Pimodivir–oseltamivir useful for treating influenza patients of all ages
In the treatment of patients with influenza, the combination of pimodivir plus oseltamivir is well tolerated and has pharmacokinetic profiles unaffected by age, according to the results of a phase II trial.
A total of 102 patients with influenza A infection were randomized to twice-daily treatment with either pimodivir 600 mg or placebo, in combination with oseltamivir 75 mg for 7 days. Of these, 99 patients (pimodivir, n=64; placebo, n=35) received ≥1 dose of study drug and were included in the safety analysis. The full analysis set (FAS) comprised 95 patients (pimodivir, n=63; placebo=32), among whom 39 were elderly (aged 65–85 years) and 56 were nonelderly (aged 18–64 years) patients.
Demographics between treatment groups in FAS were generally similar. The median age was 61 years, and the time from the onset of influenza symptoms to enrolment in the trial was ≤72 hours for 36 patients and ≤96 hours for 55.
The primary outcome of pimodivir pharmacokinetics was similar in elderly and nonelderly patients. Resolution of influenza symptoms occurred sooner with pimodivir than with placebo (72.45 vs 94.15 hours).
Treatment was generally well tolerated. There were no significant between-treatment differences in safety profiles, including grade 3 or 4 treatment-emergent adverse events (TEAEs), severe or life-threatening TEAEs, and serious AEs. Diarrhoea was the most commonly reported TEAE, and it was typically mild and transient.
Finally, fewer patients in the pimodivir group developed influenza-related complications than in the placebo group (7.9 percent vs 15.6 percent).
The present data demonstrate the need for a larger study of pimodivir plus oseltamivir to test whether it produces a clinically significant decrease in time-to-influenza symptom alleviation and/or the frequency of influenza complications, according to researchers.