Use of Remdesivir in Pregnancy: Experience from the COVID-19
International Drug Pregnancy Registry and Literature Review
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.