Systematic review of clinical trials and cohort studies evaluating HIV post-exposure prophylaxis (PEP) regimens to inform updated Canadian guidelines.

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Stanley O Onyegbule, Maryam Habib, Rija Khalid, Jessie Tu, Deborah Yoong, Jaris Swidrovich, Wale Ajiboye, Patrick O'Byrne, Ameeta E Singh, Jean-Guy Baril, Tatiana Sotindjo, Mark W Hull, Darrell H S Tan
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引用次数: 0

Abstract

Background: We conducted a systematic review of clinical trials and cohort studies on HIV post-exposure prophylaxis (PEP) regimens to inform updated 2025 Canadian guidelines.

Methods: We searched Medline and Embase (July 2017-June 2024) for studies reporting on: HIV acquisition, PEP completion, adverse events (AEs) leading to discontinuation and/or moderate to severe adverse events. Two reviewers independently screened abstracts and publications and extracted data from eligible articles.

Results: Of 5226 abstracts screened, we retrieved 112 full-text articles and included 22. Median study size was 160 (range = 52-26 988) participants. Regimens included DTG + TDF/XTC (n = 4, 18%), EVG/c/TDF/FTC (n = 4, 18%), BIC/TAF/FTC (n = 4, 18%), RAL + TDF/FTC (n = 4, 18%), EVG/c/TAF/FTC (n = 3, 14%), RPV/TDF/FTC (n = 2, 9%), DOR/TDF/FTC (n = 2, 9%), MVC + TDF/FTC (n = 1, 5%), a wide variety of protease inhibitor-based regimens (n = 7, 32%) and novel combinations with the injectable fusion inhibitor albuvirtide (n = 1, 5%); a third of studies included three or more regimens (n = 8, 36%). Among studies examining PEP completion rates (n = 12, 55%), cumulative completion rate was 86.6% (7779/8983 PEP episodes) and appeared highest for RAL + TDF/FTC, BIC/FTC/TAF and DOR/TDF/3TC at 96.4%, 96.3% and 95.0%, respectively. PEP tolerability was good, with few discontinuations due to adverse events; where data were available, this was lowest for INSTI-based regimens at 0.5% (pooled across two studies) for RAL + TDF/FTC, 1.0% (1/99) for DTG + TDF/XTC, 1.8% (2/109) for BIC/TAF/FTC and zero with albuvirtide (0/198). HIV seroconversions were rare (n = 5/8134, 0.06%) and often related to premature PEP discontinuation or repeated exposures.

Conclusions: Multiple PEP regimens have been associated with high completion, good tolerability and rare seroconversion, supporting their inclusion in clinical guidelines.

对评估HIV暴露后预防(PEP)方案的临床试验和队列研究进行系统回顾,为更新的加拿大指南提供信息。
背景:我们对HIV暴露后预防(PEP)方案的临床试验和队列研究进行了系统回顾,为更新的2025年加拿大指南提供信息。方法:我们检索了Medline和Embase(2017年7月- 2024年6月)关于HIV感染、PEP完成、不良事件(ae)导致停药和/或中度至重度不良事件的研究报告。两位审稿人独立筛选摘要和出版物,并从符合条件的文章中提取数据。结果:在筛选的5226篇摘要中,我们检索到112篇全文文章,其中包括22篇。中位研究规模为160(范围= 52- 26988)名参与者。方案包括DTG + TDF/XTC (n = 4,18 %)、EVG/c/TDF/FTC (n = 4,18 %)、BIC/TAF/FTC (n = 4,18 %)、RAL + TDF/FTC (n = 4,18 %)、EVG/c/TAF/FTC (n = 3,14 %)、RPV/TDF/FTC (n = 2,9 %)、DOR/TDF/FTC (n = 2,9 %)、MVC + TDF/FTC (n = 1,5 %)、多种基于蛋白酶抑制剂的方案(n = 7,32 %)以及与可注射融合抑制剂白蛋白肽的新型组合(n = 1,5 %);三分之一的研究包括三个或更多的方案(n = 8,36%)。在检查PEP完成率的研究中(n = 12,55%),累计完成率为86.6% (7779/8983 PEP发作),RAL + TDF/FTC、BIC/FTC/TAF和DOR/TDF/3TC的最高完成率分别为96.4%、96.3%和95.0%。PEP耐受性良好,很少因不良事件而停药;在可获得的数据中,基于isi的方案中最低,RAL + TDF/FTC为0.5%(两项研究合并),DTG + TDF/XTC为1.0% (1/99),BIC/TAF/FTC为1.8%(2/109),白蛋白肽为零(0/198)。HIV血清转化很少(n = 5/8134, 0.06%),通常与过早停用PEP或重复暴露有关。结论:多种PEP方案具有高完成率、良好耐受性和罕见的血清转化,支持将其纳入临床指南。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
6.30
自引率
8.80%
发文量
419
审稿时长
1 months
期刊介绍: Published on behalf of the British Pharmacological Society, the British Journal of Clinical Pharmacology features papers and reports on all aspects of drug action in humans: review articles, mini review articles, original papers, commentaries, editorials and letters. The Journal enjoys a wide readership, bridging the gap between the medical profession, clinical research and the pharmaceutical industry. It also publishes research on new methods, new drugs and new approaches to treatment. The Journal is recognised as one of the leading publications in its field. It is online only, publishes open access research through its OnlineOpen programme and is published monthly.
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