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Infant exposure to ART during first trimester did not increase risk for birth defects
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No significant association was found between women who received antiretroviral therapy during their first trimester of pregnancy and risk of birth defects in their children, according to recent study findings published in The Pediatric Infectious Disease Journal.
Kelesitse Phiri, MS, ScD, of the department of epidemiology at Harvard School of Public Health, and colleagues evaluated 806 infants born to women with HIV between Jan. 1, 1994, and Dec. 31, 2009; 83% of which were exposed to ART during their mother’s pregnancy to determine if exposure was associated with birth defects.
Kelesitse Phiri
Thirty-three percent were exposed during the first trimester and 67% were exposed during the second or third trimesters. Only 17% of infants were not exposed to ART during their mother’s pregnancy. Early maternal prenatal care was more likely in patients who were exposed to ART during the first trimester compared with patients who were exposed during the second or third trimester or those not exposed.
Thirty-three malformations were identified, 31 of which were major birth defects. One patient was also identified as having major birth defects from 50 potential non-cases. Prevalence rate of major birth defects among the patients was 4% (95% CI, 2.6-5.3).
Patients exposed to ART in the first trimester did not have an increased risk of birth defects, overall or by drug class, compared with patients not exposed during the first trimester.
Patients never exposed to ARTs in utero had a lower prevalence of birth defects (2.2%) compared with those exposed during the first trimester (4.1%) or the second or third trimester (4.4%).
None of the 20 patients exposed to efavirenz (Sustiva, Bristol-Myers Squibb) had a birth defect (0%; 95% CI, 0.0-13.2).
“The data reflects real clinical practice in the United States, compared to other studies previously conducted in volunteers,” the researchers wrote. “While Medicaid recipients represent a disadvantaged, poorer population of the country, the program is the single largest source of health care coverage for people living with HIV and covers medical expenses for over 40% of all births in the nation. Future studies could combine several similar health care databases, for example Medicaid data from different states, to increase the study sample size and power to better define the safety boundaries for specific ARTs. In conclusion, our analysis did not detect an increased risk of birth defects associated with first trimester ART dispensing in a cohort of infants born to HIV-infected women enrolled in Medicaid.”
Disclosure: The study was funded in part by the Eunice Kennedy Shriver National Institute of Child and Human Development. The researchers report no relevant financial disclosures.
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