Janes Holly, Corey Lawrence, Ramjee Gita, Carpp Lindsay N, Lombard Carl, Cohen Myron S, Gilbert Peter B, Gray Glenda E
1 Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center , Seattle, Washington.
2 Department of Biostatistics, University of Washington , Seattle, Washington.
AIDS Res Hum Retroviruses. 2018 Aug;34(8):645-656. doi: 10.1089/AID.2018.0031. Epub 2018 Jun 19.
As oral tenofovir-based regimens for preexposure prophylaxis (PrEP) are adopted as standard of care for HIV prevention, their utilization in clinical trials among women in southern Africa will require an accurate estimate of oral PrEP efficacy in this population. This information is critical for women in choosing this prevention strategy, and in public health policy making. Estimates of the efficacy of oral PrEP regimens containing tenofovir have varied widely across trials that enrolled women, with some studies reporting high efficacy and others reporting no efficacy. Although poor adherence is strongly associated with lack of efficacy, other factors, such as mode of transmission (sexual vs. parenteral), predominant HIV subtype (C vs. non-C), intensity of exposure, and percentage of stable serodiscordant couples, may also contribute to the variation in efficacy estimates. In this article, we evaluate the evidence for PrEP efficacy in women and propose potential explanations for the observed differences in efficacy among studies. Our review emphasizes the need to continue to refine estimates of efficacy and effectiveness of tenofovir-based oral PrEP so as to best develop the next generation of HIV prevention tools, and to inform public policies directed toward HIV prevention.
随着基于替诺福韦的口服暴露前预防（PrEP）方案被采纳为预防HIV的标准治疗方法，在南非女性中开展的临床试验中使用这些方案将需要准确估计该人群中口服PrEP的疗效。这些信息对于女性选择这种预防策略以及公共卫生政策制定至关重要。在纳入女性的各项试验中，含替诺福韦的口服PrEP方案的疗效估计差异很大，一些研究报告了高疗效，而另一些研究则报告无疗效。尽管依从性差与缺乏疗效密切相关，但其他因素，如传播方式（性传播与非性传播）、主要的HIV亚型（C型与非C型）、暴露强度以及稳定的血清学不一致伴侣的比例，也可能导致疗效估计的差异。在本文中，我们评估了女性中PrEP疗效的证据，并对研究中观察到的疗效差异提出了潜在解释。我们的综述强调需要继续完善基于替诺福韦的口服PrEP疗效和有效性的估计，以便最好地开发下一代HIV预防工具，并为针对HIV预防的公共政策提供信息。
