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J Infect Dis . 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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  • J Infect Dis . A Phase 2 Study of Pimodivir (JNJ-63623872) in Combination With Oseltamivir in Elderly and NonElderly Adults Hospitalized With Influenza A Infection: OPAL Study


    J Infect Dis


    . 2020 Jun 30;jiaa376.
    doi: 10.1093/infdis/jiaa376. Online ahead of print.
    A Phase 2 Study of Pimodivir (JNJ-63623872) in Combination With Oseltamivir in Elderly and NonElderly Adults Hospitalized With Influenza A Infection: OPAL Study

    Brian O'Neil 1 , Michael G Ison 2 , Marie-Charlotte Hallouin-Bernard 3 , Anna C Nilsson 4 , Antoni Torres 5 , John M Wilburn 1 , Wilbert van Duijnhoven 6 , Ilse Van Dromme 6 , David Anderson 7 , Sofie Deleu 6 , Teddy Kosoglou 7 , Johan Vingerhoets 6 , Stefaan Rossenu 6 , Lorant Leopold 7


    AffiliationsExpand

    Abstract

    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 non-elderly adults (aged 18-64 years). Secondary endpoints included time-to-patient-reported symptom resolution.
    Results: Pimodivir pharmacokinetic parameters in non-elderly 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.

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

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