Monitoring birth defects among HIV positive, ART exposed pregnant women: 20 years of antiretroviral pregnancy registry data
Presented by Vani Vannappagari (United States).
V. Vannappagari1, J. Albano2, H. Tilson3, A. Scheuerle4, K. Beckerman5, D. Seekins6, S. Storfer7, N. David8, H. Watts9
1GlaxoSmithKline, WorldWideEpidemiology, Research Triangle Park, United States, 2Kendle International Inc, Durham, United States, 3UNC School of Public Health, Chapel Hill, United States, 4Tesserae Genetics, Dallas, United States, 5Albert Einstein College of Medicine, Bronx, United States, 6Bristol-Myers Squibb Company, Plainsboro, United States, 7Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, United States, 8Aurobindo Pharma Ltd., Dayton, United States, 9National Institutes of Health, Bethesda, Uruguay
Background: Antiretroviral (ARV) therapy has been instrumental in reducing mother to child transmission of HIV. The Antiretroviral Pregnancy Registry (APR) is an ongoing international registry that monitors prenatal exposures to ARV drugs to detect potential increase in risk for birth defects through prospective exposure-registration cohort
Methods: Clinicians prospectively register pregnant women with prenatal exposures to any ARV before the outcome is known, report data on exposure throughout pregnancy, and provide birth outcome data. Birth defect prevalence is compared to both internal and external comparator groups. The external comparator is a population-based surveillance system and internal comparators include exposures during 2nd or 3rd trimester of pregnancy relative to 1st trimester. Statistical inference is based on exact methods for binomial proportions. APR has 80% power and Type 1 error rate of 5% to detect doubling of risk for overall birth defects
Results: From January 1989 through July 2009, the APR has monitored 10803 live births exposed to ARV with 288 birth defects identified for an overall prevalence of 2.7 defects per 100 live births (95% CI 2.4-3.0). Among the 4702 first trimester ARV exposures, 134 outcomes with defects were reported for a prevalence of 2.8% (95% CI: 2.4-3.4). This rate is not significantly different from the population based surveillance system (2.7%, 95% CI=2.68-2.76) or the internal comparator of 2nd/3rd trimester exposures (2.5%, 95% CI=2.2-3.0) (prevalence ratio1.14, 95% CI=0.90-1.43).
Conclusions: For overall population exposed to ARVs in this Registry, no increases in risk of overall birth defects or specific defects have been detected to-date when compared with observed rates in population-based birth defects surveillance systems or when 1st trimester ARV exposure rates are compared to those with second or third trimester exposure. In analyzing individual drugs with sufficient data to warrant separate analysis, no increases in risk of concern have been detected.
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