Among pregnant women who use a human immunodeficiency virus (HIV) drug called tenofovir disoproxil fumarate (TDF) — which is also being evaluated for the treatment of COVID-19 — there does not appear to be any greater risk of malformations in their newborns than from other antiretroviral therapies (ARTs), according to new research from Harvard T.H. Chan School of Public Health.

The study, led by Sonia Hernández-Díaz, professor of epidemiology, was published April 13, 2021, in the American Journal of Epidemiology.

TDF is expected to be effective against COVID-19 because it is a drug in the same family as remdesivir, which is known to be effective in treating the virus, according to the study authors. A key difference between these drugs is that TDF can be administered orally, whereas remdesivir requires daily intravenous infusion. Also, TDF is generic and would be much more feasible to use in large populations. Hernández-Díaz and colleagues wanted to look at the health effects of TDF on newborns to shed light on whether it can be safely used more broadly among pregnant women to treat COVID-19.

Researchers looked at 14 years’ worth of data from a nationwide cohort of pregnant women with HIV from a database of Medicaid beneficiaries. They compared women who used TDF during the first trimester of their pregnancies with women who used other ARTs, and found that the prevalence of malformations in the newborns was similar in the two groups. The researchers also conducted a systematic literature review, which also showed no increased risk of malformations linked with TDF use in the first trimester.

“These findings are reassuring for pregnant women that may be eligible for TDF treatments in the context of the COVID-19 pandemic,” the researchers wrote. Results should also provide reassurance for women of childbearing age with HIV, as well as for those using the drug combination TDF-emtricitabine to help prevent HIV, said Hernández-Díaz.

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