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Alleviation of COVID-19 Symptoms and Reduction in Healthcare Utilization Among High-Risk Patients Treated With Nirmatrelvir/Ritonavir (NMV/R): A phase 3 randomized trial

Hammond et al., Clinical Infectious Diseases, doi:10.1093/cid/ciae551, NCT04960202
Nov 2024  
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Additional analysis of Hammond et al.. Results are shown with the main paper1.
Hammond et al., 11 Nov 2024, Double Blind Randomized Controlled Trial, placebo-controlled, USA, peer-reviewed, 12 authors, trial NCT04960202 (history). Contact: heidi.leister-tebbe@pfizer.com.
This PaperPaxlovidAll
Alleviation of COVID-19 Symptoms and Reduction in Healthcare Utilization Among High-Risk Patients Treated With Nirmatrelvir/Ritonavir (NMV/R): A phase 3 randomized trial
PhD Jennifer Hammond, BSN Heidi Leister-Tebbe, MPH, MSPT Annie Gardner, PhD Paula Abreu, PhD Weihang Bao, MA Wayne Wisemandle, MPH Wajeeha Ansari, PhD Magdalena Alicja Harrington, MD Abraham Simón-Campos, MD Kara W Chew, MD Rienk Pypstra, MD, PhD James M Rusnak
Clinical Infectious Diseases, doi:10.1093/cid/ciae551
Methods: This phase 2/3, double-blind, randomized (1:1) study assessed oral NMV/r 300 mg/100 mg versus placebo every 12 hours for 5 days in high-risk, unvaccinated, nonhospitalized, symptomatic adults with COVID-19 from 343 sites across 21 countries. In testing the primary endpoint of COVID-19-related hospitalization and all-cause deaths and key secondary endpoints including symptom duration and COVID-19-related medical visits, Type I error was controlled with prespecified sequential testing and the Hochberg procedure. Results: Among 2113 randomized patients enrolled from July 2021 through December 2021, 1966 (NMV/r, n=977; placebo, n=989) were included in the prespecified analysis population (symptom onset ≤5 days, did not receive monoclonal antibodies). NMV/r significantly reduced times to sustained alleviation (median, 13 vs 15 days; hazard ratio [HR]=1.27, p<0.0001) and resolution (16 vs 19 days; HR=1.20, p=0.0022) through Day 28 and significantly reduced the number of COVID-19-related medical visits and the proportion of patients with such visits. Hospitalized patients treated with NMV/r had shorter stays, none required ICU admission or mechanical ventilation, and all were discharged to home/self-care. Fewer NMV/r-treated patients required additional treatment for COVID-19. No NMV/r-treated patients died through Week 24 compared with 15 placebo-treated patients. Conclusions: In addition to reducing COVID-19-related hospitalization or death from any cause through Day 28, NMV/r was found to also reduce duration of COVID-19 symptoms and utilization of healthcare resources versus placebo in patients at high risk of progressing to severe disease.
Author Contributions: JH and HLT were involved in study design, data analysis, and data verification. AG, WA, KWC, RP, and JMR were involved in study design and data analysis. PA, WB, and WW were involved in study design, data analysis, data verification, and statistical analysis. MAH was involved in study design. ASC was involved in data analysis. All authors had access to the data and contributed to the writing of the manuscript. Conflicts of Interests
References
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Dryden-Peterson, Kim, Kim, Nirmatrelvir Plus Ritonavir for Early COVID-19 in a Large U.S. Health System : A Population-Based Cohort Study, Ann Intern Med
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Ganatra, Dani, Ahmad, Oral nirmatrelvir and ritonavir in nonhospitalized vaccinated patients with coronavirus disease 2019, Clin Infect Dis
Hammond, Leister-Tebbe, Gardner, Oral nirmatrelvir for high-risk, nonhospitalized adults with COVID-19, N Engl J Med
Jones, Manrique, Stone, Estimates of SARS-CoV-2 Seroprevalence and Incidence of Primary SARS-CoV-2 Infections Among Blood Donors, by COVID-19 Vaccination Status -United States, April 2021-September 2022, MMWR Morb Mortal Wkly Rep
Kaboré, Laffont, Diop, Real-world effectiveness of nirmatrelvir/ritonavir on COVID-19-associated hospitalization prevention: a population-based cohort study in the province of Québec, Canada, Clin Infect Dis
