Positively Aware


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Positively Aware

  1. 1. positivelyaware.com September+OCTOBER 2012 CURE NEWS FROM AIDS 2012 facing up to lipoatrophy POSITIVE Women Making decisions, creating policy, and improving lives
  2. 2. ABOUT PREZISTA ®PREZISTA® (darunavir) is a prescription medicine. It is one treatment option Rifamate,® Rimactane®), sildenafil (Revatio®) when used to treatin the class of HIV (human immunodeficiency virus) medicines known as pulmonary arterial hypertension, indinavir (Crixivan®), lopinavir/protease inhibitors. ritonavir (Kaletra®), saquinavir (Invirase®), boceprevir (Victrelis™),PREZISTA® is always taken with and at the same time as ritonavir (Norvir ®), or telaprevir (Incivek™)in combination with other HIV medicines for the treatment of HIV infection • Before taking PREZISTA, tell your healthcare professional if you are ®in adults. PREZISTA® should also be taken with food. taking sildenafil (Viagra, Revatio®), vardenafil (Levitra,® Staxyn®), ® • The use of other medicines active against HIV in combination with tadalafil (Cialis,® Adcirca®), atorvastatin (Lipitor ®), rosuvastatin PREZISTA®/ritonavir (Norvir ®) may increase your ability to fight HIV. (Crestor ®), pravastatin (Pravachol®), or colchicine (Colcrys,® Your healthcare professional will work with you to find the right Col-Probenecid®). Tell your healthcare professional if you are taking combination of HIV medicines estrogen-based contraceptives (birth control). PREZISTA® might reduce the effectiveness of estrogen-based contraceptives. You must take • It is important that you remain under the care of your healthcare additional precautions for birth control, such as condoms professional during treatment with PREZISTA® This is not a complete list of medicines. Be sure to tell yourPREZISTA® does not cure HIV infection or AIDS and you may healthcare professional about all the medicines you are taking orcontinue to experience illnesses associated with HIV-1 infection, plan to take, including prescription and nonprescription medicines,including opportunistic infections. You should remain under the vitamins, and herbal supplements.care of a doctor when using PREZISTA. ® What should I tell my doctor before I take PREZISTA®?Please read Important Safety Information below, and talk to yourhealthcare professional to learn if PREZISTA® is right for you. • 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 hemophiliaIMPORTANT SAFETY INFORMATION • Tell your healthcare professional if you are pregnant or planningWhat is the most important information I should know to become pregnant, or are breastfeedingabout PREZISTA®? — The effects of PREZISTA® on pregnant women or their unborn • PREZISTA® can interact with other medicines and cause babies are not known. You and your healthcare professional will serious side effects. See “Who should not take PREZISTA®?” need to decide if taking PREZISTA® is right for you • PREZISTA® may cause liver problems. Some people taking — Do not breastfeed. It is not known if PREZISTA® can be passed PREZISTA, together with Norvir ® (ritonavir), have developed liver ® to your baby in your breast milk and whether it could harm your problems which may be life-threatening. Your healthcare professional baby. Also, mothers with HIV should not breastfeed because HIV should do blood tests before and during your combination treatment can be passed to your baby in the breast milk with PREZISTA. If you have chronic hepatitis B or C infection, your ® healthcare professional should check your blood tests more often What are the possible side effects of PREZISTA®? because you have an increased chance of developing liver problems • High blood sugar, diabetes or worsening of diabetes, and increased • Tell your healthcare professional if you have any of these signs and bleeding in people with hemophilia have been reported in patients symptoms of liver problems: dark (tea-colored) urine, yellowing taking protease inhibitor medicines, including PREZISTA® of your skin or whites of your eyes, pale-colored stools (bowel • Changes in body fat have been seen in some patients taking HIV movements), nausea, vomiting, pain or tenderness on your right medicines, including PREZISTA. The cause and long-term health ® side below your ribs, or loss of appetite effects of these conditions are not known at this time • PREZISTA® may cause a severe or life-threatening skin • Changes in your immune system can happen when you start taking reaction or rash. Sometimes these skin reactions and skin rashes HIV medicines. Your immune system may get stronger and begin can become severe and require treatment in a hospital. You should to fight infections that have been hidden call your healthcare professional immediately if you develop a rash. However, stop taking PREZISTA® and ritonavir combination treatment • The most common side effects related to taking PREZISTA® include and call your healthcare professional immediately if you develop any diarrhea, nausea, rash, headache, stomach pain, and vomiting. This is skin changes with these symptoms: fever, tiredness, muscle or joint not a complete list of all possible side effects. If you experience these pain, blisters or skin lesions, mouth sores or ulcers, red or inflamed or other side effects, talk to your healthcare professional. Do not stop eyes, like “pink eye.” Rash occurred more often in patients taking taking PREZISTA® or any other medicines without first talking to your PREZISTA® and raltegravir together than with either drug separately, healthcare professional but was generally mild You are encouraged to report negative side effects ofWho should not take PREZISTA®? prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. • Do not take PREZISTA® if you are taking the following 28PRZDTC0288R8 medicines: alfuzosin (Uroxatral®), dihydroergotamine (D.H.E.45, ® Please refer to the ritonavir (Norvir ®) Product Information (PI and PPI) Embolex, Migranal ), ergonovine, ergotamine (Cafergot, Ergomar ®), ® ® ® for additional information on precautionary measures. methylergonovine, cisapride (Propulsid®), pimozide (Orap®), oral Please read accompanying Patient Information for PREZISTA® midazolam, triazolam (Halcion®), the herbal supplement St. John’s wort and discuss any questions you have with your doctor. (Hypericum perforatum), lovastatin (Mevacor,® Altoprev,® Advicor ®), simvastatin (Zocor,® Simcor,® Vytorin®), rifampin (Rifadin,® Rifater,®
  3. 3. IS THE PREZISTA ® EXPERIENCE RIGHT FOR YOU? There is no other person in the world who is exactly like you. And no HIV treatments are exactly alike, either. That’s why you should ask your healthcare professional about PREZISTA® (darunavir). Once-Daily PREZISTA® taken with ritonavir and in combination with other HIV medications can help lower your viral load and keep your HIV under control over the long term. In a clinical study* of almost 4 years (192 weeks), 7 out of 10 adults who had never taken HIV medications before maintained undetectable† viral loads with PREZISTA® plus ritonavir and Truvada.® Find out if the PREZISTA® EXPERIENCE is right for you. Ask your healthcare professional and learn more at DiscoverPREZISTA.com Please read the Important Safety Information and Patient Information on adjacent pages. Snap a quick pic of our logo to show your doctor and get the conversation started. *A randomized open label Phase 3 trial comparing PREZISTA®/ritonavir 800/100 mg once daily (n=343) vs. Kaletra®/ritonavir 800/200 mg/day (n=346). †Undetectable was defined as a viral load of less than 50 copies per mL. Registered trademarks are the property of their respective owners. Janssen Therapeutics, Division of Janssen Products, LP © Janssen Therapeutics, Division of Janssen Products, LP 2012 06/12 28PRZ12036G
