Botswana Birth Outcomes Surveillance Extension

摘要 抗逆转录病毒治疗(ART)指南取决于怀孕期间的安全数据。虽然发达国家 已经转向基于多洛替格列韦(DTG)的非怀孕成人一线抗逆转录病毒药物，世界卫生组织 (世卫组织)在等待安全性数据期间，仍建议使用EFV/恩曲他滨/替诺福韦(TDF) DTG，这可能会协调怀孕和非怀孕成年人的指南。2016年6月，博茨瓦纳成为 非洲第一个将DTG/TDF/FTC作为成人，包括孕妇一线抗逆转录病毒治疗的国家。 这一变化发生在美国国立卫生研究院正在进行的8个地点的出生结局监测中 博茨瓦纳(R01HD080471)，旨在评估ART方案和 神经管缺陷按EFV暴露状态。这个监控系统已经提供了初步的安全数据 对于DTG的推出，并对特定奈韦拉平和洛匹那韦/利托那韦的安全性提出了担忧 孕期的“传统”艺术养生法。博茨瓦纳改为DTG/TDF/FTC，结合 政府计划从2018年开始让女性不再接受传统艺术，这为 这个监控系统。因此，我们正在申请新的R01，以继续(和改善)出生结果 博茨瓦纳的监控系统。我们的建议有以下主要目标：1)执行第一个大型分析 从受孕时起接触DTG后的不良生育结局和先天异常，以及 2)评估继续“传统”抗逆转录病毒疗法或改用DTG/TDF/FTC的妇女的分娩结局 怀孕前(或怀孕期间)。这些新颖的目标充分利用了博茨瓦纳独特的艺术景观。 (包括一项即将出台的停止女性传统艺术养生法的计划)，并建立在新兴的科学 来自我们高效监控系统的发现。这项研究产生的数据将对 更新世界卫生组织(和美国)关于孕妇使用抗逆转录病毒治疗的指南，以及可能 怀孕了。

Abstract Antiretroviral treatment (ART) guidelines depend upon safety data in pregnancy. Although developed countries have moved to dolutegravir (DTG)-based first-line ART for non-pregnant adults, the World Health Organization (WHO) still recommends efavirenz (EFV)/emtricitabine (FTC)/tenofovir (TDF) while awaiting safety data for DTG that may harmonize guidelines for pregnant and non-pregnant adults. In June 2016, Botswana became the first country in Africa to switch to DTG/TDF/FTC as first-line ART for adults, including pregnant women. This change occurred in the setting of ongoing NIH-supported birth outcomes surveillance at 8 sites throughout Botswana (R01HD080471), which was designed to evaluate adverse birth outcomes by ART regimen and neural tube defects by EFV exposure status. This surveillance system has already provided initial safety data for the DTG roll-out, and has raised concerns about the safety of specific nevirapine- and lopinavir/ritonavir- based “legacy” ART regimens in pregnancy. Botswana's change to DTG/TDF/FTC, combined with the government's plan to switch women off “legacy” ART starting in 2018, opens new scientific opportunities for this surveillance system. We are therefore applying for a new R01 to continue (and enhance) birth outcomes surveillance in Botswana. Our proposal has the following primary aims: 1) to perform the first large analysis of adverse birth outcomes and congenital abnormalities following DTG exposure from the time of conception, and 2) to evaluate birth outcomes among women who either continue “legacy” ART or switch to DTG/TDF/FTC prior to (or during) pregnancy. These novel aims take advantage of the unique ART landscape in Botswana (including an upcoming plan to switch women off legacy ART regimens), and build on the emerging scientific findings from our highly productive surveillance system. Data generated from this study will be critical for updating WHO (and US) guidelines for the use of ART among pregnant women, and for women who may become pregnant.