FDA Authorizes First Oral Antiviral Treatments for COVID-19
On December 22, 2021 the Food and Drug Administration issued an Emergency Use Authorization (EUA) for Pfizer’s Paxlovid, an oral treatment for mild to moderate COVID-19 infection in adults and pediatric patients. Currently, it is available for prescription only and should be administered as soon as a positive diagnosis is received and within five days of onset of symptoms.
Last year, Pfizer shared a study to prove the effectiveness of their COVID-19 treatment pill which consists of a 30 day regimen of three pills, twice daily that reduced the risk of hospitalization or death by 88 percent in unvaccinated patients; newer data suggests that this pill is also effective against the Omicron variant. This treatment pill has also been approved for use by the United Kingdom as well.
“This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, in a press release.
Paxlovid is not authorized for a pre-exposure or post-exposure prevention treatment for COVID-19, nor is it a substitute for vaccination or booster dose. The mechanism of Paxlovid works in three tablets, two of nirmatrelvir inhibits a protein in SARS-CoV-2 and stops its ability to replicate, and one of ritonavir which slows down the degradation of nirmatrelvir so that it may remain in the body for a longer period of time.
Possible side effects include impaired taste, diarrhea, high blood pressure and muscle aches; Paxlovid may also interact with other drugs and may cause HIV-1 drug resistance in people with uncontrolled or undiagnosed HIV-1 infection. Ritonavir may cause liver damage so caution should be exercised when using this treatment on patients with preexisting liver diseases, abnormalities or inflammation.
The FDA also approved Merck’s COVID-19 pill, Molnupiravir, the next day which had shown to reduce hospitalization and death in COVID-19 cases where other treatments were not accessible or clinically appropriate; these patients must be at a high risk for death or hospitalization as the the FDA’s recommendation for Merck’s COVID-19 pill is narrow. The pill showed only moderate effectiveness over the course of 5 days. Data also showed that it could cause birth defects in pregnant people so it is not recommended for this population, though doctors are able to prescribe it at their own discretion.
With this in mind, the FDA’s EUA authorization comes wrapped in warnings and precautions. Anyone who is of childbearing age are all recommended to use contraception during treatment and for four days after the final dose (people with a uterus) or for three months after the final dose (people without a uterus).
While Merck’s effectiveness rate shows only a 30% reduction in hospitalization, Dean Li, Merck’s head of research and development stresses the drugs optimal performance, citing its lack of interaction with other drugs and the lack of need to reduce the dose for those with kidney impairments. There could still be a place on the market for this drug to make some contributions to those who contract severe COVID-19 cases.
https://www.cidrap.umn.edu/news-perspective/2021/12/fda-approves-pfizers-covid-19-pill-emergency-use
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