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In ' 'testing the primary endpoint of COVID-19‒related hospitalization and all-cause deaths and key ' 'secondary endpoints including symptom duration and COVID-19‒related medical visits, Type I ' 'error was controlled with prespecified sequential testing and the Hochberg ' 'procedure.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>Among 2113 randomized patients enrolled from July 2021 through ' 'December 2021, 1966 (NMV/r, n=977; placebo, n=989) were included in the prespecified analysis ' 'population (symptom onset ≤5 days, did not receive monoclonal antibodies). NMV/r ' 'significantly reduced times to sustained alleviation (median, 13 vs 15 days; hazard ratio ' '[HR]=1.27, p&amp;lt;0.0001) and resolution (16 vs 19 days; HR=1.20, p=0.0022) through Day 28 ' 'and significantly reduced the number of COVID-19‒related medical visits and the proportion of ' 'patients with such visits. Hospitalized patients treated with NMV/r had shorter stays, none ' 'required ICU admission or mechanical ventilation, and all were discharged to home/self-care. ' 'Fewer NMV/r-treated patients required additional treatment for COVID-19. No NMV/r-treated ' 'patients died through Week 24 compared with 15 placebo-treated patients.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Conclusions</jats:title>\n' ' <jats:p>In addition to reducing COVID-19‒related hospitalization or death ' 'from any cause through Day 28, NMV/r was found to also reduce duration of COVID-19 symptoms ' 'and utilization of healthcare resources versus placebo in patients at high risk of ' 'progressing to severe disease.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Clinical Trial Information</jats:title>\n' ' <jats:p>ClinicalTrials.gov, NCT04960202, ' 'https://clinicaltrials.gov/study/NCT04960202</jats:p>\n' ' </jats:sec>', 'DOI': '10.1093/cid/ciae551', 'type': 'journal-article', 'created': { 'date-parts': [[2024, 11, 11]], 'date-time': '2024-11-11T05:51:09Z', 'timestamp': 1731304269000}, 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'Alleviation of COVID-19 Symptoms and Reduction in Healthcare Utilization Among High-Risk ' 'Patients Treated With Nirmatrelvir/Ritonavir (NMV/R): A phase 3 randomized trial', 'prefix': '10.1093', 'author': [ { 'given': 'Jennifer', 'family': 'Hammond', 'sequence': 'first', 'affiliation': [ { 'name': 'Pfizer Research and Development, Pfizer Inc , 500 Arcola Road, ' 'Collegeville, PA, 19426 ,', 'place': ['USA']}]}, { 'given': 'Heidi', 'family': 'Leister-Tebbe', 'sequence': 'additional', 'affiliation': [ { 'name': 'Pfizer Research and Development, Pfizer Inc , 500 Arcola Road, ' 'Collegeville, PA, 19426 ,', 'place': ['USA']}]}, { 'given': 'Annie', 'family': 'Gardner', 'sequence': 'additional', 'affiliation': [ { 'name': 'Pfizer Research and Development, Pfizer Inc , 1 Portland St, ' 'Cambridge, MA, 02139 ,', 'place': ['USA']}]}, { 'given': 'Paula', 'family': 'Abreu', 'sequence': 'additional', 'affiliation': [ { 'name': 'Pfizer Research and Development, Pfizer Inc , 66 Hudson ' 'Boulevard East, New York, NY 10001 ,', 'place': ['USA']}]}, { 'given': 'Weihang', 'family': 'Bao', 'sequence': 'additional', 'affiliation': [ { 'name': 'Pfizer Research and Development, Pfizer Inc , 66 Hudson ' 'Boulevard East, New York, NY 10001 ,', 'place': ['USA']}]}, { 'given': 'Wayne', 'family': 'Wisemandle', 'sequence': 'additional', 'affiliation': [ { 'name': 'Pfizer Research and Development, Pfizer Inc , 275 &, 375 N Field ' 'Dr, Lake Forest, IL, 60045 ,', 'place': ['USA']}]}, { 'ORCID': 'http://orcid.org/0000-0002-1910-5836', 'authenticated-orcid': False, 'given': 'Wajeeha', 'family': 'Ansari', 'sequence': 'additional', 'affiliation': [ { 'name': 'Global Access & Value, Pfizer Inc , 66 Hudson Boulevard East, ' 'New York, NY 10001 ,', 'place': ['USA']}]}, { 'given': 'Magdalena Alicja', 'family': 'Harrington', 'sequence': 'additional', 'affiliation': [ { 'name': 'Global Access & Value, Pfizer Inc , 66 Hudson Boulevard East, ' 'New York, NY 10001 ,', 'place': ['USA']}]}, { 'given': 'Abraham', 'family': 'Simón-Campos', 'sequence': 'additional', 'affiliation': [ { 'name': 'Köhler and Milstein Research, Anahuac-Mayab University , Km ' '15.5, Carr. 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