  4. 4. IMPORTANT PATIENT INFORMATION PREZISTA (pre-ZIS-ta) • o not have any kind of sex without protection. Always practice D (darunavir) safe sex by using a latex or polyurethane condom to lower the Oral Suspension chance of sexual contact with semen, vaginal secretions, or blood. PREZISTA (pre-ZIS-ta) Ask your healthcare provider if you have any questions on how to (darunavir) prevent passing HIV to other people. Tablets Who should not take PREZISTA?Read this Patient Information before you start taking PREZISTA and Do not take PREZISTA with any of the following medicines:each time you get a refill. There may be new information. This • lfuzosin (Uroxatral®) ainformation does not take the place of talking to your healthcare • ihydroergotamine (D.H.E. 45®, Embolex®, Migranal®), ergonovine, dprovider about your medical condition or your treatment. ergotamine (Cafergot®, Ergomar®) methylergonovineAlso read the Patient Information leaflet for NORVIR® (ritonavir). • isapride cWhat is the most important information I should • imozide (Orap®) pknow about PREZISTA? • ral midazolam, triazolam (Halcion®) o• REZISTA can interact with other medicines and cause serious P • he herbal supplement St. John’s Wort (Hypericum perforatum) t side effects. It is important to know the medicines that should not be • he cholesterol lowering medicines lovastatin (Mevacor®, Altoprev®, t taken with PREZISTA. See the section “Who should not take Advicor®) or simvastatin (Zocor®, Simcor®, Vytorin®) PREZISTA?” • ifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®) r• REZISTA may cause liver problems. Some people taking PREZISTA P • ildenafil (Revatio®) only when used for the treatment of pulmonary s in combination with NORVIR® (ritonavir) have developed liver arterial hypertension. problems which may be life-threatening. Your healthcare provider Serious problems can happen if you take any of these medicines with should do blood tests before and during your combination treatment PREZISTA. with PREZISTA. If you have chronic hepatitis B or C infection, your healthcare provider should check your blood tests more often What should I tell my doctor before I take PREZISTA? because you have an increased chance of developing liver problems. PREZISTA may not be right for you. Before taking PREZISTA, tell your• ell your healthcare provider if you have any of the below signs and T healthcare provider if you: symptoms of liver problems. • ave liver problems, including hepatitis B or hepatitis C h • ark (tea colored) urine D • re allergic to sulfa medicines a • ellowing of your skin or whites of your eyes y • ave high blood sugar (diabetes) h • ale colored stools (bowel movements) p • ave hemophilia h • ausea n • re pregnant or planning to become pregnant. It is not known if a • omiting v PREZISTA will harm your unborn baby. • ain or tenderness on your right side below your ribs p Pregnancy Registry: You and your healthcare provider will need to • oss of appetite l decide if taking PREZISTA is right for you. If you take PREZISTA while you are pregnant, talk to your healthcare provider about howPREZISTA may cause severe or life-threatening skin reactions or rash. you can be included in the Antiretroviral Pregnancy Registry. TheSometimes these skin reactions and skin rashes can become severe purpose of the registry is follow the health of you and your baby.and require treatment in a hospital. You should call your healthcare • re breastfeeding or plan to breastfeed. Do not breastfeed. We do aprovider immediately if you develop a rash. However, stop taking not know if PREZISTA can be passed to your baby in your breastPREZISTA and ritonavir combination treatment and call your healthcare milk and whether it could harm your baby. Also, mothers with HIV-1provider immediately if you develop any skin changes with symptoms should not breastfeed because HIV-1 can be passed to the baby inbelow: the breast milk.• fever Tell your healthcare provider about all the medicines you take including• iredness t prescription and nonprescription medicines, vitamins, and herbal• uscle or joint pain m supplements. Using PREZISTA and certain other medicines may affect• listers or skin lesions b each other causing serious side effects. PREZISTA may affect the way• mouth sores or ulcers other medicines work and other medicines may affect how PREZISTA• ed or inflamed eyes, like “pink eye” (conjunctivitis) r works.Rash occurred more often in patients taking PREZISTA and raltegravir Especially tell your healthcare provider if you take:together than with either drug separately, but was generally mild. • edicine to treat HIV mSee “What are the possible side effects of PREZISTA?” for more • strogen-based contraceptives (birth control). PREZISTA might einformation about side effects. reduce the effectiveness of estrogen-based contraceptives. YouWhat is PREZISTA? must take additional precautions for birth control such as a condom.PREZISTA is a prescription anti-HIV medicine used with ritonavir and • edicine for your heart such as bepridil, lidocaine (Xylocaine mother anti-HIV medicines to treat adults with human immunodeficiency Viscous®), quinidine (Nuedexta®), amiodarone (Pacerone®,virus (HIV-1) infection. PREZISTA is a type of anti-HIV medicine called a Cardarone®), digoxin (Lanoxin ®), flecainide (Tambocor ®),protease inhibitor. HIV is the virus that causes AIDS (Acquired Immune propafenone (Rythmol®)Deficiency Syndrome). • arfarin (Coumadin®, Jantoven®) w • edicine for seizures such as carbamazepine (Carbatrol®, Equetro®, mWhen used with other HIV medicines, PREZISTA may help to reduce Tegretol®, Epitol®), phenobarbital, phenytoin (Dilantin®, Phenytek®)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 • edicine for depression such as trazadone and desipramine mwhich help fight off other infections. Reducing the amount of HIV and (Norpramin®)increasing the CD4 (T) cell count may improve your immune system. • larithromycin (Prevpac®, Biaxin®) cThis may reduce your risk of death or infections that can happen when • edicine for fungal infections such as ketoconazole (Nizoral®), myour immune system is weak (opportunistic infections). itraconazole (Sporanox®, Onmel®), voriconazole (VFend®)PREZISTA does not cure HIV infection or AIDS and you may continue to • olchicine (Colcrys®, Col-Probenecid®) cexperience illnesses associated with HIV-1 infection, including • ifabutin (Mycobutin®) ropportunistic infections. You should remain under the care of a doctor • edicine used to treat blood pressure, a heart attack, heart failure, mwhen using PREZISTA. or to lower pressure in the eye such as metoprolol (Lopressor®, Toprol-XL®), timolol (Cosopt®, Betimol®, Timoptic®, Isatolol®,Avoid doing things that can spread HIV-1 infection. Combigan®)• Do not share needles or other injection equipment. • idazolam administered by injection m• o not share personal items that can have blood or body fluids on D • edicine for heart disease such as felodipine (Plendil®), nifedipine m them, like toothbrushes and razor blades. (Procardia®, Adalat CC®, Afeditab CR®), nicardipine (Cardene®)
