Jamar's Voice: Following his run on TV's "The Voice," singer Jamar Rogers takes to the stage—to share his life story of life with HIV. Also: Are you read for PrEP?
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 JAMAR'S VOICE Following his run on TV's "The Voice," Jamar Rogers takes to the stage again --to share his story of life with HIV ABOUT PREZISTA � PREZISTA� (darunavir) is a prescription medicine. It is one treatment option in the class of HIV (human immunodeficiency virus) medicines known as protease inhibitors. 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. Rifamate,� Rimactane�), sildenafil (Revatio�) when used to treat pulmonary arterial hypertension, indinavir (Crixivan�), lopinavir/ ritonavir (Kaletra�), saquinavir (Invirase�), boceprevir (VictrelisTM), or telaprevir (IncivekTM) � � 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 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,� � Tell your healthcare professional if you are pregnant or planning to become pregnant, or are breastfeeding -- The effects of PREZISTA� on pregnant women or their unborn babies are not known. You and your healthcare professional will need to decide if taking PREZISTA� is right for you -- Do not breastfeed. It is not known if PREZISTA� can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV should not breastfeed because HIV can be passed to your baby in the breast milk What are the possible side effects of PREZISTA�? � High blood sugar, diabetes or worsening of diabetes, and increased bleeding in people with hemophilia have been reported in patients taking protease inhibitor medicines, including PREZISTA� � Changes in body fat have been seen in some patients taking HIV � medicines, including PREZISTA. The cause and long-term health effects of these conditions are not known at this time � Changes in your immune system can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden � The most common side effects related to taking PREZISTA� include diarrhea, nausea, rash, headache, stomach pain, and vomiting. This is not a complete list of all possible side effects. If you experience these or other side effects, talk to your healthcare professional. Do not stop taking PREZISTA� or any other medicines without first talking to your healthcare professional You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please refer to the ritonavir (Norvir �) Product Information (PI and PPI) for additional information on precautionary measures. Please read accompanying Patient Information for PREZISTA� and discuss any questions you have with your doctor. 28PRZDTC0288R8 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? � REZISTA can interact with other medicines and cause serious P side effects. It is important to know the medicines that should not be taken with PREZISTA. See the section "Who should not take PREZISTA?" � REZISTA may cause liver problems. Some people taking PREZISTA P 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. � ellyourhealthcareproviderifyouhaveanyofthebelowsignsand T symptoms of liver problems. � ark(teacolored)urine D � ellowingofyourskinorwhitesofyoureyes y � alecoloredstools(bowelmovements) p � ausea n � omiting v � ainortendernessonyourrightsidebelowyourribs p � ossofappetite l 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: � ever f � iredness t � uscleorjointpain m � listersorskinlesions b � mouthsoresorulcers � edorinflamedeyes,like"pinkeye"(conjunctivitis) r 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 proteaseinhibitor.HIVisthevirusthatcausesAIDS(AcquiredImmune DeficiencySyndrome). When used with other HIV medicines, PREZISTA may help to reduce the amount of HIV in your blood (called "viral load"). PREZISTA may alsohelptoincreasethenumberofwhitebloodcellscalledCD4(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). PREZISTAdoesnotcureHIVinfectionorAIDSandyoumaycontinueto 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. � Donotshareneedlesorotherinjectionequipment. � onotsharepersonalitemsthatcanhavebloodorbodyfluidson D them, like toothbrushes and razor blades. � o not have any kind of sex without protection. Always practice D 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? DonottakePREZISTAwith any of the following medicines: � lfuzosin (Uroxatral�) a � ihydroergotamine(D.H.E.45�, Embolex�, Migranal�), ergonovine, d ergotamine (Cafergot�, Ergomar�) methylergonovine � isapride c � imozide (Orap�) p � ral midazolam, triazolam (Halcion�) o � he herbal supplement St. John's Wort (Hypericum perforatum) t � he cholesterol lowering medicines lovastatin (Mevacor�, Altoprev�, t Advicor�) or simvastatin (Zocor�, Simcor�, Vytorin�) � ifampin (Rifadin�, Rifater�, Rifamate�, Rimactane�) r � ildenafil (Revatio�) only when used for the treatment of pulmonary s 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: � aveliverproblems,includinghepatitisBorhepatitisC h � reallergictosulfamedicines a � avehighbloodsugar(diabetes) h � avehemophilia h � re pregnant or planning to become pregnant. It is not known if a 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. � re breastfeeding or plan to breastfeed. Do not breastfeed. We do a 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: � edicinetotreatHIV m � strogen-based contraceptives (birth control). PREZISTA might e reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control such as a condom. � edicine for your heart such as bepridil, lidocaine (Xylocaine m Viscous�), quinidine (Nuedexta�), amiodarone (Pacerone�, Cardarone�), digoxin (Lanoxin �), flecainide (Tambocor �), propafenone (Rythmol�) � arfarin(Coumadin�, Jantoven�) w � edicineforseizuressuchascarbamazepine(Carbatrol�, Equetro�, m Tegretol�, Epitol�),phenobarbital,phenytoin(Dilantin�, Phenytek�) � edicine for depression such as trazadone and desipramine m (Norpramin�) � larithromycin(Prevpac�, Biaxin�) c � edicine for fungal infections such as ketoconazole (Nizoral�), m itraconazole (Sporanox�, Onmel�), voriconazole (VFend�) � olchicine(Colcrys�, Col-Probenecid�) c � ifabutin(Mycobutin�) r � edicineusedtotreatbloodpressure,aheartattack,heartfailure, m or to lower pressure in the eye such as metoprolol (Lopressor�, Toprol-XL�), timolol (Cosopt�, Betimol�, Timoptic�, Isatolol�, Combigan�) � idazolamadministeredbyinjection m � edicine for heart disease such as felodipine (Plendil�), nifedipine m (Procardia�, Adalat CC�, Afeditab CR�), nicardipine (Cardene�) IMPORTANT PATIENT INFORMATION � teroids such as dexamethasone, fluticasone (Advair Diskus�, s 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�) � edicine to prevent organ transplant failure such as cyclosporine m (Gengraf�, Sandimmune�, Neoral�), tacrolimus (Prograf�), sirolimus (Rapamune�) � almeterol(Advair�, Serevent�) s � medicinefornarcoticwithdrawalsuchasmethadone(Methadose�, Dolophine Hydrochloride), buprenorphine (Butrans�, Buprenex�, Subutex�), buprenorphine/naloxone (Suboxone�) � edicine to treat schizophrenia such as risperidone (Risperdal�), m thioridazine � edicine to treat erectile dysfunction or pulmonary hypertension m such as sildenafil (Viagra�, Revatio�), vardenafil (Levitra�, Staxyn�), tadalafil (Cialis�, Adcirca�) � edicine to treat anxiety, depression or panic disorder such as m 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? � akePREZISTAeverydayexactlyasprescribedbyyourhealthcare T provider. � oumusttakeritonavir(NORVIR�) at the same time as PREZISTA. Y � o not change your dose of PREZISTA or stop treatment without D talking to your healthcare provider first. � TakePREZISTAandritonavir(NORVIR�) with food. � wallowPREZISTAtabletswholewithadrink.Ifyouhavedifficulty S 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. � REZISTA oral suspension should be given with the supplied oral P dosing syringe. Shake the suspension well before each usage. � fyoutaketoomuchPREZISTA,callyourhealthcareproviderorgo I 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: � f you miss a dose of PREZISTA by less than 12 hours, take your I missed dose of PREZISTA right away. Then take your next dose of PREZISTA at your regularly scheduled time. � fyoumissadoseofPREZISTAbymorethan12hours,waitandthen I take the next dose of PREZISTA at your regularly scheduled time. People who take PREZISTA two times a day � f you miss a dose of PREZISTA by less than 6 hours, take your I missed dose of PREZISTA right away. Then take your next dose of PREZISTA at your regularly scheduled time. � fyoumissadoseofPREZISTAbymorethan6hours,waitandthen I take the next dose of PREZISTA at your regularly scheduled time. IfadoseofPREZISTAisskipped,donotdoublethenextdose.Donot 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: � ee "What is the most important information I should know about S PREZISTA?" � iabetes and high blood sugar (hyperglycemia). Some people who D 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. � hanges in body fat. These changes can happen in people who take C 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. � ncreased bleeding for hemophiliacs. Some people with hemophilia I have increased bleeding with protease inhibitors including PREZISTA. The most common side effects of PREZISTA include: � diarrhea � headache � nausea � abdominalpain � 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 sideeffectstotheFDAat1-800-FDA-1088. How should I store PREZISTA? � tore PREZISTA oral suspension and tablets at room temperature S [77�F(25�C)]. � DonotrefrigerateorfreezePREZISTAoralsuspension. � KeepPREZISTAawayfromhighheat. � REZISTAoralsuspensionshouldbestoredintheoriginalcontainer. P 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. Formoreinformation,call1-800-526-7736. 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, hydrochloricacid(forpHadjustment),purifiedwater. 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 glycol3350,polyvinyl lcohol-partiallyhydrolyzed,talc,titaniumdioxide). a ThisPatientInformationhasbeenapprovedbytheU.SFoodandDrug Administration. Manufactured by: PREZISTA Oral Suspension Janssen Pharmaceutica, N.V. Beerse, Belgium PREZISTA Tablets JanssenOrthoLLC,Gurabo,PR00778 Manufactured for: JanssenTherapeutics,DivisionofJanssenProducts,LP,TitusvilleNJ 08560 NORVIR� is a registered trademark of its respective owner. PREZISTA� is a registered trademark of Janssen Pharmaceuticals �JanssenPharmaceuticals,Inc.2006 Revised:May2012 JULY+AUGUST 2012 VOLUME 24 NUMBER 5 D E PA R T M E N T S 6 6 7 IN BOX READERS' POLL EDITOR'S NOTE WishHIVaway. 13 BRIEFLY HepatitisCtreatmentwithoutinterferon. Activistsissuereportoncureresearch. TrendingonTwitter. 23 CULTURE CLUB Rememberingwherewe'vebeen. 44 ASK THE HIV SPECIALIST Howsafeissafe? 45 SALIENT RAMBLINGS "It`ssostrangethewaythingsturn." COVER STORY 24 Jamar's voice AfterhisrunonTV's"TheVoice,"JamarRogers takestothestageformorethansinging. F E AT U R E S 19 Treatment strategies DIGITAL EDITION READ THE PRINT VERSION OF POSITIVELY AWARE ON YOUR COMPUTER OR TABLET. Astherapiesimprove,howtochoosewhat's rightforyou. http://issuu.com/positivelyaware 34 PrEP'ing Areyouready?Doctorsandadvocatesgear uptobringTruvadaPrEPtothosewhoareat greatestriskofinfection. 39 Leather, porn, and kink They'reactuallysaferthanyoumightthink. 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 COL�N. STYLIST: KENZIE CROSLEY. CLOTHING PROVIDED BY KITSON IN BEVERLY HILLS, CA. 4 J U LY+AUGUST 2012 P OS I T I V E LYAWA R E .CO M 5537 N. BROADWAY ST. CHICAGO, IL 60640 phone: (773) 989�9400 fax: (773) 989�9494 email: email@example.com www.positivelyaware.com EDITOR-IN-CHIEF Jeff Berry EXCLUSIVELY ON www.positivelyaware.com Jamar in full ListentotheaudioorreadthefullinterviewwithJamarRogers. www.positivelyaware.com/jamar ASSOCIATE EDITOR Enid V�zquez COPY EDITOR Sue Saltmarsh PROOFREADER Jason Lancaster WEB MASTER Joshua Thorne CREATIVE DIRECTOR Rick Guasco CONTRIBUTING WRITERS What's next? HowtheSupremeCourt'srulingwillaffecthealthcare. www.positivelyaware.com/2012/12_05/aca.shtml Keith R. Green, Liz Highleyman, Sal Iacopelli, Laura Jones, Jim Pickett, Matt Sharp PHOTOGRAPHERS Chris Knight, Joshua Thorne CONTRIBUTING PHOTOGRAPHER Matthew Garsteck FOLLOW US ON FACEBOOK AND ON TWITTER (@POSAWARE) MEDICAL ADVISORS WE READ YOU COMMENT ON OUR ARTICLES ATPOSITIVELYAWARE.COM � 2012. POSITIVELY AWARE (ISSN: 1523-2883) is published bi-monthly by Test Positive Aware Network (TPAN), 5537 N. Broadway St, Chicago, IL 60640. TPAN is an Illinois not-for-profit corporation, providing information and support to anyone concerned with HIV and AIDS issues. POSITIVELY AWARE is a registered trademark of TPAN. All rights reserved. Circulation: 100,000. For reprint permission, contact Sue Saltmarsh. Six issues mailed bulk rate for $30 donation; mailed free to those living with HIV or those unable to contribute. We accept contribution of articles covering medical or personal aspects of HIV/AIDS. We reserve the right to edit or decline submitted articles. When published, the articles become the property of TPAN and its assigns. You may use your actual name or a pseudonym for publication, but please include your name and phone number. 