Two Oral Treatments for Outpatients with COVID-19

At the end of December 2021, two novel oral antiviral agents received FDA emergency use authorization for outpatient use in mild-to-moderate COVID-19. Although both agents generated substantial premarketing enthusiasm, they come to market with lingering uncertainties.

Nirmatrelvir (Paxlovid, Pfizer) is a viral protease inhibitor with expected in vitro activity against all clinically significant SARS-CoV-2 variants to date. In an unpublished manufacturer-supported study, nirmatrelvir boosted with the CYP3A inhibitor ritonavir reduced rates of hospitalization or all-cause death by almost 90% among unvaccinated high-risk adult outpatients with confirmed mild-to-moderate COVID-19. A study involving vaccinated standard-risk adults is ongoing. The…