Botswana Birth Outcomes Surveillance Extension

博茨瓦纳出生结果监测扩展

• 批准号: 10001130
• 负责人: Roger L Shapiro
• 金额: $ 19.06万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-03 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10001130
• 关键词: Adult; Africa; African; Birth; Botswana; Childhood Acute Lymphocytic Leukemia; Conceptions; Congenital Abnormality; Country; Data; Data Set; Developed Countries; Exposure to; Government; Guidelines; HIV; HIV Infections; Hospitals; Incidence; Individual; Infant; Lead; Lopinavir/Ritonavir; Neural Tube Defects; Nevirapine; Outcome; Policies; Pregnancy; Pregnant Women; Premature Birth; Randomized Clinical Trials; Regimen; Reporting; Research; Risk; Risk Estimate; Safety; Signal Transduction; Site; Small for Gestational Age Infant; System; Tenofovir; Time; Treatment Protocols; United States National Institutes of Health; Update; Woman; World Health Organization; adverse birth outcomes; adverse outcome; antiretroviral therapy; base; design; early pregnancy; efavirenz; emtricitabine; infant outcome; neonatal death; novel; pregnant; programs; randomized trial; stillbirth; surveillance data; treatment guidelines; treatment program

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.

摘要 抗逆转录病毒治疗（ART）指南取决于怀孕期间的安全性数据。虽然发达国家 已转移到基于dolutegravir（DTG）的非妊娠成人一线ART，世界卫生组织 (WHO)仍然推荐依法韦仑（EFV）/恩曲他滨（FTC）/替诺福韦（TDF），同时等待 DTG可以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）一线抗逆转录病毒疗法的国家。 这一变化发生在美国国立卫生研究院支持的8个研究中心的出生结局监测中。 博茨瓦纳（R 01 HD 080471），旨在评价ART方案的不良出生结局， EFV暴露状态下的神经管缺陷。这个监测系统已经提供了初步的安全数据 对于DTG的推出，并提出了对特定奈韦拉平和洛匹那韦/利托那韦的安全性的担忧， 基于“传统”的抗逆转录病毒疗法。博茨瓦纳改为DTG/TDF/FTC， 政府计划从2018年开始将女性从“传统”ART中剔除，为女性提供新的科学机会。 这个监控系统。因此，我们正在申请一个新的R 01，以继续（和提高）生育结果 博茨瓦纳的监控我们的建议有以下主要目标：1）进行第一次大型分析， 从受孕开始暴露于DTG后的不良出生结局和先天性畸形，以及 2)评价继续“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）。这些新颖的目标利用了博茨瓦纳独特的艺术景观 （包括即将推出的将女性从传统的ART方案中剔除的计划），并建立在新兴的科学基础上。 从我们高效的监控系统中得到的发现本研究生成的数据对于以下方面至关重要： 更新世卫组织（和美国）关于孕妇使用抗逆转录病毒疗法的指南， 怀孕了