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A Phase 2 Study of Pimodivir (JNJ-63623872) in Combination With Oseltamivir in Elderly and Nonelderly Adults Hospitalized With Influenza A Infection: OPAL Study 

A Phase 2 Study of Pimodivir (JNJ-63623872) in Combination With Oseltamivir in Elderly and... BackgroundBoth the elderly and individuals with comorbidities are at increased risk of developing influenza-related complications. Novel influenza antivirals are required, given limitations of current drugs (eg, resistance emergence and poor efficacy). Pimodivir is a first-in-class antiviral for influenza A under development for these patients.MethodsHospitalized patients with influenza A infection were randomized 2:1 to receive pimodivir 600 mg plus oseltamivir 75 mg or placebo plus oseltamivir 75 mg twice daily for 7 days in this phase 2b study. The primary objective was to compare pimodivir pharmacokinetics in elderly (aged 65–85 years) versus nonelderly adults (aged 18–64 years). Secondary end points included time to patient-reported symptom resolution.ResultsPimodivir pharmacokinetic parameters in nonelderly and elderly patients were similar. Time to influenza symptom resolution was numerically shorter with pimodivir (72.45 hours) than placebo (94.15 hours). There was a lower incidence of influenza-related complications in the pimodivir group (7.9%) versus placebo group (15.6%). Treatment was generally well tolerated.ConclusionsNo apparent relationship was observed between pimodivir pharmacokinetics and age. Our data demonstrate the need for a larger study of pimodivir in addition to oseltamivir to test whether it results in a clinically significant decrease in time-to-influenza-symptom alleviation and/or the frequency of influenza complications.Clinical trials registrationNCT02532283. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Infectious Diseases Oxford University Press

A Phase 2 Study of Pimodivir (JNJ-63623872) in Combination With Oseltamivir in Elderly and Nonelderly Adults Hospitalized With Influenza A Infection: OPAL Study 

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References (57)

Publisher
Oxford University Press
Copyright
© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America.
ISSN
0022-1899
eISSN
1537-6613
DOI
10.1093/infdis/jiaa376
Publisher site
See Article on Publisher Site

Abstract

BackgroundBoth the elderly and individuals with comorbidities are at increased risk of developing influenza-related complications. Novel influenza antivirals are required, given limitations of current drugs (eg, resistance emergence and poor efficacy). Pimodivir is a first-in-class antiviral for influenza A under development for these patients.MethodsHospitalized patients with influenza A infection were randomized 2:1 to receive pimodivir 600 mg plus oseltamivir 75 mg or placebo plus oseltamivir 75 mg twice daily for 7 days in this phase 2b study. The primary objective was to compare pimodivir pharmacokinetics in elderly (aged 65–85 years) versus nonelderly adults (aged 18–64 years). Secondary end points included time to patient-reported symptom resolution.ResultsPimodivir pharmacokinetic parameters in nonelderly and elderly patients were similar. Time to influenza symptom resolution was numerically shorter with pimodivir (72.45 hours) than placebo (94.15 hours). There was a lower incidence of influenza-related complications in the pimodivir group (7.9%) versus placebo group (15.6%). Treatment was generally well tolerated.ConclusionsNo apparent relationship was observed between pimodivir pharmacokinetics and age. Our data demonstrate the need for a larger study of pimodivir in addition to oseltamivir to test whether it results in a clinically significant decrease in time-to-influenza-symptom alleviation and/or the frequency of influenza complications.Clinical trials registrationNCT02532283.

Journal

Journal of Infectious DiseasesOxford University Press

Published: Jul 1, 2020

Keywords: pimodivir; oseltamivir; influenza A virus; hospitalized; elderly; clinical trial; pharmacokinetics; viral clearance; influenza complications; duration of symptoms

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