Efficacy and Safety of Pimodivir Combined With Standard of Care in Hospitalized and Nonhospitalized High-Risk Adolescents and Adults With Influenza A Infection.

Abstract

Background: An unmet need exists for effective antivirals to treat patients hospitalized with influenza. The results of 2 phase 3 studies that evaluated the efficacy and safety of pimodivir in combination with investigator-chosen standard of care (SoC) treatment are presented.

Methods: Hospitalized patients (hospital study; NCT03376321) and high-risk outpatients (outpatient study; NCT03381196) with laboratory-confirmed influenza A infection were randomized 1:1 to 600 mg pimodivir twice daily + SoC or placebo twice daily + SoC for 5 days. For most patients, SoC included oseltamivir. Primary end points were Hospital Recovery Scale (HRS) at day 6 (hospital study) and median time to resolution (TTR) of influenza-related symptoms (outpatient study).

Results: Pimodivir + SoC (oseltamivir) treatment showed no clinical benefit over placebo + SoC on HRS at day 6 (common odds ratio, 0.943; 95% confidence interval [CI], .609-1.462; P = .397; hospital study). A shorter median TTR of 7 symptoms was estimated with pimodivir + SoC versus placebo (92.6 hours; 95% CI, 77.6-104.2 vs 105.1 hours; 95% CI, 92.7-128.6; P = .0216; outpatient study).

Conclusions: Pimodivir + SoC showed no additional clinical benefit versus SoC treatment alone in hospitalized patients. Pimodivir + SoC demonstrated shorter TTR of influenza symptoms versus placebo + SoC in high-risk outpatients.

Clinical trial registration: NCT03376321 and NCT03381196.