Paxlovid OK for Use in Pregnant Women Infected With COVID
Moms-to-be can safely take Paxlovid to help keep their COVID infection from turning serious, a new study shows.
Nearly everyone in a group of 47 pregnant women prescribed Paxlovid did well on the drug, which did not appear to interfere with their pregnancy in any significant way, researchers report in the Nov. 29 issue of the journal JAMA Network Open.
"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," said lead researcher Dr. William Garneau, an assistant professor of medicine at the Johns Hopkins University School of Medicine in Baltimore.
Previous clinical trials have established that Paxlovid reduces risk of severe illness and death by 89% in people infected with COVID, researchers said in background notes.
Based on that data, the U.S. Food and Drug Administration granted Paxlovid emergency use authorization in December 2021 for use in adults and children 12 or older.
Paxlovid consists of two medicines: the antiviral drug nirmatrelvir, which inhibits a key enzyme the coronavirus needs to replicate, and ritronavir, a drug that boosts the action of nirmatrelvir.
For the new study, researchers selected 47 participants from more than 3,400 pregnant women treated by Johns Hopkins Health Systems who were diagnosed with mild to moderate COVID-19 between March 15 and Aug. 20, 2022.
The women all started Paxlovid therapy within one day of COVID symptom onset. Their average age was 34, and they were 28 weeks into their pregnancies, on average.
Of those women, 96% completed their course of Paxlovid therapy, tolerating it well, researchers said. Twelve deliveries were done by cesarean section, but nine had been previously scheduled and were not related to their treatment.
Overall, maternal and fetal complications from Paxlovid were within expected limits, researchers concluded.
"We believe that our study is the largest to date looking at Paxlovid's safety and efficacy in people who were pregnant at the time of therapy, and therefore, indicates that the treatment should be an option for these patients," Garneau said in a Hopkins news release.
A number of medical organizations already recommend Paxlovid for pregnant women, including the Society for Maternal-Fetal Medicine and the American College of Obstetricians and Gynecologists (ACOG).
Pregnancy is among the conditions that put people at high risk of severe COVID, and as such is a risk factor that justifies prescribing Paxlovid, ACOG says.
"While more study of Paxlovid is needed to confirm our findings of its safety and efficacy during pregnancy, we feel that even at this time, the medication should be strongly considered for pregnant patients who are unvaccinated or at risk for progression to severe COVID disease or not likely to have drug-drug interactions," said co-senior researcher Dr. Kelly Gebo, a professor of medicine at the Johns Hopkins University School of Medicine.
The U.S. Centers for Disease Control and Prevention has more about COVID-19 treatments.
SOURCE: Johns Hopkins Medicine, news release, Dec. 1, 2022