The safety of antiretroviral drugs in pregnancy.

Advances in HIV therapy and mother-to-child transmission (MTCT) prophylaxis have led to increasing use of antiretroviral drugs in pregnancy. Highly active antiretroviral therapy in pregnancy has been associated with prematurity, pre-eclampsia and gestational diabetes. Women may be at increased risk of nevirapine-associated hepatotoxicity but whether or not pregnancy is an additional risk is uncertain. Although animal studies suggest a possibility of congenital abnormalities with specific antiretrovirals, such as efavirenz, results from registries and cohort studies do not support an excess of congenital malformations associated with in utero antiretroviral exposure. Concerns regarding the health of uninfected, antiretroviral-exposed children include the potential for cancers, mitochondrial disease and haematological abnormalities. However, the absence of any excess mortality in large observational cohort studies of uninfected, antiretroviral therapy-exposed children born to HIV-infected women is reassuring. Based on current knowledge, the immense benefits of antiretroviral prophylaxis in reducing the risk of MTCT, far outweigh the potential for adverse effects.