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

Journal of Pregnancy

卷:2026

Research Article

Diego F. Wyszynski¹  Cheryl Renz²  Aprille Espinueva³  Lee P. Shulman⁴  EunYoung Lee³  Andrew Fitzgibbon¹  Gina Brown³ 

[1] Thermo Fisher Scientific, Waltham, Massachusetts, USA, thermofisher.com

[2] Thermo Fisher Scientific, London, UK, thermofisher.com

[3] Division of Clinical Genetics, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA, nwu.edu.cn

[4] Gilead Sciences Inc., Foster City, California, USA

关键词: antiviral therapy;    drug safety;    maternal health;    perinatal outcomes;    pregnancy complications;   

DOI  :  10.1155/jp/8700344

 received in 2024-10-21, accepted in 2026-06-17,  发布年份 2026

来源: Hindawi Publishing Corporation

【 摘 要 】

Background and AimsRemdesivir (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.MethodsSafety 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.ConclusionsThis 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 SummaryRDV 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.

【 授权许可】

CC BY   
Copyright © 2026 Diego F. Wyszynski et al. Journal of Pregnancy published by John Wiley & Sons Ltd. 2026

【 图 表 】

Figure 27