Preexposure Prophylaxis in Men Who Have Sex with Men: iPrEx Trial
Preexposure Prophylaxis (PrEP) for HIV prevention in men who have sex with men was studied in the iPrEx Trial, focusing on the efficacy and safety of tenofovir DF-emtricitabine. The trial included HIV-seronegative men (or transgender women) with high-risk for HIV acquisition, randomized into placebo or tenofovir DF-emtricitabine treatment arms. Results showed a significant reduction in HIV infections with tenofovir DF-emtricitabine. Detectable drug levels in patients on the treatment were also analyzed, showing promising outcomes. The study design, enrollment criteria, treatment arms, and results of the trial are detailed in the findings.
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Preexposure Prophylaxis in Men who have Sex with Men iPrEx Trial
Preexposure Prophylaxis (PrEP) for HIV Prevention in MSM iPrEx Trial: Study Design Study Design: iPrEx Background: Randomized, placebo-controlled trial that examined efficacy and safety of tenofovir DF-emtricitabine as preexposure prophylaxis in HIV-seronegative men (or transgender women) who have sex with men Placebo (n = 1248) Inclusion Criteria (2499 enrolled) - 18 years of age or older - HIV-seronegative - Men (or transgender women) who have sex with men - Evidence of high-risk for HIV acquisition Tenofovir DF-Emtricitabine (n = 1251) Treatment Arms: - Placebo: 1 pill daily - Tenofovir DF-emtricitabine: 1 pill daily Note: 10 subjects infected with HIV at onset of study Source: Grant RM, et al. N Engl J Med. 2010;363:2587-99.
Preexposure Prophylaxis (PrEP) for HIV Prevention in MSM iPrEx Trial: Study Design n = 2499 MSM or TG Women - Sexual Contact Sexual Contact Tenofovir DF-Emtricitabine Sexual Contact Sexual Contact Placebo Source: Grant RM, et al. N Engl J Med. 2010;363:2587-99.
Preexposure Prophylaxis (PrEP) for HIV Prevention in MSM iPrEx Trial: Results (Intent-to-Treat) 100 P = 0.001 80 72 47% HIV Infections 60 38 40 20 0 Placebo Tenofovir DF-Emtricitabine Source: Grant RM, et al. N Engl J Med. 2010;363:2587-99.
Preexposure Prophylaxis (PrEP) for HIV Prevention in MSM iPrEx Trial: Results (Modified Intent-to-Treat) 100 P = 0.005 80 44% HIV Infections 64 60 36 40 20 0 Placebo Tenofovir DF-Emtricitabine Source: Grant RM, et al. N Engl J Med. 2010;363:2587-99.
Preexposure Prophylaxis (PrEP) for HIV Prevention in MSM iPrEx Trial: Results Detectable Drug Levels in Patients on Tenofovir DF-Emtricitabine A. Intracellular Emtricitabine-Diphosphate Level B. Intracellular Tenofovir-Diphosphate Levels 3/34 Detectable 9% 22/42 Detectable 52% 2/34 Detectable 6% 21/42Detectable 50% 15 100 TFV-DP (fmol/106 cells) FTC-TP (pmol/106 cells) 75 10 50 5 25 0 0 Case Control (HIV-negative) Case Control (HIV-negative) (HIV-positive) (HIV-positive) Adjusted relative risk reduction (any detectable level) = 95% Source: Grant RM, et al. N Engl J Med. 2010;363:2587-99.
Preexposure Prophylaxis (PrEP) for HIV Prevention in MSM iPrEx Trial: Conclusions Conclusions: Oral tenofovir DF-emtricitabine provided protection against the acquisition of HIV infection among the subjects. Detectable blood levels strongly correlated with the prophylactic effect. Source: Grant RM, et al. N Engl J Med. 2010;363:2587-99.
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.
