Real World & Late Phase, Syneos Health, Morrisville, North Carolina, USA.
Department of Pediatrics, Division of Genetics and Metabolism, University of Texas Southwestern, Dallas, Texas, USA.
Pharmacoepidemiol Drug Saf. 2024 Jun;33(6):e5801. doi: 10.1002/pds.5801.
Antiretrovirals (ARVs) are life-saving drugs used for the treatment and prevention of HIV infection and antiviral drugs (AVs) for the treatment of chronic HBV infection. ARVs have proven highly effective in reducing perinatal HIV transmission, however the risk of birth defects from prenatal exposure to ARVs/AVs is an ongoing concern. The Antiretroviral Pregnancy Registry (APR), an international, prospective exposure-registration cohort study, monitors ARV and AV use in pregnancy for early signals of teratogenicity. This communication reports results of 30-years' experience of ARV/AV exposure during pregnancy and lessons learned through continuous quality improvement.
Birth defect prevalence is estimated and compared to internal and external groups. Statistical inference is based on exact methods for binomial proportions. Between 2006 and 2023, cumulative enrollment more than tripled from 6893 to 25 960 pregnancies and ARVs/AVs monitored increased from 29 to 222. Through January 2023, there were 21 636 live births and 631 outcomes with birth defects, for overall prevalence of 2.9/100 live births (95% CI 2.7, 3.2). The birth defect prevalence was 3.0% (95% CI 2.7%, 3.3%) among first trimester exposures and 2.8% (95% CI 2.5%, 3.2%) among second/third trimester exposures (prevalence ratio 1.04 [95% CI 0.89, 1.21]).
Birth defect prevalence is not statistically significantly different between first trimester ARV/AV pregnancy exposures compared to second/third trimester exposures and is also not different from two population-based surveillance systems: 2.72/100 live births reported in the Metropolitan Atlanta Congenital Defects Program (MACDP); and 4.17/100 live births from the Texas Birth Defects Registry (TBDR).
抗逆转录病毒药物（ARV）是用于治疗和预防 HIV 感染的救命药物，抗病毒药物（AV）用于治疗慢性乙型肝炎病毒感染。ARV 已被证明在降低围产期 HIV 传播方面非常有效，然而，产前暴露于 ARV/AV 导致出生缺陷的风险仍然是一个持续存在的问题。抗逆转录病毒妊娠登记处（APR）是一个国际性的、前瞻性的暴露登记队列研究，监测妊娠期间 ARV 和 AV 的使用情况，以早期发现致畸性信号。本通讯报告了 30 年来在妊娠期间暴露于 ARV/AV 的经验以及通过持续质量改进获得的经验教训。
估计出生缺陷的患病率，并与内部和外部组进行比较。统计推断基于二项式比例的精确方法。2006 年至 2023 年期间，累积入组人数从 6893 例增加到 25960 例，监测的 ARV/AV 从 29 种增加到 222 种。截至 2023 年 1 月，共有 21636 例活产和 631 例出生缺陷结局，总患病率为 2.9/100 活产（95%CI 2.7，3.2）。在第一孕期暴露中，出生缺陷的患病率为 3.0%（95%CI 2.7%，3.3%），在第二/第三孕期暴露中为 2.8%（95%CI 2.5%，3.2%）（患病率比 1.04[95%CI 0.89，1.21]）。
第一孕期 ARV/AV 妊娠暴露与第二/第三孕期暴露相比，出生缺陷的患病率无统计学显著差异，也与两个基于人群的监测系统无差异：亚特兰大都市先天性缺陷计划（MACDP）报告的活产儿 2.72/100；德克萨斯州出生缺陷登记处（TBDR）报告的活产儿 4.17/100。
