The Antiretroviral Pregnancy Registry: 30 Years of Monitoring for Congenital Anomalies [OP04-6D

Abstract

INTRODUCTION: Antiretroviral (ARV) treatment saves lives and prevents vertical transmission of HIV. The Antiretroviral Pregnancy Registry (APR) began prospectively monitoring prenatal ARV use for potential teratogenicity in 1989 and depends on voluntary registration of ARV exposed pregnancies (www.APRegistry.com). METHODS: The APR is an IRB approved, prospective exposure-registration cohort study with data from 70 countries. Prevalence of congenital anomalies (CAs) are estimated and compared to internal and external comparison groups. Twenty-two ARVs have sufficient 1st trimester exposures to detect at least a 2-fold increase in risk of CAs overall, of which 11 can detect a 1.5-fold increase. RESULTS: Of the 20,759 pregnancies prospectively enrolled through 31 July 2019, reported outcomes include 19,642 live births (LB) with ARV exposure at any time during pregnancy and 554 CAs. Prevalence of CAs was 2.8% (95% CI 2.6-3.1) overall, 2.8% (95% CI 2.5-3.1) among 1st trimester exposures and 2.8% (95% CI 2.5-3.2) among 2nd/3rd trimester exposures to ARVs (prevalence ratio 1.00 [95% CI 0.85-1.18]). CONCLUSION: The APR has not detected a significant difference in overall CA prevalence compared to two population based surveillance systems: 2.72/100 LB (95% CI 2.68-2.76) Metropolitan Atlanta Congenital Defects Program (MACDP) and 4.17/100 LB (95% CI 4.15-4.19) Texas Birth Defects Registry (TBDR). Two ARVs, didanosine and nelfinavir, have modest statistically significant increased prevalence compared to MACDP but not TBDR. The APR independent Advisory Committee concludes, “The Registry finds no apparent increases in frequency of specific defects with first trimester exposures and no pattern to suggest a common cause; however, potential limitations of registries should be recognized.”