男男性行为人群中的 HIV 预防：替诺福韦艾拉酚胺复方制剂与安慰剂的比较。

HIV Prevention Among Men Who Have Sex With Men: Tenofovir Alafenamide Combination Preexposure Prophylaxis Versus Placebo.

机构信息

Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

Institute of Global Health and Infectious Diseases, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

出版信息

J Infect Dis. 2024 Apr 12;229(4):1123-1130. doi: 10.1093/infdis/jiad507.

DOI:10.1093/infdis/jiad507

PMID:37969014

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11011171/

Abstract

BACKGROUND

While noninferiority of tenofovir alafenamide and emtricitabine (TAF/FTC) as preexposure prophylaxis (PrEP) for the prevention of human immunodeficiency virus (HIV) has been shown, interest remains in its efficacy relative to placebo. We estimate the efficacy of TAF/FTC PrEP versus placebo for the prevention of HIV infection.

METHODS

We used data from the DISCOVER and iPrEx trials to compare TAF/FTC to placebo. DISCOVER was a noninferiority trial conducted from 2016 to 2017. iPrEx was a placebo-controlled trial conducted from 2007 to 2009. Inverse probability weights were used to standardize the iPrEx participants to the distribution of demographics and risk factors in the DISCOVER trial. To check the comparison, we evaluated whether risk of HIV infection in the shared tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) arms was similar.

RESULTS

Notable differences in demographics and risk factors occurred between trials. After standardization, the difference in risk of HIV infection between the TDF/FTC arms was near zero. The risk of HIV with TAF/FTC was 5.8 percentage points lower (95% confidence interval [CI], -2.0% to -9.6%) or 12.5-fold lower (95% CI, .02 to .31) than placebo standardized to the DISCOVER population.

CONCLUSIONS

There was a reduction in HIV infection with TAF/FTC versus placebo across 96 weeks of follow-up.

CLINICAL TRIALS REGISTRATION

NCT02842086 and NCT00458393.

摘要

背景

替诺福韦艾拉酚胺和恩曲他滨（TAF/FTC）作为预防人类免疫缺陷病毒（HIV）的暴露前预防（PrEP）已被证明不劣效，但其与安慰剂相比的疗效仍引起关注。我们评估了 TAF/FTC PrEP 预防 HIV 感染的疗效。

方法

我们使用来自 DISCOVER 和 iPrEx 试验的数据来比较 TAF/FTC 与安慰剂。DISCOVER 是一项 2016 年至 2017 年进行的非劣效性试验。iPrEx 是一项 2007 年至 2009 年进行的安慰剂对照试验。采用逆概率权重法将 iPrEx 参与者的分布标准化为 DISCOVER 试验中的人口统计学和危险因素分布。为了检查比较结果，我们评估了在共同使用替诺福韦二吡呋酯和恩曲他滨（TDF/FTC）的手臂中，HIV 感染的风险是否相似。

结果

两项试验在人口统计学和危险因素方面存在显著差异。标准化后，TDF/FTC 手臂中 HIV 感染的风险差异接近零。与安慰剂相比，TAF/FTC 降低了 5.8 个百分点（95%置信区间[CI]，-2.0%至-9.6%）或 12.5 倍（95% CI，.02 至.31）的 HIV 感染风险，根据 DISCOVER 人群进行标准化。