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. Distribution of POSITIVELY AWARE is supported in part through an unrestricted grant from ViiV Healthcare. Daniel S. Berger, MD Gary Bucher, MD Michael Cristofano, PA Joel Gallant, MD Swarup Mehta, PharmD ADVERTISING INQUIRIES Lorraine Hayes firstname.lastname@example.org DISTRIBUTION MANAGER Bradley P Mazzie email@example.com POSITIVELY AWARE IS PUBLISHED BY P OS I T I VELYAWARE.COM J U LY + AU G U ST 2 01 2 5 IN BOX JOIN THE CONVERSATION: INBOX@TPAN.COM AND @POSAWARE READERS' POLL IN THE MAY+JUNE ISSUE, WE ASKED READERS Sharing and educating I JUST OPENED THE 2012 PA DRUG GUIDE AND CURLED UP What do you think is the best way to provide HIV testing in prisons? NOT SURE IF REQUESTED foracover-to-coverread.Ididn'tgetpasttheeditor'snote.Like always,Jeff'sopensharingwasmoving,andcausedmetopause. Noonetalkssobluntlyaboutswitching,theshiftingparadigmsof treatment,and/oraging.Nooneelselaysitallouttherewithhonesty,conviction,andgentleness. Idon'tknowwhyhisideasgetmeall chokedup.Maybethereisatraceofprovider'sguilt.Iusedtoworry24hoursaday, whenIwaspracticing.IwonderedifImade therightdecisions,weretheguidelines makingtherightcall,weretheavailable regimensaone-size-fits-all.Therewere somanychoices,Ihavecometosee,that couldhavebeenbetter.Letmephraseit differently.Therearesomanyaspectsof treatmentthathavegottenbetter!Oneof thoseistheimprovedsideeffectprofiles. Also,initiatingtreatmentearly...inthegood way.Notthe"hitithard;hititearly"way. MaybeIjustgetmovedbyhearingthat thereisanothervoiceouttherefightingthe samefight,andlookingatthesameideas, likeswitchingasanoption.LikeJeffsaid, whenweknowbetter,wedobetter. Ithasbeenajourney.ThankstoJefffor sharinghis.ThankstoPAforbeingapart ofmine. --Name withheld by request TheresponsefromDr.BickintheMay+June "AsktheSpecialist"columnwasnotaccurate.Thewriteraskedaboutherbrother gettingtreatmentforHIVwhileinprison andDr.Bicksaidhehasarighttoit. Actually,whileyoumayhavethatright, youdonotnecessarilygettreatmentwhen injail.Ihadtoservetwoweeksinjail. BeforeIwentin,thejudgewasinformedof myillnessandIhandedallmymedsover aftersentencing.Iwenttojail,mymeds wereshelved,andIwasgivennoaccessto them.BeforeenteringjailmyT-cellcount wasstableandIwashealthy.Afterleaving, myT-cellswerebelow200,Ihadlostalot ofweight,andIhadAIDS.Sopleasedon't misinformpeopleaboutrightsthatarenot given,evenbythejudges. IwillneverbefreeoftheangerIhave forthesepeople. --KS VIA THE INTERNET 2% 8% OPT-OUT 36% MANDATORY 54% YOUR COMMENTS: "Testasrequested--andprovideeducation.Makecondomsandlubeavailableso thatwhensexhappens,it'slowerrisk." "Asatransgenderwomanwhowasin prisonandinfectedwithHIV,Ifeelit shouldbeofferedtoallinmates." "Testingpositiveinjailorprisonhas anegativeimpactonaperson'slife, soinmatesshouldbeabletochoose. Testingshouldbeofferedonlywhere immediateaccesstoqualitycareand treatmentisavailable." "Wetestuponintake,thenin120days andagainuponrelease.Mandatory testingshouldbedoneinallcorrectionalfacilities.Thatwaywecangetthem intotreatmentandtrytokeepthemin treatmentwhenreleased." THIS ISSUE'S POLL QUESTION: Correction IntheMay+Juneissue,inthearticle aboutThe Normal Heart,theexecutiveproduceratArenaStagewas referredtoasEdgarObie.Hisname isactuallyEdgarDobie. Also,thisproductionisactually notthefirstregionalone,butrather thefirstD.C.-areaprofessional production. Thephotocaptionshouldread "JimParsonsandLeePaceinthe 2011BroadwayproductionofThe Normal Heart." Weapologizefortheerrorsand thankArenaStageforbringing themtoourattention. DO THE WRITE THING. POSITIVELY AWAREtreatsallcommunications(letters,e-mail, etc.)asletterstotheeditorunlessotherwiseinstructed.Wereservetherighttoeditfor length,style,orclarity.Unlessyoutellusnotto,wewilluseyournameandcity. POSITIVELY AWARE 5537 N. BROADWAY ST. CHICAGO, IL 60640 WE READ YOU. SHARE YOUR COMMENTS ABOUT OUR ARTICLES AT POSITIVELYAWARE.COM 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 firstname.lastname@example.org 6 J U LY+AUGUST 2012 POSITIVELYAWARE.COM P OS I T I V E LYAWA R E .CO M EDITOR'S NOTE JEFF BERRY @PAEDITOR ON TWITTER Wish HIV away T RUTHISAFUNNYTHING.ITHASAWAYOFSNEAKING uponyouwhenyouleastexpectit,likeaguest whoshowsupataparty,uninvited. PHOTO: CHRIS KNIGHT Wish Me Awayisthenameofasongbycountry musicsingerChelyWright,andisalsothetitleofher recentlyreleaseddocumentaryfilm,whichchronicles herstrugglescomingoutasalesbiantoherfans,the countrymusicindustry,andtheworldatlarge.It'sa touching,sometimessad,oftenintense,andultimately empoweringfilmthattellshertruth,asshehaslivedit, inthehopesthatitmighthelpotherswhomayalso bestruggling. Duringthefilm'sopening,Chelystatesthatsheis justtryingtoliveherownlifeopenlyandhonestly, becausenotdoingsoisnearlykillingher.Sheknew fromaveryearlyagethatshewasdifferent,thatshe wasgay,andfordecadesshesworetoherselfthatshe wouldtakethatsecrettohergrave.Yearsago,Imadea similarvowtomyself--thatIwouldtaketothegravemy ownsecretthatIhadbeensexuallyabusedasachildby myfather. Ihavenodoubtthatasimilarconvictionexistsfor countlessotherswhenitcomestotheirHIVstatus. Weliveinfear--fearoflosingourjobs,ourfamily,our friends,ourverysafety.SowewishHIVaway.Wetake ourpillsinhiding,sootherswon'taskquestions.Ifthere isablooddriveattheoffice,wecallinsick,ratherthan havetoexplainwhywecan'tdonate.Wedrivehoursto visitadoctororclinicinanothertown,ratherthanbe recognizedat"thatclinic"athome.WewishHIVaway. I'msureweallhavethatonefriendwhohasnever beentested,andrefusesto,becausetheywouldjust rathernotknow.TheywishHIVawaybypretendingit doesn'tevenexist.Thereisthefamilywhohidesthe causeofdeathoftheirsonordaughterbysayingthey diedofcancer.ThechurchthatpreachesthatAIDSis God'spunishmentforbeinggay.Thelegislatorswho slashbudgetsandfundinganddenylifesavingmedicationstopeoplewithHIV.TheyallwishHIVaway,and sweepitundertherug,erroneously believingitcan'thappentothem, attachingshameandstigmatosimplyhavingavirus. WeneedtostopwishingHIV away,andithastobeginwithus.Iknowforsomeofus thefearoflosingourjobs,andhenceourhealthinsurance,isaveryreal,palpablefear.Butweneedtostart byspeakingandowningourowntruth,ifonlyinthe mirror.Inthisissue,JamarRogersspeaksveryopenly andhonestlyabouthisownstruggles,andthepower ofspeakinghisowntruthregardinghisHIVstatus. However,therearesomeofuswhocontinuetohide, orliveindenial,becauseit'smorecomfortable,orit's easier,orweareafraidoftheunknown.Butitmightbe thatwecouldhavearealimpactbycomingoutabout ourstatus,ifonlytoourselves.HIVisnothingtobe ashamedof.TheonlystigmaattachedtoHIVisthat whichweallow.Ithasnopowertodictateouractions, ourfeelings,orourbeliefs,otherthanthepowerthat wechoosetoletithaveoverus. Let'sstopthefantasy.Let'sstoppretendingthatHIV canbewishedaway.Untilthereisacure,HIVisunfortunatelyheretostay.Justlikethatuninvitedguestatthe party,itcaneitherbeshunned,merelytolerated,orit canbeembraced. Remember,youarethehost,andit'syourparty-- whathappensisuptoyou.Soshineyourlightbrightly, holdyourheaduphigh,don'tbeashamed,andrefuse toliveinfear.It'sonlywhenwefinallydecideto embraceandrejoiceinourowntruth,thatwecan begintoseethetruthandlightinothers.Andbyjoiningtogether,wecreateaforceandalightsobright,so strong,thatitspresenceisundeniableanditcannotbe extinguishedorignored. Takecareofyourself,andeachother. 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. P OS I T I VELYAWARE.COM J U LY + AU G U ST 2 01 2 7 This page intentionally left blank. This page intentionally left blank. This page intentionally left blank. This page intentionally left blank. A DAY 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. 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! FOR DETAILS, GO TO www.duh4all.org www.ADayWithHIV.com 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 SPONSORED BY TICKETS AVAILABLE AT WWW.TPAN.COM BRIEFLY ENID V�ZQUEZ The Quad goes before the FDA AnFDAadvisorycommitteevoted13�1torecommend that the FDA approve a new once-daily HIV drug known as the Quad.TheFDAusuallyfollowstherecommendationsofitsadvisorycommitteeandisscheduledtoconsiderapprovaloftheQuadby August27.Ifapproved,itbecomesthethirdsingle-tabletHIVregimenonthemarket, alongwithAtriplaandComplera. Asitsnicknameimplies,theQuadismadeupoffourdifferentmedications.These arethenewintegraseinhibitorelvitegravir(brandnamenotyetavailable),plusViread andEmtriva(tenofovirandemtricitabine--availablebothseparatelyaswellastogether underthebrandnameTruvada),andcobicistat.ThisfourthdrugisnotanHIVmedication,butaboosteragenttoimprovethebioavailabilityofelvitegravir.Currently,Norvir (ritonavir)istheonlysuchboosteragentavailable.ElvitegravirwouldjointheonlyHIV integraseinhibitorcurrentlyonthemarket,Isentress. FormoreinformationontheQuad,gotowww.positivelyaware.com/quad. HIV the musical: Living with Henry Living with Henryisthetitleofa new Canadian musical that explores present day issues of living with HIVsuchas stigma,disclosure,andinterpersonalrelationships.Themusicalwillbepremiering inNewYorkCitythissummerfromJuly 23�29aspartoftheNewYorkMusical TheatreFestival. "Ithasbecomeapparentthatthere arefew,ifany,theatricalproductionsthat discussHIVinthe`now'context,"says writeranddirectorChristopherWilson, whoishimselfHIV-positive."Living With Henryisacontemporarytheatricalview ofHIV/AIDS,framingitasachronicillness ratherthanadeathsentence." Formoreinformationgotowww. LivingWithHenry.com;Living With Henry ticketsare$25andcanbepurchased onlineatwww.nymf.orgorbycalling (212)352-3101.--JEFF BERRY Ryan Kelly (left) and Dale Miller star in Living with Henry. HIV patients often drop out of care Onlyone in five HIV patients maintained a high level of medical carebasedon threecriteria,accordingtoananalysisof 12clinicsintheU.S.Thestudy,publishedin theApril23editionofJournal of Acquired Immune Deficiency Syndrome(JAIDS),was basedonthemedicalrecordsofmorethan 22,000peoplereceivingcarebetween 2001and2009.Inlookingatthethree criteria--establishmentofcare(afollow-up appointmentsixormoremonthsafterfirst engagingwithcare);retentionincare(two ormorefollow-upappointmentsatleast90 daysapartineachyearofcare);andloss tofollow-up(novisitformorethantwelve monthswithoutreturn)--theresearchers foundthat:21.7% ofthesepatientsnever establishedHIVcareaftertheirfirstvisit; 57.4%didnotmeetretentioncriteria;and 34.9%werelosttofollow-up.20.4%of patientsestablishedandretainedcare underthedefinitionsofthestudy. "Foroptimalclinicalbenefit,HIVinfectedpatientsshouldreceiveperiodic outpatientcareindefinitely,"theresearchersstated."Thesedatahighlighttheneed toimproveestablishmentandretentionin HIVcare." P OS I T I VELYAWARE.COM HIV prevention pill recommended AnadvisorycommitteeoftheFDArecommended that the agency approve the use of the HIV medication Truvada for HIV-negative people to prevent infectionwiththevirus(seestoryonpage34). TheFDAwasscheduledtoconsiderthe newindicationforTruvadainSeptember, asPOSITIVELY AWAREwenttopress. Anactualindicationforprevention onthedruglabelwouldmakeiteasier formedicalproviderstoprescribeitand insurerstopayforit. Another home HIV test AnotherFDAadvisorycommitteerecommended that the agency approve the OraQuick In-Home HIV Test.Unlikeother over-the-counterHIVtestsavailablefrom HomeAccess,inwhichpeoplemailin samplesonaswabandgettheirresults overthephone,theOraQuicktestresults wouldbeavailablein20minutesandcan bereadrightathome,aswithhomepregnancytests.Anoralswabisused. J U LY + AU G U ST 2 01 2 PHOTO: JOSHUA THORNE 13 BRIEFLY ENID V�ZQUEZ Breast milk antibodies help neutralize HIV AntibodiesthathelptostopHIVfrom replicatinghavebeenfoundinbreast milk.ResearchersatDukeUniversity MedicalCenterisolatedtheantibodies fromimmunecells,calledBcells,inthe breastmilkofinfectedmothersinMalawi. HIV-1canbetransmittedfrommotherto childviabreastfeeding,butonlyonein10 HIV-positivenursingmothersisknownto passthevirustotheirinfants.Research showedthattheB cells in breast milk can generate neutralizing antibodies that may inhibit the virus. Thediscoveryofthetwoantibodies inbreastmilkmayalsohelpresearchers withnewinvestigationsintoadult-toadulttransmission,aswellastomotherto-childtransmission. "Thisisimportantworkthatseeksto understandwhatavaccinemustdoto protectbabiesfrommucosaltransmissionduringbreastfeeding,"saidBarton Haynes,MD,co-authoranddirectorofthe CenterforHIV/AIDSVaccineImmunology (CHAVI),aswellasdirectoroftheDuke HumanVaccineInstitute(DHVI)."The antibodiesisolatedarethefirstHIV antibodiesisolatedfrombreastmilkthat reactwiththeHIV-1envelope,anditis importanttounderstandhowtheywork toattackHIV-1." TheCentersforDiseaseControland Prevention(CDC)recommendagainst breastfeedingifamotherhasHIV-1, becausebabyformulaisasafealternative forU.S.