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Cited by 512Influenza Virus Research StudiesRespiratory viral infections researchBacterial Infections and Vaccines

Use of the Selective Oral Neuraminidase Inhibitor Oseltamivir to Prevent Influenza

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Hayden, Frederick G., Atmar, Robert L., Schilling, Margo, Johnson, Casey, Poretz, Donald, Paar, David, Huson, Les, Ward, Penelope +1 more·1999·New England Journal of Medicine
DOI 10.1056/nejm199910283411802
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Abstract

BACKGROUND: Safe and effective antiviral agents are needed to prevent infection with influenza A and B virus. Oseltamivir (GS4104), which can be administered orally, is the prodrug of GS4071, a potent and selective inhibitor of influenzavirus neuraminidases. We studied the use of oseltamivir for long-term prophylaxis against influenza in two placebo-controlled, double-blind trials at different U.S. sites during the winter of 1997-1998. METHODS: We randomly assigned 1559 healthy, nonimmunized adults 18 to 65 years old to receive either oral oseltamivir (75 mg given once or twice daily, for a total daily dose of 75 or 150 mg) or placebo for six weeks during a peak period of local influenzavirus activity. The primary end point with respect to efficacy was laboratory-confirmed influenza-like illness (defined as a temperature of at least 37.2 degrees C accompanied by at least one respiratory and at least one systemic symptom). RESULTS: In the two studies combined, the risk of influenza among subjects assigned to either once-daily or twice-daily oseltamivir (1.2 percent and 1.3 percent, respectively) was lower than that among subjects assigned to placebo (4.8 percent; P<0.001 and P=0.001 for the comparison with once-daily and twice-daily oseltamivir, respectively). The protective efficacy of oseltamivir in the two active-treatment groups combined was 74 percent (95 percent confidence interval, 53 to 88 percent) at all the sites combined and 82 percent (95 percent confidence interval, 60 to 93 percent) at sites in Virginia, where the rate of influenza infection was higher than the overall rate. For culture-proved influenza, the rate of protective efficacy in the two oseltamivir groups combined was 87 percent (95 percent confidence interval, 65 to 96 percent). The rate of laboratory-confirmed influenza infection was lower with oseltamivir than with placebo (5.3 percent vs. 10.6 percent, P<0.001). Oseltamivir was well tolerated but was associated with a greater frequency of nausea (12.1 percent and 14.6 percent in the once-daily and twice-daily groups, respectively) and vomiting (2.5 percent and 2.7 percent, respectively) than was placebo (nausea, 7.1 percent; vomiting, 0.8 percent). However, the frequency of premature discontinuation of drug or placebo was similar among the three groups (3.1 to 4.0 percent). CONCLUSIONS: Oseltamivir administered daily for six weeks by the oral route is safe and effective for the prevention of influenza.

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  • Specific antivirals are efficacious for seasonal prophylaxis and post-exposure prophylaxis of influenza within families.

    “The antiviral drug approach to prevention of respiratory infections is currently to influenza, for which the efficacy of the specific antivirals has been shown for both seasonal prophylaxis and post-exposure prophylaxis within families.138, 139, 140, 141, 142”

    From The common cold (2003) · cites this paper as [140]

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Authors
Hayden, F. G., Atmar, R. L., Schilling, M., Johnson, C., Poretz, D., Paar, D., Huson, L., Ward, P., & Mills, R. G.
Affiliations
  • University of Virginia (US)
  • Baylor College of Medicine (US)
  • Eastern Virginia Medical School (US)
  • Roche (United Kingdom) (GB)
  • Gilead Sciences (United States) (US)
ORCID
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
1999-10-28
Volume
341
Issue
18
Pages
1336-1343
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejm199910283411802
OpenAlex
W2027368298
Cited by
512
References
22
Citations by year
2026: 5 · 2025: 10 · 2024: 7 · 2023: 6 · 2022: 10 · 2021: 5 · 2020: 8 · 2019: 7 · 2018: 7 · 2017: 10 · 2016: 9 · 2015: 13 · 2014: 15 · 2013: 20 · 2012: 22
FWCI
36.09
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
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
oseltamivir, neuraminidase inhibitors, influenza prevention, influenza A virus, influenza B, antiviral agents, influenza-like illness, protective efficacy, dosing frequency, nausea, drug safety, healthy adults
MeSH terms
Administration, Oral, Adolescent, Adult, Aged, Amines, Double-Blind Method, Drug Administration Schedule, Enzyme Inhibitors, Female, Humans, Influenza, Human, Male, Middle Aged, Neuraminidase, Influenza A virus, Influenza B virus, Oseltamivir

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