Will a Pill a Day Keep HIV Away?

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1 Will a Pill a Day Keep HIV Away? Sybil Hosek, PhD Department Of Psychiatry Stroger Hospital Of Cook County

2 YES! BUT ONLY IF YOU TAKE IT

3 What is PrEP? PrEP stands for Pre-Exposure Prophylaxis Prophylaxis is any method that is used to prevent, rather than treat or cure a disease For example: Using birth control pills to prevent pregnancy Getting the measles vaccine to prevent measles Brushing and flossing your teeth to prevent cavities and gum disease PrEP for HIV is the use of medicines for HIVnegative people who are at risk for HIV. So, if they are exposed to HIV, the medicines will already be in their blood and may lower the risk of becoming HIV infected.

4 Why did scientists think PrEP might work? We know that giving HIV medicines to pregnant women during labor and delivery greatly reduces the chances of passing HIV from the mother to the baby. We know that giving HIV medicines after an accidental exposure to HIV (for example: when an a health worker accidently gets stuck by a needle) decreases the risk of an adult getting HIV. We know that when HIV medicines were given to SHIV + animals, such as monkeys and mice, it greatly reduced their risk of passing on SHIV (HIV like virus found in animals). We also know that when HIV medicines were given to SHIV- monkeys, it substantially decreased their risk of becoming infected with SHIV after repeated exposure to SHIV.

5 What is the current PrEP medication? Truvada is a combination of 2 drugs: tenofovir and emtricitabine (Nucleoside Reverse Transcriptase Inhibitors) Approved by the FDA in 2004 to treat HIV+ adults and children over age 12 Approved for prevention July 16 th, 2012 To reduce the risk of sexually acquired HIV infection in adults who do not have HIV but are at high risk of becoming infected

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7 What do we know about PrEP?

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9 How well does it work? Study (location) Population # Enrolled Overall Efficacy Estimated Risk Reduction Partners PrEP (Kenya) Serodiscordant couples 4747 couples 75% 90% risk reduction with detectable drug iprex (The Americas, Africa, Thailand) TDF2 (Botswana) Fem PrEP (South Africa) VOICE (South Africa) Bangkok Tenofovir Study (Thailand) MSM and trans women Young Heterosexual men and women % 63% Young Women % Stopped for futility Young Women % (2 arms stopped for futility) Male and Female IDUs % 92% risk reduction with detectable drug 78% risk reduction excluding participants with no refills for >30 days Adherence too low to assess efficacy Adherence too low to assess efficacy 74% risk reduction with detectable drug

10 Relative efficacy of HIV prevention strategies Study HPTN 052 (ARV treatment as prevention) 1 iprex (FTC/TDF) in MSM 1 Subjects with detectable drug levels 2 Reduction in HIV Transmission 96% 44% 94% Partners PrEP (FTC/TDF) in discordant couples 1 Subjects with detectable drug levels 3 Condoms in heterosexuals 4 TDF2 (FTC/TDF) in men & women 1 Medical male circumcision 1 75% 90% Condoms in US MSM 5 80% 70% 62% 54% STD treatment 1 42% CAPRISA 004 (1% TFV vaginal gel) in women 1 FEM-PrEP (FTC/TDF) in women 6, VOICE (FTC/TDF, TDF, TFV vaginal gel) in women 7, HIV vaccine (RV144) 1 1. Adapted from Abdool Karim S and QA. Lancet 2011;S : Amico R, et al. IAC Washington DC. #TUPE Baeten J, et al. NEJM 2012;367: Weller S, et al. Cochrane Database Syst Rev 2002:CD Efficacy (%) 39% Not Significant 5. Smith DK, et al. CROI 2013; Atlanta, GA. Oral #32 6. van Damme L, et al. NEJM 2012;367: Marrazzo JM, et al. CROI 2013; Atlanta, GA. Oral #26LB

11 Is PrEP safe? Because PrEP medicines are the same as those being used for people with HIV, a lot of information about their safety is already available. Across all PrEP studies, there have been no serious safety problems There appears to be a general start-up syndrome that includes nausea, diarrhea, abdominal pain and headaches. Safety concerns tied to Truvada have to do with its effect on the bones and kidneys.

