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Assessing the risk of birth defects associated with antiretroviral exposure during pregnancy
D Heather Watts1, Deborah L Covington, Karen Beckerman
1Pediatric, Adolescent, and Maternal AIDS Branch, National Institute of Child Health and Human Development, NIH, Bethesda, Md 20892, USA. hw59i@nih.gov
Objective:
The purpose of this study was to examine teratogenic risk of antiretroviral (ARV) drugs.
Study Design:
The Antiretroviral Pregnancy Registry (APR) monitors prenatal exposures to ARV drugs and pregnancy outcome through a prospective exposure-registration cohort. Statistical inference uses exact methods for binomial proportions.
Results:
Through July 2003, APR has monitored 3583 live births exposed to ARV. Among 1391 first trimester exposures, there were 38 birth defects, prevalence of 2.7% (95% CI 1.9-3.7), not significantly higher than the CDC's population surveillance rate, 3.1 per 100 live births (95% CI 3.1-3.2). For lamivudine, nelfinavir, nevirapine, stavudine, and zidovudine, sufficient numbers of live births (>200) following first-trimester exposures have been monitored to allow detection of a 2-fold increase in risk of birth defects overall; no increases have been detected.
Conclusion:
APR data demonstrate no increase in prevalence of birth defects overall or among women exposed to lamivudine, nelfinavir, nevirapine, stavudine, and zidovudine.
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