A Phase 2 Study of Pimodivir (JNJ-63623872) in Combination With Oseltamivir in Elderly and Nonelderly Adults Hospitalized With Influenza A Infection: OPAL Study
| Autor: | Antoni Torres, Lorant Leopold, Sofie Deleu, John Wilburn, Anna Christine Nilsson, Brian J. O'Neil, Stefaan Rossenu, Marie-Charlotte Hallouin-Bernard, Wilbert van Duijnhoven, Teddy Kosoglou, Ilse Van Dromme, Michael G. Ison, David E. Anderson, Johan Vingerhoets |
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| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
Adult Oseltamivir medicine.medical_specialty Adolescent Pyridines Phases of clinical research medicine.disease_cause Placebo Placebo group Antiviral Agents 03 medical and health sciences chemistry.chemical_compound Young Adult 0302 clinical medicine Pharmacokinetics Internal medicine Influenza Human Influenza A virus Immunology and Allergy Medicine Humans Pyrroles 030212 general & internal medicine Aged Aged 80 and over business.industry Influenza a Middle Aged Clinical trial 030104 developmental biology Infectious Diseases Treatment Outcome chemistry business |
| Zdroj: | The Journal of infectious diseases. 226(1) |
| ISSN: | 1537-6613 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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