Risk of birth defects associated with nelfinavir exposure during pregnancy.
OBJECTIVE
The objective of this study was to examine the human teratogenic risk of the protease inhibitor, nelfinavir mesylate, used to treat human immunodeficiency virus.


METHODS
This study used a subset of data from the Antiretroviral Pregnancy Registry, which was designed to monitor prenatal exposures to antiretroviral therapy and detect a potential increase in the risk of birth defects. The registry uses a prospective exposure-registration cohort design. All records of pregnant women exposed to nelfinavir, used alone or in combination, were extracted and analyzed. The prevalence of birth defects was compared with the Centers for Disease Control and Prevention's (CDC) population-based surveillance system.


RESULTS
Through July 2002, the registry had monitored 915 live births exposed to nelfinavir. Among 301 first-trimester exposures, there were 9 birth defects, for a prevalence of 3% (95% confidence interval 1.4, 5.6). This rate is not significantly different from the CDC's system, which had a prevalence of 3.1 per 100 live births (95% confidence interval 3.1, 3.2; P =.99). There was no consistent pattern among reported birth defects.


CONCLUSIONS
Adequate numbers of first-trimester exposures to nelfinavir have been monitored to detect a 2-fold increase in the prevalence of overall birth defects. No such increases have been detected when compared with the CDC rate. However, the numbers are not sufficient to detect any increased rate of specific defects. Although nelfinavir should only be used in pregnancy if the benefits outweigh the potential risks, the findings from this study should provide some assurance.


METHODS
III
Covington
Deborah L
DL
Inveresk, 1011 Ashes Drive, Wilmington, NC 28405, USA. deborah.covington@inveresk.com
Conner
Susan D
SD
Doi
Peggy A
PA
Swinson
Jayme
J
Daniels
Elaine M
EM
D000014:Abnormalities, Drug-Induced / Q000453:epidemiology*; D019380:Anti-HIV Agents / Q000627:therapeutic use / Q000633:toxicity*; D001724:Birth Weight; D015331:Cohort Studies; D005260:Female; D005865:Gestational Age; D015658:HIV Infections / Q000188:drug therapy; D017320:HIV Protease Inhibitors / Q000627:therapeutic use / Q000633:toxicity*; D006801:Humans; D007231:Infant, Newborn; D019888:Nelfinavir / Q000627:therapeutic use / Q000633:toxicity*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy; D011256:Pregnancy Outcome / Q000453:epidemiology*; D015995:Prevalence; D011446:Prospective Studies; D012042:Registries / Q000706:statistics & numerical data*; D012306:Risk
D019380:Anti-HIV Agents; D017320:HIV Protease Inhibitors; D019888:Nelfinavir