ICTM logo
No evidence of problems with pregnancies or children born to women taking the anti-retroviral drug tenofovir

16 May 2012

The anti-retroviral drug tenofovir does not seem to have negative effects on pregnancy outcomes or the health of children, when taken by pregnant women, compared to other anti-retroviral drugs. The research, published in the journal PLoS Medicine, followed children born to women who were part of the DART trial.

Tenofovir is a drug that is used in combination with other drugs to combat HIV. It is becoming more commonly used, and is recommended in World Health Organisation guidelines. There were concerns that it might cause problems with birth defects, renal function, bone strength and growth if taken during pregnancy. But little has been known about what effect it actually has on pregnancies and children born to women who take it.

The DART trial was a large randomised controlled trial that took place in Uganda and Zimbabwe, comparing different approaches for monitoring anti-retroviral therapy. As part of the trial researchers collected data on any pregnancies of women taking part, and which drugs they received.

Researchers found no difference in the outcomes of pregnancies among women who took tenofovir with those who took other anti-retroviral drugs. They also followed up the 226 children born to these women for up to four years. None of the children tested for HIV had the disease. Tenofovir did not increase the rate of birth defects, prematurity or renal impairment, and no broken bones were reported. Tenofovir did not lead to lower birth weight or growth. The weights and heights of children in the study were similar to that of other HIV-uninfected children in Uganda.

These findings are encouraging, as no evidence was found that tenofovir had any negative effects on pregnancy outcomes or the children born to women who took the drug. However, the number of pregnancies and children observed in this study is quite small, and women were not randomly allocated to which drugs they received, so there may be some bias.

The findings of this study suggest that tenofovir is a reasonable anti-retroviral drug for women who may become pregnant while taking it. This is good news, as it is being used increasingly. The findings are timely given the FDA’s decision to approve the use of Truvada (which contains tenofovir) to help prevent the disease among HIV-negative people who are at high risk of being infected.