  5. 5. IMPORTANT PATIENT INFORMATION• teroids such as dexamethasone, fluticasone (Advair Diskus®, s • Changes in your immune system (Immune Reconstitution Syndrome) Veramyst®, Flovent®, Flonase®) can happen when you start taking HIV medicines. Your immune• bosentan (Tracleer®) system may get stronger and begin to fight infections that have been• medicine to treat chronic hepatitis C such as boceprevir hidden in your body for a long time. Call your healthcare provider (VictrelisTM), telaprevir (IncivekTM) right away if you start having new symptoms after starting your HIV• medicine for cholesterol such as pravastatin (Pravachol®), medicine. atorvastatin (Lipitor®), rosuvastatin (Crestor®) • ncreased bleeding for hemophiliacs. Some people with hemophilia I• edicine to prevent organ transplant failure such as cyclosporine m have increased bleeding with protease inhibitors including (Gengraf®, Sandimmune®, Neoral®), tacrolimus (Prograf®), sirolimus PREZISTA. (Rapamune®) The most common side effects of PREZISTA include:• almeterol (Advair®, Serevent®) s • diarrhea • headache• medicine for narcotic withdrawal such as methadone (Methadose®, • nausea • abdominal pain Dolophine Hydrochloride), buprenorphine (Butrans®, Buprenex®, Subutex®), buprenorphine/naloxone (Suboxone®) • rash • vomiting• edicine to treat schizophrenia such as risperidone (Risperdal®), m Tell your healthcare provider if you have any side effect that bothers thioridazine you or that does not go away.• edicine to treat erectile dysfunction or pulmonary hypertension m These are not all of the possible side effects of PREZISTA. For more such as sildenafil (Viagra®, Revatio®), vardenafil (Levitra®, Staxyn®), information, ask your health care provider. tadalafil (Cialis®, Adcirca®) Call your doctor for medical advice about side effects. You may report• edicine to treat anxiety, depression or panic disorder such as m side effects to the FDA at 1-800-FDA-1088. sertraline (Zoloft®), paroxetine (Paxil®) How should I store PREZISTA?This is not a complete list of medicines that you should tell your • tore PREZISTA oral suspension and tablets at room temperature Shealthcare provider that you are taking. Ask your healthcare provider [77°F (25°C)].or pharmacist if you are not sure if your medicine is one that is listedabove. Know the medicines you take. Keep a list of them to show your • Do not refrigerate or freeze PREZISTA oral suspension.doctor or pharmacist when you get a new medicine. Do not start any • Keep PREZISTA away from high heat.new medicines while you are taking PREZISTA without first talking with • REZISTA oral suspension should be stored in the original container. Pyour healthcare provider. Keep PREZISTA and all medicines out of the reach of children.How should I take PREZISTA? General information about PREZISTA• ake PREZISTA every day exactly as prescribed by your healthcare T provider. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use PREZISTA for a • ou must take ritonavir (NORVIR®) at the same time as PREZISTA. Y condition for which it was not prescribed. Do not give PREZISTA to • o not change your dose of PREZISTA or stop treatment without D other people even if they have the same condition you have. It may talking to your healthcare provider first. harm them.• Take PREZISTA and ritonavir (NORVIR®) with food. This leaflet summarizes the most important information about• wallow PREZISTA tablets whole with a drink. If you have difficulty S PREZISTA. If you would like more information, talk to your healthcare swallowing PREZISTA tablets, PREZISTA oral suspension is also provider. You can ask your healthcare provider or pharmacist for available. Your health care provider will help determine whether PREZISTA tablets or oral suspension is right for you. information about PREZISTA that is written for health professionals.• REZISTA oral suspension should be given with the supplied oral P For more information, call 1-800-526-7736. dosing syringe. Shake the suspension well before each usage. What are the ingredients in PREZISTA?• f you take too much PREZISTA, call your healthcare provider or go I Active ingredient: darunavir to the nearest hospital emergency room right away. Inactive ingredients:What should I do if I miss a dose? PREZISTA Oral Suspension: hydroxypropyl cellulose, microcrystallinePeople who take PREZISTA one time a day: cellulose, sodium carboxymethylcellulose, methylparaben sodium, citric• f you miss a dose of PREZISTA by less than 12 hours, take your I acid monohydrate, sucralose, masking flavor, strawberry cream flavor, missed dose of PREZISTA right away. Then take your next dose of hydrochloric acid (for pH adjustment), purified water. PREZISTA at your regularly scheduled time. PREZISTA 75 mg and 150 mg Tablets: colloidal silicon dioxide,• f you miss a dose of PREZISTA by more than 12 hours, wait and then I crospovidone, magnesium stearate, microcrystalline cellulose. The film take the next dose of PREZISTA at your regularly scheduled time. coating contains: OPADRY® White (polyethylene glycol 3350, polyvinyl People who take PREZISTA two times a day alcohol-partially hydrolyzed, talc, titanium dioxide).• f you miss a dose of PREZISTA by less than 6 hours, take your I PREZISTA 400 mg and 600 mg Tablets: colloidal silicon dioxide, missed dose of PREZISTA right away. Then take your next dose of crospovidone, magnesium stearate, microcrystalline cellulose. The film PREZISTA at your regularly scheduled time. coating contains: OPADRY® Orange (FD&C Yellow No.  6, polyethylene • f you miss a dose of PREZISTA by more than 6 hours, wait and then I glycol 3350, polyvinyl lcohol-partially hydrolyzed, talc, titanium dioxide). a take the next dose of PREZISTA at your regularly scheduled time. This Patient Information has been approved by the U.S Food and Drug If a dose of PREZISTA is skipped, do not double the next dose. Do not Administration.take more or less than your prescribed dose of PREZISTA at any onetime. Manufactured by:What are the possible side effects of PREZISTA? PREZISTA Oral Suspension Janssen Pharmaceutica, N.V.PREZISTA can cause side effects including: Beerse, Belgium• ee “What is the most important information I should know about S PREZISTA?” PREZISTA Tablets• iabetes and high blood sugar (hyperglycemia). Some people who D Janssen Ortho LLC, Gurabo, PR 00778 take protease inhibitors including PREZISTA can get high blood Manufactured for: sugar, develop diabetes, or your diabetes can get worse. Tell your Janssen Therapeutics, Division of Janssen Products, LP, Titusville NJ healthcare provider if you notice an increase in thirst or urinate 08560 often while taking PREZISTA. NORVIR® is a registered trademark of its respective owner.• hanges in body fat. These changes can happen in people who take C antiretroviral therapy. The changes may include an increased PREZISTA® is a registered trademark of Janssen Pharmaceuticals amount of fat in the upper back and neck (“buffalo hump”), breast, © Janssen Pharmaceuticals, Inc. 2006 and around the back, chest, and stomach area. Loss of fat from the Revised: June 2012 986588P legs, arms, and face may also happen. The exact cause and long- term health effects of these conditions are not known.
