Efficacy and Safety of Intravenous Peramivir Compared With Oseltamivir in High-Risk Patients Infected With Influenza A and B Viruses: A Multicenter Randomized Controlled Study

Author:

Nakamura Shigeki12,Miyazaki Taiga13,Izumikawa Koichi3,Kakeya Hiroshi4,Saisho Yutaka5,Yanagihara Katsunori6,Miyazaki Yoshitsugu2,Mukae Hiroshi1,Kohno Shigeru1

Affiliation:

1. Department of Respiratory Diseases, Nagasaki University Hospital

2. Department of Chemotherapy and Mycoses, National Institute of Infectious Diseases, Tokyo, Japan

3. Department of Infectious Diseases, Nagasaki University Graduate School of Biomedical Sciences

4. Department of Infection Control Science, Graduate School of Medicine, Osaka City University

5. Medical Affairs, Shionogi & Co, Ltd, Osaka

6. Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences , and

Abstract

Abstract Background Clinical studies comparing the different neuraminidase inhibitors for treatment of at-risk patients with influenza have not been performed. To optimize such treatments, we assessed the efficacy and safety of intravenous peramivir compared with oral oseltamivir in treating seasonal influenza A or B virus infection. Methods A multicenter, randomized, controlled clinical trial was conducted from December 2012 to May 2014 in high-risk patients infected with seasonal influenza. A total of 92 adult inpatients and outpatients with high risk factors (HRFs) were treated by either a single intravenous infusion of peramivir (600 mg) or oral administration of oseltamivir (75 mg, twice per day for 5 days). Results The median times to clinical stability (time to reach <37°C) were 40.0 hours (95% confidence interval [CI] = 23.3–64.5) and 37.8 hours (95% CI = 26.3–45.3) in the peramivir and oseltamivir groups, respectively; these values did not reveal a significant difference. The virus titer and change of mean total symptom scores decreased similarly with both treatments. Results of step-wise regression suggested that virus type was a significantly effective prognostic factor with respect to illness resolution. Adverse events (AEs) with peramivir and oseltamivir occurred in 2.2% (n = 1/46) and 13.0% (n = 6/46) of patients, respectively. The severity of AEs was mild in all cases except 2 patients who showed pneumonia or COPD aggravation; both were in the oseltamivir group. Conclusions Intravenous peramivir was effective based on the result of direct comparison with oral oseltamivir. Thus our data show that peramivir is a useful option for the treatment of influenza-infected patients with HRFs.

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Oncology

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