TY - JOUR
T1 - Assessing the risk of birth defects associated with antiretroviral exposure during pregnancy
AU - Heather Watts, D.
AU - Covington, Deborah L.
AU - Beckerman, Karen
AU - Garcia, Patricia
AU - Scheuerle, Angela
AU - Dominguez, Kenneth
AU - Ross, Brenda
AU - Sacks, Susan
AU - Chavers, Scott
AU - Tilson, Hugh
N1 - Funding Information:
The Antiretroviral Pregnancy Registry is supported by: Abbott Laboratories; Agouron Pharmaceuticals, Inc, a Pfizer Company; Boehringer Ingelheim Pharmaceuticals, Inc; Bristol-Myers Squibb Company; Gilead Sciences, Inc; GlaxoSmithKline; F. Hoffmann-La Roche, Ltd; Merck & Co, Inc.
PY - 2004/9
Y1 - 2004/9
N2 - 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.
AB - 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.
KW - Anti-retroviral therapy
KW - Birth Defects
KW - HIV
KW - Pregnancy
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U2 - 10.1016/j.ajog.2004.05.061
DO - 10.1016/j.ajog.2004.05.061
M3 - Article
C2 - 15467577
AN - SCOPUS:4644291083
SN - 0002-9378
VL - 191
SP - 985
EP - 992
JO - American journal of obstetrics and gynecology
JF - American journal of obstetrics and gynecology
IS - 3
ER -