  6. 6. 5537 N. Broadway St.Chicago, IL 60640phone: (773) 989–9400fax: (773) 989–9494email: inbox@tpan.comwww.positivelyaware.comeditor-in-Chief Jeff Berryassociate editor Enid Vázquezcopy Editors Sue Saltmarsh, Jason LancasterWeb Master Joshua Thorne EXCLUSIVELY ON www.positivelyaware.comCreative director Rick Guascocontributing writersKeith R. Green, Liz Highleyman,Sal Iacopelli, Laura Jones,Jim Pickett, Matt Sharp Surface vs. substance A website—and app—that encourages truth in Internet datingphotographers www.positivelyaware.com/2012/12_06/mister.shtmlChris Knight, Joshua Thorne Additional conference coverage from AIDS 2012 www.positivelyaware.com/2012/12_06/aids2012.shtmlMedical advisorsDaniel S. Berger, MDGary Bucher, MDMichael Cristofano, PA Follow us We read youJoel Gallant, MD on Facebook and on comment on our articlesSwarup Mehta, PharmD TwitteR (@posaware) at POSITIVELYAWARE.COM © 2012. Positively Aware (ISSN: 1523-2883) is published bi-monthly by Test Positive Aware Networkadvertising inquiries (TPAN), 5537 N. Broadway St, Chicago, IL 60640. TPAN is an Illinois not-for-profit corporation, providingLorraine Hayes 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. Sixl.hayes@tpan.com 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 ordistribution Manager decline submitted articles. When published, the articles become the property of TPAN and its assigns. You may useBradley P Mazzie your actual name or a pseudonym for publication, but please include your name and phone number.distribution@tpan.com Although Positively Aware takes great care to ensure the accuracy of all the information that it presents, Positively Aware staff and volunteers, TPAN, or the institutions and personnel who provide us with information cannot be held responsible for any damages, direct or consequential, that arise from use of this material or due to errors contained herein. Opinions expressed in Positively Aware are not necessarily those of staff or TPAN, its supporters and sponsors, or distributing agencies. Information, resources, and advertising in Positively Aware do not constitute endorsement or recommendation of any medical treatment or product. TPAN recommends that all medical treatments or products be discussed thoroughly and frankly with a licensed and fully HIV-informed medical practitioner, preferably a personal physician.POSITIVELY AWARE A model, photographer, or author’s HIV status should not be assumed based on their appearance in PositivelyIS PUBLISHED BY Aware, association with TPAN, or contributions to this journal. Distribution of Positively Aware is supported in part through an unrestricted grant from ViiV Healthcare.4 SEPTE MB E R +O C TO B ER 201 2 P os i t i v e lyAware .com
  7. 7. SEP+OCT 2012 VOLUME 24 NUMBER 6 D e pa r t m e n t s 6 In Box 6 Readers’ poll 7 editor’s Note What is a woman? 13 Briefly FDA approves Truvada for HIV prevention. Rapid home HIV test approved. Initial study results find dolutegravir/Epzicom is superior to Atripla. 34 Conference Update News from the XIX International AIDS Conference in Washington, D.C. 44 ask the HIV specialist Safe sex is for seniors, too. 45 WHOLISTIC PICTURE Battle of the sexes? c o v e r F e at u r e s 22 Securing care for HIV-positive women Challenges and solutions for women living with HIV. 26 Black women, society, and HIV An expert talks about the context of infection. 28 ‘Everyone needs a support system’ How one therapist helps HIV-positive women learn to take care of themselves. 30 Nine months to birth day HIV and pregnancy—keeping yourself and your baby healthy. F e at u r e 41 The mirror has two faces A personal account of using facial filler for lipoatrophy. On the cover and this page: Tamara wilson, HIV-Positive since 1999, photographed by chris KnightP osi t i ve lyAware.com S E P T E MB E R+ OC TOB E R 2 01 2 5
  8. 8. In Box join the conversation: inbox@tpan.com and @posaware Readers’ poll In the JULY+AUGUST issue, we askedHIV testing in prison? Before you tested HIV-positive, did you think you were at risk?First let me say this is I had no idea that anyonestrictly my opinion in has the same problems as No. I didn’tanswer to your reader’s me. The issue touched me 8% thinkpoll question concern- deeply. about it.ing HIV testing in prison. Simply knowing you’re 16% Yes, but II believe it should be there, that I can reach out practicedrequired upon entering to someone for information safer sex.and leaving prison. seems to make everything a 24% Yes, but I Prior to my incarcera- little bit better. I’m not sure thought I was at low risk.tion, I worked at Prevention how to receive future issues,Point Philadelphia (a needle but put me on your mailing Yes, but I 33% didn’t care.exchange program), the Gay list if at all possible! 19%& Lesbian AIDS Education —Dwayne E.Initiative, and I spoke at various events Floridaabout HIV/AIDS in the prison system. I’vebeen positive for 18 years and for the last Good wishes Your comments:11 years I’ve been trying to get as many Comment on July+August Editor’s Note: “I barebacked all the way after my firstpeople tested as possible. Thank you for the uplifting article, “Wish encounter—I have no one to blame but At present, I have three and a half years HIV Away.” Though easier said than done, I myself and my lack of self-esteem.”left on my sentence. During my incarcera- know that I’ll be able to pick my head up intion, I have been a Peer Educator teaching the morning and continue on with a posi- “After I found out, I wanted to kill myself—a class called Positive Voices behind the tive outlook on the day. I’m not at the stage my partner never told me he had HIV.”Walls (a little plug never hurts!) and an yet where people can know, only becauseadvocate for testing. I’m open about my I’m just two months into this disease, but I “Before I tested positive, I alwaysHIV status, so HIV can have a “face” that know I will get there (fingers crossed). practiced safe sex. But I also rememberdefies the expectations of some of the —Steven feeling like no matter how much of amen in here. via thebody.com good boy I was, HIV was going to get me.” After taking my class for 16 weeks, Ihave seen men’s attitudes change com- Hidden no more “I practiced safer sex until depressionpletely because they see me living healthy, I have to let you guys know how much and drugs got in my way.”happy, with a loving family, and looking I appreciated the article, “The Hiddenforward to a long life. People,” in your January+February 2012 “I never thought about it. I suspect I So, yes, testing should be mandatory, issue. I would love to have the Muslim was infected in 1986. At that time, therealong with education and good informa- brothers come to Memphis to speak in the wasn’t much information availabletion about prevention. very near future. My southern hat goes off about infection and I had no idea what —Larry to the writer Sue Saltmarsh for the article. behavior was risky and what wasn’t.” White Deer, Pennsylvania And love to Karim Rush, Shadeed Jenkins, and Iman Boyd. “I thought those who caught HIV ledYou’re not the only one Great job, POSITIVELY AWARE! You reckless lives, taking drugs and hav-Finally, I’ve found relief! On May 21st, I guys rock! ing many anonymous partners andread my first ever issue of Positively  —Anthony Hardaway unprotected sex. I was naïve to believeAware—the March+April Drug Guide. via the Internet I would be OK if I limited myself to one casual partner every few months.”Do the write thinG. Positively Aware treats all communications (letters, e-mail,etc.) as letters to the editor unless otherwise instructed. We reserve the right to edit for this issue’s poll question:length, style, or clarity. Unless you tell us not to, we will use your name and city. Who is more stigmatized because of HIV? Positively aware We read you. 5537 N. Broadway St. SHare your comments Chicago, IL 60640 about our articles at cast your vote at inbox@tpan.com POSITIVELYAWARE.COM positivelyaware.com6 SEPTE M B E R +O C TO B ER 201 2 P os i t i v e lyAware .com