-borninfants.TheWorldHealth Organization,however,encouragesHIVpositivenursingmothersinresource-poor regionstobreastfeedwhilemotherand/ orbabytakeantiretroviraldrugstopreventtheinfectionintheinfant.Without thenutrientsandimmunefactorsin mothers'milk,manymorebabieswould diefromotherdiseases. ThestudywaspublishedMay18in PLoS One. --SUE SALTMARSH 14 J ULY+AUGUST 2012 Treatment for hep C without interferon BoehringerIngelheim(BI)issuedapress releaseon12-weekdatawithtwoinvestigationalcompoundsforthetreatment ofhepatitisC,BI201335andBI207127. Althoughnotyetstudiedinpeoplewith HIV,it'sa beginning for a new treatment option that can be expected to help people co-infected with HIV and hepatitis C(HCV)inthefuture.Thetwodrugs wereusedtogether,alongwithribavirin, butimportantly,withoutinterferon,a drugthatisverydifficulttotolerate,but iscurrentlypartofeveryhepCtreatment regimen. "EliminatinginterferonfromHCV treatmentisanurgentneed,"said StefanZeuzem,MD.HeisChiefofthe DepartmentofMedicineandProfessorof MedicineattheJohannWolfgangGoethe UniversityHospitalinFrankfurt,Germany, andleadinvestigatorofthestudy. Theplannedinterimresultsshowed that68%ofstudyparticipantsachieved asustainedviralresponse(SVR)against theirhepC.SVRat12weekshasbeen independentlycorrelatedtoSVRat week24,whichisconsideredacure.The participants(lessthan100ofthem)had genotype1,themostdifficulttypeofhep Ctotreat.Theresultswerepresentedat theEuropeanAssociationoftheStudy oftheLiver(EASL)conference,heldin BarcelonainApril. Clue found to Ziagen and Epzicom hypersensitivity Accordingtoapressreleasefromthe FDAissuedinMay,"AteamofresearchersledbytheU.S.FoodandDrug Administrationhasdiscovereda new mechanism for identifying and understanding drug-related autoimmune reactions. "Inanarticlepublishedinthejournal AIDS,theteamdescribesthatincertain at-riskpatients,theanti-HIVdrugZiagen (abacavir)causestheimmunesystem to`see'apatient'sownhealthytissues andproteinsasaforeigninvader.The affectissimilartowhathappenswhen theimmunesystemrecognizesaviralor bacterialproteinduringaninfection." Theagencysaidthe"latestdiscovery willadvancetheFDA'sabilitytoapprove therapiesthatarepersonalizedforsafety." Ziagenisalsofoundinthetwo-drug combinationpillEpzicom.Bothmedicationscancauseallergicreactionsthat canbeseriousandevenfatal,buttherisk hasbeenvirtuallyeliminatedbyaneasy andinexpensivetestforthegeneHLAB*5701,whichmakespeoplesusceptible tothereaction. ZiagenandEpzicomareratherrarely usedintheU.S.,withcompetitorTruvada probablybeingthenumberoneselling HIVdruginthecountry. Activists issue report on HIV cure research ActivistsfromtheAIDSTreatmentActivistsCoalition(ATAC),ProjectInform (inSanFrancisco),andtheTreatmentActionGroup(TAG,inNewYorkCity) issuedareport summarizing the talks presented at the Community HIV Cure Workshop,whichtookplaceinMarchinSeattlebeforeCROI.Thereportreceived fundingsupportfromBionorPharma,GileadSciences,andMerck. "AcureforHIVwillbeessentialtoendingtheAIDSpandemic,butsciencethat isfocuseddirectlyonacureisstillinearlystagesandwilllikelyrequirethesupportofmultiplestakeholderstoproceedatthefastestpace,"thereportbegins. "Amongrecentsignsofprogress,researchershavecontributednewinsights intowhereandwhyHIVpersistsdespitepotentARVtherapy."Readthe10-page reportatwww.positivelyaware.com. P OS I T I V E LYAWA R E .CO M E-NEWS | SIGN UP FOR THE WEEKLY EMAIL NEWSLETTER OF POSITIVELY AWARE. GO TO POSITIVELYAWARE.COM COMPILED FROM THE WEEKLY E-NEWS Nickelodeon seeks positive youth Trending HIV/AIDS on Twitter SixHIV/AIDSactivistsareurging Twittererstouse the hashtags #HIV, #AIDS, or #IAC during the International AIDS Conference,beingheldJuly22�27 inWashington,D.C.Thesuggestionwill helpto"trend"HIV/AIDSonTwitter, meaningthatinsteadofKimKardashian beingoneofthemosttalkedabouttopics onTwitter,itcouldbeHIVandAIDSat thetopofthelistinstead. "Together,throughthiscampaign,we (theglobalcommunity)can,wemust, make#HIVand#AIDSatrend.Thisisa hugeopportunitytobringmuch-needed awarenesstotheHIV/AIDSglobalepidemic. Toachievesuccess,wemustallmakea consciousefforttotweetourlittlefingers off!"writesactivistKevinMaloneyina recentblogonTheBody.com."#HIV:Let's TrenduntiltheEndwillredefinehowHIV, AIDS,andhepatitisC(alongwithother sexuallytransmittedinfections)awareness,prevention,outreach,activism,and muchmoreareputintoactioninareas thatareindesperateneedofsupport." Toparticipate,RSVPonthecampaign'sFacebookeventpage,andclickon "going,"orgototwitter.com/hashtaghiv. MalloryKydd,fromNick News with Linda Ellerbee,islookingforyouth ages 11-17 to share their stories of living with HIV foradocumentarytobeairedonWorldAIDSDay, December1. "Weareprimarilylookingforstoriesthathavealotofdepth.Forexample,therecent newspieceaboutthe13-year-oldboywhohadhisadmissionrejectedataprivateschool inPennsylvania,"saidKyddinanemailsenttoAIDSserviceorganizations. AnyoneinterestedshouldcontactKyddatMallory@LDP.comor1-212-463-0029. Justice Dept. settles HIV bias lawsuits TheJusticeDepartmenthasreachedtwo settlements resolving claims that health care providers refused to serve people with HIVinviolationoftheAmericanswith DisabilitiesAct(ADA). ThefirstcomplaintwasfiledbyamanwithHIVwhowenttotheMercyMedical GroupMidtownClinicinSacramentoandwasincorrectlytoldbythepodiatristseeing himthatsurgerywasnotanoptionbecauseoftheriskofthesurgeoncontractingHIV fromhim. ThesecondcomplaintwasfiledbyamanwithHIVwhowenttotheKnoxville ChiropracticClinicNorthforchiropractictreatmentfollowinganautomobileaccident, whereadoctordeterminedthatheneeded24appointmentstotreathisinjuries. However,hewasinformedonhisthirdvisitthatthecliniccouldnottreatpeople"like him." TheJusticeDepartmentdeterminedthattheKnoxvilleChiropracticCentershada blanketpolicyofrefusingtreatmenttopeoplewithHIVinviolationoftheADA. "Itiscriticalthatpeoplewithdisabilities,includingHIV,notbedeniedequalaccessto goodsandservices,especiallytohealthcareservices. TheCivilRightsDivisiontakesdiscriminationbasedonunfoundedfearsandstereotypesaboutHIVveryseriously,"said ThomasE.Perez,AssistantAttorneyGeneralfortheCivilRightsDivision. Thesettlementagreementsrequiretheentitiestodevelopandimplementanon-discriminationpolicyandtotrainstaffontherequirementsoftheADA. Inaddition,Mercy MedicalGroupandCHWMedicalFoundationarerequiredtopay$60,000tothecomplainantand$25,000asacivilpenalty,andKnoxvilleChiropracticCentersisrequiredto pay$10,000asacivilpenalty. AnnouncementofthesettlementswasmadeinMay. Combivir, Viramune go generic TheFDAhasapprovedgenericformulationsoftheHIVmedicationsViramune(nevirapine)andCombivir,acombination ofEpivir(lamivudine)andRetrovir(zidovudineorAZT).The approvalsmeanthatthesegenericformulationscanbemarketed intheUnitedStates.Theavailability of these generics could be problematic forHIVtreatment,sinceinanefforttosavemoney, peoplecouldbeforcedtoswitchtothecheapergenericsfrom other,moretolerableantiretrovirals.Acomprehensivelistofthe approvedgenericHIVtherapeuticdrugproductsisavailableon theFDA'sHIVwebsite. P OS I T I VELYAWARE.COM Isentress drug label update InMay,theFDAapprovedofalabelingupdateforIsentress,an HIVintegraseinhibitor. Thethree-yeardata(156weeks,fromaplannedfive-year study)showedthat76% of participants given Isentress had reached the goal ofviralloadlessthan50copies/mL,compared to68%oftheSustivagroup.Moreover,theaverageCD4+T-cell increaseseenwithIsentresswas281comparedto241forSustiva. Thisstudylookedat600peopletakingHIVtreatmentforthe firsttime,agroupthatisexpectedtoachievethebestresults withtherapy. J U LY + AU G U ST 2 01 2 15 Model 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: � o not share needles or other injection equipment. D � o not share personal items that can have blood or body fluids on them, D like toothbrushes and razor blades. � o not have any kind of sex without protection. Always practice safe sex by using D 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: � aveliverproblems. h � 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. � aveanyothermedicalconditions. h � 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: � ifampin(Rifadin,Rifamate,Rifater,Rimactane),amedicinecommonlyused r 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. � YoushouldstayunderthecareofyourdoctorwhiletakingISENTRESS. � o not change your dose of ISENTRESS, switch between the film-coated tablet and the D chewable tablet or stop your treatment without talking with your doctor first. � TakeISENTRESSbymouth,withorwithoutfood. � fyourchildistakingISENTRESS,yourchild'sdoctorwilldecidetherightdosebased I onyourchild'sageandweight. � ISENTRESSChewableTabletsmaybechewedorswallowedwhole. � ISENTRESSFilm-CoatedTabletsmustbeswallowedwhole. � fyoumissadose,takeitassoonasyouremember.Ifyoudonotrememberuntilit I 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. � f you take too much ISENTRESS, call your doctor or go to the nearest emergency room I right away. � onotrunoutofISENTRESS.GetyourISENTRESSrefilledfromyourdoctororpharmacy D 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 � troublesleeping � tiredness Less common side effects include: � weakness � depression � stomachpain � suicidalthoughtsandactions � 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. ThesearenotallthepossiblesideeffectsofISENTRESS.Formoreinformation,askyour doctor or pharmacist. Callyourdoctorformedicaladviceaboutsideeffects.YoumayreportsideeffectstoFDA at1-800-FDA-1088. How should I store ISENTRESS? Film-CoatedTablets: � toreISENTRESSFilm-CoatedTabletsatroomtemperature S between68�Fto77�F(20�Cto25�C). Chewable Tablets: � toreISENTRESSChewableTabletsatroomtemperature S between68�Fto77�F(20�Cto25�C). � Store ISENTRESS Chewable Tablets in the original package with the bottle tightly closed. � eepthedryingagent(desiccant)inthebottletoprotectfrommoisture. K 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. Formoreinformationgotowww.ISENTRESS.comorcall1-800-622-4477. What are the ingredients in ISENTRESS? ISENTRESS Film-Coated Tablets: Active ingredient: raltegravir Inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium phosphate dibasicanhydrous,hypromellose2208,poloxamer407(contains0.01%butylated hydroxytoluene as antioxidant), sodium stearyl fumarate, magnesium stearate. The film coating contains:polyvinylalcohol,titaniumdioxide,polyethyleneglycol3350,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,naturalandartificialflavors(orange,banana,andmasking that contains aspartame), crospovidone, magnesium stearate, sodium stearyl fumarate, ethylcellulose 20 cP, ammonium hydroxide, medium chain triglycerides, oleic acid, hypromellose2910/6cP,PEG400. ThisPatientInformationhasbeenapprovedbytheU.S.FoodandDrugAdministration. Distributed by: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA Revised April 2012 USPPI-T-05181204R018 Copyright�2007,2009,2011MerckSharp&DohmeCorp.,asubsidiaryofMerck & Co., Inc. All rights reserved. INFC-1038369-000005/12 U.S.PatentNos.US7,169,780 HIV TREATMENT STRATEGIES As therapies improve, how to choose what's right for you BY ROSS SLOTTEN, MD, MPH ILLUSTRATION � MICHAEL POWERS B EFORETHEMID-1990S,HIVINFECTIONWASADEATHSENTENCE. Andalmostworsethantheprognosisitselfwasthe diseasecourse:suffocationfrompneumonia,blindness, dementia,hideouspurpleskinlesionsengulfinglimbsand internalorgans,andincurablecancers,tonameafew.Nodisease thatIcanthinkofisasmercilessandmean-spiritedasHIV/AIDS. TREATMENT STRATEGY HISTORY StrategiesforthetreatmentofHIV/AIDS haveevolvedsincetheintroductionofAZT P OS I T I VELYAWARE.COM (Retrovir)inthelate1980s.AZTalonewas afailure.Atmost,itextendedlifebyonly afewmonths.DualtherapywithAZTand didanosine(ddI)orlamivudine(3TC),or stavudine(d4T)andddIor3TCwasbetter, succeedinginathirdofthosetreated;the othertwo-thirdsdied.Realprogresscame in1996,withthedevelopmentofpotent triple-drugtherapies.Inthatbanneryear, themantrabecame"hitearlyandhithard." Buthittingearlyandhittinghardhad itsdrawbacks.Someofthesideeffects-- especiallytheso-called"Crixivanbelly," buffalohump,wastingoffacialandlimb fat,and"AZTbutt"--weresoalarmingthat J U LY + AU G U ST 2 01 2 19 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. arepregnant,haveahistoryofanAIDSdefiningillness,haveHIV-relatedkidney disease,orareco-infectedwithhepatitis B.Inallfourconditions,randomized,controlledstudieshaveprovenbeyonddoubt thatthebenefitsoftherapyfaroutweigh thenegatives.Randomized,controlled trialshavealsoproventhattreatmentis beneficialforthoseindividualswithCD4 countsoflessthan350butwhodonot haveanAIDS-definingillnessandappear perfectlyhealthy. Non-randomizedorobservationaltrials alsosupporttheinitiationoftherapyin peoplewithCD4countsbetween350and 500.Suchtrialsareconsideredlessscientificallyrigorous,sincetheysometimes lackacontrolarmandarenotrandomized,potentiallyintroducingbiasintothe