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Cited by 762Influenza Virus Research StudiesRespiratory viral infections researchBacterial Infections and Vaccines

Efficacy and Safety of the Neuraminidase Inhibitor Zanamivir in the Treatment of Influenzavirus Infections

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Hayden, Frederick G., Osterhaus, Albert D.M.E., Treanor, John J., Fleming, Douglas M., Aoki, Fred Y., Nicholson, Karl G., Bohnen, Arthur M., Hirst, Hilary M. +2 more·1997·New England Journal of Medicine
DOI 10.1056/nejm199709253371302
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Abstract

BACKGROUND: The sialic acid analogue zanamivir (GG167) is a selective inhibitor of influenza A and B virus neuraminidases. These viral enzymes are essential for the release of virus from infected cells, and they may also reduce the inactivation of virus by respiratory secretions. When administered experimentally directly to the respiratory tract, zanamivir has potent antiviral effects. We assessed the therapeutic activity of zanamivir in adults with acute influenza. METHODS: We conducted separate randomized, double-blind studies in 38 centers in North America and 32 centers in Europe during the influenza season of 1994-1995. A total of 417 adults with influenza-like illness of < or =48 hours' duration were randomly assigned to one of three treatments: 6.4 mg of zanamivir by intranasal spray plus 10 mg by inhalation, 10 mg of zanamivir by inhalation plus placebo spray, or placebo by both routes. Treatments were self-administered twice daily for five days. RESULTS: Of 262 patients with confirmed influenza-virus infection (63 percent of all patients), the median length of time to the alleviation of all major symptoms was one day shorter (four days vs. five days) in the 88 patients given inhaled and intranasal zanamivir (P=0.02) and the 85 patients given inhaled zanamivir alone (P=0.05) than in the 89 patients given placebo. Among the infected patients who were febrile at enrollment and among those who began treatment within 30 hours after the onset of symptoms, the median time to the alleviation of major symptoms was four days in both zanamivir groups and seven days in the placebo group (P< or =0.01). Viral titers of nasal washings in the group given inhaled and intranasal zanamivir were significantly lower than those in the placebo group. The topically administered zanamivir was well tolerated. CONCLUSIONS: In adults with influenza A or B virus infections, direct administration of a selective neuraminidase inhibitor, zanamivir, to the respiratory tract is safe and reduces symptoms if begun early.

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Research works printed but not linked: 6

  1. Hayden FG. Amantadine and rimantadine -clinical aspects. In: Rich- man DD, ed. Antiviral drug resistance. Chichester, England: John Wiley, 1996:59-77.
  2. Hayden FG, Gwaltney JM Jr. Viral infections. In: Murray JF, Nadel JA, eds. Textbook of respiratory medicine. 2nd ed. Vol. 1. Philadelphia: W.B. Saunders, 1994:977-1035.
  3. Koch GG, Edwards S. Clinical efficacy trials with categorical data. In: Peace KE, ed. Biopharmaceutical statistics for drug development. Vol. 86 of Statistics: textbooks and monographs. New York: Marcel Dekker, 1988: 403-57.
  4. Hayden FG, Lobo M, Hussey EK, Eason CU. Efficacy of intranasal GG167 in experimental human influenza A and B virus infection. In: Brown LE, Hampson AW, Webster RG, eds. Options for the control of in- fluenza III. Amsterdam: Elsevier Science B.V., 1996:718-25.
  5. Cass LMR, Efthymiopoulos C, Bye A. An overview of the pharmaco- kinetics of the neuraminidase inhibitor GG167. In: Conference program and abstracts of the Third International Conference on Options for Con- trol of Influenza, Cairns, Australia, May 4-9, 1996:37. abstract.
  6. Hayden FG, Gwaltney JM Jr. Intranasal interferon-a2 treatment of ex- perimental rhinoviral colds. J Infect Dis 1984;150:174-80.

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Authors
Hayden, F. G., Osterhaus, A. D. M. E., Treanor, J. J., Fleming, D. M., Aoki, F. Y., Nicholson, K. G., Bohnen, A. M., Hirst, H. M., Keene, O., & Wightman, K.
Affiliations
  • University of Virginia (US)
  • Erasmus University Rotterdam (NL)
  • University of Rochester (US)
  • University of Manitoba (CA)
  • University of Leicester (GB)
  • Sigma Xi (US)
ORCID
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
1997-09-25
Volume
337
Issue
13
Pages
874-880
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejm199709253371302
OpenAlex
W2334261876
Cited by
762
References
21
Citations by year
2026: 6 · 2025: 14 · 2024: 5 · 2023: 11 · 2022: 16 · 2021: 11 · 2020: 9 · 2019: 12 · 2018: 14 · 2017: 14 · 2016: 13 · 2015: 21 · 2014: 18 · 2013: 27 · 2012: 17
FWCI
56.82
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • EUR Research Repository (Erasmus University Rotterdam) (publishedVersion, other-oa)
  • EUR Research Repository (Erasmus University Rotterdam) (submittedVersion, other-oa)
  • RePub (Erasmus University Rotterdam) (submittedVersion, other-oa)
  • Figshare (submittedVersion, cc-by)
  • Leicester Research Archive (University of Leicester) (submittedVersion)
Funders
Wellcome Trust
Topics
  • Health Sciences › Medicine › Epidemiology › Influenza Virus Research Studies
  • Health Sciences › Medicine › Epidemiology › Respiratory viral infections research
  • Life Sciences › Immunology and Microbiology › Microbiology › Bacterial Infections and Vaccines
Keywords
zanamivir, neuraminidase inhibitors, influenza A virus, influenza B, antiviral therapy, intranasal administration, inhalation, symptom relief, viral titer, drug safety
MeSH terms
Administration, Inhalation, Administration, Intranasal, Adolescent, Adult, Antiviral Agents, Double-Blind Method, Enzyme Inhibitors, Guanidines, Humans, Influenza, Human, Neuraminidase, Nose, Influenza A virus, Influenza B virus, Pyrans, Sialic Acids, Time Factors, Treatment Outcome, Zanamivir

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