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Tenofovir is safe for pregnant women living with HIV and their babies

Caitlin Mahon

27 April 2018

Reassurance for women living with HIV as commonly prescribed HIV drug deemed as safe as other regimes.

A child listens to mother's pregnant tummy with a stethoscope
Photos are used for illustrative purposes. They do not imply health status or behaviour. Credit: iStock/FatCamera

New study reveals leading antiretroviral drug, tenofovir (TDF), is safe for pregnant women living with HIV when compared to other antiretroviral treatment (ART) regimes, despite concerns in the past that it could lead to adverse pregnancy outcomes.

Previous results published in late 2016 from the Promoting Maternal and Infant Survival Everywhere (PROMISE) trial, had shown that women living with HIV randomly assigned to receive tenofovir-based treatment (TDF–FTC–LPV/r) had infants at greater risk for very premature birth and death within 14 days of delivery than those assigned to receive zidovudine-based treatment (ZDV–3TC–LPV/r).

The results had not been seen elsewhere and were surprising, causing some alarm in the sector as tenofovir is one of the most widely prescribed antiretroviral drugs. Tenofovir is also currently recommended by the World Health Organization as a treatment backbone for pregnant women living with HIV.

In a re-analysis of two cohorts of women living with HIV published this week in the New England Journal of Medicine, researchers from Harvard University looked at the risk of pre-term birth and other adverse birth outcomes among 4,600 babies and 3,847 women receiving either:

  • Zidovudine, lamivudine, lopinavir/ritonavir (ZDV/3TC/LPV/r)
  • Tenofovir, emtricitabine, lopinavir/ritonavir (TDF/FTC/LPV/r)
  • Tenfofovir, emtricitabine, atazanavir/ritonavir (TDF/FTC/ATV/r)

The researchers found no significant difference in birth outcomes in any of the groups. Furthermore they found no increased risk in pre-term birth or low birth weight.

“The analysis provides reassurance that regimens containing TDF are appropriate for use during pregnancy,” said Rohan Hazra, M.D., chief of NICHD’s Maternal and Pediatric Infectious Disease Branch, which oversaw funding for the study.

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