Pimodivir, an investigational first-in-class inhibitor of influenza virus polymerase basic protein 2 (PB2), was found to be beneficial in the treatment of acute uncomplicated influenza A virus infection in adult patients, according to the results of a Phase 2b study.
To evaluate the safety and antiviral activity of the treatment, patients in the TOPAZ trial (N=292) were randomized to receive pimodivir 300mg or 600mg, pimodivir 600mg plus oseltamivir 75mg, or placebo twice daily for 5 days; of the 292 patients included, 223 had confirmed influenza A and were treated.
Results showed that in patients with acute uncomplicated influenza A virus infection, pimodivir, both as monotherapy and in combination with oseltamivir, was associated with significant virologic improvements vs placebo. Moreover, the combination of pimodivir plus oseltamivir was found to result in the largest decrease in viral load. The most commonly reported adverse events were diarrhea and nausea, which were mild to moderate in severity; overall, the treatment was well-tolerated.
“While only trends toward a clinical benefit were observed in this study, owing to a low power to detect statistically significant differences, these trends, along with the favorable safety and dosing profiles, provide an overall compelling case for further investigation,” concluded the authors.
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