Oral Nirmatrelvir and Ritonavir in Non-hospitalized Vaccinated Patients with Covid-19
MD Sarju Ganatra, MD, MSc Sourbha S Dani, MD Javaria Ahmad, MD Ashish Kumar, MD Jui Shah, MD, MPH George M Abraham, MD Daniel P Mcquillen, MD Robert M Wachter, MD Paul E Sax
doi:10.1093/cid/ciac673/6672670
Background Treatment of coronavirus disease-2019 (Covid-19) with nirmatrelvir plus ritonavir (NMV-r) in high-risk non-hospitalized unvaccinated patients reduced the risk of progression to severe disease. However, the potential benefits of NMV-r among vaccinated patients are unclear.
Methods We conducted a comparative retrospective cohort study using the TriNetX research network. Patients ≥18 years of age who were vaccinated and subsequently developed Covid-19 between December 1, 2021, and April 18, 2022, were included. Cohorts were developed based on the use of NMV-r within five days of diagnosis. The primary composite outcome was all-cause emergency room (ER) visit, hospitalization, or death at a 30-days follow-up. Secondary outcomes included individual components of primary outcomes, multisystem symptoms, Covid-19 associated complications, and diagnostic test utilization.
Results After propensity score matching, 1,130 patients remained in each cohort. A primary composite outcome of all-cause ER visits, hospitalization, or death in 30 days occurred in 89 (7.87%) patients in the NMV-r cohort as compared to 163 (14.4%) patients in the non-NMV-r cohort (OR 0.5, CI 0.39-0.67; p<0.005) consistent with 45% relative risk reduction. A significant reduction in multisystem symptom burden and subsequent complications such as lower respiratory tract infection, cardiac arrhythmia, and diagnostic radiology testing were noted in NMV-r treated patients. There was no apparent increase serious complications between days 10 to 30.
Conclusion Treatment with NMV-r in non-hospitalized vaccinated patients with Covid-19 was associated with a reduced likelihood of emergency room visits, hospitalization, or death. Complications and overall resource utilization were also decreased.
References
Bernal, Da Silva, Musungaie, Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients, N Engl J Med
Commissioner, The, Coronavirus (COVID-19) Update: FDA Authorizes New Monoclonal Antibody for Treatment of COVID-19 that Retains Activity Against Omicron Variant
Gottlieb, Vaca, Paredes, Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients, N Engl J Med
Hammond, Leister-Tebbe, Gardner, Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19, N Engl J Med
Mensah, Lacy, Stowe, Disease severity during SARS-COV-2 reinfection: a nationwide study, Journal of Infection
Paxlovid, added to PANORAMIC study -PANORAMIC
Pfizer, An Interventional Efficacy And Safety, Phase 2/3, Double-Blind, 2 Arm Study To Investigate Orally Administered Pf
Tenforde, Self, Adams, Association Between mRNA Vaccination and COVID-19 Hospitalization and Disease Severity, JAMA
Vanderweele, Ding, Sensitivity Analysis in Observational Research: Introducing the E-Value, Ann Intern Med