Abstract

Introduction: The efficacy of pre-exposure prophylaxis (PrEP) in preventing sexual acquisition of human immunodeficiency virus (HIV) is well established. Little is known about the feasibility of PrEP implementation in middle-income settings with concentrated epidemics among men who have sex with men (MSM) and transgender women (TGW).Methods: PrEP Brasil is a prospective, multicentre, open-label demonstration project assessing PrEP delivery in the context of the Brazilian Public Health System. HIV-uninfected MSM and TGW in 3 referral centres in Rio de Janeiro and São Paulo were evaluated for eligibility and offered 48 weeks of daily emtricitabine/tenofovir for PrEP. Concentrations of tenofovir diphosphate in dried blood spot samples (DBS) at week 4 after enrolment (early adherence) were measured. Predictors of drug levels were assessed using ordinal logistic regression models considering the DBS drug level as a 3 level variable (<350 fmol/punch, ≥350–699 fmol/punch and ≥700 fmol/punch).Results: 1,270 individuals were assessed for participation; n = 738 were potentially eligible and n = 450 were offered PrEP (PrEP uptake was 60.9%). Eligible but not enrolled individuals were younger, had lower HIV risk perception and had lower PrEP awareness. At week 4, 424 participants (of the 450 enrolled) had DBS TFV-DP concentrations, 94.1% in the protective range (≥350 fmol/punch, consistent with ≥2 pills per week), and 78% were in the highly protective range (≥700 fmol/punch, ≥4 pills per week). Participants with ≥12 years of schooling had 1.9 times the odds (95%CI 1.10–3.29) of a higher versus lower drug level than participants with <12 years of schooling. Condomless receptive anal intercourse in the prior 3 months was also associated with higher drug levels (adjusted OR = 1.78; 95% CI 1.08–2.94).Conclusions: The high uptake and early adherence indicate that PrEP for high-risk MSM and TGW can be successfully delivered in the context of the Brazilian Public Health System. Interventions to address disparities on PrEP awareness and HIV risk perception among the younger and less educated are urgently needed in order to maximize the impact of this prevention strategy on the reduction of HIV infection among MSM and TGW in Brazil.

Highlights

  • The efficacy of pre-exposure prophylaxis (PrEP) in preventing sexual acquisition of human immunodeficiency virus (HIV) is well established

  • We describe PrEP uptake and early adherence [16] assessed by TDF/FTC drug levels measured in dried blood spots (DBS) at week 4 after enrolment and its associated factors in the PrEP Brasil demonstration study

  • The final number of potentially eligible participants (738) used for PrEP uptake calculations was given by the initial 753 minus the subsequent 15 participants who were subsequent deemed ineligible during screening and enrolment visits

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Summary

Introduction

The efficacy of pre-exposure prophylaxis (PrEP) in preventing sexual acquisition of human immunodeficiency virus (HIV) is well established. The effectiveness of oral pre-exposure prophylaxis (PrEP) using tenofovir/emtricitabine (TDF/FTC) for prevention of sexually acquired human immunodeficiency virus (HIV) infection for men who have sex with men (MSM) and transgender women (TGW) has been demonstrated in randomized trials and open-label studies [1,2,3,4,5]. In the iPrEx study, protection was estimated to be over 90% in those with detectable drug levels in their blood [1], with pharmacokinetic modelling suggesting that efficacy reaches 96 and 99% with dosing of four and seven days per week, respectively [8]. Subsequent results from the open-label extension of the iPrEx study estimated that 90% protection was achieved with 2–3 drug doses/week and that 4 or more doses/ week were highly protective against HIV infection [9]. Drug levels consistent with the intake of 4 or more pills/week were observed in only about one-third of study follow-up visits in iPrEx OLE [11], corroborating that adherence is a significant challenge to PrEP effectiveness

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