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No benefit seen with IV peramivir in hospitalized patients with influenza
Treatment with the IV antiviral peramivir did not demonstrate a significant clinical benefit compared with placebo among patients hospitalized with suspected influenza, according to data from the University of Amsterdam.
“The study was terminated for futility following a planned interim analysis, because the sample size required to maintain power exceeded a predefined boundary based on practical considerations for feasible total sample size,” the researchers wrote in Clinical Infectious Diseases. “These results illustrate the challenges in conducting clinical studies in hospitalized influenza, and highlight factors confounding study design and demonstration of a treatment effect for antivirals in hospitalized influenza.”
Patients with suspected influenza were randomly assigned to 5-day treatment with IV peramivir (BioCryst) 600 mg once daily or placebo. Participants also received the standard of care treatment for patients hospitalized with influenza. The researchers analyzed time to clinical resolution and viral shedding in nasopharyngeal samples.
Among the 405 enrolled patients, 338 had confirmed influenza. At the preplanned interim analysis, the population for the primary efficacy analysis included 121 patients who did not receive oseltamivir (Tamiflu, Genentech) or zanamivir (Relenza, GlaxoSmithKline) as part of the standard of care.
The median time to clinical resolution was 42.5 hours (95% CI, 34-57.9) for peramivir vs. 49.5 hours (95% CI, 40-61.9) for placebo. Patients with symptoms for less than 48 hours or who had been admitted to an ICU demonstrated a larger treatment effect. In addition, there were greater reductions in viral shedding among patients who received peramivir, but this was not significant. The incidence and severity of adverse events was similar between the groups.
“No antiviral treatment has been approved for the treatment of influenza in hospitalized patients; nonetheless, the need remains for an IV influenza antiviral drug,” the researchers wrote. “However, based on the challenges [outlined], it would be inappropriate to conclude that IV peramivir was ineffective in hospitalized influenza.”
Disclosure: See study for list of relevant disclosures.