Assessing the risk of birth defects associated with antiretroviral exposure during pregnancy

D. Heather Watts, Deborah L. Covington, Karen Beckerman, Patricia Garcia, Angela Scheuerle, Kenneth Dominguez, Brenda Ross, Susan Sacks, Scott Chavers, Hugh Tilson

Research output: Contribution to journalArticlepeer-review

49 Scopus citations


The purpose of this study was to examine teratogenic risk of antiretroviral (ARV) drugs. 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. 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. APR data demonstrate no increase in prevalence of birth defects overall or among women exposed to lamivudine, nelfinavir, nevirapine, stavudine, and zidovudine.

Original languageEnglish (US)
Pages (from-to)985-992
Number of pages8
JournalAmerican journal of obstetrics and gynecology
Issue number3
StatePublished - Sep 2004


  • Anti-retroviral therapy
  • Birth Defects
  • HIV
  • Pregnancy

ASJC Scopus subject areas

  • General Medicine
  • Obstetrics and Gynecology


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