Tenofovir safe for HIV-positive pregnant mothers

Tenofovir, the anti-HIV drug, is safe to use during pregnancy according to a new study published in PloS Medicine. The researchers, led by Diana Gibb from the MRC Clinical Trials Unit in London, UK, found that the drug does not increase the risk of kidney problems, birth defects or growth abnormalities in infants born to HIV-positive women in Africa. The team examined data from the Development of AntiRetroviral Therapy of Africa (DART) trial in order to determine what affect Antiretroviral therapy (ART - a combination of anti-HIV drugs) had on infants born to Ugandan and Zimbabwean HIV-positive women who took ART during pregnancy. The majority of women the team examined were taking a tenofovir-containing combination of anti-HIV drugs before and throughout their pregnancies. After comparing infants exposed and not exposed to tenofovir-containing ART during pregnancy, the researchers found that that out of the 226 live births, there was no increase in the proportion of infants who died shortly after birth (3%) or had birth defects (3%). In a follow-up study, the team found that 14 of the 182 surviving infants died - giving a one-year mortality rate of 5%. This figure is comparable to the normal infant mortality rate in the region (2-4%), and significantly lower than infants born to severely HIV-Infected untreated mothers. In addition, none of the surviving infants were HIV-positive, none suffered kidney problems or bone fractures during follow-up and the researchers found no effect on growth at two years. The researchers explained: "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 among children born to women with severe HIV immunodeficiency at ART initiation and exposed throughout the intrauterine period. Our findings suggest tenofovir-containing ART is a reasonable choice in pregnancy and that tenofovir pre-exposure prophylaxis is also reasonable for women who are at high risk of seroconverting during pregnancy." They conclude: "Detailed safety of tenofovir for pre-exposure prophylaxis will need confirmation from longer term follow-up of larger numbers of exposed children."