condom and are rampant in the gay male community. He said there’s also some knowledge of Truvada PrEP, but misinformation around it, too. He overheard one young man at CLAW say he had just gone through all of his condoms, “but I’ve got Truvada upstairs, so I’m okay.” “I said no, no, no,” said Sir Bear. “I gave him more condoms and he kissed me on the cheek and said, ‘Thank you for taking care of me.’ “
KINK Like leather groups, communities formed around sexual kinks do not necessarily involve sexual intercourse. Bruce, president of Leather SINS in the Chicago area, says, “The sexual act is only about 25% of what we do. Sex is rarely a part of fantasy and fetish.” In terms of safety, Bruce says, “Since we deal in risk all the time and since safety is such an important part of what we do, with all the physiological stuff that can happen, STIs [sexually transmitted infections] are, for some people, just another of the many risks.” Perhaps the greatest promotion of safer sex and play comes through what is explicitly discussed during a “negotiation” before engaging in activity. “Part of it focuses on physical health— any physical condition or injury that could be exacerbated. So discussion of bloodborne pathogens comes easily to us,” said Bruce. Sir Bear said that in two years of free HIV testing at Kinky Kollege, run by Leather SINS, nearly every person at the event was tested. Not one was HIV-positive. J U LY + AU G U ST 2 01 2
Actual patient living with HIV since 2000
YOU’VE WORKED TO CONTROL YOUR HIV. NOW, TIME TO WORK ON YOUR
HIV-RELATED EXCESS BELLY FAT. In two separate clinical trials of HIV-infected people with lipodystrophy, each lasting 6 months, EGRIFTA® (tesamorelin for injection) reduced HIV-related excess belly fat by an average of 18% in the first trial, and 14% in the second trial. This reduction in excess belly fat resulted in an approximate 1-inch reduction in waist size. Individual results may vary. On average, patients on EGRIFTA® did not lose weight. Like HIV, HIV-related excess belly fat is a chronic condition. In clinical studies: • People who used EGRIFTA® continuously for 1 year maintained their results over this time period • People who stopped taking EGRIFTA® after 6 months had their HIV-related excess belly fat come back EGRIFTA® is believed to work with your own body to produce natural growth hormone to reduce your excess belly fat. Indication: EGRIFTA® is a daily injectable prescription medicine to reduce the excess abdominal fat in HIV-infected patients with lipodystrophy. Limitations of use: • The impact and safety of EGRIFTA® on cardiovascular health has not been studied • EGRIFTA® is not indicated for weight-loss management • It’s not known whether taking EGRIFTA® helps improve compliance with antiretroviral medications • EGRIFTA® is not recommended to be used in children Important Risk Information Do not use EGRIFTA® if you: • Have pituitary gland tumor, pituitary gland surgery, or other problems related to your pituitary gland • Have active cancer (either newly diagnosed or recurrent) or are receiving treatment for cancer • Are allergic to tesamorelin or any of the ingredients in EGRIFTA®, including mannitol or sterile water • Are pregnant or become pregnant Before using EGRIFTA,® tell your healthcare provider if you: • Have or have had cancer • Have diabetes • Are breastfeeding or plan to breastfeed • Have kidney or liver problems • Have any other medical condition • Take prescription or non-prescription medicines, vitamins, or herbal supplements EGRIFTA® may cause serious side effects, including: • Serious allergic reaction. Stop using EGRIFTA® and get emergency help right away if you have any of the following symptoms: rash over your body, hives, swelling of your face or throat, shortness of breath or trouble breathing, fast heartbeat, feeling of faintness or fainting • Swelling (fluid retention). EGRIFTA® can cause swelling in some parts of your body. Call your healthcare provider if you have an increase in joint pain, or pain or numbness in your hands or wrist (carpal tunnel syndrome) • Increase in glucose (blood sugar) intolerance and diabetes 120127-102148 2/12
• Injection-site reactions, such as redness, itching, pain, irritation, bleeding, rash, and swelling. Change (rotate) your injection site to help lower your risk for injection-site reactions The most common side effects of EGRIFTA® include: • joint pain • numbness and pricking • pain in legs and arms • nausea • swelling in your legs • vomiting • muscle soreness • rash • tingling • itching EGRIFTA® will NOT cure HIV or lower your chance of passing HIV to others. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see Consumer Brief Summary of EGRIFTA® on following page.
Ask your healthcare provider if EGRIFTA®, the first and only FDA-approved medicine for HIV-related excess belly fat, may be right for you. For more information, visit www.egrifta.com or call the AXIS Center at 1-877-714-AXIS (2947).
