Evaluation of SARS-CoV-2 RNA Rebound After Nirmatrelvir/Ritonavir Treatment in Randomized, Double-Blind, Placebo-Controlled Trials — United States and International Sites, 2021–2022

Patrick R. Harrington, PhD 1 ; Jie Cong, PhD 2 ; Stephanie B. Troy, MD 1 ; Jonathan M.O. Rawson, PhD 1 ; Julian J. O’Rear, PhD 1 ; Thamban Illath Valappil, PhD 2 ; Sarah McGarry Connelly, MD 1 ; John Farley, MD 3 ; Debra Birnkrant, MD 1 ( View author affiliations ) View suggested citation Summary What is already known about this topic? Nirmatrelvir/ritonavir (Paxlovid) is recommended for treatment of mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19. Rebound in SARS-CoV-2 shedding or COVID-19 signs and symptoms has been described after nirmatrelvir/ritonavir treatment, although the drug’s direct contribution to rebound remains unclear. What is added by this report? Similar SARS-CoV-2 RNA rebound rates were observed in nirmatrelvir/ritonavir and placebo recipients in two randomized, double-blind, clinical trials. Virologic rebound after nirmatrelvir/ritonavir treatment was not associated with COVID-19–related hospitalization or death. What are the implications for public health practice? SARS-CoV-2 RNA rebound can occur with or without nirmatrelvir/ritonavir treatment, supporting the Food and Drug Administration’s determination of safety and efficacy of nirmatrelvir/ritonavir in eligible patients at high risk for severe COVID-19. Article Metrics Altmetric: News (6) X (54) Facebook (1) Citations: Views: Views equals page views plus PDF downloads Metric Details Figure Tables Table 1 Table 2 Related Materials Article PDF Full Issue PDF Abstract Rebound of SARS-CoV-2 shedding or COVID-19 signs and symptoms has been described after treatment with nirmatrelvir/ritonavir (Paxlovid). The direct association of nirmatrelvir/ritonavir to COVID-19 rebound remains unclear because most reports are based on individual cases or nonrandomized studies. Viral RNA shedding data from two phase 2/3, randomized, double-blind, placebo-controlled clinical trials of nirmatrelvir/ritonavir (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients [EPIC-HR] and Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients [EPIC-SR]) were analyzed to investigate the […]

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