Fonner Virginia A, Dalglish Sarah L, Kennedy Caitlin E, Baggaley Rachel, O'Reilly Kevin R, Koechlin Florence M, Rodolph Michelle, Hodges-Mameletzis Ioannis, Grant Robert M
aJohns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA bHIV Department, World Health Organization, Geneva, Switzerland cMedical University of South Carolina, Charleston, South Carolina, USA dHIV Department, World Health Organization, Switzerland; Gladstone Institutes and the University of California; San Francisco AIDS Foundation, San Francisco, California, USA.
AIDS. 2016 Jul 31;30(12):1973-83. doi: 10.1097/QAD.0000000000001145.
Preexposure prophylaxis (PrEP) offers a promising new approach to HIV prevention. This systematic review and meta-analysis evaluated the evidence for use of oral PrEP containing tenofovir disoproxil fumarate as an additional HIV prevention strategy in populations at substantial risk for HIV based on HIV acquisition, adverse events, drug resistance, sexual behavior, and reproductive health outcomes.
Rigorous systematic review and meta-analysis.
A comprehensive search strategy reviewed three electronic databases and conference abstracts through April 2015. Pooled effect estimates were calculated using random-effects meta-analysis.
Eighteen studies were included, comprising data from 39 articles and six conference abstracts. Across populations and PrEP regimens, PrEP significantly reduced the risk of HIV acquisition compared with placebo. Trials with PrEP use more than 70% demonstrated the highest PrEP effectiveness (risk ratio = 0.30, 95% confidence interval: 0.21-0.45, P < 0.001) compared with placebo. Trials with low PrEP use did not show a significantly protective effect. Adverse events were similar between PrEP and placebo groups. More cases of drug-resistant HIV infection were found among PrEP users who initiated PrEP while acutely HIV-infected, but incidence of acquiring drug-resistant HIV during PrEP use was low. Studies consistently found no association between PrEP use and changes in sexual risk behavior. PrEP was not associated with increased pregnancy-related adverse events or hormonal contraception effectiveness.
PrEP is protective against HIV infection across populations, presents few significant safety risks, and there is no evidence of behavioral risk compensation. The effective and cost-effective use of PrEP will require development of best practices for fostering uptake and adherence among people at substantial HIV risk.
暴露前预防（PrEP）为预防艾滋病病毒（HIV）提供了一种有前景的新方法。本系统评价和荟萃分析评估了基于HIV感染、不良事件、耐药性、性行为及生殖健康结局，使用含富马酸替诺福韦二吡呋酯的口服PrEP作为HIV高风险人群额外HIV预防策略的证据。
严格的系统评价和荟萃分析。
采用全面检索策略，检索了三个电子数据库及截至2015年4月的会议摘要。采用随机效应荟萃分析计算合并效应估计值。
纳入18项研究，包括来自39篇文章和6篇会议摘要的数据。在不同人群和PrEP方案中，与安慰剂相比，PrEP显著降低了HIV感染风险。PrEP使用率超过70%的试验显示，与安慰剂相比，PrEP有效性最高（风险比=0.30，95%置信区间：0.21-0.45，P<0.001）。PrEP低使用率的试验未显示出显著的保护作用。PrEP组和安慰剂组的不良事件相似。在急性HIV感染时开始使用PrEP的使用者中发现更多耐药HIV感染病例，但PrEP使用期间获得耐药HIV的发生率较低。研究一致发现PrEP使用与性风险行为变化之间无关联。PrEP与妊娠相关不良事件增加或激素避孕效果无关。
PrEP对各人群均有预防HIV感染的作用，几乎没有重大安全风险，且没有行为风险补偿的证据。PrEP的有效及成本效益使用将需要制定最佳实践，以促进HIV高风险人群的接受和依从。
