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Antimicrob Agents Chemother. 2011 Nov;55(11):5267-76. doi: 10.1128/AAC.00360-11. Epub 2011 Aug 8.

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

Collaborators (159)

Kohno S, Yen M-, Cheong H-, Hirotsu N, Ishida T, Kadota J, Mizuguchi M, Kida H, Kohno S, Kida H, Mizuguchi M, Shimada J, Seki M, Makita H, Sakai N, Hachinohe H, Kokubun T, Ura N, Tsutahara S, Ikeda K, Munakata Y, Eiro M, Ishii H, Nawa T, Araki N, Kaizan T, Okada T, Okano A, Fujikawa M, Kaneko M, Kouguchi T, Ishizuya Y, Murakawa Y, Nakamura M, Totokawa S, Yamamoto M, Yamashita A, Yamaguchi T, Tsurumachi T, Kono K, Sekino H, Aizawa S, Akimoto Y, Yamato T, Suzuki S, Isono T, Kanemitu H, Kawa I, Maezawa Y, Miyazono Y, Toyoda H, Wada M, Fumimori T, Kuroda H, Shirai H, Ohto T, Miyachi K, Hirotsu N, Miyashita K, Yamada K, Noda Y, Morikawa S, Nishi T, Kitada M, Kitada-iin IK, Kose E, Bandou A, Kato M, Tashiro M, Senpuku S, Yagi M, Yasumoto H, Irie Y, Nakatani Y, Wada S, Yoshimura T, Hara H, Kawanishi M, Yagi S, Hozawa S, Nishio T, Kinoshita M, Tanaka S, Takahashi K, Rikimaru T, Irie T, Akiyama T, Inoue K, Higashi K, Seki M, Umezu T, Yoshida N, Yamamoto M, Osaki S, Hatama S, Shibata J, Harada Y, Fukuda K, Hashiguchi K, Yamamoto Y, Futsuki Y, Inoue Y, Higashiyama Y, Koga H, Doutsu Y, Onodera T, Yamagata E, Miyazaki T, Tokimatsu I, Karimata Y, Sakugawa H, Gushiken M, Nakamura H, Nakamura Clinic R, Tokuyama K, Chou Y, Hu BS, Yen MY, Wang TH, Lue JF, Yen YF, Wu TZ, Lin HI, Woo P, Wang PC, Chang WH, Tsai KC, Lee YJ, Chang KC, Hu KH, Pan HH, Yeh PS, Chuang YC, Tsai SC, Liu CY, Yang CH, Wie SH, Chung JW, Choo EJ, Choi HJ, Yoon HJ, Kim HY, Kwak YG, Cheong HJ, Park YS, Lee SR, Lee SH, Lee JS, Bum JJ, Lee SS, Hong SK, Choi JP, Kim ES, Lee H, Choi SH, Kim YS, Kim ES, Kim DM, Park DW.

Author information

1
Second Department of Internal Medicine, Nagasaki University School of Medicine, Nagasaki, Japan. s-kohno@nagasaki-u.ac.jp

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.

PMID:
21825298
PMCID:
PMC3195028
DOI:
10.1128/AAC.00360-11
[Indexed for MEDLINE]
Free PMC Article

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