results.Onestudy,HIV-CAUSAL,acollaborativestudybetweenU.S.andEuropean sites,includedsome8,300antiretroviral- na�ve(thatis,untreated)patientswith initialCD4countsover500whothen experienceddropsbelow500cells.Those individualswhosetreatmentwasdelayed untiltheircountsdroppedbelow350had ahigherriskofanAIDS-definingillnessor deaththanthosewhostartedtreatment whentheircountsweregreaterthan350 butlessthan500.Anotherstudyfrom Europe,Australia,andCanada,called CASCADE,showedsimilaroutcomes.Asa result,theexpertpanelrecommendstherapyforpatientswithCD4countsbetween 350and500. TheevidenceisweakerfortheinitiationoftherapyinpeoplewithCD4counts greaterthan500,inpartbecauseitmay takeadecadeormoretoknowabout thebenefits(orharms)ofearlytreatment.Becausetrialsareongoing,arenot randomizedorcontrolled,orareobservationalonly,thepanel'srecommendation fortreatmentismoderate,ratherthan strong.Nevertheless,manyoftheexperts wouldoffertreatmenttothoseintheearliestphasesofHIVinfection.Thismakes sense--fornoothertreatableinfectious diseasedoweopttodelaytherapy.Ifyou hadsyphilis,youwouldn'twaitsixmonths P OS I T I V E LYAWAR E .CO M patientsandtheiradvocatesaskedwhy therapycouldnotbedelayeduntilabsolutelynecessary.Thoseofuswhotreated peoplewithHIVreluctantlyagreed.Asa result,untilrecently,mostHIV-infected individualsweren'tofferedtreatmentuntil theirCD4countsapproached250.Now thatwehavesimplerregimenswithfewer disturbingsideeffects,thereareonce againwhispersof"hitearly,hithard." WHAT TO DO You'renewlydiagnosedwithHIVinfection andtoldthatyourCD4countis510andyour viralloadis7,000.Whatshouldyoudo? Theprospectoftreatmentstillterrifies manypeoplewithHIV,sometimesmore thantheinfectionitself.Forsomeofus over40,thedisfigurementofbodyshape changeshasbeenadisturbingexperience,whetherforourselvesorourfriends, partners,orrelativeswhotookearlyHIV therapies.It'struethatthosepeoplewould notbealivetodaywithoutthosetherapies, buttheemotionalandphysicalcosthas beenhigh.Evenchangingtonewerregimensdoesn'treversethedisfigurement. Unfortunately,despiteextensiveresearch, thecauseremainsamysteryandthere's noeffectivesolutioninsight.Today,we canassurepeoplethatiftheynevertake AZTord4T,they'reunlikelytodevelop theso-calledlipodystrophysyndrome. Ihaven'tseenanewcaseinmorethan adecade. Moreover,nooneknowswhatkind ofsideeffectsmightoccuraftertaking antiretroviraltherapyfor30to40years ormore.Yes,that'showlongmostpeople willbetakingthesemedications,since thetreatmentofHIVissosuccessfulthat many,ifnotmostpeopleinthedeveloped worldcanexpecttolivenormallifespans, aslongastheydon'tstoptheirtherapy, ever.Andacureisunlikelysoon;maybe nonewilleverbefound.Avaccine,ifone canbedeveloped,willpreventdisease, 20 J ULY+AUGUST 2012 butit'sunlikelytohelpthosealready infected.Therearepotentialsideeffects ofanti-HIVmedications--cardiovascular disease,osteoporosis,kidneyandliver disease,evencancers.Butlet'sputthis diseaseinperspective:UntreatedHIV infectionisfatalinmorethan95%ofthose infected.Onlyrabiesismorelethal.No currentHIVtherapywilleverapproach thatkindofmortalityrate.Thefearof long-termeffects,thoughunderstandable, isnotareasontoavoidtreatment. THE GUIDELINES Nowthatweagreethatthemajorityof peoplewithHIVinfectionshouldbetreatedatsomepoint,thequestionis,when shouldwestarttherapy?Sincetheearly partofthelastdecade,apanelofexperts undertheauspicesoftheDepartmentof HealthandHumanServiceshasissueda seriesofguidelinesfortheuseofantiretroviralagentsinHIV-1infectedadultsand adolescents.Theseguidelinesarebased onthelatestscientificevidenceandthe expertopinionsofthepaneliststhemselveswhenthatevidenceisscanty. Theprimarygoaloftreatment,of course,istoreducethemorbidityand mortalityofHIVinfection.Morbidity meansthedevelopmentofdiseasesthat arebothdirectlyandindirectlyrelatedto theAIDSvirus.Diseasessuchaspneumocystispneumonia,cytomegaloviral retinitis,cryptococcalmeningitis,and cryptosporidialdiarrheaaredirectconsequencesofadvancingdisease,whenthe immunesystemissoseverelyimpaired thatusuallyharmlessorganismscause dreadfulillness.Indirectconsequences arerelatedtoT-cellactivation,CD4cell depletion,andinflammation,allofwhich increasetherisksforheartattacks, cognitiveimpairment(dementia),and everytypeofcancer.Thepanelrecommendsantiretroviraltherapyforall people,regardlessofCD4count,who 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. togetashotofpenicillin.You'dtreatitat thetimeofdiagnosis. Thispastyear,thepaneladdedasecondarygoalofantiretroviraltherapy:publichealthconsiderations.Althoughstudies longagodemonstratedthattreatingpregnantwomenpreventedperinataltransmissionofHIV,itwasnotuntilrecentlythat studiesshowedasimilarbenefitinserodiscordantcouples.Inamulti-continental trialof1,700HIV-discordantheterosexual couples,halfoftheHIV-infectedpartners wererandomizedtoreceiveantiretroviral treatmentimmediately,theotherhalf delayedtherapyuntiltheirCD4counts droppedto250.Allwerecounseledabout safesexpractices.Inthedelayedarm, therewere28newinfections;intheimmediatetreatmentarm,onlyoneinfection. Therewasthereforea96%reductionin rateoftransmissionfromtheHIV-positive partnertotheuninfectedone.Thepanel nowrecommendsthattheHIV-positive partnerinasero-discordantcouple, straightorgay,betreated,regardlessof CD4countorviralload.Onecanmakea caseforadvisingthetreatmentofanyHIVpositivepersonwhohasmultiplesexpartners,someofwhommaybeHIV-negative. n n n n n n Thepresenceofresistancetoone(or more)antiretroviralagent Genderandpre-treatmentCD4countif consideringViramune(nevirapine) ThepresenceofHLA-B*5701ifconsideringZiagen(abacavir)orthecoformulationEpzicom Co-receptortropismifconsidering Selzentry(maraviroc) Patientadherenceissues Pillburden Assumingthatnoneofthoseninefactorsisaconcern,thepanelrecommends oneoffourregimensbasedontheresults ofrandomized,controlledtrials: n Atripla(efavirenz/tenofovir/ emtricitabine) n BoostedReyataz(atazanavir+ ritonavir)andTruvada(tenofovir/ emtricitabine) n BoostedPrezista(darunavir+ritonavir) andTruvada n Isentress(raltegravir)andTruvada That'srelativelyeasy.Butwhatifoneor moreofthoseninefactorsareconcerns? WHICH WILL IT BE? Oncewe'vedecidedwhentotreat,we needtoknowwhattreatmenttoinitiate. Asof2012,thereare30FDAapproved antiretroviralagentsinsixdifferent classes:nucleosidereversetranscriptase inhibitors(NRTIs),non-nucleosidereverse transcriptaseinhibitors(NNRTIs),proteaseinhibitors(PIs),fusioninhibitors(FIs) CCR5antagonists,andintegraseinhibitors (INSTIs).Thedecisionofwhichcombinationofdrugstouseisbasedonatleast ninefactors: n THE OLDER CROWD It'sbeyondthescopeofthisarticleto examineeverypossiblereasonforprescribingalternativeregimenstothose recommendedabove.Theexpertpanel addressesinpainstakingdetailthepros andconsofvariousdrugcombinationsin avarietyofsettings.However,forthefirst timetheguidelinesacknowledgeareality oftheHIV/AIDSepidemicintheUnited Statesandotherdevelopedcountries: MorethanathirdofpeoplelivingwithHIV/ AIDSareolderthan50.Inanotherdecade, thatnumberwillbemorethanhalfof allcases.Mosttrialsfocusonyounger patients.Dataforolderpatients,especiallythoseinthe60-to80-year-oldage group,arelimited.Inpharmaceuticaltrials, drugdeveloperscontrolforanumberof variables,likegenderandrace,butthey don'twantpeopleintheirtrialswhotake medicationsthatmayinterferewiththe drugthey'retesting.Theirgoalistoget theirparticulardrugtomarket.Diabetics, orpeopleonbloodthinners,orthosewith kidneyandliverdisease--inshort,many elderlyindividuals--maybeexcluded fromastudybecausetheirtreatmentsor diseasestatesmaymuddytheoutcomeof thestudy. Second,thepanelistsrightlyurge healthcareproviderstotakeagood sexualhistory.Toooften,weforgetthat olderpeoplearesexuallyactive.Infact, 70%ofmenandmorethan50%ofwomen overtheageof60arestillhavingsex. Manyoftheseseniorsdon'tviewthemselvesathighriskforHIVinfection.Postmenopausalvaginaldryness,thefailure ofheterosexualcouplestouseacondom becausepregnancyisnolongeranissue, andtheavailabilityofdrugsforerectile dysfunctionallincreasetheriskofsexually transmitteddiseases. Andthird,forthoseindividualsover 50whoaretakingantiretroviralagents, it'sessentialtomonitorbone,kidney, cardiovascular,metabolic,andliverhealth. Thisistrueforyoungerpatientstoo,but co-morbidconditionsand"polypharmacy"--thatis,takingmedicationsforother diseasesaswellasHIV--aremorecommon intheover-50group. THE COST What'salsonewisthatthepanelhascompiledalistoftheAverageWholesalePrice (AWP)ofindividualantiretroviralagents andco-formulationslikeAtripla,Complera, Truvada,andEpzicom.I'mnotsurewhat purposethisservesexcepttosatisfyour curiosity.Everyoneknowsthattreating HIViscrazyexpensive.Thewholesale monthlycostofAtriplais$2,080.97;the wholesalemonthlycostofPrezista,Norvir, J U LY + AU G U ST 2 01 2 Thepresenceofcardiovasculardisease,chemicaldependency,liveror kidneydisease,psychiatricillness,or tuberculosis n Potentialadverseeffects n Potentialinteractionswithother medications P OS I T I VELYAWARE.COM 21 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. than200copies.Occasionally,afterbeing ontherapyforyears,apersonmight experiencea"blip"--thatis,arareinstance inwhichthevirusisdetectable,usuallyat verylowlevels(between76and199copies).It'snotnecessarytochangetherapy ortrytoperformresistancetestingwhena blipoccurs.Thevastmajorityofthetime, virallevelswillbeundetectableatthenext monitoringvisit. Ingeneral,apoorCD4responseto therapyisnotareasontochangeregimens.ThoseindividualswhobegintreatmentwhentheirCD4countsareverylow (under200cells)sometimesdonothave asrobustaresponsetotherapyasthose withhigherCD4countsattheinitiationof therapy.Theviralloadisthebestmeasure oftreatmentsuccess.Themainconcern aboutCD4countsremainingunder200 istheriskofopportunisticinfections,like pneumocystispneumonia,soit'snecessarytocontinueprophylaxis(prevention) againsttheseinfectionsuntilcountsriseto saferlevels. andTruvadais$2,930.25.Thedifference betweengenericlamivudineandthe brandEpivirisonly$48permonth.Most peopledon'tpayfortheirmedications anyway,althoughsomehavesubstantial co-pays,especiallythoseonmultipledrug regimens.I'mnotawarethatinsurershave botheredtolookattreatmentguidelines todeterminewhatco-payshouldbe chargedtoapatient.Inmyexperience, thecoststopatientsaregoingup,not down.Butasmoreantiretroviralagents gogeneric,perhapsthoseco-payswill godown. FINDING THE ANSWER Let'sreturntotheproblemofwhata newlydiagnosedpersonshoulddo.Iagree withmanyontheexpertpanelthatmost peoplewithHIVshouldbetreated,no matterwhattheirCD4countis.I'veseen toomanypeopledietofeelotherwise.I'm alsoconcernedabouttransmissiontoan uninfectedsexualpartner.Althoughthis imaginaryindividualhasanormalCD4 countandnotaterriblyhighviralload, he'snotanelitecontroller(thatis,he doesn'thaveanundetectableviralload withouttreatment)andhe'sunlikelytobe along-termnon-progressor(generally, someonewithanaverageviralloadless than2,000copies). Afterdoingaresistanceprofile(genotype)anddeterminingthatthisindividual didnothaveunderlyingresistancetoone ormoremedicationsinourarmament,I wouldmostlikelyofferasingletreatment regimen(Atripla)ratherthanamulti-drug regimen.That'sapersonalpreference becauseofconcernsaboutcompliance, notbecauseIfeelthattheotherregimens areinferior. Ifthisindividualwereafemaleofchildbearingage,orwaspregnantortryingto conceive,aregimencontainingSustiva (efavirenz)shouldbeavoided,especially inthefirsttrimesterwhentoxiceffects onthefetusaregreatest.Ingeneral,a 22 J ULY+AUGUST 2012 proteaseinhibitor-basedregimenhasbeen provensafer.AZT,nolongerapreferred agentformostpeople,mayevenbe consideredasoneofthecomponentsof therapybecauseofitsprovenefficacyin preventingmother-to-childtransmission. Atripla(andpossiblyComplera,though Compleraisnewandstillconsideredan alternativetothepreferredregimens) couldbeagoodchoiceforanelderly patientonmultiplemedications.Drugdruginteractionsarefewerthaninthose onboostedproteaseinhibitorregimens. However,ifthatindividualsufferedfrom underlyingkidneydisease,Iwouldnot recommendAtriplaorComplerasince theybothcontaintenofovir,whichcan exacerbatekidneydisease.Inthatcase,I mightrecommendSustivaandEpzicom (abacavirandlamivudine).Abacavir, however,mustbeusedwithcaution,especiallyinindividualswithaknownriskof cardiovasculardisease,andatestmustbe performedtoruleoutpotentialhypersensitivity(severeallergy)tothatdrug.Ah, thecomplexitiesoftreatingHIV!Havingso manychoices--andtakingsomanythings intoconsideration--canmakeone'shead spin. Onceapersonbeginsanantiretroviral regimen,heorsheneedstobemonitored periodically.Thetreatmentgoalisviral suppressiontolevelsoflessthan75or 20copies/milliliterofblood,depending ontheassayusedformonitoring.Itmay takeupto16weeksforvirallevelstofall belowdetectability,butdramaticdrops inviralloadaregenerallyseenwithin twotofourweeksofstartingtherapy. Accordingtotheexpertguidelines,aviral levelshouldbemeasurednolaterthan eightweeksafterbeginningtreatmentto preventfurtherresistancetomedications iftheresponsetotreatmentissuboptimal. Thereafter,itshouldbemeasuredevery