Acknowledgments
EMERGENCY
The nirmatrelvir/ritonavir sponsor (Pfizer) and the EPIC-HR and EPIC-SR study investigators and study volunteers; Glen Huang, Cristina Miglis, Barbara Styrt, and the Food and Drug Administration nirmatrelvir/ritonavir New Drug Application review team.Nirmatrelvir/ritonavir (Paxlovid) first became available in the United States for the treatment of mild-to-moderate COVID-19 through Emergency Use Authorization from the Food and Drug Administration (FDA) on December 22, 2021, (Data from clinical trials EPIC-HR and EPIC-SR were submitted to FDA by the applicant (Pfizer) in support of the review and approval of New Drug Application (NDA) 217188 (Paxlovid). Analyses of viral RNA and symptom rebound for this report were conducted for all randomized subjects in these trials who took ≥1 dose of nirmatrelvir/ritonavir or placebo and were randomized ≤5 days of symptom onset. Viral RNA levels in nasopharyngeal samples were measured in a central laboratory (University of Washington) using the Abbott RealTime Quantitative SARS-CoV-2 assay, which had a lower limit of quantification (LLOQ) and limit of detection of 2 logAnalysis of selected samples from EPIC-HR for cell culture infectious SARS-CoV-2 demonstrated a trend of positive infectivity for samples with viral RNA ≥5 logIn the EPIC-HR modified intent-to-treat-2 population, which included all randomized subjects who took ≥1 dose of study intervention and were dosed ≤5 days of symptom onset, 1.0% (10 of 1,038) of nirmatrelvir/ritonavir recipients and 6.2% (65 of 1,053) of placebo recipients experienced COVID-19–related hospitalization through day 28 (per FDA Integrated Review of NDA 217188). All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. No potential conflicts of interest were disclosed.