Phase III randomized, double-blind study comparing single-dose intravenous peramivir with oral oseltamivir in patients with seasonal influenza virus infection

Shigeru Kohno, Muh Yong Yen, Hee-Jin Cheong, Nobuo Hirotsu, Tadashi Ishida, Jun Ichi Kadota, Masashi Mizuguchi, Hiroshi Kida, Jingoro Shimada

Research output: Contribution to journalArticle

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Abstract

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 twice a day [b.i.d.] for 5 days). To demonstrate the noninferiority of peramivir in reducing the time to alleviation of influenza symptoms with hazard model analysis and a noninferiority margin of 0.170, we planned to recruit 1,050 patients in South Korea, Japan, and Taiwan. A total of 1,091 patients (364 receiving 300 mg and 362 receiving 600 mg of peramivir; 365 receiving oseltamivir) were included in the intent-to-treat infected population. The median durations of influenza symptoms were 78.0, 81.0, and 81.8 h in the groups treated with 300 mg of peramivir, 600 mg of peramivir, and oseltamivir, respectively. The hazard ratios of the 300- and 600-mg-peramivir groups compared to the oseltamivir group were 0.946 (97.5% confidence interval [CI], 0.793, 1.129) and 0.970 (97.5% CI, 0.814, 1.157), respectively. Both peramivir groups were noninferior to the oseltamivir group (97.5% CI, <1.170). The overall incidence of adverse drug reactions was significantly lower in the 300-mg-peramivir group, but the incidence of severe reactions in either peramivir group was not different from that in 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.

Original languageEnglish
Pages (from-to)5267-5276
Number of pages10
JournalAntimicrobial Agents and Chemotherapy
Volume55
Issue number11
DOIs
Publication statusPublished - 2011 Nov 1

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Oseltamivir
Virus Diseases
Orthomyxoviridae
Double-Blind Method
Human Influenza
Confidence Intervals
peramivir
Influenza B virus
Republic of Korea
Incidence
Influenza A virus
Neuraminidase
Drug-Related Side Effects and Adverse Reactions
Taiwan
Proportional Hazards Models
Intravenous Infusions
Antiviral Agents
Oral Administration
Japan

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)
  • Infectious Diseases

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Phase III randomized, double-blind study comparing single-dose intravenous peramivir with oral oseltamivir in patients with seasonal influenza virus infection. / Kohno, Shigeru; Yen, Muh Yong; Cheong, Hee-Jin; Hirotsu, Nobuo; Ishida, Tadashi; Kadota, Jun Ichi; Mizuguchi, Masashi; Kida, Hiroshi; Shimada, Jingoro.

In: Antimicrobial Agents and Chemotherapy, Vol. 55, No. 11, 01.11.2011, p. 5267-5276.

Research output: Contribution to journalArticle

Kohno, Shigeru ; Yen, Muh Yong ; Cheong, Hee-Jin ; Hirotsu, Nobuo ; Ishida, Tadashi ; Kadota, Jun Ichi ; Mizuguchi, Masashi ; Kida, Hiroshi ; Shimada, Jingoro. / Phase III randomized, double-blind study comparing single-dose intravenous peramivir with oral oseltamivir in patients with seasonal influenza virus infection. In: Antimicrobial Agents and Chemotherapy. 2011 ; Vol. 55, No. 11. pp. 5267-5276.
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AU - Ishida, Tadashi

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