  9. 9. Editor’s NOTE Jeff Berry @PAeditor What is a woman? I’ve had many teachers in life, including women up of mostly women, HIV-positive There are who have taught me particularly important lessons about educator and activist Linda Scruggs countless said it best by stating she wasn’t examples in courage, strength, resilience, caring, and compassion. going to ask for anything, because our culture of women have been asking to be strong, coura- Cindy, the oldest of my three sisters, realized at an counted in for the last two decades. “Today I stand here geous women early age that it was her job to help look after the other to give you some directions. We’ve decided to stop ask- and their four kids in the Berry clan. My sister Barb became a ing, and maybe you just need the recipe.” many accom- veterinarian, the first doctor in our family. The one who Scruggs called for meaningful involvement of women plishments was closest to me in age, Wendy, became my best friend at every level, from the government to local communities and contribu- growing up. My mother Norma went back to work when and organizations, and also made it clear that women are tions to the I started preschool in the early 1960’s, and continued not just asking for male-run organizations that “tolerate” a world. So why working as a schoolteacher and elementary school prin- women’s program. “We need the support and resources… is it that so cipal until she retired. And my grandmother, Ruby, lived to give us the power to heal our sisters, to change our many women to be 101, and would often recount to us colorful stories men. We are the mothers of the earth.” who are in from her life, such as the one about traveling all day in In her talk, Scruggs also shared part of what she says positions a covered wagon to see the Wright Brothers perform got her to the stage that day. She learned she was HIV- of power breathtaking feats in their amazing flying machines. positive while visiting a perinatal clinic and was 13-weeks and leader- All these women and others demonstrated to me pregnant, and had to decide whether to terminate the ship appear wonderful qualities that I respected and admired, and pregnancy and live five years, or have the baby and pos- threatening sought to emulate and incorporate into my own sense sibly live three. She says she’s glad that day the doctor to so many of values and ideals. There are countless examples in was wrong, and her son, Isaiah, was born free of HIV, who live in our culture of strong, courageous women and their and he just recently turned 21. our male- many accomplishments and contributions to the world. “I could’ve made the decision to have an abortion. dominated So why is it that so many women who are in positions An abortion would not have been the first one I had had, society? of power and leadership appear threatening to so many but I had an experience with God. I had an experience who live in our male-dominated society? that…made me really look and reflect about women. A recurring theme at this year’s International AIDS After all, what is a woman who thinks she’s ugly? What Conference was the role of women in ending the is a woman who feels she has no self-value? What is a epidemic. In her address at the conference opening woman who allows not one, but two men to rape her in plenary, Secretary of State Hillary Clinton talked about silence? What is a woman who allows an uncle to molest the essential role of communities, especially people liv- her and others and still be silent?... What is a woman ing with HIV, in turning the tide on the epidemic. “And it who feels that she’s been broken and voiceless? What is will come as no surprise to you,” Clinton told the packed a woman who’s afraid of understanding herself? What audience, “that I would like to highlight the particular is a woman who spent a lifetime trying to be someone role that women play.” other than herself? Clinton pointed out that in Sub-Saharan Africa “I’ll tell you, that cold November day, that woman women account for 60% of people living with HIV. was me, but it was through the support of this commu- “Women want to protect themselves, and they want nity that I was able to find a voice and a place, thatPHOTO: Chris Knight adequate health care, and we need to answer their call,” I could be just who I say I am. I am a woman.” said Clinton. “Every woman should be able to decide when and whether to have children. This is true if she is Take care of yourself, and each other. HIV-positive or not. Women need and deserve a voice in the decisions that affect their lives.” In a lively morning plenary session by a panel made P osi t i ve lyAware.com S E P T E MB E R+ OC TOB E R 2 01 2 7
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  15. 15. BRIEFLY Enid Vázquez FDA approves Truvada for PrEP The Food and Drug Administration (FDA) reduction counseling, consistent and participants who in July approved Truvada as the first correct condom use, regular HIV testing, took Truvada in the medication to help prevent HIV infec- and screening for and treatment of other prescribed once- tion. As expected, the approval came sexually-transmitted infections, stating daily dose. with restrictions. that “Truvada is not a substitute for safer “The Partners Truvada, a combination of tenofovir sex practices.” PrEP trial was conducted (Viread) and emtricitabine (Emtriva), is Truvada now carries a Boxed Warning in 4,758 heterosexual couples, one of the most prescribed medications on its drug label alerting health care where one partner was HIV-infected and for HIV in this country. For HIV preven- professionals and uninfected individuals the other was not (serodiscordant cou- tion, the use of Truvada is called “PrEP,” that Truvada for PrEP must only be used ples),” the press release continued. “The for “pre-exposure prophylaxis.” by people confirmed to be HIV-negative trial evaluated the efficacy and safety of “[We] commend the FDA’s approval of before being prescribed the drug and [both] Truvada and [Viread] tenofovir [Truvada] for the use of [PrEP] to prevent tested at least every three months dur- versus placebo in preventing HIV infection HIV transmission. This approach can ing use to reduce the risk of developing in the uninfected male or female partner. prevent many new infections and could drug resistance. Both the antiviral and the Results showed Truvada reduced the risk dramatically impact HIV transmission PrEP dose is one pill taken once daily. of becoming infected by 75% compared worldwide,” said Kenneth H. Mayer, MD, Truvada maker Gilead Sciences worked with placebo. Medical