Department of Epidemiology, Fielding School of Public Health, University of California, Los Angeles, CA, USA.
Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.
J Int AIDS Soc. 2020 Jan;23(1):e25426. doi: 10.1002/jia2.25426.
HIV incidence is high during pregnancy and breastfeeding with HIV acquisition risk more than doubling during pregnancy and the postpartum period compared to when women are not pregnant. The World Health Organization recommends offering pre-exposure prophylaxis (PrEP) to pregnant and postpartum women at substantial risk of HIV infection. However, maternal PrEP national guidelines differ and most countries with high maternal HIV incidence are not offering PrEP. We conducted a systematic review of recent research on PrEP safety in pregnancy to inform national policy and rollout.
We used a standard Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) approach to conduct a systematic review by searching for completed, ongoing, or planned PrEP in pregnancy projects or studies from clinicaltrials.gov, PubMed and NIH RePORTER from 2014 to March 2019. We performed a systematic review of studies that assess tenofovir disoproxil fumarate (TDF)-based oral PrEP safety in pregnant and breastfeeding HIV-uninfected women.
We identified 14 completed (n = 5) and ongoing/planned (n = 9) studies that evaluate maternal and/or infant outcomes following PrEP exposure during pregnancy or breastfeeding. None of the completed studies found differences in pregnancy or perinatal outcomes associated with PrEP exposure. Nine ongoing studies, to be completed by 2022, will provide data on >6200 additional PrEP-exposed pregnancies and assess perinatal, infant growth and bone health outcomes, expanding by sixfold the data on PrEP safety in pregnancy. Research gaps include limited data on (1) accurately measured PrEP exposure within maternal and infant populations including drug levels needed for maternal protection; (2) uncommon perinatal outcomes (e.g. congenital anomalies); (3) infant outcomes such as bone growth beyond one year following PrEP exposure; (4) outcomes in HIV-uninfected women who use PrEP during pregnancy and/or lactation.
Expanding delivery of PrEP is an essential strategy to reduce HIV incidence in pregnancy and breastfeeding women. Early safety studies of PrEP among pregnant women without HIV infection are reassuring and ongoing/planned studies will contribute extensive new data to bolster the safety profile of PrEP use in pregnancy. However, addressing research gaps is essential to expanding PrEP delivery for women in the context of pregnancy.
怀孕期间艾滋病毒发病率较高，与非妊娠时期相比，怀孕期间和产后感染艾滋病毒的风险增加一倍以上。世界卫生组织建议为艾滋病毒感染风险高的孕妇和产后妇女提供暴露前预防（PrEP）。然而，各国的孕产妇 PrEP 国家指南不同，而且大多数艾滋病毒发病率高的国家并未提供 PrEP。我们对最近关于妊娠期间 PrEP 安全性的研究进行了系统综述，以为国家政策和推广提供信息。
我们使用标准的系统评价和荟萃分析（PRISMA）方法，从 2014 年至 2019 年 3 月，在 clinicaltrials.gov、PubMed 和 NIH RePORTER 上搜索已完成、正在进行或计划进行的妊娠 PrEP 项目或研究，对 PrEP 在妊娠期间的安全性进行了系统评价。我们对评估替诺福韦二吡呋酯（TDF）为基础的口服 PrEP 在感染艾滋病毒的孕妇和哺乳期妇女中的安全性的研究进行了系统评价。
我们确定了 14 项已完成（n=5）和正在进行/计划（n=9）的研究，这些研究评估了在妊娠或哺乳期暴露于 PrEP 后母婴结局。没有一项已完成的研究发现 PrEP 暴露与妊娠或围产期结局相关的差异。9 项正在进行的研究将于 2022 年完成，将提供超过 6200 例额外的 PrEP 暴露妊娠的数据，并评估围产期、婴儿生长和骨骼健康结局，将妊娠期间 PrEP 安全性的数据扩大六倍。研究空白包括：（1）在母婴人群中准确测量 PrEP 暴露情况，包括母婴保护所需的药物水平；（2）罕见的围产期结局（例如先天畸形）；（3）婴儿结局，例如 PrEP 暴露后一年以上的骨骼生长；（4）在怀孕期间和/或哺乳期使用 PrEP 的未感染艾滋病毒的妇女的结局。
扩大 PrEP 的提供是减少妊娠和哺乳期妇女艾滋病毒发病率的重要策略。对未感染艾滋病毒的孕妇使用 PrEP 的早期安全性研究令人感到欣慰，正在进行的/计划中的研究将提供大量新数据，以支持 PrEP 在妊娠期间使用的安全性。然而，解决研究空白对于在妊娠期间扩大 PrEP 的提供至关重要。
