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Sponsored by NIH/NIAID/DAIDS

Completed Observation of the Randomized Placebo-Controlled Phase of iPrEx. Sponsored by NIH/NIAID/DAIDS. with co-funding by the Bill & Melinda Gates Foundation. and drug donated by Gilead Sciences. Grant et al, IAS Rome 2011. The iPrEx Study. MSM and Trans women

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Sponsored by NIH/NIAID/DAIDS

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  1. Completed Observation of the Randomized Placebo-Controlled Phase of iPrEx Sponsored by NIH/NIAID/DAIDS with co-funding by the Bill & Melinda Gates Foundation and drug donated by Gilead Sciences Grant et al, IAS Rome 2011

  2. The iPrEx Study • MSM and Trans women • Randomized 1:1 daily oral PrEP • FTC/TDF vsplacebo • Prevention services provided to all • Followed monthly on drug for: • HIV seroconversion • Adverse events (especially renal & liver) • Metabolic effects (bone, fat, lipids) • HBV flares among HBsAg+ • Risk behavior & STIs • Adherence • If infected • Drug resistance • Viral load • Immune responses & CD4 count New England Journal of Medicine, online Nov 23, 2010

  3. iPrEx Timeline Intention to Treat – Primary Analysis (May 1, 2010) Intention to Treat – Final Analysis (Aug 2010) Post Stop - Analysis (Nov 21, 2010) Final DEXA/HBV Visit (February 28, 2011) Enrollment 30 Jun 07 30 Sept 07 31 Dec 07 31 Mar 08 30 Jun 08 30 Sept 08 31 Dec 08 31 Mar 09 30 Jun 09 30 Sept 09 31 Dec 09 31 Mar 10 30 Jun 10 30 Sept 10 31 Dec 10 28 Feb 11 Grant et al, IAS Rome 2011

  4. Fully enrolled as of December 2009 San Francisco Boston Chiang Mai Iquitos Guayaquil Sao Paulo Lima Rio de Janeiro Cape Town New England Journal of Medicine, online Nov 23, 2010

  5. Efficacy (MITT) 42% (18-60%) Through End of StudyInfection Numbers: 83 – 48 = 35 averted P = 0.002 Grant et al, CROI Boston 2011

  6. Efficacy of Oral FTC/TDF PrEP Subgroups Grant et al, IAS Rome 2011

  7. Oral FTC/TDF Prophylactic Activity * Matched on site and time on study. - 92% reduction in HIV risk associated with drug detection at the timepoint nearest first evidence of infection. -Analysis adjusted for age, URAI baseline and follow-up, schooling, BMI. Anderson et al, IAS, Rome 2011

  8. Drug Detection in Hair • Correlates to dose (DOT) • Liu CROI 2011 • Opt-in substudy • Not case matched • 100 hairs cut • FTC and TNF • Higher detection in… • Older persons • US/SA • Lower detection in… • Trans-identified N=94 N=128 Liu et al, IAS, Rome 2011

  9. Unprotected Receptive Anal Intercourse p=0.30

  10. Perceived Drug Assignment Based on Week 12 CASI p=0.89 New England Journal of Medicine, online Nov 23, 2010

  11. Unprotected Receptive Anal Intercourse Those who believed they were taking FTC/TDF p=0.44

  12. Acute HIV Infection p=0.004 for Placebo p=0.002 for FTC/TDF

  13. The Aims: Provide post-trial access in accordance with the Declaration of Helsinki and Good Participatory Practices. Learn from PrEPusers about implementation issues. Learn if PrEPuse increases when people know the tablet is safe and effective and not a placebo. Learn what happens with sexual practices. Learn if every 12 week monitoring Is sufficient.

  14. Status on July 20, 2011

  15. Conclusions Oral FTC/TDF PrEP provides additional protection against the acquisition of HIV infection among MSM receiving a comprehensive package of prevention services. Detectable drug is associated with a 92% reduction in HIV risk after adjusting for other benefits. Oral FTC/TDF use was nearly 90 to 100% at some sites; Lower at other sites; Hair is promising for monitoring. There is no evidence for risk compensation even among those who thought they were taking FTC/TDF.

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