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Antiviral Agents

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
Shigeru Kohno
1Second Department of Internal Medicine, Nagasaki University School of Medicine, Nagasaki
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  • For correspondence: s-kohno@nagasaki-u.ac.jp
Muh-Yong Yen
2Taipei City Hospital, National Yang-Ming University, Taipei, Taiwan
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Hee-Jin Cheong
3Department of Internal Medicine, Korea University Guro Hospital, Seoul, South Korea
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Nobuo Hirotsu
4Hirotsu Clinic, St. Marianna University School of Medicine, Kawasaki
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Tadashi Ishida
5Department of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki
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Jun-ichi Kadota
6Department of Internal Medicine II, Oita University Faculty of Medicine, Yufu
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Masashi Mizuguchi
7Department of Developmental Medical Sciences, Graduate School of Medicine, University of Tokyo, Tokyo
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Hiroshi Kida
8Department of Disease Control, Graduate School of Veterinary Medicine, Hokkaido University, Sapporo, Japan
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Jingoro Shimada
9St. Marianna University School of Medicine, Kawasaki
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DOI: 10.1128/AAC.00360-11
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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.

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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
Shigeru Kohno, Muh-Yong Yen, Hee-Jin Cheong, Nobuo Hirotsu, Tadashi Ishida, Jun-ichi Kadota, Masashi Mizuguchi, Hiroshi Kida, Jingoro Shimada for the S-021812 Clinical Study Group
Antimicrobial Agents and Chemotherapy Oct 2011, 55 (11) 5267-5276; DOI: 10.1128/AAC.00360-11

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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
Shigeru Kohno, Muh-Yong Yen, Hee-Jin Cheong, Nobuo Hirotsu, Tadashi Ishida, Jun-ichi Kadota, Masashi Mizuguchi, Hiroshi Kida, Jingoro Shimada for the S-021812 Clinical Study Group
Antimicrobial Agents and Chemotherapy Oct 2011, 55 (11) 5267-5276; DOI: 10.1128/AAC.00360-11
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