Teratogenicity risk of antiretroviral therapy in pregnancy.

Highly active antiretroviral regimens are recommended for use in pregnancy to prevent vertical transmission of HIV, and many women enter pregnancy already on these regimens for their own health. Sources of data on the potential teratogenicity of antiretroviral drugs include animal studies, cohort studies, the Antiretroviral Pregnancy Registry, and case reports, but data on newly approved drugs are often limited. Thus far, concerns have been identified regarding a potential association between first trimester efavirenz exposure and neural tube defects based on a study in monkeys and case reports in humans, a possible association between first trimester exposure to zidovudine and an increased risk of hypospadias based on one cohort study, and an increased risk of septal heart defects in animals with delavirdine. Additional data on risks of antiretrovirals during pregnancy are needed. Providers should report cases of antiretroviral drug exposures during pregnancy to the Antiretroviral Pregnancy Registry.