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HIV drug is safe in pregnancy

Babies of HIV-infected mums on tenofovir remained negative without adverse effects

Louise Prime

Wednesday, 16 May 2012

Babies of HIV-infected women who took the antiretroviral drug tenofovir during pregnancy remained HIV-negative and were no more likely than unexposed babies to die perinatally or suffer congenital defects or other adverse outcomes, a UK-led study has found. The research published today in PLoS Medicine showed that none of the surviving babies tested was HIV-positive.

During a study of more than 3000 adults taking part in a study of antiretroviral therapy (ART) in Uganda and Zimbabwe, 302 HIV-infected women had 382 pregnancies between them. Researchers gathered data on the medicines that these women took during pregnancy, and monitored the health of the babies subsequently born alive, for up to 4 years.

They found that outcomes in babies whose mothers took ART including tenofovir while pregnant, were not significantly different from outcomes in babies not exposed antenatally to tenofovir. Among the 226 live-born babies, rates of congenital abnormality, prematurity, low birthweight and death soon after birth were not significantly increased in infants exposed to the drug.

The one-year mortality of 182 babies enrolled in a follow-up study was 5% – similar, say the authors, to the 2% to 4% normally seen in the region, and much lower than the rate among babies born to severely HIV-infected mothers who are untreated. None of the surviving children tested were positive for HIV. In addition, none suffered bone fractures or kidney problems, and none showed any effect on their growth by 2 years.

The study authors wrote: “We observed no evidence that tenofovir versus non-tenofovir ART had any adverse effects on pregnancy outcomes or on congenital, renal, bone, or growth abnormalities up to age 4 y among children born to women with severe HIV immunodeficiency at ART initiation and exposed throughout the intrauterine period.”

They acknowledged that larger, longer-term studies are needed into the safety of pre-exposure prophylaxis, but concluded: “These findings support the use of tenofovir-containing ART during pregnancy among HIV-positive African women, and suggest that it could also be used to prevent women of child-bearing age acquiring HIV-infection heterosexually.”

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