threetofourmonths.Apersonisconsideredtohavefailedantiretroviraltherapyif hisorhervirallevelispersistentlygreater CONCLUSION Toconclude,althoughHIVisnotcurable,it'streatable.Andmorethanthat, ifstartedearly,thetreatmentisusually welltoleratedandhasfewersideeffects, especiallythenewerregimensdeveloped inthepastdecade.Selectingtheoptimal treatmentmaybetricky,dependingon theunderlyinghealthoftheHIV-positive person.Elderlypatients,pregnantwomen, peoplewithahistoryofsubstanceabuse, andthosealsoinfectedwithhepatitisBor C,ortuberculosispresentgreatchallenges toclinicians.Butnounderlyingdisease state,exceptthediagnosisofaterminalillness,shouldpreventsomeonefrombeing treated.Treatmentmeansalongerlifeand betterqualityoflife,perhapsanormallife span.Notreatment,whentreatmentis warranted,meanscertaindeath. ROSS SLOTTEN, MD, MPH,isafamilyprac- titionerinprivatepracticeinChicago.He hastreatedpeoplewithHIVfor29years. P OS I T I V E LYAWA R E .CO M CULTURE CLUB Remembering where we've been juxtapositionofnormalcyandinsanity."It wasveryimportantthatthestorybetold bysomeonewhohadlivedthroughit," saysWeismanninabonusfeatureonthe DVD,"ratherthanbetoldbysomeonewho waslearningaboutitfromtheoutside." Thefilm'seditorandco-directorBill Weber,wholivedinNewYorkandthen movedtoSanFranciscointhe1980s, notedthedifferencesbetweenactivistsin NewYork,whoworetheirblackACTUP t-shirts,andthoseinSanFrancisco,some ofwhomwouldbealittlemoredaringin theiroutfits.Herecountsaninstancewhen copsdonnedrubbergloveswhilearresting activistsduringaprotest,andtheactivists chanted,"Yourglovesdon'tmatchyour shoes,you'llseeitonthenews!" Itwasimportant,saythedirectors,that thestorybetoldinawaythatwasnottoo heavy-handedoroverwhelming,sothere aremomentsofhumorandperiodsinthe filmwhenyouareintentionallygivena breakfromtheemotionalrollercoaster. Butintheend,themovieisupliftingand inspirationalandabeautifultributetoa bygoneera.Ihighlyrecommenditnotonly tothosewholivedthroughthatperiod, butalsoforanyonewantingtolearnmore aboutwhatitwasreallylike,havingonly heardaboutitthroughfriends'storiesor newsclippings. SaysWeiss,"I'mhopingthatitempowersthoseofuswhohavelivedthrough ittorealizethatwehavebecomericher, morebeautifulpeoplebecauseofwhatwe livedthrough...andnotfeelanyshameor hesitationinsharingthatpartofourselves. Thatwecanbementors,andteachers,and examples..." "Andthatwe'resexy,too,"saysWeber, withachuckle. An award-winning documentary looks back at the arrival and impact of AIDS in San Francisco R PHOTO: RICK GERHARTER BY JEFF BERRY ECENTLY A PRESS RELEASE cameacrossmydeskpromotingthedocumentaryfilmWe Were Here,whichIhadwantedtoseeforsometime.Isatdownona Fridayafternoontoviewthefilmathome, alone.Ireallyhadnopreconceivednotions aboutthefilmotherthanthatitwasabout theearlydaysoftheAIDSepidemicinSan Francisco.Iwaswoefullyunpreparedfor theexperienceofthenext90minutes,and theeffectandholdthefilmwouldhave overmeforthenextfewweeks. Accordingtothepressrelease,"We Were Hererevisitsthebeginningof theAIDScrisisinAmericathroughthe eyesoffiveindividualswholivedinSan Franciscopriortotheepidemic.Fromtheir differentvantagepointsascaregivers, activists,researchers,friendsandlovers oftheafflicted,andpeoplewithAIDS themselves,theintervieweessharestories whicharenotonlyintenselypersonal,but illuminatethemuchlargerthemesofthat era:thepoliticalandsexualcomplexities, P OS I T I VELYAWARE.COM theterribleemotionaltoll,andtheroleof women--particularlylesbians--incaring andfightingfortheirgaybrothers." Themovietakesyoubacktoaspecifictimeandplaceinhistory,anddoes itextremelywell.Iremembermyvery firstvisittoSanFrancisco,in1983--Iwas stillquiteyoung(24)andyetsomehow seeminglyoblivioustothehorrorand devastationthattheepidemichadalready inflictedupontheinhabitantsofthegay mecca.AsPaulBonebergstatesinthe film,it'sestimatedthatby1977,10%ofthe gaymeninSanFranciscowerealready infected.Bythetimethefirstcaseswere seenin1981,20%wereinfected,andby thetimetheyhadatestforHIV(in1985), 50%wereinfected. Thisprogressionoftheepidemicinthe CitybytheBayasdepictedinthefilmis,in thewordsofArmisteadMaupin,"absolutelyelectrifying."DirectorDavidWeissman, wholivedinSanFranciscoatthetime, saysthatthemoviereflectshisownpersonalexperienceandview,throughthe WE WERE HEREisnow availableonDVDinstores,at www.amazon.com,andfor rentorpurchasethroughthe iTunesStore. J U LY + AU G U ST 2 01 2 23 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 I NTHISYEAR'SSECONDSEASONOFNBC'SHITREALITYTALENTSHOW "TheVoice,"wewereintroducedtothevibrantandeffusive JamarRogers,whosecoverofBonJovi's"It'sMyLife"was namedBestPerformanceonTheVoicebyRolling Stone magazine,whichcalledhisperformance"simplyelectrifying." PAspokewithRogersjustafewweeksafterhelostouttoJuliet Simmsinthesemi-finalsandwaseliminated. ButRogers'storydoesn'tendthere, andhehasabitofadifferenttakeon thefinaloutcomeofthecompetition.His journeyoffacingadversity,overcoming despair,andfindingredemptionandhealing,isonethatwillresonatewithmany, andcaninspireusall. 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 changing.Myexperienceontheshowhas givenmefaiththatsocietyisinagood placerightnow,whereweallcanreceive thisasastory,andmaybeinourlifetime, stigmaandprejudicewillgoaway,once andforall. Absolutely. I agree. So, tell us about yourself. You grew up in Oklahoma, right? Icompletelyrebelled.Ihadhadenough ofmyparents'rules,andIstarteddabblingindrugs,Iendeduprunning awayfromhomeattheageof17 andwasbasicallystrungoutfrom theagesof18�23oncrystal meth--wasjustpartyingallthe time,allIeverreallywanted todowasparty.OnceI decidedtoactuallyget offofmeth,acouple ofmonthslaterI foundoutIwas HIV-positive. I'vebeen offofmethfor others watching the show, too. Firstofall,Jeff,hatsoff toyou,brother.It'sjust crazyhowtheworldis I'mfrom allovertheplace,Idon't reallyhaveahometown.NewYork isthetenthstatethatI'velivedininmy lifetimebecausemyparentsmoved aroundalot.Iwasraised inavery,verystrict Christianhousehold,andwhenI turned17, sevenyearsthismonth,so IfoundoutIwaspositive about6�yearsago.Igot really,reallysick.Ihadlike 24 J ULY+AUGUST 2012 P OS I T I V E LYAWA R E .CO M CE fiveT-cells,and IhadKaposi's sarcoma,pneumonia,andthrushin mymouth.Ihadbeen gettingsickwhileIwas usingmeth,andIjust thoughtthatthemeth didn'tagreewithmy body.IcontinuedgettingsickafterIstopped usingmethandIwent totheemergency room.Whenthe doctorfirstcame inandtoldme thatIwaspositive, Idon'tknowwhat others'experiences are,Ijustknowthat atthatmoment,Ifelt thebiggestpeace washoverme.Ican't believehowatease andpeacefulIfelt. Iwasactuallyvery calm,andIsuddenly felt,I'mgoingtobealright,I'mgoingto beokay,I'mgoingtogetthroughthis. ContractingHIVwasalifechanger,obviously,butitwassort ofbetterformebecauseIsettled down.Ibegantolearnsomuch aboutmyself,andmyowndefensivebehavior,andstartedseeking counseling,andmyrelationshipwith Godflourished.IbegantoseeGodas apartner,asalovingFather,andnotas someonewhowaswaitingformetoscrew up.Thatchangedmywholeperspective onhowIviewedmyself. I'mnolongermarriednow,butthegirl Iwasmarriedtothenhelpedsavemylife. Shewenttoallmydoctor'sappointments withme,didalloftheresearchforme,and whenIfirststartedtakingAtripla,shetook careofmeforthosefirstcoupleofweeks whenIwasallwoozy.BythegraceofGod, I'vebeenundetectableforfiveyears,and I'mveryhealthy. WhenImovedtoNewYorktopursue musicfull-timeaboutthreeyearsago,Iwas notcomfortablesharingmyHIVstatus. MAKEUP: JACKIE MGIDO. JAMAR ROGERS' ASSISTANT: MICHELLE ROGERS. JAMAR ROGERS' MANAGER: SALLY COL�N. STYLIST: KENZIE CROSLEY. CLOTHING PROVIDED BY KITSON IN BEVERLY HILLS. P OS I T I VELYAWARE.COM J U LY + AU G U ST 2 01 2 25 Idecidedawhileagoto live for something greater thanmyself...Iwantedtomake animpactontheworld,and Iwantedtoreallyhelppeople. Myclosefamilyandfriendsknew,butthat wasjustahandfulofpeople.Istillcarried somuchstigmaandshame,andsomuch embarrassment.Iwasveryopenandcandidaboutmydruguseinthepast[includingduringauditionsforseasonseightand nineofAmericanIdol],butIdidn'tfeelthat IwasreadytodiscussmyHIVstatus.Over thecourseof[TheVoice]audition,Iknewit wastimetotalkaboutthis,fortworeasons. One,becauseIdecidedawhileagotolive forsomethinggreaterthanmyself--mejust beingfamousforthesakeofbeingfamous wasn'tenough.Iwantedtomakeanimpact ontheworld,andIwantedtoreallyhelp people.Two,IthoughtthatmaybeIcould usethisasawaytochangepeople'sminds, tomaybeshowpeoplethatHIVcomesin allshapes,sizes,colors,creeds,races,and maybeifIputamodern,humanfaceonit, itwouldn'tbethisthingthatwewhispered about,thatmaybewecouldtalkaboutit outloud. Honestly,Jeff,I'msogladthatIdidit. I'msogladthatIovercamethefearthatI had,becauseIcan'tevenbegintotellyou thenumberofmessagesIreceivedfrom peoplesayingI'mthefirstpersonthey've evertoldtheywereHIV-positive.And becauseIwasabletosharemystory,they nowfeelempoweredtotelltheirfamilies ortheirlovedones.Ijustfeellike,nomatterwhatplaceIgotontheshow,Iwon. Idefinitelywon,becauseIovercameso muchfear,andIreallythinkIwasonthe pathofchangingpeople'sminds. 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? Itwasaseriesofeventsthatmademe realizeIwasjustdonewithmeth.Forone thing,Iwasjustgettingmoreandmore depressedandsuicidal.ItwasonlyamatteroftimebeforeIwasjustnotgoing tobehereanymore,Ireallybelievethat. Two,noneofmyfriendswouldletmestay 26 J ULY+AUGUST 2012 withthemanymorebecauseIwasstealing fromthem,sothatwaspartofmy"rock bottom."Andthree,Iwasengagedatthe time,andeventhoughshewaspregnant [withanotherman's]child,weagreedto raisethebabytogetherasourown.The dayofthedelivery,IwentintothebathroomandshotupandIgotreallyhigh,I rememberIwassogeekedthatIcouldn't cutthebaby'scord,andthatwaskindof mya-hamoment.Irememberthinking, howareyougoingtotakecareofthis childwhenyoucan'tevencutthecord, youcan'teventakecareofyourself? TheverynextdayIsaidtomyfianc�e atthetime,let'sgetoutofAtlanta,Ireally wanttomakeachange,andshewas reallyhappy,shehadbeensosupportive ofme.SowemovedtoMilwaukeewhere mymomwas,andIdidn'tknowanyone there,andIdidn'tknowhowtogetany meth,andthatwasthebeginningofmy recovery.ItwasafewmonthsafterI madethatdecisionthatIfoundoutIwas HIV-positive.Iknowsomepeoplemight havegonebackwards,butifanything,it justkindofencouragedmetokeepdoing whatIwasdoinginmyrecovery,because Iwantedtolivemorethanever,andif methwasgoingtokillme,thenobviouslyI neededtocutthatoutofmylife. 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? Itmeanssomuch,becausewhenIran away,myrelationshipwithmymomreally suffered,andfortwoyearswhileIwas outthere,shehadnoideawhereIwas. Christmaseswentby,andshedidn'tgeta phonecallfromme.Thetruemiracleofmy recoveryisthereconciliationofmeandmy mom.Peoplelookatusandtheythink,oh, P OS I T I V E LYAWAR E .CO M good.Iwasn'treallyevennervous,Iwas moreexcitedthananything.Youhaveto understand,Ihadbeenwaiting10years toshakeCeeLo[Green's]hand,andeven ifhedidn'tturnaroundforme[andwant meonhisteam],Iwasgoingtoshakehis hand[laughs].Iwassoexcitedtojustlet himknowhowmuchhemeanttome,and howmuchhisartistrymeanttome,soI wasstoked. 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? Growingup,Iwasjustaweirdkid,you know?WhenIdidliveinOklahoma,I didn'tfitinwiththeblackkids,Ididn'tfit inwiththewhitekids.Iwasjustkindof there,andIwasintowhatpeoplewould consideraweirdtypeofmusic,andI alwaysdressedkindofweird.I'venever reallybeenthepopularguy.Ithinkatthat momentIrealizedthatpeoplelikedme, andIhadgenuinelybeenmyself,there werenosecrets,everythingwasoutthere intheopen,andpeopledidn'tcare.They likedmeinspiteofit,andthatwaswhat touchedme.Ihadsuchalowopinion ofmyselfforsomanyyearsandI'djust begunbuildingupmyself-esteemafew yearsago,sotohaveitrewardedinsuch away,itstillstrikesmeemotionallysometimes.Thatmoment,I'llneverforgetthat moment,itwasabeautifulthing. IrespectCeeLoasasongwriter,asa rapper,asasinger,Irespecteverything thathedoes,andtohearhimgiveme accolades--hell,notevenjusthim,allof thecoaches.IhadChristinaAguilera'sand MaroonFive'sfirstalbums,andtohear thesepeoplethatIlistentotellmethat theythinkI'mgreat,Imean,that'sjusta goodfeeling!That'swhyItellpeopleall thetimethatIwon.Iwonthatshow,asfar asI'mconcerned.Iwoninsomanydifferentways...yeah,Iwon[laughs]. CeeLo has been so supportive of you from the start of the show... Andthathasn'tended,ithasn'tstopped. 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'ssofunny,becauseIwasnot abigfanoftheoriginal.Ihadnevergotten intothewords.WhenCeeLofirstsuggestedthatIsingit,everyinstinctinside ofmewaslike,hellno,Iamnotsinging thatsong.Togetherwecameupwiththat renditionthateveryoneheard,andhesaid, Ijustneedyoutolistentothewords.Once Ilistenedtothewords,Iwaslikethissong issoperfect,foreverythingthatIbelieve in,everythingthatIstandfor.I'mallabout nevergivingup,I'mallaboutchasinglife, andsavoringlife,andtastinglife,insteadof justmerelytoleratinglife.I'maboutliving lifewithpassion,andI'malsoaboutbeing theexceptiontotherule,andtellingpeople don'tletsocietydictateyourpersonality, yourself-esteem,anddefinitelydon'tlet yourpastdictatethat.Ireallybelievethat songembodieseverythingthatIfeel.In fact,I'vebeeninvitedtosingalotofplaces sincemyelimination,andthat'sthesong thateveryonewantstohear. 