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

Am J Obstet Gynecol. 2004 Sep;191(3):985-92. doi: 10.1016/j.ajog.2004.05.061.

Abstract

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abnormalities, Drug-Induced / epidemiology*
  • Anti-Retroviral Agents / adverse effects*
  • Female
  • Gestational Age
  • Humans
  • Lamivudine / adverse effects
  • Maternal-Fetal Exchange*
  • Nelfinavir / adverse effects
  • Nevirapine / adverse effects
  • Pregnancy
  • Pregnancy Outcome*
  • Prospective Studies
  • Risk Factors
  • Stavudine / adverse effects
  • Zidovudine / adverse effects

Substances

  • Anti-Retroviral Agents
  • Lamivudine
  • Zidovudine
  • Nevirapine
  • Stavudine
  • Nelfinavir