Tenofovir Gel as PrEP for African Women CAPRISA-004
Tenofovir Gel as PrEP for African Women CAPRISA-004: Study Design Study Design: CAPRISA 004 • Background : Randomized, phase 2b double-blind, placebo-controlled trial to examine the efficacy and safety of tenofovir gel as preexposure prophylaxis in sexually-active heterosexual women in South Africa Placebo Gel • Inclusion Criteria (889 enrolled) (n = 444) - 18-40 years of age - HIV-negative - Sexually active (vaginal sex >2x in prior 30d) - Using non-barrier form of contraceptive 1% Tenofovir Gel - Excluded if had genital deep epithelial disruption (n = 445) - Excluded if pregnant - Excluded if CrCl <50 mL/min *Gel Application Schedule: apply before • Treatment Arms: sex and again as soon as possible after - Placebo: per gel application schedule sex dose (within 12 hours). - Tenofovir gel: per gel application schedule* Maximum: 2 doses of gel per 24 hours Source: Abdool Karim Q, et al. Science 2010;329:1168-74.
Tenofovir Gel as PrEP for African Women CAPRISA-004: Results 14 HIV Incidence/100 person-years P = 0.017 12 ⇓ 39% 10 9.1 8 5.6 6 4 2 0 Placebo Gel 1% Tenofovir Gel Source: Abdool Karim Q, et al. Science 2010;329:1168-74.
Tenofovir Gel as PrEP for African Women CAPRISA-004: Results based on Adherence Placebo Gel 1% Tenofovir Gel HIV Incidence/100 person-years 16 P = 0.017 P = 0.025 P = 0.343 P = 0.303 14 12 10.0 9.3 10 9.1 8.6 8 6.3 6.2 5.6 6 4.2 4 2 0 Overall High (>80%) Intermediate (50- Low (<50%) 80%) Gel Adherence Source: Abdool Karim Q, et al. Science 2010;329:1168-74.
Tenofovir Gel as PrEP for African Women CAPRISA-004: Results (Months of Follow-Up Placebo Gel 1% Tenofovir Gel 16 HIV Incidence/100 person-years P = 0.064 P = 0.007 P = 0.004 P = 0.013 P = 0.017 14 11.2 12 10.5 10.2 10.2 10 9.1 8 6.0 5.6 5.6 5.3 5.2 6 4 2 0 6 12 18 24 30 Months of Follow-Up Source: Abdool Karim Q, et al. Science 2010;329:1168-74.
Tenofovir Gel as PrEP for African Women CAPRISA-004: Conclusions Conclusions : “ Tenofovir gel reduced HIV acquisition by an estimated 39% overall, and by 54% in women with high gel adherence. Tenofovir gel could potentially fill an important HIV prevention gap, especially for women unable to successfully negotiate mutual monogamy or condom use.” Source: Abdool Karim Q, et al. Science 2010;329:1168-74.
Acknowledgment The National HIV Curriculum is an AIDS Education and Training Center (AETC) Program supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of an award totaling $800,000 with 0% financed with non-governmental sources. This project is led by the University of Washington’s Infectious Diseases Education and Assessment (IDEA) Program. The content in this presentation are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS, or the U.S. Government.
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