Consumer Brief Summary for EGRIFTA® (tesamorelin for injection) EGRIFTA® (eh-GRIF-tuh) (tesamorelin for injection) for subcutaneous use Read the Patient Information that comes with EGRIFTA® before you start to take it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or your treatment. What is EGRIFTA®? • EGRIFTA® is an injectable prescription medicine to reduce the excess in abdominal
fat in HIV-infected patients with lipodystrophy. EGRIFTA® contains a growth hormone-releasing factor (GRF) • The impact and safety of EGRIFTA® on cardiovascular health has not been studied • EGRIFTA® is not indicated for weight-loss management • It is not known whether taking EGRIFTA® helps improve compliance with antiretroviral medications • It is not known if EGRIFTA® is safe and effective in children. EGRIFTA® is not recommended to be used in children Who should not use EGRIFTA®? Do not use EGRIFTA® if you: • have pituitary gland tumor, pituitary gland surgery, or other problems related to your pituitary gland • have active cancer (either newly diagnosed or recurrent) or are receiving treatment for cancer • are allergic to tesamorelin or any of the ingredients in EGRIFTA®. See the end of this leaflet for a complete list of ingredients in EGRIFTA® • are pregnant or become pregnant. If you become pregnant, stop using EGRIFTA® and talk with your healthcare provider. See “What should I tell my healthcare provider before using EGRIFTA®?” What should I tell my healthcare provider before using EGRIFTA®? Before using EGRIFTA®, tell your healthcare provider if you: • have or have had cancer • have diabetes • are breastfeeding or plan to breastfeed. It is not known if EGRIFTA® passes into your breast milk. The Centers for Disease Control and Prevention (CDC) recommends that HIV-infected mothers not breastfeed to avoid the risk of passing HIV infection to your baby. Talk with your healthcare provider about the best way to feed your baby if you are taking EGRIFTA® • have kidney or liver problems • have any other medical condition Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. EGRIFTA® may affect the way other medicines work, and other medicines may affect how EGRIFTA® works. Know the medicines you take. Keep a list with you to show your healthcare provider and pharmacist when you get a new medicine. How should I use EGRIFTA®? • Read the detailed “Instructions for Use” that comes with EGRIFTA® before you start using EGRIFTA®. Your healthcare provider will show you how to inject EGRIFTA® • Use EGRIFTA® exactly as prescribed by your healthcare provider • Inject EGRIFTA® under the skin (subcutaneously) of your stomach area (abdomen) • Change (rotate) the injection site on your stomach area (abdomen) with each dose. Do not inject EGRIFTA® into scar tissue, bruises, or your navel • Do not share needles or syringes with other people. Sharing of needles can result in the transmission of infectious diseases, such as HIV What are the possible side effects of EGRIFTA®? EGRIFTA® may cause serious side effects including: • Serious allergic reaction. Some people taking EGRIFTA® may have an allergic reaction. Stop using EGRIFTA® and get emergency help right away if you have any of the following symptoms: – a rash over your body
– hives – swelling of your face or throat – shortness of breath or trouble breathing – fast heartbeat – feeling of faintness or fainting • Swelling (fluid retention). EGRIFTA® can cause swelling in some parts of your body. Call your healthcare provider if you have an increase in joint pain, or pain or numbness in your hands or wrist (carpal tunnel syndrome) • Increase in glucose (blood sugar) intolerance and diabetes. Your healthcare provider
will measure your blood sugar periodically • Injection-site reactions. Change (rotate) your injection site to help lower your risk for
