FIOCRUZ, Instituto Nacional de Infectologia Evandro Chagas, Rio de Janeiro, Brazil.
School of Medicine, Universidade de São Paulo, Brazil.
J Int AIDS Soc. 2017 Apr 6;20(1):21472. doi: 10.7448/IAS.20.1.21472.
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).
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).
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).
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.
暴露前预防（PrEP）在预防人类免疫缺陷病毒（HIV）性传播方面的功效已得到充分证实。但对于在男男性行为者（MSM）和跨性别女性（TGW）集中流行的中等收入国家实施 PrEP 的可行性知之甚少。
PrEP Brasil 是一项前瞻性、多中心、开放性标签的示范项目，旨在评估巴西公共卫生系统中 PrEP 的实施情况。在里约热内卢和圣保罗的 3 个转诊中心，对 HIV 阴性的 MSM 和 TGW 进行了资格评估，并为他们提供了 48 周的每日恩曲他滨/替诺福韦酯用于 PrEP。在入组后第 4 周（早期依从性）测量了干血斑样本（DBS）中替诺福韦二磷酸的浓度。使用有序逻辑回归模型评估了药物水平的预测因素，考虑了 DBS 药物水平作为 3 个水平变量（<350 fmol/打孔，≥350-699 fmol/打孔和≥700 fmol/打孔）。
共评估了 1270 人参与；n=738 人有潜在资格，n=450 人接受了 PrEP（PrEP 使用率为 60.9%）。有资格但未入组的人更年轻，对 HIV 风险的认知更低，对 PrEP 的认识也更低。在第 4 周，450 名入组者中有 424 名（450 名入组者中的 424 名）进行了 DBS TFV-DP 浓度检测，94.1%的浓度在保护范围内（≥350 fmol/打孔，与每周≥2 片相符），78%的浓度在高度保护范围内（≥700 fmol/打孔，每周≥4 片）。与接受≤12 年教育的参与者相比，接受≥12 年教育的参与者有更高药物水平的可能性高出 1.9 倍（95%CI 1.10-3.29）。在过去 3 个月内有过无保护的接受性肛交的参与者，药物水平也较高（调整后的 OR=1.78；95%CI 1.08-2.94）。
高使用率和早期依从性表明，在巴西公共卫生系统中，可以成功地为高危 MSM 和 TGW 提供 PrEP。迫切需要采取干预措施，解决年轻和受教育程度较低者在 PrEP 认识和 HIV 风险认知方面的差异，以最大限度地发挥这一预防策略对减少巴西 MSM 和 TGW 中 HIV 感染的影响。
