Who should be offered HIV pre-exposure prophylaxis (PrEP)?: A secondary analysis of a Phase 3 PrEP efficacy trial in men who have sex with men and transgender women
Abstract
Background Pre-exposure prophylaxis (PrEP) has been proven to reduce HIV acquisition in men who have sex with men and transgender women (MSM/TGW). For maximal impact, PrEP should be targeted to subpopulations accounting for the largest proportion of infections (population attributable fraction, PAF) and for whom the number needed to treat (NNT) to prevent infection is lowest. Methods The iPrEx study was a randomized controlled efficacy trial of tenofovir-disoproxil-fumarate/emtricitabine PrEP in 2499 MSM/TGW on 4 continents. We calculated the association between demographic and risk behavior during screening with subsequent seroconversion among placebo recipients using a Poisson model, and the PAF and NNT for risk behavior subgroups. Findings Of 1248 placebo participants enrolled, 83 became HIV infected in follow-up. Participants reporting non-condom receptive anal intercourse (ncRAI) seroconverted significantly more often than MSM/TGW reporting no condomless anal sex (adjusted hazard ratio (AHR) 5·11, 95% CI 1·55-16·79). The overall PAF for MSM/TGW reporting ncRAI was 64% (prevalence=60%). Most of this risk came from ncRAI with unknown serostatus partners (PAF 53%, prevalence=54%, AHR 4·76); in contrast, the PAF for ncRAI with an HIV positive partner, an uncommon practice, was only 1% (prevalence 1%, AHR=7·11). The overall NNT per year for the cohort was 62 (95% CI 44-147). NNTs were lower for MSM/TGW self-reporting ncRAI, cocaine use, or a sexually transmitted infection…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 1,248 participants or records.
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