title: Safety and efficacy of peramivir for influenza treatment.
abstract: OBJECTIVE
  This report presents a review of the efficacy and safety of peramivir, a neuraminidase inhibitor that was granted Emergency Use Authorization by the US Food and Drug Administration (FDA) from October 23, 2009 to June 23, 2010 during the 2009 H1N1 pandemic.
  
  
  METHODS
  Literature was accessed via PubMed (January 2000-April 2014) using several search terms: peramivir; BCX-1812; RWJ 270201; H1N1, influenza; antivirals; and neuraminidase inhibitors. The peramivir manufacturers, Shionogi and Co Ltd and BioCryst Pharmaceuticals, were contacted to obtain unpublished data and information presented at recent scientific meetings. Information was obtained from the Centers for Disease Control and Prevention (CDC) and from US FDA websites. English-language and Japanese-language reports in the literature were reviewed and selected based on relevance, along with information from the CDC, US FDA, and the drug manufacturers.
  
  
  RESULTS
  We obtained eleven clinical trial reports of intravenous peramivir, two of which described comparisons with oseltamivir. Seven of nine other recently reported published studies was a dose-response study. Clinical reports of critically ill patients and pediatric patients infected with pandemic H1N1 described that early treatment significantly decreased mortality. Peramivir administered at 300 mg once daily in adult patients with influenza significantly reduces the time to alleviation of symptoms or fever compared to placebo. It is likely to be as effective as other neuraminidase inhibitors.
  
  
  CONCLUSIONS
  Although peramivir shows efficacy for the treatment of seasonal and pH1N1 influenza, it has not received US FDA approval. Peramivir is used safely and efficiently in hospitalized adult and pediatric patients with suspected or laboratory-confirmed influenza. Peramivir might be a beneficial alternative antiviral treatment for many patients, including those unable to receive inhaled or oral neuraminidase inhibitors, or those requiring nonintravenous drug delivery.
authors.affiliation: Department of Pediatrics, Division of Respiratory Medicine, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan ; Department of Infectious Diseases, Division of Respiratory Medicine, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan.
authors.forename: Atsuko
authors.initials: A
authors.lastname: Hata
authors.affiliation: Department of Pediatrics, Division of Respiratory Medicine, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan.
authors.forename: Ryoko
authors.initials: R
authors.lastname: Akashi-Ueda
authors.affiliation: Respiratory Disease Center, Division of Respiratory Medicine, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan.
authors.forename: Kazufumi
authors.initials: K
authors.lastname: Takamatsu
authors.affiliation: Department of Infectious Diseases, Division of Respiratory Medicine, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan.
authors.forename: Takuro
authors.initials: T
authors.lastname: Matsumura
mesh_terms: D000146:Acids, Carbocyclic; D003517:Cyclopentanes / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D064420:Drug-Related Side Effects and Adverse Reactions; D006146:Guanidines / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D006801:Humans; D007251:Influenza, Human / Q000188:drug therapy*
chemical_list: D000146:Acids, Carbocyclic; D003517:Cyclopentanes; D006146:Guanidines; C414210:peramivir
keywords: antiviral therapy; avian flu; drug resistance; neuraminidase inhibitor; pH1N1; pandemic