Single dose peramivir for the treatment of acute seasonal influenza: Integrated analysis of efficacy and safety from two placebo-controlled trials

Antiviral Therapy

Volumn 20, Issue 7, 2015, Pages 709-719

  Whitley, Richard ^a   Laughlin, Alan ^b   Carson, Simon ^c   Mitha, Essack ^d   Tellier, Guy ^e   Stich, Mark ^f   Elder, Jenna ^g   Alexander, W James ^h   Dobo, Sylvia ^h   Collis, Phil ^h   Sheridan, William P ^h  

^a UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^b Merrylands Medical Centre   (Australia)

^c Christchurch South Health Centre   (New Zealand)

^d Newgate Centre   (South Africa)

^e Omnispec Clinical Research   (Canada)

^f Jacksonville Center for Clinical Research   (United States)

^g Pharpoint Research   (United States)

^h BIOCRYST PHARMACEUTICALS INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PERAMIVIR; PLACEBO; SIALIDASE INHIBITOR; ANTIVIRUS AGENT; CYCLOPENTANE DERIVATIVE; GUANIDINE DERIVATIVE;

ADULT; ANTIVIRAL SUSCEPTIBILITY; ARTICLE; ASTHMA; BRONCHOSPASM; DIARRHEA; DISEASE DURATION; DIZZINESS; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EPISTAXIS; FAINTNESS; FEMALE; FEVER; GASTROINTESTINAL DISEASE; HEADACHE; HERPES SIMPLEX; HERPES ZOSTER; HUMAN; HYPERGLYCEMIA; INFLUENZA A VIRUS; INFLUENZA A VIRUS (H1N1); INFLUENZA A VIRUS (H3N2); INFLUENZA B VIRUS; INJECTION SITE CONTUSION; INJECTION SITE PAIN; INSOMNIA; MAJOR CLINICAL STUDY; MALE; MENINGITIS; MULTICENTER STUDY (TOPIC); MYALGIA; NAUSEA; NEUTROPENIA; NOSE SMEAR; OUTPATIENT; PHARYNGITIS; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); POST HOC ANALYSIS; PRIORITY JOURNAL; PROTEINURIA; PYELONEPHRITIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); SEASONAL INFLUENZA; SINGLE DRUG DOSE; SMOKING; SYMPTOM; THROAT CULTURE; TIME; TONSILLITIS; TREATMENT OUTCOME; URINARY TRACT INFECTION; VIRUS DETECTION; VIRUS LOAD; VIRUS SHEDDING; VOMITING; ACUTE DISEASE; CLASSIFICATION; CONTROLLED CLINICAL TRIAL (TOPIC); DRUG EFFECTS; IC50; INFLUENZA, HUMAN; META ANALYSIS; MICROBIAL SENSITIVITY TEST; MIDDLE AGED; SEASON; VIROLOGY; YOUNG ADULT;

ACUTE DISEASE; ADULT; ANTIVIRAL AGENTS; CONTROLLED CLINICAL TRIALS AS TOPIC; CYCLOPENTANES; FEMALE; GUANIDINES; HUMANS; INFLUENZA A VIRUS; INFLUENZA, HUMAN; INHIBITORY CONCENTRATION 50; MALE; MICROBIAL SENSITIVITY TESTS; MIDDLE AGED; MULTICENTER STUDIES AS TOPIC; SEASONS; TREATMENT OUTCOME; VIRAL LOAD; YOUNG ADULT;

EID: 84973483758     PISSN: 13596535     EISSN: 20402058     Source Type: Journal    
DOI: 10.3851/IMP2874     Document Type: Article

References (15)

1. Harper SA, Bradley JS, Englund JA, et al. Seasonal influenza in adults and children - diagnosis, treatment, chemoprophylaxis, and institutional outbreak management: clinical practice guidelines of the Infectious Diseases Society of America. Clin Infect Dis 2009; 48:1003-1032.
2. Centers for Disease Control and Prevention. Influenza antiviral medications: summary for clinicians. (Updated 21 January 2011.Accessed 19 August 2015.) Available from http://www.cdc.gov/flu/professionals/antivirals/summaryclinicians.htm
3. Bantia S, Parker CD, Ananth SL, et al. Comparison of the anti-influenza virus activity of RWJ-270201 with those of oseltamivir and zanamivir. Antimicrob Agents Chemother 2001; 45:1162-1167.
4. Gubareva LV, Trujillo AA, Okomo-Adhiambo M, et al. Comprehensive assessment of 2009 pandemic influenza A (H1N1) virus drug susceptibility in vitro. Antivir Ther 2010; 15:1151-1159.
5. Cao RY, Xiao J-H, Cao B, Li S, Kumaki Y, Zhong W. Inhibition of novel reassortant avian influenza H7N9 virus infection in vitro with three antiviral drugs, oseltamivir, peramivir and favipiravir. Antivir Chem Chemother 2013; 23:237-240.
6. Babu YS, Chand P, Bantia S, et al. BCX-1812 (RWJ-270201): discovery of a novel, highly potent, orally active, and selective influenza neuraminidase inhibitor through structure-based drug design. J Med Chem 2000; 43:3482-3486.
7. Bantia S, Arnold CS, Parker CD, Upshaw R, Chand P. Antiinfluenza virus activity of peramivir in mice with single intramuscular injection. Antiviral Res 2006; 69:39-45.
8. Kohno S, Kida H, Masashi M, Shimada J, S-021812 Clinical Study Group. Efficacy and safety of intravenous peramivir for treatment of seasonal influenza virus infection. Antimicrob Agents Chemother 2010; 54:4568-4574.
9. Wetherall NT, Trivedi T, Zeller J, et al. Evaluation of neuraminidase enzyme assays using different substrates to measure susceptibility of influenza virus clinical isolates to neuraminidase inhibitors: report of the Neuraminidase Inhibitor Susceptibility Network. J Clin Microbiol 2003; 41:742-750.
10. Treanor JJ, Hayden FG, Vrooman PS, et al. Efficacy and safety of the oral neuraminidase inhibitor oseltamivir in treating acute influenza: a randomized controlled trial. JAMA 2000; 283:1016-1024.
11. Nicholson KG, Aoki FY, Osterhaus ADME, et al. Efficacy and safety of oseltamivir in treatment of acute influenza: a randomised controlled trial. Lancet 2000; 355:1845-1850.
12. Monto AS, Fleming DM, de Groot R, et al. Efficacy and safety of the neuraminidase inhibitor zanamivir in the treatment of influenza A and B virus infections. J Infect Dis 1999; 180:254-261.
13. Hsu J, Santesso N, Mustafa R, et al. Antivirals for treatment of influenza: a systematic review and meta-analysis of observational studies. Ann Intern Med 2012; 156:512-524.
14. US Food and Drug Administration. Guidance for industry influenza: developing drugs for treatment and/or prophylaxis. (Updated April 2011. Accessed 19 August 2015.) Available from http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
15. Cooper NJ, Sutton AJ, Abrams KR, Wailoo A, Turner D, Nicholson KG. Effectiveness of neuraminidase inhibitors in treatment and prevention of influenza A and B: systematic review and meta-analyses of randomized controlled trials. BMJ 2003; 326:1235.