Birth Outcomes Surveillance in Botswana

描述（由申请人提供）：世界卫生组织指南推荐阿特里普拉(Efavirenz (EFV) /恩曲他滨（FTC) /替诺福韦（TDF））用于抗逆转录病毒治疗（ART），包括在妊娠的所有三个月。由于早期灵长类动物数据和有限的人类报告对EFV引起神经管缺陷（NTDs）的担忧，迄今为止，在妊娠前三个月使用EFV的情况很少见，并且很少有数据可以保证目前世卫组织的建议不会对ntd造成轻微的风险增加。此外，关于Atripla对其他出生结局（如早产、小于胎龄儿、先天性异常、死产和新生儿死亡）的影响的数据有限。因此，我们计划建立一个全国性的监测系统，对博茨瓦纳50%的新生儿进行监测，并研究Atripla对不良出生结果和被忽视热带病发病率的影响。博茨瓦纳最近修改了国家指导方针，允许将Atripla用于治疗和预防艾滋病毒感染妇女之间的母婴艾滋病毒传播。这一指南的改变使我们能够捕捉Atripla的推出期，并比较EFV暴露和其他ART方案暴露的结果。在进行这项监测的过程中，我们还将确定艾滋病毒感染和未感染艾滋病毒的妇女所生婴儿中被忽视热带病和其他临床重要先天性异常的基线率。博茨瓦纳是建立这一监测的理想环境，因为从受孕开始就接触抗逆转录病毒药物的人数众多（我们预计将是目前全世界接触抗逆转录病毒药物的记录结果数量的三倍以上），在产科病房分娩的妇女比例很高，以及之前对全国33,000多例分娩的成功监测研究。本研究的综合目的是全面了解在怀孕期间使用Atripla与其他ART方案相比的风险。

DESCRIPTION (provided by applicant): World Health Organization guidelines recommend Atripla (Efavirenz (EFV) / Emtricitabine (FTC) / Tenofovir (TDF)) for antiretroviral treatment (ART), including during all trimesters of pregnancy. Because of concerns for neural tube defects (NTDs) with EFV from early primate data and from limited human reports, EFV use in the first trimester of pregnancy has been rare to date, and few data exist to provide reassurance that the current WHO recommendations do not pose a small increased risk for NTDs. In addition, limited data are available regarding the effect of Atripla on other birth outcomes such as preterm delivery, small for gestational age infants, congenital abnormalities, stillbirths, and neonatal deaths. We therefore plan to create a nationwide surveillance system to capture 50% of births that occur in Botswana, and to study the effect of Atripla on adverse birth outcomes and on the rate of NTDs. National guidelines in Botswana have recently changed to allow Atripla use for both treatment and for the prevention of mother- to-child HIV transmission among HIV-infected women. This guideline change allows us to capture the rollout period for Atripla, and to compare outcomes for both EFV exposures and other ART regimen exposures from conception. In the process of performing this surveillance, we will also establish baseline rates of NTDs and other clinically important congenital abnormalities among infants born to HIV-infected and HIV-uninfected women. Botswana is an ideal setting to establish this surveillance because of the large number of ART exposures from conception (we expect to more than triple the current number of documented outcomes with EFV exposure worldwide), the high percentage of women delivering at maternity wards, and a successful previous surveillance study of over 33,000 births throughout the country. The combined aims of this study will provide a comprehensive understanding of the risks of using Atripla compared with other ART regimens during pregnancy.