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Use of Remdesivir in Pregnancy: Experience from the COVID-19 International Drug Pregnancy Registry and Literature Review
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  • Diego F. Wyszynski,
  • Cheryl Renz,
  • Aprille Espinueva,
  • Lee P. Shulman,
  • EunYoung Lee,
  • Andrew Fitzgibbon,
  • Gina Brown
Diego F. Wyszynski
Thermo Fisher Scientific

Corresponding Author:[email protected]

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Cheryl Renz
Thermo Fisher Scientific
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Aprille Espinueva
Gilead Sciences Inc
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Lee P. Shulman
Northwestern University Feinberg School of Medicine
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EunYoung Lee
Gilead Sciences Inc
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Andrew Fitzgibbon
Thermo Fisher Scientific
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Gina Brown
Gilead Sciences Inc
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Abstract

Remdesivir (RDV), an inhibitor of coronavirus replication including SARS-CoV-2, has gained approval as a therapy for COVID-19. Nevertheless, its utilization 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 hospitalized adult patients with severe or moderate COVID manifestations. Overall, RDV seems to be well-tolerated in pregnant patients, with rare occurrences of severe adverse events. The most commonly reported adverse event is transaminitis, which rarely necessitates treatment discontinuation. In this study, we present safety data for RDV treatment collected by the COVID-19 International Drug Pregnancy Registry (COVID-PR) between December 2021 and November 2023. Of 23 participants receiving RDV treatment during pregnancy, eight were followed-up until the end of pregnancy (7 livebirths and one spontaneous abortion). Nine women reported a total of 15 adverse events (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 specific patterns of AEs prohibiting the use of RDV during pregnancy were identified.