injection-site reactions. Call your healthcare provider for medical advice if you have the following symptoms around the area of the injection site: – redness – bleeding – itching – rash – pain – swelling – irritation The most common side effects of EGRIFTA® include: – joint pain – nausea – pain in legs and arms – vomiting – swelling in your legs – rash – muscle soreness – itching – tingling, numbness, and pricking 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 EGRIFTA®. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. To report side effects, contact EMD Serono toll-free at 1-800-283-8088, ext. 5563. You may report side effects to the FDA at 1-800-FDA-1088. Keep EGRIFTA® and all medicines out of the reach of children. General information about the safe and effective use of EGRIFTA®: Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use EGRIFTA® for a condition for which it was not prescribed. Do not give EGRIFTA® to other people, even if they have the same symptoms you have. It may harm them. Do not share your EGRIFTA® syringe with another person, even if the needle is changed. Do not share your EGRIFTA® needles with another person. This Patient Information leaflet summarizes the most important information about EGRIFTA®. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about EGRIFTA® that is written for healthcare professionals. For more information about EGRIFTA®, go to www.EGRIFTA.com or contact the AXIS Center toll-free at 1-877-714-2947. What are the ingredients in EGRIFTA®? Active ingredient: tesamorelin Inactive ingredients: mannitol and Sterile Water for Injection
© 2012 EMD Serono, Inc. 120120-161843 2/12 All rights reserved. EGRIFTA® is a registered trademark of Theratechnologies Inc. Distributed by EMD Serono, Inc., Rockland, MA 02370
SATURDAY, AUGUST 18, 2012 Auditorium Theatre of Roosevelt University, 50 East Congress Parkway, Chicago For more information or to purchase tickets call 312.922.5812 or visit danceforlifechicago.com Benefiting: AIDS Foundation of Chicago, the Dancersâ€™ Fund and Chicago Womenâ€™s AIDS Project Performances by: Giordano Jazz Dance Chicago, Hubbard Street Dance Chicago, The Joffrey Ba l l e t , L u n a N e g r a D a n c e T h e a t e r , R i v e r N o r t h D a n c e C h i c a g o , R o n d e J e s u s D a n c e World Premieres by: Harrison McEldowney and Randy Duncan Presenting Sponsor:
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ASK THE HIV SPECIALIST HELEN C. KOENIG, MD, MPH
How safe is safe?
I AM IN A RELATIONSHIP WITH AN
an open wound with visible bleeding or exposed deeper tissue would put you at higher risk. Since this doesn’t sound like a high-risk exposure, and your partner had an undetectable viral load, the risk of infection in your case is likely slim to none and I do not think that taking a 28-day course of post-exposure prophylaxis is warranted. If the cut was on the deeper side or if your partner’s viral load may have been detectable, post-exposure prophylaxis might have been prudent, but it would have needed to be administered within 72 hours of exposure. As for your second question: in my experience as a physician, patients often report being in monogamous relationships and then find out later that their partner was not being as monogamous as they were. In addition, your partner may believe that his viral load is undetectable, but he may not know if his viral load crept up since his last check-up several months prior (although the chance of this happening if he is 100% adherent to his antiretroviral therapy is extremely low). While the possibility of infidelity is never fun to consider, figuring out your level of risk is only as good as the information you have! Therefore, in general, all partners of HIV-positive individuals should be tested for HIV at least annually, and those at higher risk of acquiring HIV (those with multiple partners, those who share needles for IV drug use, those whose HIV-positive partners have detectable viral loads, etc.) should be tested more frequently. That said, mutual masturbation as the sole form of sexual activity, in the setting of an undetectable viral load, confers almost no risk of transmission. In summary, you and your partner are to be commended for your safe sex practices and your partner’s excellent virologic control. Your risk of having acquired HIV from the exposure you describe is virtually nonexistent, but it never hurts to get tested for peace of mind, and on a regular basis as a healthy habit. In fact, the CDC recommends that all adults, regardless of risk, be tested for HIV in all healthcare settings.
HIV-positive man with an undetectable viral load. I am negative. We refrain from oral and anal sex. Last night while masturbating some of his semen got on my hand and I had an open cut. I have not been able to sleep.
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Since we are in a monogamous relationship and he is undetectable, should I get tested regularly? Going for testing freaks me out. I have not been tested since three months after his diagnosis, which was three years ago.
