The Food and Drug Administration on Wednesday made it easier for clinicians to prescribe the COVID-19 antiviral drugs Paxlovid and Lagevrio in cases where transmission is evident and the patient is at high risk of severe illness.
The two drugs originally were indicated for use after receipt of a positive COVID-19 test. Now, physicians may use their judgment “in rare instances” to determine that a patient has COVID-19 based on a recent known exposure — even if a direct SARS-CoV-2 viral test result is negative.
“In such instances, their healthcare provider may determine that treatment with authorized therapeutics may be appropriate if the patient reports mild-to-moderate symptoms of COVID-19 and is at high risk for progression to severe COVID-19, including hospitalization or death,” the FDA stated in a notice from its Center for Drug Evaluation and Research.
Clinicians must continue to follow the other conditions of the drugs’ emergency use authorizations. Patients must have a clinical diagnosis of mild-to-moderate COVID-19, for example.
Provider fact sheets for Paxlovid and Lagevrio have been updated with the changes.
Few treatments remain
The news comes shortly after the FDA de-authorized the monoclonal antibody treatment Evusheld, used for pre-exposure prevention of COVID-19. Fewer than 10% of circulating SARS-CoV-2 variants are now susceptible to the product, the agency said.
The therapeutic cocktail was the last holdout among COVID-19 antibodies, which briefly were mainstay treatments until new viral variants rendered them ineffective. Without Evusheld, there is now no COVID-19 prophylactic available.
Aside from the Paxlovid and Lagevrio, which come in pill form, remaining COVID-19 treatments include Veklury, which is an infused antiviral, and convalescent plasma.
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