White A, Eldridge R, Andrews E, Elkins M; National Conference on Human Retroviruses and Related Infections.
Program Abstr Second Natl Conf Hum Retrovir Relat Infect Natl Conf Hum Retrovir Relat Infect 2nd 1995 Wash DC. 1995 Jan 29-Feb 2; 124.
Burroughs Wellcome Co, Research Triangle Park, NC.
Introduction: The recent release of zidovudine for the prevention of maternal-infant transmission of HIV will result in increased numbers of fetal exposures. Any potential risk of adverse events associated with the use of antiretrovirals during pregnancy must be assessed. Data through June 1994 are reported from the Antiretroviral Pregnancy Registry on the incidence of structural birth defects. Methods: The Zidovudine in Pregnancy Registry, established by Burroughs Wellcome Co. in 1989 in collaboration with the CDC as an international registry, was expanded in 1993 to include zalcitabine with co-management by Hoffmann-LaRoche Inc. Physicians register pregnant women prior to delivery, providing information on HIV disease stage, dosage, length of therapy and trimester of exposure. Follow-up is at time of delivery. Results are reviewed semi- annually by an Advisory Committee, and the registry follows CDC guidelines for definitions of birth defects. Results: From 1989 through June 30, 1994, 65 first-trimester exposures to zidovudine were reported. Birth defects were reported in 1 infant (agenesis of right kidney), 55 infants had no defects; 8 induced and 1 spontaneous abortion were reported. Of 79 second- and third-trimester exposures, 4 infants had defects (pectus excavatum, atrial septal defect, fetal alcohol syndrome, and small muscular VSD with multiple minor abnormalities) and 75 infants had no defects. Conclusion: Based on these preliminary findings from the Antiretroviral Pregnancy Registry, the observed proportion of infants with defects does not appear to differ from that expected in the general population, and no pattern of defects has been observed. The sample size (144) is limited, however, and the registry must continue to monitor for possible teratogenicity.
Publication Types:
Keywords:
- Accidents
- Female
- HIV Infections
- Humans
- Infant
- Lamivudine
- Maternal-Fetal Exchange
- Pregnancy
- Pregnancy Complications
- Pregnancy Outcome
- Pregnancy Trimester, First
- Registries
- Zalcitabine
- Zidovudine
- abnormalities
- injuries
Other ID:
UI: 102213359
From Meeting Abstracts