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Women and ARV-based Prevention: Challenges and Opportunities

Women and ARV-based Prevention: Challenges and Opportunities. Tim Mastro , MD, DTM&H AIDS 2014 Melbourne, Australia 24 July 2014. Women and Risk for HIV Infection. Women at risk due to complex mix of biological , behavioral, structural, cultural and social factors Varying risk

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Women and ARV-based Prevention: Challenges and Opportunities

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  1. Women and ARV-based Prevention:Challenges and Opportunities Tim Mastro, MD, DTM&H AIDS 2014 Melbourne, Australia 24 July 2014

  2. Women and Risk for HIV Infection • Women at risk due to complex mix of biological, behavioral, structural, cultural and social factors • Varying risk • Young women in Africa at particular risk • HIV incidence: 4% to 9% per year in recent studies, despite best available HIV prevention • Risk perception often low, despite high rates of HIV

  3. HIV prevalence in pregnant women in rural Vulindlela, South Africa

  4. HIV Testing and Counselling Behavioral Interventions ART – Treatment as Prevention Male circumcision Male & femalecondoms ARV PrEP COMBINATION HIV Prevention Treatmentof STIs PMTCT Clean injection equipment for people who inject drugs Blood Supply Screening Medication assisted therapy for people who use drugs Structural Interventions

  5. Approaches to Reducing HIV Transmission HIV+ HIV- Exposure to HIV INFECTED PARTNER EXPOSED PARTNER Reduce infectiousness Reduce susceptibility Reduce exposure

  6. HIV Suppression Stops Transmission 96% HPTN 052: If an HIV-infected person adheres to ART, the risk of transmitting the virus is reduced by 96% UNAIDS 2011 AIDS at 30 SMARTER , FASTER , BETTER CAMPAIGN “HPTN 052 is a game changer” Michel Sidibe, Executive Director of UNAIDS

  7. ART Coverage and HIV Incidence, KwaZulu Natal, South Africa Tanser F, Science, Feb 2013 • Africa Centre, Univ of KwaZulu Natal • Africa’s largest population-based cohort study; >16,000 HIV-negative people followed, 2004-11 • HIV incidence decline associated with increased ART coverage • Communities with 30-40% ART coverage had 38% lower HIV incidence than communities with <10% ART coverage

  8. HIV prevention, care and treatment cascade – major gaps in operational guidance All people HIV- Reached by prevention in the health sector HIV- People aware of HIV status HIV- Enrolled in HIV care on ART Viral suppression HIV+ HIV+ HIV+ HIV+ Retained Retained Referral Prevention targeting HTC demand creation Prevention opportunities for negatives Prevention opportunities for PLWHIV, care and treatment for PLWHIV

  9. Effectiveness in HIV Prevention Trials Effect size (CI) Study 31% (1, 51) Prime-Boost vaccine (Thai RV144, 2009) 39% (6, 60) 1% tenofovir gel (CAPRISA 004, 2010) 44% (15, 63) TDF/FTC oral PrEP (iPrEx, 2010) 49% (10, 72) TDF oral PrEP (CDC, IDU, 2013) 57% (42, 68) Medical male circumcision (x3) (Orange Farm, 2005; Rakai, Kisumu, 2007) TDF/FTC oral PrEP (TDF2, CDC, 2011) 63% (22, 83) TDF oral PrEP (Partners PrEP, 2011) 62% (34, 78) 73% (49, 85) TDF/FTC oral PrEP (Partners PrEP, 2011) 96% (82, 99) Immediate ART for HIV-positive partners (HPTN 052, 2011) 0% 20 40 60 80 100% Efficacy

  10. Challenges

  11. Effectiveness in HIV Prevention Trials Effect size (CI) Study 31% (1, 51) Prime-Boost vaccine (Thai RV144, 2009) 0 - 39% ( 60) 0, 1% tenofovir gel (CAPRISA 004, 2010) (VOICE, 2011) TDF/FTC oral PrEP (iPrEx, 2010) 44% (15, 63) TDF oral PrEP (CDC, IDU, 2013) 49% (10, 72) Medical male circumcision (x3) (Orange Farm, 2005; Rakai, Kisumu, 2007) 57% (42, 68) TDF/FTC oral PrEP (TDF2, CDC, 2011) 63% (22, 83) 0 - 62% (0, 78) TDF oral PrEP (Partners PrEP, 2011) (VOICE, 2011) 0 - 73% (0, 85) TDF/FTC oral PrEP (Partners PrEP, 2011) (FEM-PrEP, 2011; VOICE, 2013) 96% (82, 99) Immediate ART for HIV-positive partners (HPTN 052, 2011) 0% 20 40 60 80 100% Efficacy

  12. Effectiveness by adherence Pearson correlation = 0.86, p=0.003 Source: Salim S. Abdool Karim, personal communication

  13. Summary of PrEPTrials for Women • Tenofovir gel safe & effective in CAPRISA-004 (BAT-24 dosing). But, not effective in VOICE (daily dosing) • FACT 001 (BAT-24) ongoing, results in 2015 • TDF/FTC (daily) effective and well tolerated: • For hetero men & women in CDC TDF2 and Partners PrEP (also showed TDF effective) • But, not effective for women in FEM-PrEPand VOICE (low adherence) • Demonstration programs ongoing, or planned

  14. Opportunities

  15. Long-acting ARV Products • Dapivirine (NNRTI) vaginal ring; monthly • ASPIRE (MTN 020) & IPM RING Study ongoing • Expect results in 2015 • Vaginal rings – multipurpose prevention • Injectable, long-acting agents – 1-3 monthly • TMC278 LA (rilpivirine, NNRTI) • GSK744LA (integrase inhibitor)

  16. Issues for ARVs for Prevention • Who will use PrEP? • For what phase(s) of life? • For how long? • Who will pay? • Intermittent dosing? • Adherence • Service delivery • Reproductive health needs • Many, many more………..

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