Emergency use authorization for intravenous peramivir: evaluation of safety in the treatment of hospitalized patients infected with 2009 H1N1 influenza A virus.

@article{Sorbello2012EmergencyUA,
  title={Emergency use authorization for intravenous peramivir: evaluation of safety in the treatment of hospitalized patients infected with 2009 H1N1 influenza A virus.},
  author={A. Sorbello and S. Jones and W. Carter and K. Struble and R. Boucher and Melissa D. Truffa and D. Birnkrant and Neha Gada and S. Camilli and I. Chan and S. Dallas and Twanda Scales and Robert Kosko and Elizabeth G Thompson and J. Goodman and H. Francis and G. D. Dal Pan},
  journal={Clinical infectious diseases : an official publication of the Infectious Diseases Society of America},
  year={2012},
  volume={55 1},
  pages={
          1-7
        }
}
  • A. Sorbello, S. Jones, +14 authors G. D. Dal Pan
  • Published 2012
  • Medicine
  • Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
BACKGROUND On 23 October 2009, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for intravenous peramivir, an unapproved antiviral, to treat suspected or confirmed 2009 H1N1 influenza A virus infection. Eligible hospitalized patients were unresponsive to or unable to tolerate available antivirals or lacked dependable oral or inhaled drug delivery routes. The EUA required healthcare providers to report medication errors, selected adverse events (AEs), serious… Expand
Peramivir use for treatment of hospitalized patients with influenza A(H1N1)pdm09 under emergency use authorization, October 2009-June 2010.
  • Yon C Yu, S. Garg, +5 authors T. Uyeki
  • Medicine
  • Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
  • 2012
TLDR
Almost 1274 hospitalized patients received peramivir through EUA program during the pH1N1 pandemic, with estimates for the potential total number of peramvir recipients ranging from 1185 to 1490. Expand
Evaluation of intravenous peramivir for treatment of influenza in hospitalized patients.
  • M. D. de Jong, M. Ison, +7 authors W. Sheridan
  • Medicine
  • Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
  • 2014
TLDR
A significant clinical benefit was not demonstrated for peramivir plus SOC compared with placebo plus SOC and the findings highlight the challenges in designing studies to evaluate influenza antiviral agents in a hospitalized setting. Expand
Editorial commentary: What did we learn from the emergency use authorization of peramivir in 2009?
  • A. Pavia
  • Medicine
  • Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
  • 2012
TLDR
Two articles in this issue describe the available data from the experience and leave many questions unanswered about the efficacy, safety, and impact of peramivir on pH1N1 infection. Expand
Safety and efficacy of peramivir for influenza treatment
TLDR
Peramivir shows efficacy for the treatment of seasonal and pH1N1 influenza, and 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. Expand
Intravenous Peramivir for Treatment of Influenza in Hospitalized Patients
TLDR
This open-label trial of intravenous peramivir in subjects hospitalized predominantly with 2009 influenza A (H1N1) demonstrated that once- or twice-daily administration was associated with decreases in viral shedding and clinical improvement. Expand
Reply to Ison et Al.
TLDR
Clinical trials of intravenous peramivir in hospitalized patients with influenza would provide a more appropriate setting in which to evaluate the drug’s safety and efficacy. Expand
Peramivir: evidence to support the use of the first approved intravenous therapy for influenza
TLDR
With the recent FDA approval of single-dose therapy for uncomplicated influenza infection, the preclinical and clinical data, to date, on peramivir are reviewed. Expand
Peramivir: A Novel Intravenous Neuraminidase Inhibitor for Treatment of Acute Influenza Infections
TLDR
Successful clinical trials and post-marketing data in pediatric populations in Japan support the safety and efficacy of peramivir in this population where administration of other antivirals might not be feasible. Expand
Assessment of adverse events related to anti-influenza neuraminidase inhibitors using the FDA adverse event reporting system and online patient reviews
TLDR
Adverse symptoms related to NAIs varied and depended on the drugs used and the age of the patient, while gastrointestinal disorders were most common in adult given oseltamivir in the FAERS and WebMD. Expand
Safety and Effectiveness of Peramivir in Korean Adult Influenza Patients: Prospective Observational Study Based on Post-Marketing Surveillance Data
TLDR
Peramivir showed a tolerable safety profile and acceptable effectiveness in Korean adult patients with seasonal influenza and in the effectiveness evaluation, the severity of influenza symptoms decreased and daily living performance improved. Expand
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Peramivir use for treatment of hospitalized patients with influenza A(H1N1)pdm09 under emergency use authorization, October 2009-June 2010.
  • Yon C Yu, S. Garg, +5 authors T. Uyeki
  • Medicine
  • Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
  • 2012
TLDR
Almost 1274 hospitalized patients received peramivir through EUA program during the pH1N1 pandemic, with estimates for the potential total number of peramvir recipients ranging from 1185 to 1490. Expand
Intravenous Peramivir for Treatment of Influenza A and B Virus Infection in High-Risk Patients
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Copyright © 2010 Massachusetts Medical Society. During the spring of 2009, a novel influenza A (H1N1) virus of swine origin caused human infection and acute respiratory illness in Mexico.1,2 AfterExpand
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