12 Drug Resistance ARV drug resistance has been seen in PrEP trials, but only among those with undetected infection at the time of enrollment

13 Is there Sexual Disinhibition with PrEP? None of the PrEP trials to date have shown increases in sexual risk behavior among participants On the contrary, most studies have shown a decline in sexual risk based on both self-report increases in condom use or decreased number of partners Declines in incident STIs from baseline

14 What about PrEP Adherence? Adherence has been a significant focus in all PrEP trials and low adherence has impacted efficacy Discrepancies between self-reported adherence (even pill counts) and detectable drug levels have been significant Study Adherence Adherence estimated by drug detection Partners PrEP 92% (pill count) 82% iprex TDF2 Fem PrEP VOICE ~90% (pill count) 95% (self-report) 84% (pill count) 94% (self-report) 88% (pill count) 95% (self-report) 89% (pill count) 90% (self-report) 51% 80% ~35% 25-30%

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16 For Prescribers: You must confirm a negative HIV-1 test immediately prior to initiating TRUVADA for a PrEP indication. If clinical signs or symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected, delay starting PrEP for at least 1 month and reconfirm HIV-1 status or use a test approved by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection Screen for HIV-1 infection at least once every 3 months while taking TRUVADA for PrEP. If symptoms consistent with acute HIV-1 infection develop following a potential exposure event, PrEP should be discontinued until negative infection status is confirmed using a test approved by the FDA as an aid in the diagnosis of HIV-1, including acute or primary HIV-1 infection TRUVADA for a PrEP indication is contraindicated in individuals with unknown or HIV-1 positive status

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18 What are we still learning about PrEP? How and when will PrEP be implemented? Who will prescribe it? How much will it cost? Who will pay for it? Who will have access to it? What s the minimum number of days people can take it and still be protected? Will PrEP be safe in real world? Who s going to monitor it? How will people adhere to PrEP now that efficacy is known?

19 Demonstration Projects: Common Elements Acceptability, uptake Safety Adherence Risk practices Deliverability Best practices Cost effectiveness

20 PrEP Demonstration Projects Study (Sponsor) Population # enrolling Sites Estimated start iprex OLE (NIAID) MSM and Trans Women 1770 All previous iprex sites Closed to enrollment iprex OLE (NICHD/OAR) Young MSM from ATN Chicago Closed to enrollment NIAID MSM and trans women 500 San Francisco & Miami Enrolling now Project PrEPare (NICHD/NIMH/NIDA) Young MSM ages ATN sites Enrolling now CHAMPS (NIAID) Males and females ages Cape Town, South Africa Late 2013 HPTN 073 (NIAID/NIMH/NIDA) Black MSM 225 Los Angeles, DC, Chapel Hill Summer 2013 California HIV Research Program (CHRP) MSM and trans women 700 Los Angeles Long Beach San Diego Enrolling now

21 Project PrEPare Chicago

22 What is Project PrEPare about? How safe is PrEP use is among HIV-uninfected YMSM; What is the acceptability, patterns of use, rates of adherence and measured levels of drug exposure when YMSM are provided PrEP and information regarding the safety and efficacy of PrEP; When YMSM are provided a behavioral intervention as well as PrEP and information regarding the safety and efficacy of PrEP what are the patterns of risk.

23 What else does Project PrEPare want to know? Is implementing an efficacious group level or a brief individual level sexual risk reduction intervention prior to the provision of PrEP acceptable and feasible; Is implementing a text messaging adherence reminder intervention for youth whose adherence is less than 80% acceptable and feasible; Are there any demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use; Are there any demographic and/or behavioral differences between youth who are interested in participating in a PrEP study versus those who are not.

24 We are now recruiting 100 HIV-uninfected YMSM ages for the younger age cohort of Project PrEPare C O N T A C T S : C H R I S T O P H E R V. B A L T H A Z A R, MA C O U N S E L I N G C O O R D I N A T O R ( ) C H R I S B A L T H A Z A Y A H O O. C O M P E D R O A. S E R R A N O R E C R U I T M E N T C O O R D I N A T O R ( ) P E D R O A L O N S O S E R R A N G M A I L. C O M

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26 Who is a good candidate for PrEP? CDC guidelines suggest individuals at high risk for acquiring HIV has HIV-1 infected partner(s), or engages in sexual activity in a high prevalence area or social network, and have one or more of the following: inconsistent or no condom use, diagnosis of sexually transmitted infections (STIs) exchange of sex for commodities (money, food, shelter or drugs), use of illicit drugs or alcohol dependence, incarceration and/or sexual partners of unknown HIV status Injects illicit drugs (currently off-label)

27 How will we pay for it? Gilead s Medication Assistance Program Affordable Care Act CountyCare Private insurance Medicaid/Medicare Other???

28 PrEP won t always be Truvada

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30 Other Web Resources RSP on FB https://www.facebook.com/projectrsp Thanks to RSP for several slides Project PrEPare Truvada as PrEP Project Inform AVAC Thanks to AVAC for several slides iprex OLE _embedded&v=i8v2ehmv7ng

31 Questions?

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