Assessing the risk of birth defects associated with antiretroviral exposure during pregnancy.
OBJECTIVE
The purpose of this study was to examine teratogenic risk of antiretroviral (ARV) drugs.


METHODS
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.


CONCLUSIONS
APR data demonstrate no increase in prevalence of birth defects overall or among women exposed to lamivudine, nelfinavir, nevirapine, stavudine, and zidovudine.
Pediatric, Adolescent, and Maternal AIDS Branch, National Institute of Child Health and Human Development, NIH, Bethesda, Md 20892, USA. hw59i@nih.gov
D Heather
DH
Watts
Deborah L
DL
Covington
Karen
K
Beckerman
Patricia
P
Garcia
Angela
A
Scheuerle
Kenneth
K
Dominguez
Brenda
B
Ross
Susan
S
Sacks
Scott
S
Chavers
Hugh
H
Tilson
D000014:Abnormalities, Drug-Induced / Q000453:epidemiology*; D044966:Anti-Retroviral Agents / Q000009:adverse effects*; D005260:Female; D005865:Gestational Age; D006801:Humans; D019259:Lamivudine / Q000009:adverse effects; D008431:Maternal-Fetal Exchange; D019888:Nelfinavir / Q000009:adverse effects; D019829:Nevirapine / Q000009:adverse effects; D011247:Pregnancy; D011256:Pregnancy Outcome; D011446:Prospective Studies; D012307:Risk Factors; D018119:Stavudine / Q000009:adverse effects; D015215:Zidovudine / Q000009:adverse effects
D044966:Anti-Retroviral Agents; D019259:Lamivudine; D015215:Zidovudine; D019829:Nevirapine; D018119:Stavudine; D019888:Nelfinavir