End points for testing influenza antiviral treatments for patients at high risk of severe and life-threatening disease

Michael G. Ison, Menno D. De Jong, Kevin J. Gilligan, Elizabeth S. Higgs, Andrew T. Pavia, Jerome Pierson, Frederick G. Hayden

Research output: Contribution to journalReview article

50 Scopus citations

Abstract

Influenza infection results in substantial morbidity and mortality in hospitalized patients, including those who are immunocompromised or pregnant. Antiviral therapy likely provides considerable benefit to these patients, but few studies have been successfully conducted in these high-risk populations, and no drugs are specifically licensed for treating these subgroups. One of the key challenges facing novel antiviral drug development for influenza is determining the appropriate efficacy end points that would enable rapid regulatory approval for drug use in seriously ill patients, for whom risk-benefit assessments differ from those with uncomplicated illness. All available antiviral drugs currently affect viral replication, and respiratory tract viral titers correlate with both symptoms and measures of host inflammatory responses, including cytokine and chemokine expression that are likely responsible for many of the clinical symptoms. Consequently, we outline the evidence to support the use of primary virological end points in studies of antiviral agents involving patients who are hospitalized with severe influenza or those who are at high risk of severe and life-threatening disease.

Original languageEnglish (US)
Pages (from-to)1654-1662
Number of pages9
JournalJournal of Infectious Diseases
Volume201
Issue number11
DOIs
StatePublished - Jun 1 2010

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

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