Comparison of single-dose intravenous peramivir with oral oseltamivir in patients with seasonal influenza virus infection: A phase III randomized, double-blind study.
Antimicrob Agents Chemother. 2011 Aug 8;
Authors: Kohno S, Yen MY, Cheong HJ, Hirotsu N, Ishida T, Kadota JI, Mizuguchi M, Kida H, Shimada J,
Antiviral medications with activity against influenza viruses are important in controlling influenza. We compared intravenous peramivir, a potent neuraminidase inhibitor, with oseltamivir in patients with seasonal influenza virus infection. In a multinational, multicenter, double-blind, double-dummy, randomized controlled study, patients aged ?20 years with influenza A or B virus infection were randomly assigned to receive either a single intravenous infusion of peramivir (300 or 600 mg) or oral administration of oseltamivir (75 mg b.i.d. for 5 days). To demonstrate the non-inferiority of peramivir in reducing the time to alleviate influenza symptoms with hazard model analysis and a non-inferiority margin of 0.170, we planned to recruit 1,050 patients in Korea, Japan, and Taiwan. A total of 1,091 patients (peramivir: 300 mg: 364, 600 mg: 362; oseltamivir: 365) were included in the Intent-To-Treat Infected population. The median duration of influenza symptoms was 78.0, 81.0, and 81.8 h in the 300-mg, 600-mg, and oseltamivir groups, respectively. The hazard ratios of the 300- and 600-mg groups compared to the oseltamivir group were 0.946 (97.5% confidence interval (CI): 0.793, 1.129) and 0.970 (0.814, 1.157), respectively. Both peramivir groups were non-inferior to the oseltamivir group (97.5% CI <1.170). The overall incidence of adverse drug reactions was significantly lower in the 300-mg group, but the incidence of severe reactions was not different in either peramivir group compared to the oseltamivir group. Thus, a single intravenous dose of peramivir may be an alternative to a 5-day oral dose of oseltamivir for patients with seasonal influenza virus infection.
PMID: 21825298 [PubMed - as supplied by publisher]