A recent study based on women in Africa has shown that taking tenofovir, manufactured by Gilead Sciences, does not lead to a greater risk of birth defects, pregnancy problems, growth problem, or kidney issues in the babies.
"Taking Viread (tenofovir) while pregnant is safe."
Diana Gibb, of the MRC Clinical Trials Unit in London, led the study that collected data on pregnancies and babies involved in the Development of AntiRetroviral Therapy in Africa (DART) trial.
The study followed over 3,000 people in Uganda and Zimbabwe taking anti-retroviral therapy from January 2003 through September 2009.
Of the 382 pregnancies that occurred among women in the DART trial, 226 resulted in live births, and those children were followed for up to four years. Most of the mothers had been taking tenofovir as part of their anti-retroviral regimen.
Seven babies died, and seven had birth defects, but there was no greater proportion of deaths or defects among the women taking the tenofovir compared to those who were not.
None of the babies tested positive for HIV, and the researchers did not note any abnormal effects on the babies' growth at 2 years old.
"Our findings suggest tenofovir-containing anti-retroviral therapy is a reasonable choice in pregnancy," the authors wrote. "Detailed safety of tenofovir for pre-exposure prophylaxis will need confirmation from longer term follow-up of larger numbers of exposed children."
The study appeared online May 15 in PLoS Med. The research was funded by the UK Medical Research Council, the UK Department for International Development (DFID), and the Rockefeller Foundation. ViiV Healthcare/GlaxoSmithKline and Gilead. Drugs were provided by Boehringer-Ingelheim and Abbott. The authors declared no conflicts of interest.