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? Ihaveplannedondoingactivismworkfor yearsnow.Ireallywasn'tdoinghardcore J U LY + AU G U ST 2 01 2 youguysaresoclose,buttheydon'tknow thatwe'vegonetohellandbacktogether. MymomwasthefirstpersonIcalledwhen IfoundoutIwaspositive,sothatright thereshowsthatwedefinitelyrepaired whatwehadbroken.It'sabeautifulthing, it'saveryaffirmingpatontheback. 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? Iwasgladtogetitoutoftheway.We hadbeenauditioningformonthsbefore thatblindaudition,soIwaslike,I'mready todothis.Infact,Iwasactuallyrelieved tobegoingfirst,becausethatmeantI didn'thavetowaitaround,andgetin myhead.Iwentoutthere,andIjustfelt P OS I T I VELYAWARE.COM 27 Ithinkthat'llbethebestactivismIcando. I need to make music. activismworkinNewYork,Iwasjustvolunteeringatafewcommunityorganizations,butIdidhavesomeplansforthings thatIwantedtodo.NowthatIhavethis platform,Idefinitelyamattackingitwith passion.InadditiontojoiningthePOZ Army,I'llbedoingsomestuffinD.C.atthe InternationalAIDSConference. And I'll be there... Yay!Ibettergettomeetyoufacetoface! I would like that! Ijustrecordedthisamazing[CDC] campaignyesterdaythatIthinkwillbe unveilednationwide[duringtheweekof theconference],butIdon'tthinkitwould benearlyenoughformetojustgoaround givingspeeches,eventhoughthatwould help.IthinkIneedtomakemusic.Ithink that'llbethebestactivismIcando,by showing,here'sthisartistthat'srelevant today,hismusic'splayedontheradio,Isee hismusicvideos,andnoonecaresthat he'sHIV-positive.IfIcanmakeHIVnormal ormainstream,inaway,thenitbeginsto changepeople'sperspective.Ibelievethat I'vemadealittleheadway,butthere'sstill somuchworktogetdone.So,inaddition tothespeeches,andthePublicService Announcement,mynumberonegoaland focusistomakethebestmusicpossible, becauseeveryonereceivesmusic.Black, white,old,young,musiccanbeahealer,it canbeauniter,anditcandefinitelybring peopletogether.WhatI'mhopingisthat mymusicissogood,thatIwon'tbethe HIVguy,butI'lljustbethisamazingartist whohappenstohaveHIV. That's a great way of looking at it-- HIV does not define me, it's just a part of who I am. Absolutely,andmymessagetopeople whoareHIV-negativeismaybeyoucan't relatetoeveryangleofmystory,but you'vedefinitelymadebaddecisionsin 28 J ULY+AUGUST 2012 yourlife,andyouprobablyregretsomeof thechoicesyou'vemade.We'renodifferent.I'vemadesomebadchoicesandthis iswhoIamtoday.Mymessageisgetup... getup,andkeeprunning.Itdoesn'tmatterwhatyou'vebeenthrough,whetherit wasanaddiction,abadrelationship,oran eatingdisorder,whateverhashappened, whetheryouwillinglyputyourselfthere, oryouwerethereunwillingly,thereisa tomorrowthat'swaiting,sogetwithit, snapoutofit,we'vegotworktodo. 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? Ithinkthattheywantmetoperform,I havenoidea.Usually,wheneverIgive speeches,Ijustgivemyselfatheme,andI justgoupthereandwingit,anditalways worksforme[laughs].Whatpeopledon't knowaboutmeisIliketospeakasmuch asIliketosing,especiallyaboutsomethingI'mextremelypassionateabout.I'm justhonored,becauselastyearatthistime IwasjustdoingsomeworkforGod'sLove WeDeliver,andtryingtostartanAIDS outreachatmychurch,andnowIgetto actuallyspeaktotheworld...ohman,I getchillsjustthinkingaboutit,Ithink it'ssocrazy. 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? Iwasgoingtothisamazingchurchin NewYork,whichwasreallyintoalotof socialoutreaches,andIknewthatitwould kindofbewithinthechurch'smessageif P OS I T I V E LYAWA R E .CO M WhatI'mhopingisthatmymusicissogood,Iwon'tbetheHIVguy,but I'll just be this amazing artist who happens to have HIV. westartedanHIVoutreach.SoIstarted doingsomeresearchandvolunteerwork atabunchofagenciesinNewYork,andI reallyclickedwithGod'sLoveWeDeliver, soIjustcontinuedvolunteeringthere throughoutthesummerandthefall,until thingson"TheVoice"pickedupforme. Whatitdidformepersonallywasreduce myownstigmaandmyownprejudicethat wasmakingmefeelsoashamedanddirty aboutmyself.BeforeIknewit,Iwasmeetingtheseamazingpeopleandtheywere openingmyeyestosomanythings,andI waslearningsomuch,andInowseethe handofGodthroughoutitall.Becauseif Ihadn'tbeendoingthatvolunteerwork,I don'tknowifIwouldhavebeenreadyand willingtotalkaboutiton"TheVoice." SonowIhavesomeplanstostart someorganizationsofmyown.Iamall aboutpreventativemeasuresandteaching youngerpeoplethefactssothatthey're knowledgeable,butmypassionreallylies withhelpingpeoplethatarelivingwith HIV.Whatarewedoingwhensomeone hasjustfoundoutthey'repositive?I'm aboutdealingwiththepsychologyof thematter--let'streatwhatthisisreally about,let'sgetthemsomecounseling, let'shelpthemgettheirGED,somejob trainingskills.Ijustknowtheprograms thathelpedmewhenIfirstmovedtoNew York,andIwanttodothat.Thisapproach isfromaholisticstandpoint,andfroma spiritualstandpoint.Let'sseeifwecan equipsomemoresoldierstogooutthere, andgetridofthisstigmaandprejudice. Noonepersoncandoit,it'sgoingtotake alargenumberofusbandingtogether, andsaying,thisiswhatitis,butwe'renot goingtoliedownanddie.We'regoingto actuallyshowpeoplethatwe'rehere,and wehavesomethingtolivefor,andwehave somethingtosay. 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,Iloveit!Youhavetounderstand, I'vemadetheseguardrails,whicharemy ownpersonalboundariesthatI'vesetfor myself.WhatImeanis,Iknowwhatmy visionis,andIdon'tlikethetermcelebrity, butI'membracingitifitmeansIcanuse mycelebrityforgood.SowhatI'vedone isdefinewhatcelebritymeanstome.If therearerequestsformyappearances, orforinterviews,andithasnothingtodo withwhatfitsinwithmyownpersonal goalsorboundaries,thenIjustsaynoto thosekindsofthings.Ihaveaveryclear andconcisemessagerightnow,andI don'twanttogetoffmessage.Sono,it's notdifficultatall--obviouslyI'mgoingto talktoPOSITIVELY AWARE,becausethat goesalongwithmymessage[bothlaugh]. 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? ThatI'maprettyprolificwriter.Yeah, that'swhyIthinkit'sreallyfunnythatthe nightbeforeIgoteliminated,CeeLosaid thatifIweretowriteabookaboutmylife, itwouldbeabestseller.Iactuallyhave planstowriteseveralbooks. So what's ahead for you? Besidestheactivismwork,I'mstillinL.A., andI'vebeeninthestudioalmostevery dayrecording,andI'vebeeninsometalks withsomepeople,Idon'tknowifI'mat libertytosaywhojustyet.Theshowhas helpedmeinawaythat...ithasbasically fast-trackedme,andI'mjustsogratefulfor it,Iamsogratefulfor"TheVoice." GO TO WWW.POSITIVELYAWARE.COM/JAMARTO 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 29 COMPLERA (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) is a prescription medicine used as a complete single-tablet regimen to treat HIV-1 in adults who have never taken HIV medicines before. COMPLERA does not cure HIV or AIDS or help prevent passing HIV to others. The one for me Patient model. Pill shown is not actual size. INDICATION COMPLERA� (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg) is a prescription HIV medicine that contains 3 medicines, EMTRIVA� (emtricitabine), EDURANTTM (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 (EdurantTM) � 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.* 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: � 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 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 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 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 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?" 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 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. 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). 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 (EDURANTTM) 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. � 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 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. PrEP'ing Are you ready? Doctors and advocates are gearing up to bring Truvada PrEP to people at greatest risk of infection BY ENID V�ZQUEZ L OVEITORHATEIT,IT'S coming:HIVprevention withtheuseofonepill, takenonceaday. InMay,theuseoftheHIVdrugTruvada byHIV-negativepeopletopreventinfectionwiththeviruswasrecommendedfor FDAapprovalbytheagency'sAntiviral DrugsAdvisoryCommittee(AVDAC). "TodayisanexcitingdayforHIV prevention,"saidKennethH.Mayer,MD, MedicalResearchDirectorandCo-Chair ofTheFenwayInstituteatFenwayHealth inBoston,abouttherecommendation. "Although[Truvada]forPrEP[pre-exposureprophylaxis,orprevention]isnota panacea,thisapproachcanpreventmany newinfectionsandcoulddramatically impactHIVtransmissionworldwide." Butforallofitspromise,andallofits advocates,HIVpreventionwithTruvada hassomeconcernedthatitcouldbeused incorrectly,creatinganewsetofpotentiallyseriousproblems. ManyalsoworrythatpeopleonPrEP maystopusingcondomsorincreasetheir 34 J ULY+AUGUST 2012 riskinotherways,suchashavingsexwith morepartners.Doingsomaynegatethe goodthatPrEPcando. Aswell-intentionedasthesepeople maybe,theymaybeoverlookingproblemswithcondomsandHIVtreatment, bothofwhichifusedandusedcorrectly, arehighlyeffectiveinpreventingHIV transmission.Yetfewcomeoutagainst condomsorHIVtherapybecauseoftheir potentialformisuseandharm. Evensexwithcondomscanberisky, andthepromiseofpreventionforpartners withHIVtreatmentisoftenunfulfilled duetolackofaccess--theCentersfor DiseaseControlandPrevention(CDC) estimatesthatonlyoneinthreepeople withHIVintheU.S.havecontrolled,or "undetectable,"virus,andfurther,thatone infivedon'tevenknowthey'reinfected. PeoplewithHIVmayalsochoosenotto beonantiviraltherapyforanynumberof reasons,andsoremainmoreinfectious totheirsexualpartnersthaniftheywere ontreatment,especiallyintheabsence ofcondoms.Nevermindthatthosewith undetectablevirusintheirbloodmaystill beinfectious. AT RISK Theweekthattheadvisorycommittee madeitsdecision,ayoungmaninChicago struggledwiththesymptomsofseroconverting,includingnausea,diarrhea,and nightsweats,afterhavingthreeepisodes ofunprotectedsexwithapresumablyHIVnegativemaninanothercity. Chrishadchattedwiththismanfor monthsovertheInternet,butitwasn't untilaftertheyhadsexthathetoldChris, "Youknow,therearesomepeopleout therewhosaythatthey'reHIV-negative butthey'repositiveandthey'respreading thevirus.Myex-boyfriendinL.A.isoneof thoseguys." "Heevenhadawordforit,`pozzing.'I neverheardofthat,"saidChris. WouldtakingTruvadaeverydayhave helpedChris,whowasnowinastateof panic? "Idefinitelywouldbesomebodywho wouldtakesomethinglikethat,"saidChris. "Itsoundsalmostlikeamiracledrug, especiallyafterallI'vebeenthroughwith myfriends,watchingsomeofthemget infectedandsomeofthemdie.Ithinkthe drugisexciting." P OS I T I V E LYAWA R E .CO M PHOTO: JOSHUA THORNE WHEN SAFER SEX ISN'T WhenMark(nothisrealname)worked inHIVservicesinChicagomorethana decadeago,heheardfromseveralgay menthattheywereinfectedwhentheir sexpartnertookhiscondomoffwhile theywerehavingsex,usuallywithouttheir knowledge.Hebeganspreadingtheword aboutthisdangerinhisoutreachand heardbackfrommanymenwhotoldhim, "That'smystory." "Iwouldalwaystellpeopletoreach aroundandfeeltoseethatthecondom wasstillon,"saidMark."Peoplewere shocked."Heremembersmostdistinctlya handsomeyoungmanwhostoodupduringoneofhistalksandtearfullythanked him."Hewasangryathisinfector,"said Mark,"butIrememberevenmorehis angerandhurtatfriendswhodidn't believethatthishadhappenedtohim." Insomecases,gaymenwhowere "tops,"orinsertiveanalsexpartners, thoughttheywerevirtuallyrisk-free.But whiletheywereatlowerriskthanthe "bottom"(receptive)partner,manyof thembecameinfectednonetheless. He'salsohauntedbytheexperienceof P OS I T I VELYAWARE.COM testingtwoyoungmenwhowereacouple. ThefirstboyfriendtestedHIV-negative, butthesecondonetestedpositive."Right infrontofmeoutinthelobby,hesaid, `I'mnegative,let'sgohome.'Andthere wasnothingIcoulddoaboutit.Theyhad tosendmehomethatdaybecauseIwas goingoutofmymind." Afterwardshemadeitapointtotell peopletoasktobeinthesameroomwhen theirpartnergetsanHIVtestresult,and thatit'saredflagifthepersonrefuses. LikeChrisandmanyothergaymen, Markstruggledwiththedeceptionpracticed ontheInternet."Idon'tknowhowmany timesguystoldme,`OhmyGod,you'rethe firstpersontotellmeyou'repositive'or `You'rethefirstpersonI'vemetwho'spositive.'No,I'mjustprobablythefirstguywho washonest.Others[whowereHIV-positive] eitherlieortheydon'tknowthey'repositive. Ifyouputyourlifeandyourcareinsomeoneelse'shandsbasedontheirword,you're puttingyourselfatrisk."Evengaymenwho thoughttheywereinsafe,monogamous relationshipsbecameinfectedbythepartnertheytrusted,hesaid. MarksaysthatifPrEPprotectsoneor twopeople,it'sworthit."I'montheside ofusingalltheoptionswecanget." Todayonce-dailypreventionwithTruvada isanoptionthatcanbeaddedtocondom usewithanoff-labelprescriptionandis