本文由小咖机器人翻译整理

期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2024.0464

摘要内容如下：

重要性

恩曲他滨和富马酸替诺福韦二吡呋酯（F/TDF）用于HIV暴露前预防（PREP），在依从性高（>4剂/周）的情况下，对男男性行为者（MSM）的顺性别者非常有效。在顺性别的女性中，F/TDF对PrEP的实际有效性和依从性不太明显。

目的

描述F/TDF对PrEP的有效性及其与顺性别女性依从性的关系。

设计、设置和参与者

从2012年至2020年在6个国家进行的11项F/TDF Prep批准后研究（包括6296名15至69岁的顺性别女性）中汇总数据。根据客观测量的依从性水平（干血斑中的替诺福韦二磷酸盐浓度或血浆中的替诺福韦浓度；n=288）和主观（电子药丸帽监测、药丸计数、自我报告和研究报告的依从性量表；N=2954）使用基于组的轨迹建模。

曝光

F/TDF每日口服一次。根据依从性轨迹分析亚组的HIV发病率。

主要成果和措施

艾滋病发病率。

结果

在6296名参与者中，46%来自肯尼亚，28%来自南非，21%来自印度，2.9%来自乌干达，1.6%来自博茨瓦纳，0.8%来自美国。在所有研究中，PREP开始时的平均（SD）年龄为25（7）岁，61%的参与者年龄小于25岁。总体HIV发病率为0.72/100人-年（95%CI，0.51-1.01；在6296名参与者中有32起艾滋病毒诊断事件）。确定了四组不同的依从性轨迹：持续每日（7剂/周）、持续高（4-6剂/周）、高但下降（从平均4-6剂/周开始下降）和持续低（少于2剂/周）。在498名坚持每天服药的妇女中，没有一人感染艾滋病毒。在658名持续高依从性的女性中，仅有1人感染了HIV（发病率为0.13/100人-年[95%CI，0.02-0.92]）。高依从性但依从性下降组（n=1166）的发病率为0.49/100人-年（95%CI，0.22-1.08），持续低依从性组（n=632）的发病率为1.27/100人-年（95%CI，0.53-3.04）。

结论和相关性

在一项对顺性女性中用于PrEP的F/TDF的11项批准后研究的汇总分析中，总体HIV发病率为0.72/100人-年；坚持每天或坚持高依从性（4-6剂/周）PrEP的个体经历了非常低的HIV发病率。

英文原文如下：

Abstracts

Importance  Emtricitabine and tenofovir disoproxil fumarate (F/TDF) for HIV preexposure prophylaxis (PrEP) is highly effective in cisgender men who have sex with men (MSM) when adherence is high (>4 doses/week). Real-world effectiveness and adherence with F/TDF for PrEP in cisgender women is less well characterized.

Objective  To characterize the effectiveness of F/TDF for PrEP and its relationship with adherence in cisgender women.

Design, Setting, and Participants  Data were pooled from 11 F/TDF PrEP postapproval studies conducted in 6 countries that included 6296 cisgender women aged 15 to 69 years conducted from 2012 to 2020. HIV incidence was evaluated according to adherence level measured objectively (tenofovir diphosphate concentration in dried blood spots or tenofovir concentration in plasma; n = 288) and subjectively (electronic pill cap monitoring, pill counts, self-report, and study-reported adherence scale; n = 2954) using group-based trajectory modeling.

Exposures  F/TDF prescribed orally once a day. HIV incidence was analyzed in subgroups based on adherence trajectory.

Main Outcomes and Measures  HIV incidence.

Results  Of the 6296 participants, 46% were from Kenya, 28% were from South Africa, 21% were from India, 2.9% were from Uganda, 1.6% were from Botswana, and 0.8% were from the US. The mean (SD) age at PrEP initiation across all studies was 25 (7) years, with 61% of participants being younger than 25 years. The overall HIV incidence was 0.72 per 100 person-years (95% CI, 0.51-1.01; 32 incident HIV diagnoses among 6296 participants). Four distinct groups of adherence trajectories were identified: consistently daily (7 doses/week), consistently high (4-6 doses/week), high but declining (from a mean of 4-6 doses/week and then declining), and consistently low (less than 2 doses/week). None of the 498 women with consistently daily adherence acquired HIV. Only 1 of the 658 women with consistently high adherence acquired HIV (incidence rate, 0.13/100 person-years [95% CI, 0.02-0.92]). The incidence rate was 0.49 per 100 person-years (95% CI, 0.22-1.08) in the high but declining adherence group (n = 1166) and 1.27 per 100 person-years (95% CI, 0.53-3.04) in the consistently low adherence group (n = 632).

Conclusions and Relevance  In a pooled analysis of 11 postapproval studies of F/TDF for PrEP among cisgender women, overall HIV incidence was 0.72 per 100 person-years; individuals with consistently daily or consistently high adherence (4-6 doses/week) to PrEP experienced very low HIV incidence.

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