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HIV Science Update: From Rome to Addis – Biomedical Prevention

HIV Science Update: From Rome to Addis – Biomedical Prevention. Elly T Katabira, FRCP Department of Medicine Makerere University College of Health Sciences 16 th ICASA, Addis Ababa, Ethiopia, December 6, 2011. Treatment as prevention. Population level observational data: British Columbia.

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HIV Science Update: From Rome to Addis – Biomedical Prevention

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  1. HIV Science Update: From Rome to Addis – Biomedical Prevention Elly T Katabira, FRCP Department of Medicine Makerere University College of Health Sciences 16th ICASA, Addis Ababa, Ethiopia, December 6, 2011

  2. Treatment as prevention

  3. Population level observational data: British Columbia All receiving HIV prevention services Montaner Lancet 2010

  4. 1763 HIV discordant couples (HIV+ partner CD4 350-550) HAART delayed until CD 250 Immediate HAART 1° endpoint: HIV infection in HIV-negative partner Co- 1° endpoint: HIV disease progression in HIV+ partner HPTN 052: Impact of (earlier) ART on HIV transmission and disease progression 13 sites in 9 countries: Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, United States, Zimbabwe All receiving HIV prevention services Cohen et al NEJM 2011 and IAS 2011

  5. HPTN 052: HIV transmissions Total HIV-1 Transmission Events: 39 Linked Transmissions: 28 Unlinked or TBD Transmissions: 11 Immediate Arm: 1 Delayed Arm: 27 96% reduction in risk of HIV transmission within the partnership (95% CI 73-99%) p < 0.001

  6. Prevention of HIV acquisition in those who are HIV negative

  7. CAPRISA 004: proof of principle for microbicides CAPRISA 004: Pericoital 1% tenofovir gel • Phase 2B trial in 889 women, ages ≥18 years in South Africa • Coitally dependent: gel within 12 hours before & 12 hours after sex, max. 2 applications in 24 hours • Study population: Young women (mean age 23), unmarried Abdool Karim et al, Science July 2010

  8. HIV protection in CAPRISA 004 No HIV resistance mutations among seroconverters Q Abdool Karim et al. Science 2010

  9. iPrEx: PrEP works for MSM iPrEx: Daily oral FTC/TDF PrEP • 2499 MSM, randomized 1:1 daily oral FTC/TDF vs placebo • 11 sites (Brazil, Ecuador, Peru, South Africa, Thailand, US) • 70% from Andean sites • Young high risk MSM: • 50% <25 yrs • Median 18 partners in 12 wks prior to enrollment

  10. iPrEx HIV protection 100 infections after randomization 36 on FTC/TDF 64 on placebo Efficacy estimate (mITT): 44% reduction in HIV acquisition (95% CI 15%-63%) Weeks on Study 2 cases of M184V resistance in participants in “window period” at time of PrEP initiation = avoid PrEP initiation in those who have acute HIV infection

  11. 4758 HIV serodiscordant couples (HIV+ partner not yet medically eligible for ART) Randomize HIV- partners (normal liver, renal, hematologic function) TDF once daily FTC/TDF once daily Placebo once daily Follow couples for up to 36 months 1° endpoint: HIV infection in HIV- partner Co- 1° endpoint: Safety Partners PrEP Study All receiving comprehensiveHIV prevention services

  12. Slides presented IAS 2011 Primary efficacy results • Primary analysis: modified intention-to-treat (mITT) • excluding infections present at randomization (3 TDF, 3 FTC/TDF, 6 placebo) Effect of TDF and FTC/TDF statistically similar (p=0.18) ITT analysis results similar

  13. Slides presented IAS 2011 Subgroup analysis - gender • Both TDF and FTC/TDF significantly reduced HIV risk in both men and women Women: 42 total infections: 8 TDF, 9 FTC/TDF, 25 placebo Men: 36 infections: 10 TDF, 4 FTC/TDF, 22 placebo

  14. Slides presented IAS 2011 Safety • No statistically significant difference in deaths, SAEs, key laboratory AEs

  15. Some disappointments though…….

  16. Ongoing safety and effectiveness study of tenofovir gel, oral TDF, and oral FTC/TDF for prevention of HIV

  17. Ongoing safety and effectiveness study of tenofovir gel, oral TDF, and oral FTC/TDF for prevention of HIV

  18. Ongoing safety and effectiveness study of tenofovir gel, oral TDF, and oral FTC/TDF for prevention of HIV

  19. A word of caution………..

  20. CAPRISA 004 & iPrEx: PrEP is all about adherence CAPRISA 004 • High (>80% gel adherence)n=336 (38%) 54% effective • Low (<50% gel adherence)n=367 (42%) 28% effective iPrEx • 8% of seroconverters had detectable drug at first HIV+ visit (and only 54% of nonseroconverters)  92% estimated efficacy if drug was present

  21. Combination HIV prevention: a package • What works for HIV prevention: • Male circumcision (FM risk) • Male condoms, female condoms (probably) • Counseling and testing, particularly as a couple (probably) • ↓ partner #, delayed sexual debut, abstinence • Treatment of STIs (probably best to decrease infectiousness in HIV+s) • Conditional cash transfer • ART • Oral/topical PrEP • ? Vaccine • Multiple, integrated, biomedical and behavioral interventions Combination prevention. Coates, et al. Lancet 2009

  22. ACKNOWLEDGEMENT • Adaora A. Adimora • Audrey Pettifor • Dannielle Haley • Jessica Justman • Mara Nakagawa-Harwood • Jaread Baeten • Connie Celum • Pedro Cahn • Julio Montaner • And many others behind the scene

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