A reanalysis of 2 National Institutes of Health (NIH)-funded studies refutes the conclusions of PROMISE (Promoting Maternal and Infant Survival Everywhere), which found tenofovir disoproxil fumarate (TDF) combination treatment raised the risk of adverse outcomes.
The PROMISE study compared several treatments in pregnant women with HIV in India and Africa. According to those researchers, women on TDF regimens were twice as likely as those on zidovudine to have a very preterm infant, and their infants were more likely to die within the first 2 weeks.
Those results surprised the current researchers, given that other, earlier studies had found TDF combinations safe for use during pregnancy. In fact, the World Health Organization recommends that all adults with HIV, including pregnant women, receive TDF combination therapy.
In the current study, NIH researchers compared outcomes from 2 US studies, reviewing records on more than 4,600 infants born to 3,847 women. The women were on either a combination regimen including zidovudine or 1 containing TDF.
The researchers found no significant differences in the risk of preterm birth or low birth weight, nor did they find any significant difference in severe birth outcomes, including infant death, in the first 2 weeks. “Notably,” they add, comparing women on zidovudine combination treatment with TDF/emtricitabine/atazanavir/ritonavir, the researchers found the TDF group had a 10% lower chance of preterm birth, low birth weight, and infant death.
Source:
National Institutes of Health. https://www.nih.gov/news-events/news-releases/anti-hiv-drug-combination-does-not-increase-preterm-birth-risk-study-suggests. Published April 25, 2018. Accessed May 24, 2018.