Research Director and Co-chair with the FDA to create a Risk Evaluation “No new side effects were identified of The Fenway Institute at Fenway Health. and Mitigation Strategy (REMS) for in the clinical trials evaluating Truvada “My colleagues and I are delighted to have Truvada PrEP. The REMS focuses on a pre- for the PrEP indication. The most com- helped to demonstrate the utility of this scriber training and education program mon side effects reported with Truvada promising approach for HIV prevention.” in counseling and managing individuals include diarrhea, nausea, abdominal David Ernesto Munar, President/CEO who are taking or considering Truvada for pain, headache, and weight loss. Serious of the AIDS Foundation of Chicago, said, PrEP. The REMS looks at the elements of adverse events in general, as well as “Our challenge now is to implement PrEP a comprehensive HIV prevention strategy, those specifically related to kidney or as strategically as possible, and to ensure the importance of adhering to the recom- bone toxicity, were uncommon.” the people who need it most, those who mended daily dosing regimen, and the As a condition of approval, Gilead are most at risk for HIV, have access.” serious risks of taking Truvada for PrEP if Sciences is required to collect and “This is an enormous turning point, a already infected with HIV or of becoming analyze samples from individuals who real game changer, in the fight against infected while taking it. become infected with HIV while taking HIV,” said Jim Pickett, AFC’s Director According to the press release, Truvada to see if they’ve developed drug of Prevention Advocacy and Gay Men’s “Truvada’s safety and efficacy for PrEP resistance. The company is also required Health. “The toolbox we have now has were demonstrated in two large, random- to collect data on women who become Truvada as PrEP. We can look forward to ized, double-blind, placebo-controlled pregnant while taking Truvada for PrEP more sex acts being protected, especially clinical trials. The iPrEx trial evaluated and to conduct other research. among individuals who have already Truvada in 2,499 HIV-negative men “Today’s decision is the culmination chosen, for whatever reason, to not use or transgender women who have sex of almost 20 years of research involving condoms consistently.” with men and with evidence of high investigators, academic and medical According to a press release from the risk behavior for HIV infection... Results institutions, funding agencies, and nearlyPhoto: Joshua Thorne FDA, “Truvada is to be used for [PrEP] in showed Truvada was effective in reduc- 20,000 trial participants around the combination with safer sex practices to ing the risk of HIV infection by 42% com- world, and Gilead is proud to have been prevent sexually-acquired HIV infection in pared with placebo in this population. a partner in this effort,” said Norbert adults at high risk.” Efficacy was strongly correlated with Bischofberger, PhD, Executive Vice The FDA said Truvada for PrEP should drug adherence in this trial.” President, Research and Development be used as part of a comprehensive It was also shown in iPrEX that there and Chief Scientific Officer, Gilead HIV prevention plan that includes risk was a 92% reduction of risk for HIV in Sciences. >> P osi t i ve lyAware.com S E P T E MB E R+ OC TOB E R 201 2 13
  16. 16. BRIEFLY Enid Vázquez in the greatest expansion of HIV preven- Rapid homeMoises Agosto tion tools than at any other time in the history of this epidemic. Coupled with the HIV test approved reforms included in the Patient Protection and Affordable Care Act, as well as the In June, the Food and Drug National HIV/AIDS Strategy, we are in a Administration (FDA) approved the position for the first time in over three OraQuick In-Home HIV Test, an HIV decades to finally end this epidem- self-test kit that does not require sending ic. Today’s decision is another important a sample to a laboratory for analysis. The step in realizing that goal.” kit, which tests a swab from your mouth, is approved for sale in stores and online Dolutegravir/Epzicom to anyone age 17 and older. (Although HIV is not found in saliva, evidence of superior to Atripla? exposure to the virus—called HIV anti- bodies—is found in the mouth and indi- Shionogi-ViiV Healthcare LLC announced cates infection.) A positive result at home that initial results from its Phase 3 study must then be followed up with a confir- SINGLE (ING114467) show superiority of matory blood test from a laboratory. its investigational HIV medication dolute- The FDA said the test can be falsely >> The following is from a statement gravir plus Epzicom over Atripla, one of negative for reasons that include the from Moises Agosto, Director of the most widely prescribed antiviral med- occurrence of HIV infection within three Treatment Education, Adherence, and ications in the country. At 48 weeks, 88% months before testing. People who Mobilization for the National Minority of study participants on the dolutegravir engage in behaviors that put them at AIDS Council (NMAC): regimen achieved undetectable viral increased risk of getting HIV—including load (less than 50 copies/mL) vs. 81% of having unprotected sex with new part- “While PrEP shows substantial promise as those on Atripla, a statistically significant ners, or injecting illegal drugs—should be a supplement to current HIV prevention difference. The company said the dif- re-tested on a regular basis. They should efforts, it is by no means a panacea and ference was primarily driven by a higher not interpret a negative test to indicate is only effective when used in conjunction rate of discontinuation due to adverse that engaging in high risk behavior is with traditional prevention and risk reduc- events in the Atripla arm. All individuals safe. tion strategies, such as condom usage. in the study were taking antiviral therapy “Anti-retroviral medications, like for the first time, a group that does the Truvada, are extremely powerful drugs best in HIV treatment. There were 414 with the potential for serious side individuals put on dolutegravir and 419 effects. As such, PrEP should only be put on Atripla. Overall, 2% of those on the used by individuals who are highly vul- dolutegravir-based regimen discontinued nerable to HIV infection, including those due to adverse events vs. 10% of those in sero-discordant couples, sex workers, receiving the Atripla regimen. The most and gay men. Its efficacy is also directly common adverse events while on Atripla related to an individual’s adherence to were neurological (reported by 41% of a regimen, and should only be used by Atripla recipients vs. 15% of participants those who can commit to taking it regu- receiving the dolutegravir), while the larly. Finally, use of PrEP by individuals most common drug-related adverse who may already be HIV-positive could events with dolutegravir were in the gas- increase the risk of drug resistance. trointestinal system (reported by 22% of “In recent years, there have been a people on dolutegravir vs. 22% of those number of promising developments in given Atripla). biomedical interventions—from treat- Dolutegravir is an investigational ment as prevention and pre-exposure integrase inhibitor (INSTI), the same class prophylaxis to microbicides and vaccine as Isentress, the only INSTI currently on research. These advances have resulted the market. 14 SEP TE M B E R +O C TO BER 201 2 P os i t i v e lyAware .com
