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. 2023 Feb 18;76(4):563-572.
doi: 10.1093/cid/ciac673.

Oral Nirmatrelvir and Ritonavir in Nonhospitalized Vaccinated Patients With Coronavirus Disease 2019

Sarju Ganatra  1 , Sourbha S Dani  1 , Javaria Ahmad  1 , Ashish Kumar  2 , Jui Shah  1 , George M Abraham  3 , Daniel P McQuillen  4 , Robert M Wachter  5 , Paul E Sax  6
Affiliations

Oral Nirmatrelvir and Ritonavir in Nonhospitalized Vaccinated Patients With Coronavirus Disease 2019

Sarju Ganatra et al. Clin Infect Dis. .

Abstract

Background: Treatment of coronavirus disease 2019 (COVID-19) with nirmatrelvir plus ritonavir (NMV-r) in high-risk nonhospitalized 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 1 December 2021 and 18 April 2022 were included. Cohorts were developed based on the use of NMV-r within 5 days of diagnosis. The primary composite outcome was all-cause emergency room (ER) visit, hospitalization, or death at a 30-day 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, 1130 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 compared with 163 (14.4%) patients in the non-NMV-r cohort (odds ratio: .5; 95% confidence interval: .39-.67; P < .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 in serious complications between days 10 and 30.

Conclusions: Treatment with NMV-r in nonhospitalized vaccinated patients with COVID-19 was associated with a reduced likelihood of ER visits, hospitalization, or death. Complications and overall resource utilization were also decreased.

Keywords: COVID-19; Paxlovid; nirmatrelvir plus ritonavir (NMV-r); rebound symptoms; vaccination.

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Conflict of interest statement

Potential conflicts of interest. G. M. A. reports payment for expert testimony (10 000/year) and is the immediate Past-President of the American College of Physicians. R. M. W. reports that he is a member of the Lucian Leape Institute of the Institute for Healthcare Improvement (no compensation except for travel expenses); receives a yearly stipend for serving on the Board of Directors of The Doctors Company; serves on the Board of Directors of Second Wave Delivery Solution (for which he receives stock options) and the scientific advisory boards for Teladoc, a large telemedicine provider (ended 2021), Amino.com, Curai Health, and EarlySense (stock options); consults with Commure (stipend and stock options), Forward (stock options), and Notable (stock options); received honoraria as a speaker at conferences for many (>150) healthcare organizations, medical societies, hospitals (vast majority are nonprofit; for-profit entities since 2017 include Nuance, GE, Health Catalyst, AvaCare, Siemens, and Voalte); has given more than 200 talks (a few to for-profit entities including Nuance, GE, Health Catalyst, Siemens, AvaCare, and the Governance Institute) for which he has received honoraria; and holds the Benioff Endowed Chair in Hospital Medicine from Marc and Lynne Benioff and the Holly Smith Distinguished Professorship in Science and Medicine at the University of California San Francisco (UCSF). All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

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