March 05, 2013
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Birth defects linked to ART use in first trimester

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ATLANTA — Antiretroviral therapy in utero is associated with birth defects, according to findings in a paper presented at the 2013 Conference on Retroviruses and Opportunity Infections.

The large prospective study examined 13,124 live births from 1994 to 2010 by HIV-positive women. Birth defects were studies using the EUROCAT and MACDP classifications.

Researchers found the prevalence of birth defects was 4.4% (95% CI, 4.0-4.7) according to EUROCAT and 7% (95% CI, 6.5-7.4) according to MACDP. Minor defects were included when two or more were present in the same child.

Exposure to efavirenz in the first trimester was associated with neurological defects (adjusted OR=3.15; 95% CI, 1.09-9.09), according to researchers. They also found that zidovudine use in the first trimester is associated with congenital heart defects (aOR=2.34; 95% CI, 1.39-3.94). Didanosine use in the first trimester was connected with head and neck birth defects (aOR=2.89; 95% CI, 1.03-8.11). Researchers said didanosine is rarely prescribed during pregnancy.

Jeanne Sibiude, MD 

Jeanne Sibiude

Lamivudine in the first trimester was associated with minor musculoskeletal and head and neck defects, and indinavir (Crixivan, Merck) was not associated with any specific defects.

“These results do not imply that a direct causal relation exists in ART drugs and the risk of birth defects,” Jeanne Sibiude, MD, MSc, of Louis Mourier Hospital in Colombes, France, said during a press conference. “These data do not alter the importance and benefits [of these drugs] in countries where there are no alternative therapies available, but they encourage us to develop different and new therapeutic strategies, as well as continuing neurological surveillance.”

For more information:

Sibiude J. #81. Presented at: 2013 Conference on Retroviruses and Opportunistic Infections; March 3-6, 2013; Atlanta.

Disclosure: The researchers reported no relevant financial disclosures.