The Pacific Northwest Evidence-based Practice Center, Department of Medical Informatics and Clinical Epidemiology, Oregon Health & Science University, Portland.
Division of General Internal Medicine, Oregon Health & Science University, Portland.
JAMA. 2023 Aug 22;330(8):746-763. doi: 10.1001/jama.2023.9865.
IMPORTANCE: A 2019 review for the US Preventive Services Task Force (USPSTF) found oral preexposure prophylaxis (PrEP) associated with decreased HIV infection risk vs placebo or no PrEP in adults at increased HIV acquisition risk. Newer PrEP regimens are available. OBJECTIVE: To update the 2019 review on PrEP, to inform the USPSTF. DATA SOURCES: Ovid MEDLINE, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, and Embase (January 2018 to May 16, 2022); surveillance through March 24, 2023. STUDY SELECTION: Randomized clinical trials of PrEP vs placebo or no PrEP or newer vs older PrEP regimens and diagnostic accuracy studies of instruments for predicting incident HIV infection. DATA EXTRACTION AND SYNTHESIS: Dual review of titles and abstracts, full-text articles, study quality, and data abstraction. Data were pooled using the DerSimonian and Laird random-effects model. MAIN OUTCOMES AND MEASURES: HIV acquisition, mortality, and harms; and diagnostic test accuracy. RESULTS: Thirty-two studies were included in the review (20 randomized clinical trials [N = 36 543] and 12 studies of diagnostic accuracy [N = 5 544 500]). Eleven trials in the 2019 review found oral PrEP associated with decreased HIV infection risk vs placebo or no PrEP (n = 18 172; relative risk [RR], 0.46 [95% CI, 0.33-0.66]). Higher adherence was associated with greater efficacy. One new trial (n = 5335) found oral tenofovir alafenamide/emtricitabine (TAF/FTC) to be noninferior to tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in men who have sex with men (RR, 0.47 [95% CI, 0.19-1.14]). Two new trials found long-acting injectable cabotegravir associated with decreased risk of HIV infection vs oral TDF/FTC (RR, 0.33 [95% CI, 0.18-0.62] in cisgender men who have sex with men and transgender women [n = 4490] and RR, 0.11 [95% CI, 0.04-0.31] in cisgender women [n = 3178]). Discrimination of instruments for predicting incident HIV infection was moderate in men who have sex with men (5 studies; n = 25 488) and moderate to high in general populations of persons without HIV (2 studies; n = 5 477 291). CONCLUSIONS AND RELEVANCE: In adults at increased HIV acquisition risk, oral PrEP was associated with decreased risk of acquiring HIV infection compared with placebo or no PrEP. Oral TAF/FTC was noninferior to oral TDF/FTC, and injectable cabotegravir reduced the risk of HIV infection compared with oral TDF/FTC in the populations studied.
重要性：美国预防服务工作组（USPSTF）在 2019 年的一项综述发现，与安慰剂或无预防性治疗相比，在有更高 HIV 感染风险的成年人中，口服暴露前预防（PrEP）与降低 HIV 感染风险相关。现在有了更新的 PrEP 方案。 目的：更新 2019 年关于 PrEP 的综述，为 USPSTF 提供信息。 数据来源：Ovid MEDLINE、Cochrane 系统评价数据库、Cochrane 对照试验中心注册库和 Embase（2018 年 1 月至 2022 年 5 月 16 日）；截至 2023 年 3 月 24 日的监测。 研究选择：PrEP 与安慰剂或无 PrEP 或更新的 PrEP 方案与预测 HIV 感染事件的工具的诊断准确性研究的随机临床试验。 数据提取和综合：双重标题和摘要、全文文章、研究质量和数据提取的审查。使用 DerSimonian 和 Laird 随机效应模型对数据进行汇总。 主要结果和措施：HIV 获得、死亡率和危害；以及诊断测试准确性。 结果：该综述纳入了 32 项研究（20 项随机临床试验 [N=36543] 和 12 项诊断准确性研究 [N=5544500]）。2019 年综述中的 11 项试验发现，与安慰剂或无预防性治疗相比，口服 PrEP 与降低 HIV 感染风险相关（n=18172；相对风险 [RR]，0.46 [95%CI，0.33-0.66]）。更高的依从性与更高的疗效相关。一项新的试验（n=5335）发现，与替诺福韦二吡呋酯富马酸酯/恩曲他滨（TDF/FTC）相比，替诺福韦艾拉酚胺/恩曲他滨（TAF/FTC）在男男性行为者中不劣效（RR，0.47 [95%CI，0.19-1.14]）。两项新的试验发现，长效注射用卡博特韦与口服 TDF/FTC 相比，降低了 HIV 感染风险（RR，0.33 [95%CI，0.18-0.62]，在男男性行为者和跨性别女性 [n=4490]；RR，0.11 [95%CI，0.04-0.31]，在无 HIV 的女性 [n=3178]）。用于预测 HIV 感染事件的工具的预测准确性在男男性行为者中为中度（5 项研究；n=25488），在无 HIV 的人群中为中度至高度（2 项研究；n=5477291）。 结论和相关性：在有更高 HIV 感染风险的成年人中，与安慰剂或无预防性治疗相比，口服 PrEP 与降低 HIV 感染风险相关。与口服 TDF/FTC 相比，口服 TAF/FTC 不劣效，与口服 TDF/FTC 相比，注射用卡博特韦降低了研究人群的 HIV 感染风险。
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