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FDA Approves New Pill Form Antivirals for COVID-19

Last week, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for two pill form antivirals for COVID-19, providing some additional tools to long term care providers to care for residents and patients with COVID-19. The pills can be taken at home, unlike monoclonal antibodies that have to be administered by infusion in a clinical setting. A Department of Health (DOH) advisory on the treatments issued this week is available here.

On Dec. 22nd, the FDA issued an EUA for Pfizer’s Paxlovid antiviral, which provides almost 90 percent protection against severe illness and hospitalization for those at high risk. The treatment is for mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms, or about 88 pounds) with positive results of direct SARS-CoV-2 testing and who are at high risk for progression to severe COVID-19, including hospitalization or death. A press release with links to the EUA, a Frequently Asked Questions (FAQ) document on the drug, and other resources is available here.

Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset. This is a broader window than allowed for monoclonal antibody treatments and should provide a bit more flexibility for providers. Paxlovid is administered as three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken together orally twice daily for five days, for a total of 30 tablets. Paxlovid is not authorized for use for longer than five consecutive days.

Members are encouraged to review the Fact Sheet regarding Paxlovid’s interaction with other medications, its side effects, and contraindications. It is not recommended in patients with severe kidney or severe liver impairment.

Reporting indicates that this treatment is effective against the Omicron variant, though supplies are limited as Pfizer ramps up production.

The FDA also issued an EUA for Merck’s Molnupiravir antiviral pill for the treatment of mild to moderate COVID-19 in adults 18 and over with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate. A press release and related information on this treatment can be found here.

According to the Fact Sheet, Molnupiravir is a medication that works by introducing errors into the SARS-CoV-2 virus’ genetic code, which prevents the virus from further replicating. It is administered as four 200-milligram capsules taken orally every 12 hours for five days, for a total of 40 capsules. Like Paxlovid, it is not authorized for use for longer than five consecutive days.

Molnupiravir is not effective against the Omicron variant and has been shown to reduce the risk of death and hospitalization from COVID-19 by only 30 percent. Molnupiravir should not be administered to pregnant women. Members are encouraged to read the Fact Sheet for more details regarding risks associated with the treatment, drug interactions, side effects, and contraindications.

The Biden administration has purchased 3.1 million courses of Molnupiravir and 10 million courses of Paxlovid.

Shipping of Monoclonal Antibodies Paused

The Department of Health and Human Services (HHS) informed providers last week that it will pause shipping of any further allocations of bamlanivimab and etesevimab together, etesevimab alone, and REGEN-COV, pending an update from the Centers for Disease Control and Prevention (CDC). These therapies are unlikely to work against the Omicron variant, according to the FDA's updated Provider Fact Sheets. The HHS notice with links to each Fact Sheet and additional materials is available here, and a detailed set of slides on therapeutics from the HHS team is here.

Contact: Meg Everett, meverett@leadingageny.org, 518-929-9342