A Phase 2 Study of Pimodivir (JNJ-63623872) in Combination With Oseltamivir in Elderly and Nonelderly Adults Hospitalized With Influenza A Infection: OPAL Study.
- Resource Type
- journal article
- Authors
- O'Neil, Brian; Ison, Michael G; Hallouin-Bernard, Marie Charlotte; Nilsson, Anna C; Torres, Antoni; Wilburn, John M; Duijnhoven, Wilbert van; Dromme, Ilse Van; Anderson, David; Deleu, Sofie; Kosoglou, Teddy; Vingerhoets, Johan; Rossenu, Stefaan; Leopold, Lorant; van Duijnhoven, Wilbert; Van Dromme, Ilse
- Source
- Journal of Infectious Diseases. Jul2022, Vol. 226 Issue 1, p109-118. 10p.
- Subject
- Language
- ISSN
- 0022-1899
Background: Both 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.Methods: Hospitalized 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.Results: Pimodivir 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.Conclusions: No 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 Registration: NCT02532283. [ABSTRACT FROM AUTHOR]