tetano
Editor, Senior Moderator
Antimicrobial Agents and Chemotherapy, November 2010, p. 4568-4574, Vol. 54, No. 11
0066-4804/10/$12.00+0 doi:10.1128/AAC.00474-10
Copyright ? 2010, American Society for Microbiology. All Rights Reserved.
Efficacy and Safety of Intravenous Peramivir for Treatment of Seasonal Influenza Virus Infection{triangledown} ,{dagger}
Shigeru Kohno,1* Hiroshi Kida,2 Masashi Mizuguchi,3 Jingoro Shimada,4 for the S-021812 Clinical Study Group
Second Department of Internal Medicine, Nagasaki University School of Medicine, Nagasaki, Japan,1 Department of Disease Control, Graduate School of Veterinary Medicine, Hokkaido University, Sapporo, Japan,2 Department of Developmental Medical Sciences, Graduate School of Medicine, University of Tokyo, Tokyo, Japan,3 St. Marianna University School of Medicine, Kawasaki, Japan4
Received 8 April 2010/ Returned for modification 7 June 2010/ Accepted 6 August 2010
Peramivir, a sialic acid analogue, is a selective inhibitor of neuraminidases produced by influenza A and B viruses. We evaluated the efficacy and safety of a single intravenous dose of peramivir in outpatients with uncomplicated seasonal influenza virus infection. A total of 300 previously healthy adult subjects aged 20 to 64 years with a positive influenza virus rapid antigen test were recruited within 48 h of the onset of influenza symptoms and randomized to three groups: single intravenous infusion of either 300 mg peramivir per kg of body weight, 600 mg peramivir, or matching placebo on study day 1. Influenza symptoms and body temperature were self-assessed for 14 days. Nasal and pharyngeal swabs were collected to determine the viral titer. The primary endpoint was the time to alleviation of symptoms. Of the 300 subjects, 296 were included in the intent-to-treat infected population (300 mg peramivir, n = 99; 600 mg peramivir, n = 97; and placebo, n = 100). Peramivir significantly reduced the time to alleviation of symptoms at both 300 mg (hazard ratio, 0.681) and 600 mg (hazard ratio, 0.666) compared with placebo (adjusted P value, 0.0092 for both comparisons). No serious adverse events were reported. Peramivir was well tolerated, and its adverse-event profile was similar to that of placebo. A single intravenous dose of peramivir is effective and well tolerated in subjects with uncomplicated seasonal influenza virus infection.
http://aac.asm.org/cgi/content/abstract/54/11/4568
0066-4804/10/$12.00+0 doi:10.1128/AAC.00474-10
Copyright ? 2010, American Society for Microbiology. All Rights Reserved.
Efficacy and Safety of Intravenous Peramivir for Treatment of Seasonal Influenza Virus Infection{triangledown} ,{dagger}
Shigeru Kohno,1* Hiroshi Kida,2 Masashi Mizuguchi,3 Jingoro Shimada,4 for the S-021812 Clinical Study Group
Second Department of Internal Medicine, Nagasaki University School of Medicine, Nagasaki, Japan,1 Department of Disease Control, Graduate School of Veterinary Medicine, Hokkaido University, Sapporo, Japan,2 Department of Developmental Medical Sciences, Graduate School of Medicine, University of Tokyo, Tokyo, Japan,3 St. Marianna University School of Medicine, Kawasaki, Japan4
Received 8 April 2010/ Returned for modification 7 June 2010/ Accepted 6 August 2010
Peramivir, a sialic acid analogue, is a selective inhibitor of neuraminidases produced by influenza A and B viruses. We evaluated the efficacy and safety of a single intravenous dose of peramivir in outpatients with uncomplicated seasonal influenza virus infection. A total of 300 previously healthy adult subjects aged 20 to 64 years with a positive influenza virus rapid antigen test were recruited within 48 h of the onset of influenza symptoms and randomized to three groups: single intravenous infusion of either 300 mg peramivir per kg of body weight, 600 mg peramivir, or matching placebo on study day 1. Influenza symptoms and body temperature were self-assessed for 14 days. Nasal and pharyngeal swabs were collected to determine the viral titer. The primary endpoint was the time to alleviation of symptoms. Of the 300 subjects, 296 were included in the intent-to-treat infected population (300 mg peramivir, n = 99; 600 mg peramivir, n = 97; and placebo, n = 100). Peramivir significantly reduced the time to alleviation of symptoms at both 300 mg (hazard ratio, 0.681) and 600 mg (hazard ratio, 0.666) compared with placebo (adjusted P value, 0.0092 for both comparisons). No serious adverse events were reported. Peramivir was well tolerated, and its adverse-event profile was similar to that of placebo. A single intravenous dose of peramivir is effective and well tolerated in subjects with uncomplicated seasonal influenza virus infection.
http://aac.asm.org/cgi/content/abstract/54/11/4568