alreadyavailable,evenwithoutofficial FDAapproval. "Iabsolutelywouldhavetakenit,even thoughIalwaysplayedsafe.Youneverknow whensomethinglikethatisgoingtohappen. Youdoeverythingyoucantopreventitand thenyoumakeonemistakeanditchanges yourlifeforever.Itsucks,"saidVince.He sayshewouldtakeTruvadaPrEPtodayina heartbeat,ifhewasstillHIV-negativeandat risk,knowingwhatheknowsnow. "Havingbeenthroughthat[first]experience,itwouldhavehelpedwhenIgot infected,"Vincesaid. RISK PERCEPTION Realizingthatyoumaybeatrisk,however,isoneofthehurdlesforPrEPusage. Surveysofpeopleathighriskofbecoming HIV-positivehaverepeatedlyfoundthat manyreporttheywereatlowornoriskof infection,butaftertesting,manywerein factalreadypositive. Thiswasraisedasoneofthepossible reasonsforthedisappointingresults ofTruvadaPrEPinwomenintheFEMPrEPstudy.Thewomenwhobecame infected(anequalnumberinboththe placebo--fakepill--andTruvadagroups) hadindicatedthattheywereatlowriskfor acquiringHIV. DidthewomengivenTruvadanottake itbecauseofthatbelief?Theirbloodwork showedlittleornoevidenceofthedrug beingintheirsystem.Largelythanksto PrEPresearch,"riskperception"isnowan importantconsiderationinprevention. Yet,thelargePartnersPrEPstudy showedthatTruvadadidprotectwomen againstHIV.SodidaCDCstudyin Botswana. Allofwhichgoestoshowthepotential valueofPrEP.Undoubtedly,sexcanbe complicated,andasthestoriesabove show,ofteneasierdonethansaid(or discussed). SEXUAL ASSAULT Eightyearsago,Vince(nothisrealname) wenthomewithamanhe'djustmet.They madeout,butVince,drunk,fellasleep. Hewokeupwiththemaninsidehim.He foughtbackandgottheguyoffhim,but therewasnocondom,whichmystified him,since"theguydidn'tknowme." Havingalwayspracticedprotectedanal sex,Vinceknowsthatthissexualassaultis howhebecameinfected. Hehadonlyhadunprotectedsex oneothertime--andhethoughtitwas protected."Iknowhehadonacondom, Ihelpedhimputiton.Butheletitcome offinsideme."Vincewonderedwhathappenedtothecondomwhenhedidn'tsee itaftersex.Thinkingbackonthatnightin abathhouse,hesaysheshouldhaveasked aboutit.(Thecondomcameoutlater whenheusedthebathroom.)Vincewaited sixmonthstotestforHIV(therecommendationatthetime)andhewasnegative. Hesayshewaslucky. Butthatwasthenandthisisnow. WHAT YOU DON'T KNOW Ironically,Chriscouldhaveusedanother medicationinterventionthat'slongbeen available,calledPEP,forpost-exposure prophylaxis.IfcertainHIVmedications aretakenfor28days,beginningwithin J U LY + AU G U ST 2 01 2 35 Truvada is not a morning-after pill as some believe. 72hoursaftersexualexposure,theycan preventinfectionfromtakingplace.It's somethinghedidn'tthinkaboutbecause hewasn'tawareofit. Researchershavewrittenaboutthe lackofawarenessamonggaymenofthe availabilityofbothPEPandPrEP.When thereisawareness,itsometimesgoes alongwithmisunderstandingordownright misinformation.Truvadaisnot,forexample,amorning-afterpillassomebelieve. IfTruvadaisapprovedforuseinHIVnegativeindividuals,thelackofawarenessarounditspreventionpowershould changedrastically,witheducationbecomingpossiblebyitsmanufacturer,clinics, andcommunityorganizations. StrogerHospitalofCookCounty,the ChicagositefortheAdolescentTrials Network(ATN)forHIV/AIDSInterventions. "Weknowthatadolescenceisarisky time,"saidHosek."There'salotofimpulsivityandalotofbehaviorchanges--hormonal,psychological,andemotional--that putpeopleinvulnerablepositionswhen itcomestoHIV.AndsowefeelthatPrEP maybeagreatoptionduringthatmaturationperiod." TheATNpointstoCDCstatisticsshowingthatamongadolescentsandyoung adults(ages13to25),theestimatedpercentageofHIVinfectionsresultingfrom male-to-malecontactincreasedfrom57% in2005to68%in2008,whileinfections resultingfromheterosexualcontactor injectiondrugusedecreased.Forblack youth,however,theincreasewas73%in thattimeperiod. ATN'sProjectPrEParehastwostudies lookingatPrEPeffectivenessnowthat itsinitialresearchhasshownthatyouth wouldacceptandusePrEP(feasibility). Thesetwostudiesarescheduledtoenroll 300youthatthenetwork's14sitesacross thecountry,includingChicago.Visitwww. projectpare.net. LikeotherPrEPresearch,Project PrEPareprovidescondomsandcounseling alongwithmedication. Astotheargumentthatmoneyshould beusedfortreatmentofactualHIV infectionratherthanprevention,Hosek saidthey'rebothpartofthesamepackage,withPrEPexpectedtoincreaseHIV testinglevelsandawarenessofpreviouslyunknowninfectionwiththeneedfor accesstotreatment.Moreover,shesaidit wouldhelpproviderstalktotheirpatients aboutgettingHIV-positivepartnersinto careandtreatment.Likemanyadvocates, shealsopointstothefactthatTruvada PrEP--especiallyforshort-termuse--costs lessthanalifetimeofHIVtherapy. "Ithinkitwouldhelppeopletoremembertheirownyouth,"saidHosek."It'sa timeofexploration.It'satimeofemotional energyandrisktaking,ofcognitivedevelopment.Theirbrainsarematuring.Pleasure oftentakesprecedenceoverplanning. P OS I T I V E LYAWAR E .CO M TO BE YOUNG "WeseePrEPforyouthnotasalifelong medicationbutasastopgapmeasure," saidpsychologistSybilHosek,PhD,of What you should know before PrEP n n n n n n n n n n n You need to test HIV-negative beforegoingonPrEP(pre-exposure prophylaxisorprevention). Thismayrequiremultiple testing (forexample,testingHIV-negative threemonthsinarow). Youmustalsobetested for hepatitis BbeforegettingTruvada. Your kidney functionandserum phosphoruslevels(forevidence ofboneweakness)shouldbe measured. It takes about three doses(three days)forTruvadatoreachadequate levelsinyourbodyforprotection againstHIV. Adherence,ortakingPrEPcorrectly anddaily,isrequired. PrEPmustbemonitored with continued testingforHIVandother sexuallytransmittedinfectionsand reviewofanysideeffectsthatmay occur. Monitoring may be requiredevery threeorfourmonths. Side effect monitoringincludes laboratorytests(blooddraws)for potentialkidneytoxicity. It'swidelybelievedthatPrEP should include the use of condomsandbehavioralmodification (findingwaystolessentheriskof infection). Itispossiblethatnot using condoms along with PrEP may allow for the n n n n riskofinfection,possiblynegating theeffectsofPrEPaltogether. Other serious infections can occur withoutacondomandareepidemic inthegaycommunity:hepatitisC, syphilis,andgonorrhea.(Remember thatgonorrheaisalsospread throughoralsex.) PeoplewhobecomeHIV-positive whileonTruvadaPrEPrisk the development of drug resistance.In studies,theonlyriskofdrugresistanceseenwasinindividualswho werealreadypositiveatthetimeof startingPrEPbutdidn'tknowitor peoplewhowereinfectedwithan alreadydrug-resistantstrainofHIV. Healthcareprovidersmightconsider supplementing vitamin D and calciuminPrEPpatients.Some patientsmayalsobenefitfrom DEXAbonescansbeforeandduring treatment. Research continues to investigate the best usesofPrEP,suchasthe possibilityoflessthandailyusage andtheuseofothermedications besidesTruvada.Otherbiological preventionmethodssuchasmicrobicidesarealsobeingstudied. READ THE CDC'S INTERIM GUIDELINES: www.cdc.gov/mmwr/preview/ mmwrhtml/mm6003a1.htm?s_ cid=mm6003a1_w. 36 J ULY+AUGUST 2012 PrEP could be the `game changer' needed to more effectively fight HIV. Saying`justuseacondom'isnotworking. "Notthatcondomsaren'tagreat option,"shecontinued,"butsomepeople justaren'tgoingtousethem.SoIthinkthe moreoptionswehaveforyouth,thebetter." AssistanceProgramandcutstoMedicaid thatarebecomingmorecommoninthe states,moreandmorepeoplemayfind themselveswithoutaccesstotreatment, letaloneprevention.Thereisfreeaccess toTruvadaPrEPthroughtheiPrExstudy whichhasexpanded(iPrExOLE)with threeU.S.sites(Chicago,Boston,and SanFrancisco).Theremayalsobepatient assistanceorco-payassistanceprograms availableifPrEPisFDAapproved. Earlier,inAugustof2011,sixorganizationsfromaroundthecountrydevoted toHIV/AIDSworkandservices(theAIDS FoundationofChicago,AVAC,theBlack AIDSInstitute,theNationalMinorityAIDS Council,ProjectInform,andtheSan FranciscoAIDSFoundation)urgedthe DepartmentofHealth&HumanServices (DHHS)toestablishso-called"demonstrationprojects"toexaminePrEPeffectivenessoutintherealworld,especiallyamong thehardest-hitMSMofcolor.Ayearlater, fewdemonstrationprojectsareunderway. SAN FRANCISCO JOINS MIAMI SanFranciscoandMiami,twocitiesthat havetraditionallyhadsomeofthehighestratesofHIVinfectioninthecountry, haveteamedupforaPrEPdemonstration projectfundedbytheNationalInstitutes ofHealth(NIH). StephanieCohen,MD,MPH,medical directoroftheCityClinicforsexually transmittedinfections(STIs)fortheSan FranciscoDepartmentofPublicHealth, saidindividualsaccessingcarefromthe clinicwhoareatriskofHIVinfectionwill beofferedTruvadaPrEP.Inaddition,the Magnetgaymen'shealthclinicinthe Castrowillrefermentotheprogram. "WearelookingatuptakeinPrEP-- who'sinterestedinit,who'snot,andwhy," saidCohen."Weplantodevelopmarketingandeducationmessagesfromwhat welearninour,andother,demonstration projects." Thegoalistoenroll300MSMin SanFranciscoand200inMiami.A TURNING THE TIDE InFebruary,Boston'sFenwayInstitute issueda59-pagereportinwhichitstated that,basedoninitialstudyresults,"PrEP couldbethe`gamechanger'neededto moreeffectivelyfightHIV."Theinstitute,one oftwoU.S.sitesinvolvediniPrEx,urgedthe FDAtoapproveTruvadaPrEP.Itcontinues toconductPrEPresearchthroughHPTN069 (NEXTPrEP),andisalsoinvolvedinHPTN 061(theBROTHERSstudy),amultiplecomponentinterventionforblackMSM. HPTN(HIVPreventionTrialsNetwork) hailedtheTruvadaPrEPdecisionas"a milestoneforHIVprevention"andawebinarannouncementreferredtoPrEPas"a bridgetotheendofAIDS." WithflatfundingfortheAIDSDrug ARE YOU AWARE? GET POSITIVELY AWARE. 1-year subscription: $30 donation. Bulk copies (U.S. only): Bill to: CARD NUMBER NAME ON CARD SIGNATURE (REQUIRED) EXPIRES Six bi-monthly issues every year. Subscriptions are mailed freeof chargewithintheU.S.tothosewhoareHIV-positive. Available free of charge; however, a donation is requested to cover shipping. No international bulk orders. Minimum order 10 copies, shipped via UPS (No P.O. Box addresses): ______ copies Back issues: $3 per copy. Enclosed is my payment. ______copies: May+June2012 ______copies: March+April2012(HIVDrugGuide) ______copies: January+February2012 ______copies: November+December2011 ______copies: September+October2011 CHARGE MY: Visa MasterCard American Express TOTAL AMOUNT: $___________ Charges will appear on your credit card statement as TPA Network. Test Positive Aware Network (TPAN)isanot-for-profitorganizationdedicatedtoproviding supportandinformationtoallpeopleaffectedbyHIV. Ship to: NAME AGENCY (IF APPLICABLE) Sign me up for the E-News, PA'sweeklyemailnewsletter: EMAIL ADDRESS ADDRESS CITY STATE ZIP PHOTO: Enclosed is my donation of $25 $50 $100 $250 $500 $_______ PHONE E-MAIL Your contribution helps providesubscriptionstopeoplewhocan't affordthem.Alldonationsaretax-deductibletothefullextentallowed bylaw. MAIL TO: POSITIVELY AWARE 5537 N. BROADWAY ST. CHICAGO, IL 60640 "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." demonstrationprojectisalsointhe worksforNewYorkCity,shesaid. "Doesitwork?Yes,weknowitdoes, buthowdowegetitoutthere?"said Cohen. TheCaliforniaHIV/AIDSResearch Program(CHRP)oftheUniversityof CaliforniaisalsoconductingaPrEP demonstrationproject,incitiesthroughoutthestate(includingOakland,San Diego,andLongBeach),focusing onhigh-riskMSMofcolor"wholack resourcesfortestingandcounseling." Theprogramwillalsolookattheuseof TLC+(testingandlinkagetocareplus treatment)inmenwhobecomeinfected. "It'sanhistoricmomentinHIVprevention,"saidCohen,"andthere'salot ofworktobedoneinlearninghowto usethisnewpreventiontool." saidKeglovitz."It'sabigmilestonefor prevention." Shesaidthestrategyis"obviously notforeverybody,"andnotareplacementforcondoms."Preventionmessageswillbecrucial,"shesaid. WHAT NOW? TheFDAadvisorycommitteerecommendedthatPrEPbeapprovedforthree specificriskgroups--menwhohavesex withmen,HIV-negativepartnersofHIVpositivepeople,andothersathighrisk ofacquiringHIVthroughsex.Itnoted that"regularHIVtesting,adherence,and behavioralcounselingonsafersexpractices,includingcondomuse,areessentialcomponentsofhealthcaredelivery aroundPrEP." Alladvocatesarebeatingthedrum forusingcondomsalongwithPrEP. WhetherPrEPusersoutintherealworld doornotremainstobeseen. ButwithalltheunknownssurroundingPrEP,thereisperhapsonetrue take-homemessagefromstudiesand advocatesalike:PrEPdoesn'tworkifyou don'ttakeit. SittingontheFDAadvisorycommitteeandvotingtorecommendTruvada PrEPforapproval,communityrepresentativeDanielRaymondoftheHarm ReductionCoalitioninNewYorkCityeloquentlyremindedeveryonethat,"Thisis the25thanniversaryoftheAIDSCoalition toUnleashPower[ACTUP]andpartof thelegacyofthatmovementisempoweringpatientsaboutlearningandmastering thescienceandsharingitwithinour respectivecommunities.IthinkthatPrEP givesustheopportunitytodothatall overagain...justasresponsiblyaswe've beentryingtodoforthelast25years." Clearly,communityawarenessisas crucialasever. SPECIAL THANKS TO DR. JOEL GALLANT ofJohnsHopkinsUniversity CHICAGO InChicago,HowardBrownHealthCenter (HBHC),whichservestheLGBT(lesbian, gay,bisexual,andtransgender)community,doesnothaveademonstration