  17. 17. E-NEWS | Sign up for the weekly email newsletter of positively aware. go to positivelyaware.comFrom the Weekly E-News is an important step forward in our fight Studies find against the disease.” once-daily ‘Quad’Website offers ViiV Healthcare is the first pharma- ceutical company to support the program is safe and effectiveaccess to HIV meds with HIV/AIDS medications and funding.for uninsured The goal of HarborPath is to get all HIV/AIDS medications into the program The findings of two large international randomized studies published in TheHarborPath, a new non-profit organiza- and serve uninsured individuals with: Lancet medical journal indicate that thetion, has been established to create a new once-daily pill combining threeprogram that offers a single place where n An easy-to-use website with a single antiretrovirals and a booster molecule isuninsured HIV-positive people who portal to determine eligibility for the a safe and effective alternative to twootherwise qualify for manufacturer- program and to fill prescriptions for widely used drug regimens for newlysponsored patient assistance programs participating companies’ HIV/AIDS diagnosed HIV-positive adults who have(PAPs) can apply for and receive their medications. had no previous treatment. The studymedications. The “one stop shop” portal n Automatic notifications for both the results also indicate that the new “Quad”will provide a streamlined, online process individual and the case manager of pill is faster acting, doesn’t have the neu-to qualify individuals and deliver the qualification for the program. ropsychiatric side effects associated withdonated medications through a mail- n A pharmacy that ships a 3-month sup- other combinations, and could improveorder pharmacy. HarborPath will pilot the ply of all participating medications in compliance with treatment.program in states with high need, includ- one package within two business days “Patient adherence to medication ising Alabama, Texas, and Virginia. of final approval and confirms delivery vital, especially for patients with HIV, To create the portal, HarborPath of the medications. where missed doses can quickly lead toworked closely with the National Alliance n Renewal reminders to individuals and the virus becoming resistant to medica-of State and Territorial AIDS Directors case managers to improve medication tion. Older HIV treatment regimens(NASTAD) and the Clinton Health Access adherence. involve taking several pills multiple timesInitiative (CHAI), which provided the seed n A fully automated portal that case a day,” explains Paul Sax from Brighamfunding for the organization. On World managers can access at any time and Women’s Hospital, Harvard MedicalAIDS Day 2011, President Bill Clinton noted for up-to-the-minute status of an School, lead author of the first study.the need to fight HIV/AIDS in the U.S. individual’s application or shipment. If “Our results provide an additional highly “I am proud that my foundation is needed, live support is also available potent, well-tolerated treatment option,partnering with NASTAD and other through a toll-free call center. and highlight the simplicity of treatmentpharmaceutical manufacturers to make resulting from combining several anti-sure Americans living with HIV have Murray Penner, Deputy Executive retrovirals in a single pill. Studies haveaccess to the life-saving medications Director at NASTAD, said, “Under the cur- shown that single pill treatments improvethey need,” said President Clinton. “This rent PAP process, an individual or their both adherence and patient satisfaction, case manager has to apply and help prevent prescription errors, separately to each com- thereby reducing the likelihood of treat- pany’s program for these ment failure and drug resistance.” medications, which can be The first study randomly assigned complex and time-consum- 700 patients from centers across North ing. Missing doses or failing America to start treatment with two to fill prescriptions because different single tablet regimens—either of complications sometimes the Quad, combining the new integrase associated with these pro- inhibitor elvitegravir (EVG) boosted with cesses may result in serious cobicistat (a new pharmacoenhancer; health consequences, or COBI) plus emtricitabine/tenofovir even death, in addition to (Emtriva/Viread), or Atripla (efavirenz/ increased transmission of emtricitabine/tenofovir), the current gold the virus. HarborPath is standard regimen approved by the FDA designed to address this in 2006. urgent need in the U.S.” After 48 weeks of treatment, 88% >>P osi t i ve lyAware.com S E P T E MB E R+ OC TOB E R 201 2 15
  18. 18. BRIEFLYEnid Vázquezof patients given the Quad had sup- was reached by 90% of people in the first conference to be held in the U.S.pressed viral loads (less than 50 copies/ Quad group compared with 87% in the since President Obama lifted the travelmL), compared with 84% in the Atripla atazanavir/ritonavir/emtricitabine/teno- ban on HIV-positive people, his anticipa-group. fovir group. tion of such events as displays of the Adverse events that led to patients The safety of the two regimens was AIDS Memorial Quilt, a planned marchdiscontinuing treatment were infrequent also similar. and demonstration, the performanceand similar in both groups. Mild nausea of the Tony Award-winning play Thewas more common with the Quad, butpatients were less likely to have dizziness, PA’s editor debuts Normal Heart, as well as the many global leaders in AIDS policy, advocacy, andabnormal dreams, insomnia, and rash blog on HuffPo treatment advances that presented at thecompared with the Atripla regimen. conference. The second trial included 708 Positively Aware editor Jeff Berry hastreatment-naïve adults from 146 medical joined other AIDS activists and journalistscenters across Australia, Europe, NorthAmerica, and Thailand. Patients were such as The Body’s Kellee Turrell, the AIDS Foundation of Chicago’s David Ernesto Did he get infected?randomly assigned to receive a once-daily Munar, and others in becoming a blogger In the July+August issue of PositivelyQuad or a popular and recommended published by The Huffington Post. Aware, a young man in Chicago, Chris,twice-daily combination of Norvir- In advance of the upcoming AIDS 2012 was anxiously awaiting the results of hisboosted Reyataz (atazanavir/ritonavir) World AIDS Conference, Berry wrote HIV tests following a potential exposureplus Truvada (emtricitabine/tenofovir). “Reflections from an Epidemic: Carrying through sex (“PrEPing,” July+August). The primary endpoint, to achieve viral the Torch to AIDS 2012.” In it, he talks Two months later, he remainslevels below 50 copies/mL by week 48, about the significance of this being the HIV-negative. Simplify your life. Turn your assorted prescription medicine bottles into single-dose packs. Easy to remember. Easy to take. Each pack contains all the pills of a single dose. Free FedEx shipping anywhere in the continental U.S. J Discount Pharmacy Call to place your first order: (773) 278-533716 SE P TE M B E R +O C TO BER 201 2 P os i t i v e lyAware .com