YOU BRING UP SEVERAL important issues that should be addressed. Mutual masturbation is typically an excellent way to have safe sex with an HIV-positive partner, as are oral or anal sex with appropriately used condoms. In addition, the best way to prevent HIV transmission, as shown by the recent study in couples where one is positive and the other isn’t (sero-discordant), is for the HIV-positive partner to have an undetectable viral load on consistent antiretroviral therapy. Although almost all (97%) of the couples in this study were heterosexual, it is still helpful in showing how difficult it is to transmit HIV when the HIV-positive partner is taking HIV therapy. So is there still a risk of HIV transmission when your partner has an undetectable viral load on medications? The answer is yes, since viral particles have still been detected in the semen of men who have an undetectable viral load in their blood. This is because the semen is one of the so-called “sanctuary sites” where HIV can continue to replicate, since many of the HIV medications we use today are not able to get into the semen. This brings us to your first question regarding the risk of transmission of HIV from the semen of a partner with an undetectable viral load to you through an open cut in your hand. The risk of transmission through an open cut depends on the type and depth of your wound: a superficial wound with a scab would be extremely unlikely to allow HIV transmission, while
J ULY+AUGUST 2012
P OS I T I V E LYAWAR E .CO M
SALIENT RAMBLINGS SAL IACOPELLI
‘It is so strange the way things turn’
—Peter Gabriel, Don’t Give Up
WE ARE CONDITIONED TO THINK OF “SUCCESS” IN TERMS OF
after school and I would revel in listening wealth, of accumulation of property and objects, or of extensive to him speak of history power. These are rather easy to achieve when born into affluent on any subject, and describe movie plots or influential circumstances. What about most of the rest of us? so well and in the most If we compare ourselves to society’s or someone exacting detail, I felt as if I were there. In retrospect, I else’s standard of success, how can we ever feel sucsuspect he might have had a variation of Asperger’s cessful? Really, comparatively few become extensively syndrome. Brilliant, almost an idiot savant, with few rich or hugely famous. And certainly, do most of those social skills. Of course, he was teased mercilessly for who are famous deserve such accolades? Snookie of his oddness and his creative dreaminess. His nickname, Jersey Shore? The Kardashians? Oh, where are the divas much to his chagrin, was “Ancient Green.” I found it to of yesteryear, the Gabor sisters for example, who were be quite apt and somewhat romantic. John was happifamous simply by being so enchantingly fabulous? est reading about ancient cultures, dreaming of what Consider how different living with AIDS is from those it must have been like to live within them, and writing terrifying early days. If you were diagnosed with AIDS in beautiful poetry about them. I was deeply in awe and the ’80s, your life expectancy dwindled to two years. I loved him—not sexually, but rather, spiritually, intellecprogressed to AIDS in 1995, yet still walk the earth. That tually, and emotionally. alone is a success, but certainly, it was not a battle won We drifted apart after high school. I struggled without its challenges. Before you can achieve success, through self-examination, alcoholism, testing HIVdefine what success means to you. Is it a loving partpositive, and debilitating illness. Today, I am grateful ner? Enough financial resources to enable you to travel? to have good health, a wonderful home, supportive Or is it getting through the day being adherent to your friends, and many in my family whom I hold dear. Not to medication regimen? Your successes are personal. mention the best dog in the world. Furthermore, success doesn’t matter if it doesn’t make About 10 years ago, on my way to the bike track you happy or fulfilled. Is the billionaire who yearns for a along the lake, I stopped at a traffic light. A street permeaningful relationship successful? son stood near me waiting to cross. He was filthy, with What of my friend Patty who was a teenage mother matted hair, wearing a torn parka. He stood dreamily and a high school dropout who raised her child brilliantlooking up at the sky. I recognized him by his eyes, ly and who currently owns a home, has a great career, those sparkling green, flecked-with-gold wonders. It is in a strong marriage and whose daughter recently was John. I told him who I was and asked if he rememearned her master’s degree? bered me. He tore himself from his reverie, looked at me Or my buddy Tim, who lost his wife in a horrible car and mumbled “Uh, yeah.” The traffic light changed and accident not long after they were married, who has he hurried to cross the street. dealt with that loss, and has opened his heart once Since then, I spot him occasionally, shuffling along more to love? dreamily in the park as I tear along on my bike. Sure, he Or my mother who, when diagnosed with emphyended up filthy, half crazy, and homeless. But all he ever sema, immediately quit smoking and two years later, wanted was to be left alone to dream his dreams. braves each day solidly, armed with oxygen and a batSo who is the success? Is he or am I? tery of medications. They are successes, all. Success is peace of mind, which is a direct result of selfI went to high school with a guy named John Green. satisfaction in knowing you made the effort to become He had gleaming green eyes with flecks of gold, thick, the best you are capable of becoming. unruly, dark brown curls and was the smartest, most — JOHN WOODEN creative person I knew. We would walk home together P O S I T I V E LYA W A R E . C O M
If we compare ourselves to society’s or someone else’s standard of success, how can we ever feel successful? Really, comparatively few become extensively rich or hugely famous.
M AY + J U N E 2 0 1 2
A MESSAGE FROM YOUR IMMUNE SYSTEM
Starting treatment early may help you live a longer, healthier life. Treatment guidelines issued by the US Department of Health and Human Services (DHHS) recommend starting HIV medicines for all people with HIV, regardless of their CD4 count. Talk with your healthcare provider about your treatment options and all the factors you need to consider before starting HIV medicines. For more information, call toll-free 1-888-447-1728 or visit TREATHIVNOW.COM. ÂŠ2012 Gilead Sciences, Inc. All rights reserved. UN13259 06/12
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