projectperse.Rather,thecenteris makingPrEPpartofitsprimarycare services.Ithascreatedaprotocolfor stafftrainingsothateveryonecanbe onthesamepageaboutwhomakesa goodcandidateforPrEP,saidKristin Keglovitz,PA,HBHC'smedicaldirector. Shesaidtheclinic'sPrEPprotocolwillbe amultidisciplinarymodelinvolvingthe servicesofcounselorsinadditiontoprescribers.HBHChasalreadyprescribed PrEPandevenparticipatedintheiPrEx study,shesaid. LastyearsheprescribedPEPtwice toawomanwithanHIV-positivepartner beforetellingthepatientshemightbe betteroffonPrEP.It'sastrategythat's backedbyresearchshowingthatpeople takingmultiplecoursesofPEPoftengo ontobecomeinfected,becausetheyare atcontinuingriskforthevirus. "Asanorganization,andformyselfas aprovider,wedefinitelysupportPrEP," 38 J ULY+AUGUST 2012 LEATHER, They're actually not as risky W ADULT FILMS BY ENID V�ZQUEZ HILEHIVPRE- ventioninthe U.S.focuses onmenwho havesexwithmen(MSM),it's clearthatanyonecanpickupHIV. Hence,precautionsaretaken incertaincommunitiesthat revolvearoundsexualactivity. forreviewingthisarticleandsidebar. OnJanuary17,2012,LosAngelesMayor AntonioVillaraigosasignedanordinance statingthatadultfilmactorsworking withinLosAngelesmustwearcondoms. California'soccupationalsafetyandhealth P OS I T I V E LYAWA R E .CO M PORN, AND KINK as you might think agencyalreadyhasrulesstatingthatporn performersmustwearcondomsduring filming. "Since2004,nobodyhascontracted HIVonset,"saysDianeDuke,executive directoroftheFreeSpeechCoalition (FSC),locatedinsouthernCalifornia.FSC overseeshealthandsafetyservicesfor theadultfilmindustry.Dukesaidthereare approximately1,000performersfilming eachyearandthefactis,condom-free pornsellsbest. "We'vedevelopedabloodworkpathogenplanthatwebelieveisveryeffective inprotectingthehealthoftheperformers,"shesaid,"andtheysupportit." Beforefilmingbegins,performersmust haveacertificateofresultsfromarecent (thatweek)PCRRNA(HIVviralload)test, P OS I T I VELYAWARE.COM PHOTO � FERRAN TRAITE SOLER Thatdoesn'tmeansomebodygetspenetrated.Itusuallymeanssomebodygets markedup[whipped,flogged,etc.]." Hesaidhewas"veryimpressed" withtheevidenceofsafersexhesawin MayattheClevelandLeatherAwareness Weekend(CLAW).Ontheotherhand,he's heardthephrase"ifyou'reundetectable, you'reuncatchable." "I'msorry,butundetectablemeans 50copies[ofHIVpermLofblood].That couldmeantherewerestill49.You'restill atrisk,"hesaid.Hepointstootherinfections,likegonorrheaandsyphilis,thatcan beacquiredwhennotusingacondomand arerampantinthegaymalecommunity. Hesaidthere'salsosomeknowledgeof TruvadaPrEP,butmisinformationaround it,too.Heoverheardoneyoungmanat CLAWsayhehadjustgonethroughall ofhiscondoms,"butI'vegotTruvada upstairs,soI'mokay." "Isaidno,no,no,"saidSirBear."Igave himmorecondomsandhekissedmeon thecheekandsaid,`Thankyoufortaking careofme.'" KINK Likeleathergroups,communitiesformed aroundsexualkinksdonotnecessarily involvesexualintercourse. Bruce,presidentofLeatherSINSinthe Chicagoarea,says,"Thesexualactisonly about25%ofwhatwedo.Sexisrarelya partoffantasyandfetish." Intermsofsafety,Brucesays,"Since wedealinriskallthetimeandsincesafety issuchanimportantpartofwhatwedo, withallthephysiologicalstuffthatcan happen,STIs[sexuallytransmittedinfections]are,forsomepeople,justanotherof themanyrisks." Perhapsthegreatestpromotionof safersexandplaycomesthroughwhatis explicitlydiscussedduringa"negotiation" beforeengaginginactivity. "Partofitfocusesonphysicalhealth-- anyphysicalconditionorinjurythatcould beexacerbated.Sodiscussionofbloodbornepathogenscomeseasilytous," saidBruce. SirBearsaidthatintwoyearsof freeHIVtestingatKinkyKollege,runby LeatherSINS,nearlyeverypersonatthe eventwastested. NotonewasHIV-positive. J U LY + AU G U ST 2 01 2 whichcanfindactualHIVintheblood within9to11daysafterexposure.They mustalsotestmonthlyforgonorrheaand Chlamydia,andyearlyforsyphilis. TheLosAngelesCountyDepartment ofPublicHealthreportedin2010thatfour casesofHIVhaveoccurredsince2004in thepornindustryduringproduction.Duke pointstoarecentLosAngelesCounty reportlookingatHIVriskfactorsandhow tomanagethem.Notonceinthe162-page reportdoesitrefertotheindustry. LEATHER Theleathercommunity,whichfocuseson S/Msexuality,doesnotnecessarilyrevolve aroundsexualintercourse. GregoryBearAbbott,agayleatherman formorethan20years,says,"Weplay. 39 www.egrifta.com Actual patient living with HIV since 2000 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 rst 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 YOU'VE WORKED TO CONTROL YOUR HIV. NOW, TIME TO WORK ON YOUR � 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. 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 Ask your healthcare provider if EGRIFTA�, the rst 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 � 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 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 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 Dancers' Fund and Chicago Women'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: Sponsors: Media Sponsors: BestGayChicago.com, Chicago Magazine, ChicagoPride.com, SeeChicagoDance.com, GRAB Magazine, PINK Magazine, Positively Aware Magazine, Viral PR Agency Dancer: Lizzie MacKenzie - Photography: Sandro - Design: Rutger Thiellier & Brian Jones ASK THE HIV SPECIALIST HELEN C. KOENIG, MD, MPH How safe is safe? Q: SEARCH FOR AN HIV SPECIALISTTM I AM IN A RELATIONSHIP WITH AN HIV-positivemanwithanundetectable viralload.Iamnegative.Werefrainfrom oralandanalsex.Lastnightwhilemasturbatingsome ofhissemengotonmyhandandIhadanopencut. Ihavenotbeenabletosleep. Sinceweareinamonogamousrelationshipandheis undetectable,shouldIgettestedregularly?Goingfor testingfreaksmeout.Ihavenotbeentestedsincethree monthsafterhisdiagnosis,whichwasthreeyearsago. Finding an HIV SpecialistTM is easy with AAHIVM's Referral Link: www.aahivm.org. Enter your ZIP code on the home page, and click on the "Go" button for a list of HIV SpecialistsTM near you. A: YOU BRING UP SEVERAL importantissuesthatshouldbe addressed.Mutualmasturbationis typicallyanexcellentwaytohave safesexwithanHIV-positivepartner,asareoralor analsexwithappropriatelyusedcondoms.Inaddition, thebestwaytopreventHIVtransmission,asshownby therecentstudyincoupleswhereoneispositiveand theotherisn't(sero-discordant),isfortheHIV-positive partnertohaveanundetectableviralloadonconsistent antiretroviraltherapy.Althoughalmostall(97%)ofthe couplesinthisstudywereheterosexual,itisstillhelpful inshowinghowdifficultitistotransmitHIVwhenthe HIV-positivepartneristakingHIVtherapy. SoistherestillariskofHIVtransmissionwhenyour partnerhasanundetectableviralloadonmedications? Theanswerisyes,sinceviralparticleshavestillbeen detectedinthesemenofmenwhohaveanundetectableviralloadintheirblood.Thisisbecausethesemen isoneoftheso-called"sanctuarysites"whereHIVcan continuetoreplicate,sincemanyoftheHIVmedications weusetodayarenotabletogetintothesemen. Thisbringsustoyourfirstquestionregardingthe riskoftransmissionofHIVfromthesemenofapartnerwithanundetectableviralloadtoyouthrough anopencutinyourhand.Theriskoftransmission throughanopencutdependsonthetypeanddepth ofyourwound:asuperficialwoundwithascabwould beextremelyunlikelytoallowHIVtransmission,while anopenwoundwithvisiblebleedingor exposeddeepertissuewouldputyouat higherrisk.Sincethisdoesn'tsoundlike ahigh-riskexposure,andyourpartner hadanundetectableviralload,theriskof infectioninyourcaseislikelyslimtonone andIdonotthinkthattakinga28-day courseofpost-exposureprophylaxisis warranted.Ifthecutwasonthedeeper sideorifyourpartner'sviralloadmayhavebeen detectable,post-exposureprophylaxismighthavebeen prudent,butitwouldhaveneededtobeadministered within72hoursofexposure. Asforyoursecondquestion:inmyexperienceasa physician,patientsoftenreportbeinginmonogamous relationshipsandthenfindoutlaterthattheirpartner wasnotbeingasmonogamousastheywere.Inaddition,yourpartnermaybelievethathisviralloadis undetectable,buthemaynotknowifhisviralload creptupsincehislastcheck-upseveralmonthsprior (althoughthechanceofthishappeningifheis100% adherenttohisantiretroviraltherapyisextremelylow). Whilethepossibilityofinfidelityisneverfuntoconsider,figuringoutyourlevelofriskisonlyasgoodasthe informationyouhave!Therefore,ingeneral,allpartners ofHIV-positiveindividualsshouldbetestedforHIVat leastannually,andthoseathigherriskofacquiringHIV (thosewithmultiplepartners,thosewhoshareneedles forIVdruguse,thosewhoseHIV-positivepartners havedetectableviralloads,etc.)shouldbetestedmore frequently.Thatsaid,mutualmasturbationasthesole formofsexualactivity,inthesettingofanundetectable viralload,confersalmostnoriskoftransmission. Insummary,youandyourpartneraretobecommendedforyoursafesexpracticesandyourpartner's excellentvirologiccontrol.Yourriskofhavingacquired HIVfromtheexposureyoudescribeisvirtuallynonexistent,butitneverhurtstogettestedforpeaceofmind, andonaregularbasisasahealthyhabit.Infact,the CDCrecommendsthatalladults,regardlessofrisk,be testedforHIVinallhealthcaresettings. 44 J ULY+AUGUST 2012 P OS I T I V E LYAWA R E .CO M SALIENT RAMBLINGS SAL IACOPELLI `It is so strange the way things turn' WE ARE CONDITIONED TO THINK OF "SUCCESS" IN TERMS OF --PeterGabriel,Don't Give Up afterschoolandI wouldrevelinlistening wealth,ofaccumulationofpropertyandobjects,orofextensive tohimspeakofhistory power.Thesearerathereasytoachievewhenbornintoaffluent onanysubject,and describemovieplots orinfluentialcircumstances.Whataboutmostoftherestofus? sowellandinthemost Ifwecompareourselvestosociety'sorsomeone exactingdetail,IfeltasifIwerethere.Inretrospect,I else'sstandardofsuccess,howcanweeverfeelsucsuspecthemighthavehadavariationofAsperger's cessful?Really,comparativelyfewbecomeextensively syndrome.Brilliant,almostanidiotsavant,withfew richorhugelyfamous.Andcertainly,domostofthose socialskills.Ofcourse,hewasteasedmercilesslyfor whoarefamousdeservesuchaccolades?Snookieof hisoddnessandhiscreativedreaminess.Hisnickname, JerseyShore?TheKardashians?Oh,wherearethedivas muchtohischagrin,was"Ancient Green."Ifounditto ofyesteryear,theGaborsistersforexample,whowere bequiteaptandsomewhatromantic.Johnwashappifamoussimplybybeingsoenchantinglyfabulous? estreadingaboutancientcultures,dreamingofwhat ConsiderhowdifferentlivingwithAIDSisfromthose itmusthavebeenliketolivewithinthem,andwriting terrifyingearlydays.IfyouwerediagnosedwithAIDSin beautifulpoetryaboutthem.Iwasdeeplyinaweand the'80s,yourlifeexpectancydwindledtotwoyears.I lovedhim--notsexually,butrather,spiritually,intellecprogressedtoAIDSin1995,yetstillwalktheearth.That tually,andemotionally. aloneisasuccess,butcertainly,itwasnotabattlewon Wedriftedapartafterhighschool.Istruggled withoutitschallenges.Beforeyoucanachievesuccess, throughself-examination,alcoholism,testingHIVdefinewhatsuccessmeanstoyou.Isitalovingpartpositive,anddebilitatingillness.Today,Iamgrateful ner?Enoughfinancialresourcestoenableyoutotravel? tohavegoodhealth,awonderfulhome,supportive Orisitgettingthroughthedaybeingadherenttoyour friends,andmanyinmyfamilywhomIholddear.Notto medicationregimen?Yoursuccessesarepersonal. mentionthebestdogintheworld. Furthermore,successdoesn'tmatterifitdoesn'tmake About10yearsago,onmywaytothebiketrack youhappyorfulfilled.Isthebillionairewhoyearnsfora alongthelake,Istoppedatatrafficlight.Astreetpermeaningfulrelationshipsuccessful? sonstoodnearmewaitingtocross.Hewasfilthy,with WhatofmyfriendPattywhowasateenagemother mattedhair,wearingatornparka.Hestooddreamily andahighschooldropoutwhoraisedherchildbrilliantlookingupatthesky.Irecognizedhimbyhiseyes, lyandwhocurrentlyownsahome,hasagreatcareer, thosesparklinggreen,flecked-with-goldwonders.It isinastrongmarriageandwhosedaughterrecently wasJohn.ItoldhimwhoIwasandaskedifherememearnedhermaster'sdegree? beredme.Hetorehimselffromhisreverie,lookedatme OrmybuddyTim,wholosthiswifeinahorriblecar andmumbled"Uh,yeah."Thetrafficlightchangedand accidentnotlongaftertheyweremarried,whohas hehurriedtocrossthestreet. dealtwiththatloss,andhasopenedhisheartonce Sincethen,Ispothimoccasionally,shufflingalong moretolove? dreamilyintheparkasItearalongonmybike.Sure,he Ormymotherwho,whendiagnosedwithemphyendedupfilthy,halfcrazy,andhomeless.Butallheever sema,immediatelyquitsmokingandtwoyearslater, wantedwastobeleftalonetodreamhisdreams. braveseachdaysolidly,armedwithoxygenandabatSowhoisthesuccess?IsheoramI? teryofmedications. Theyaresuccesses,all. Success is peace of mind, which is a direct result of selfIwenttohighschoolwithaguynamedJohnGreen. satisfaction in knowing you made the effort to become Hehadgleaminggreeneyeswithflecksofgold,thick, the best you are capable of becoming. unruly,darkbrowncurlsandwasthesmartest,most -- JOHN WOODEN creativepersonIknew.Wewouldwalkhometogether 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 | 45 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. �2012 Gilead Sciences, Inc. All rights reserved. UN13259 06/12