  19. 19. TPAN, publisher of Positively Aware, is commemorating 25 years of service to Chicago’s HIV community. Join Jamar Rogers, of NBC’s “The Voice,” for a special performance. October 4, 2012 5:30–8:30 PM | Chicago Cultural center Tickets available at www.tpan.com Event sponsors ANNIVERSARY PARTNERS $100,000 AND ABOVE $50,000 AND ABOVE Alphawood Foundation Janssen TherapeuticsPhoto: Matthew Garsteck Bristol-Myers Squibb $25,000 AND ABOVE $10,000 AND ABOVE Abbott Virology AIDS Foundation of Chicago EMD Serono Blue Cross and Blue Shield Lloyd A. Fry Foundation of Illinois ViiV Healthcare Cheetah Gyms Walgreens Gilead Sciences, Inc. Macy’s MillerCoors Steamworks
  20. 20. 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. one The for me Patient model. Pill shown is not actual size.INDICATION Do not take COMPLERA if you are taking the following medicines: • other HIV medicines (COMPLERA provides a complete treatment for HIV infection.)COMPLERA (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate ® • the anti-seizure medicines carbamazepine (Carbatrol®, Equetro®, Tegretol®,300 mg) is a prescription HIV medicine that contains 3 medicines, EMTRIVA® Tegretol-XR®, Teril®, Epitol®), oxcarbazepine (Trileptal®), phenobarbital (Luminal®),(emtricitabine), EDURANT™ (rilpivirine), and VIREAD® (tenofovir disoproxil fumarate) phenytoin (Dilantin®, Dilantin-125®, Phenytek®)combined in one pill. COMPLERA is used as a complete single-tablet regimen to treat • the anti-tuberculosis medicines rifabutin (Mycobutin), rifampin (Rifater®,HIV-1 infection in adults (age 18 and older) who have never taken HIV medicines before. Rifamate®, Rimactane®, Rifadin®) and rifapentine (Priftin®)COMPLERA does not cure HIV and has not been shown to prevent passing HIV • a proton pump inhibitor medicine for certain stomach or intestinal problems,to others. It is important to always practice safer sex, use latex or polyurethane including esomeprazole (Nexium®, Vimovo®), lansoprazole (Prevacid®),condoms to lower the chance of sexual contact with any body fluids, and to never omeprazole (Prilosec®), pantoprazole sodium (Protonix®), rabeprazole (Aciphex®)re-use or share needles. Do not stop taking COMPLERA unless directed by your • more than 1 dose of the steroid medicine dexamethasone or dexamethasonehealthcare provider. See your healthcare provider regularly. sodium phosphate • St. John’s wort (Hypericum perforatum) • other medicines that contain tenofovir (VIREAD®, TRUVADA®, ATRIPLA®)IMPORTANT SAFETY INFORMATION • other medicines that contain emtricitabine or lamivudine (EMTRIVA®, Combivir®,Contact your healthcare provider right away if you get the following side effects Epivir® or Epivir-HBV®, Epzicom®, Trizivir®)or conditions while taking COMPLERA: • rilpivirine (Edurant™)• Nausea, vomiting, unusual muscle pain, and/or weakness. These may be • adefovir (HEPSERA®) signs of a buildup of acid in the blood (lactic acidosis), which is a serious In addition, also tell your healthcare provider if you take: medical condition • an antacid medicine that contains aluminum, magnesium hydroxide, or calcium• Light-colored stools, dark-colored urine, and/or if your skin or the whites of your carbonate. Take antacids at least 2 hours before or at least 4 hours after you eyes turn yellow. These may be signs of serious liver problems (hepatotoxicity), take COMPLERA with liver enlargement (hepatomegaly), and fat in the liver (steatosis) • a histamine-2 blocker medicine, including famotidine (Pepcid®), cimetidine• If you have HIV-1 and hepatitis B virus (HBV), your liver disease may suddenly (Tagamet®), nizatidine (Axid®), or ranitidine hydrochloride (Zantac®). Take these get worse if you stop taking COMPLERA. Do not stop taking COMPLERA without medicines at least 12 hours before or at least 4 hours after you take COMPLERA first talking to your healthcare provider. Your healthcare provider will monitor • the antibiotic medicines clarithromycin (Biaxin®), erythromycin (E-Mycin®, Eryc®, your condition Ery-Tab®, PCE®, Pediazole®, Ilosone®), and troleandomycin (TAO®)COMPLERA may affect the way other medicines work, and other medicines may • an antifungal medicine by mouth, including fluconazole (Diflucan®), itraconazoleaffect how COMPLERA works, and may cause serious side effects. (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.
  21. 21. Save up to You may be able to save on the co-pay for 200 your COMPLERA prescription with a Gilead $ HIV Co-pay Assistance Card. Call 1-877-505-6986 for more information per month or visit www.COMPLERA.com.* COMPLERA. 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: Common side effects associated with COMPLERA:• have liver problems, including hepatitis B or C virus infection • trouble sleeping (insomnia), abnormal dreams, headache, dizziness, diarrhea,• have kidney problems nausea, rash, tiredness, and depression• have ever had a mental health problem Other side effects associated with COMPLERA:• have bone problems • vomiting, stomach pain or discomfort, skin discoloration (small spots or freckles),• are pregnant or plan to become pregnant. It is not known if COMPLERA can harm and pain your unborn child• are breastfeeding; women with HIV should not breast-feed because they can pass Tell your healthcare provider if you have any side effect that bothers you or that HIV through their milk to the baby 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 providerContact your healthcare provider right away if you experience any of the for medical advice about side effects.following serious or common side effects: You are encouraged to report negative side effects of prescription drugs to theSerious side effects associated with COMPLERA:• New or worse kidney problems can happen in some people who take COMPLERA. FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. If you have had kidney problems in the past or take other medicines that can cause Take COMPLERA exactly as your healthcare provider tells you to take it kidney problems, your healthcare provider may need to do blood tests to check your • Always take COMPLERA with a meal. Taking COMPLERA with a meal is important to kidneys during your treatment with COMPLERA help get the right amount of medicine in your body. A protein drink does not replace• Depression or mood changes can happen in some people who take COMPLERA. a meal Tell your healthcare provider right away if you have any of the following symptoms: • Stay under the care of your healthcare provider during treatment with feeling sad or hopeless, feeling anxious or restless, or if you have thoughts of COMPLERA and see your healthcare provider regularly hurting yourself (suicide) or have tried to hurt yourself• Bone problems can happen in some people who take COMPLERA. Bone problems Please see Patient Information for COMPLERA on the following pages. include bone pain, softening or thinning (which may lead to fractures). Your *The co-pay program covers up to $200 per month for 1 year from card activation or until the healthcare provider may need to do additional tests to check your bones card expires, up to $2400 in a calendar year. The program is subject to change or cancellation• Changes in body fat can happen in people taking HIV medicine. These changes at any time. 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 Learn more at www.COMPLERA.com