Remdesivir Use During Pregnancy: Findings From the Prospective COVID-19 International Drug Pregnancy Registry and Narrative Literature Review.

BACKGROUND AND AIMS: Remdesivir (RDV), an inhibitor of coronavirus replication including SARS-CoV-2, has been approved for the treatment of COVID-19. Nevertheless, its use during pregnancy lacks specific efficacy and safety data due to the exclusion of pregnant patients from clinical trials. Authorization for compassionate use in pregnant women was granted during the conduct of the Phase 3 clinical trials in adult patients hospitalized with moderate or severe COVID-19. Available evidence from prior studies suggests that no consistent safety concern has been identified, although available data remain limited. The most commonly reported adverse event (AE) is transaminitis, which rarely necessitates treatment discontinuation.

METHODS: Safety data for RDV exposure during pregnancy were collected by the COVID-19 International Drug Pregnancy Registry (COVID-PR) between December 2021 and November 2023. Information was obtained through self-administered online questionnaires completed during pregnancy and up to 1 year after live birth, with medical record corroboration when available.

RESULTS: Nine women reported a total of 15 AEs, with an additional seven AEs reported in three infants. Ten of these AEs were considered serious and included a life-threatening hypersensitivity episode. No consistent pattern of AEs suggestive of a specific safety concern was identified.

CONCLUSIONS: This study contributes additional observational safety data regarding RDV use during pregnancy. However, due to the small size of the study population and various study limitations, definitive conclusions about the safety of this treatment in pregnant populations cannot be drawn.

PLAIN LANGUAGE SUMMARY: RDV is a drug used to treat COVID-19 by blocking the virus from multiplying in the body. However, since pregnant women were not included in early clinical trials, we did not have much information about how safe and effective this drug is for them. During the pandemic, some pregnant women with severe COVID-19 were allowed to receive RDV through compassionate use programs, and our study is aimed at collecting data on their experiences. We looked at 23 pregnant women who took RDV between December 2021 and November 2023. Out of these, eight were followed through the end of their pregnancy, resulting in seven live births and one miscarriage. Some women and their babies experienced side effects, with the most common being temporary increases in liver enzyme levels, and one woman had a serious allergic reaction. Overall, no consistent pattern of adverse pregnancy or infant outcomes was identified. However, because only a small number of pregnancies were available for analysis and many participants were lost to follow-up, larger studies are needed to better understand the safety of RDV use during pregnancy.