Service of Obstetrics, Department of Obstetrics and Gynecology, Faculty of Medicine, University Hospitals of Geneva, Geneva, Switzerland.
J Acquir Immune Defic Syndr. 2019 Mar 1;80(3):316-324. doi: 10.1097/QAI.0000000000001922.
To investigate the association between efavirenz (EFV) use during conception or first trimester (T1) of pregnancy and the occurrence of birth defects.
Seven observational studies of pregnant HIV-positive women across 13 European countries and Thailand.
Individual-level data were pooled on singleton pregnancies included in participating cohorts in 2002-2015. Birth defects were coded according to ICD-10 and the EUROCAT classification. We performed mixed-effects logistic regression models to assess the association between EFV exposure in utero and likelihood of birth defects.
We included 24,963 live births from 21,093 women. At conception, 30.2% (7537) women were on a non-EFV-based regimen, 4.8% (1200) on EFV, and 65% (16,226) were unexposed to antiretroviral therapy (ART). There were 412 infants with ≥1 birth defect, a prevalence of 1.65% (95% confidence interval: 1.50 to 1.82). Limb/musculoskeletal and congenital heart defects were the most common defects reported. Birth defects were present in 2.4%, 1.6%, and 1.3% of infants exposed to non-EFV, EFV, and unexposed to ART during conception/T1 (P = 0.135), respectively. The association between exposure to ART during conception/T1 and birth defects remained nonsignificant in adjusted analyses, as did exposure to EFV versus non-EFV (adjusted odds ratio 0.61; 95% confidence interval: 0.36 to 1.03, P = 0.067). Among the 21 birth defects in 19 infants on EFV, no neural tube defects were reported.
Prevalence of birth defects after exposure to EFV-based compared with non-EFV-based ART in conception/T1 was not statistically different in this multicohort study, and even lower. EFV is at least as safe as other ART drugs currently recommended for antenatal use.
研究在妊娠或妊娠早期（T1）使用依非韦伦（EFV）与出生缺陷发生之间的关联。
来自 13 个欧洲国家和泰国的 7 项观察性研究中，对 HIV 阳性孕妇的妊娠进行了研究。
对 2002-2015 年参与队列的单胎妊娠进行了个体水平数据汇总。出生缺陷按照 ICD-10 和 EUROCAT 分类进行编码。我们采用混合效应逻辑回归模型评估宫内 EFV 暴露与出生缺陷发生的相关性。
我们纳入了 21093 名女性的 24963 例活产儿。在妊娠时，30.2%（7537）的女性正在使用非 EFV 为基础的方案，4.8%（1200）的女性正在使用 EFV，65%（16226）的女性未接受抗逆转录病毒治疗（ART）。有 412 名婴儿患有≥1 种出生缺陷，患病率为 1.65%（95%置信区间：1.50 至 1.82）。报告的最常见缺陷为肢体/肌肉骨骼和先天性心脏缺陷。在妊娠/T1 时暴露于非 EFV、EFV 和未暴露于 ART 的婴儿中，出生缺陷的发生率分别为 2.4%、1.6%和 1.3%（P=0.135）。在调整分析中，妊娠/T1 时暴露于 ART 与出生缺陷之间的关联仍然无统计学意义，EFV 与非 EFV 之间的关联也是如此（调整后的优势比 0.61；95%置信区间：0.36 至 1.03，P=0.067）。在 19 名接受 EFV 治疗的婴儿的 21 种出生缺陷中，未报告神经管缺陷。
在这项多队列研究中，与妊娠/T1 时使用非 EFV 为基础的 ART 相比，EFV 为基础的 ART 暴露后出生缺陷的发生率没有统计学差异，甚至更低。EFV 至少与目前推荐用于产前使用的其他 ART 药物一样安全。
