Paxlovid can safely be used to reduce risk of severe COVID in people who are pregnant, study shows: Team finds antiviral therapy does not increase chance of serious side effects affecting pregnancy or offspring

Paxlovid can safely be used to reduce risk of severe COVID in people who are pregnant, study shows: Team finds antiviral therapy does not increase chance of serious side effects affecting pregnancy or offspring

03/12/2022

Findings from a Johns Hopkins Medicine research study published today in JAMA Network Openprovide strong evidence that people who are pregnant and have been infected with SARS-CoV-2 (the virus that causes COVID-19) can safely take the antiviral drug Paxlovid to reduce the possibility of severe disease.

“Based on our results, we feel that the benefit to both the mother and the developing fetus of preventing severe COVID outweighs any potential risks from Paxlovid therapy,” says study lead author William Garneau, M.D., M.P.H., assistant professor of medicine at the Johns Hopkins University School of Medicine.

Paxlovid is an investigational agent (still under study) being used as a treatment for patients with mild-to-moderate COVID-19. It consists of two medicines: nirmatrelvir, an antiviral agent that inhibits a key enzyme that SARS-CoV-2 needs to reproduce infectious progeny, and ritronavir, a drug that enhances the action of nirmatrelvir by keeping it longer in the body. In December 2021, the U.S. Food and Drug Administration authorized the emergency use of Paxlovid for adults and children age 12 years and older infected with SARS-CoV-2 and at high risk for progression to severe COVID, including hospitalization and death.

“The clinical trials that enabled Paxlovid to receive its emergency use authorization showed that participants were 89% less likely to develop severe illness and death; however, people who were pregnant weren’t among the participants, and pregnancy is now known to be a condition placing patients at risk of severe disease,” says co-study senior author Irina Burd, M.D., Ph.D., formerly professor of gynecology and obstetrics at the Johns Hopkins University School of Medicine and now chair of the Department of Obstetrics, Gynecology, and Reproductive Sciences at the University of Maryland School of Medicine.

In their study, the researchers selected participants from 3,442 people who were pregnant, diagnosed with mild-to-moderate COVID-19 and seen at centers within the Johns Hopkins Health Systems between March 15, 2020, and Aug. 20, 2022.

From this population, 47 people who met the study criteria were prescribed Paxlovid and monitored for outcomes and any complications. The median age of this group was 34, 17% were Black, 11% were Hispanic and the median gestational age (stage of pregnancy) was 28 weeks. The majority of participants had received at least their initial COVID vaccinations and started Paxlovid therapy within one day of symptom onset.

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