Use of the Oral Neuraminidase Inhibitor Oseltamivir in Experimental Human Influenza: Randomized Controlled Trials for Prevention and Treatment

Hayden, Frederick G.; Treanor, John J.; Fritz, R. Scott; Lobo, Monica; Betts, Robert F.; Miller, Madeline; Kinnersley, Nelson; Mills, Roger G.; Ward, Penelope; Straus, Stephen E.

doi:10.1001/jama.282.13.1240

Cited by 550Influenza Virus Research StudiesRespiratory viral infections researchBacterial Infections and Vaccines

Use of the Oral Neuraminidase Inhibitor Oseltamivir in Experimental Human Influenza: Randomized Controlled Trials for Prevention and Treatment

Hayden, Frederick G., Treanor, John J., Fritz, R. Scott, Lobo, Monica, Betts, Robert F., Miller, Madeline, Kinnersley, Nelson, Mills, Roger G. +2 more·1999·JAMA

DOI 10.1001/jama.282.13.1240

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Abstract

CONTEXT: Influenza virus neuraminidase is thought to be essential for virus replication in humans; however, to date, available neuraminidase inhibitors are limited to zanamivir, which is topically administered. OBJECTIVE: To determine the safety, tolerability, and antiviral activity of oral neuraminidase inhibitor oseltamivir (GS4104/Ro64-0796) for prevention and the early treatment of influenza in experimentally infected humans. DESIGN: Two randomized, double-blind, placebo-controlled trials conducted between June and July 1997. SETTING: Individual hotel rooms; 2 large US university medical schools. PARTICIPANTS: A total of 117 healthy adult volunteers (aged 18-40 years; median age, 21 years) who were susceptible (hemagglutination-inhibition antibody titer < or =1:8). INTERVENTIONS: All subjects were inoculated intranasally with influenza A/Texas/36/91 (H1N1) virus. For the prophylaxis study, oral oseltamivir (100 mg once daily [n = 12], 100 mg twice daily [n = 12], or matching placebo [n = 13], starting 26 hours before virus inoculation) was administered. For the treatment study, the same drug was given (20 mg, 100 mg, or 200 mg twice daily, 200 mg once daily, or matching placebo [n = 16], in each group starting 28 hours after inoculation). All regimens were continued for 5 days. MAIN OUTCOME MEASURES: Comparing placebo groups with pooled treatment groups, for prophylaxis, outcomes included frequency of infection and viral shedding; for treatment, viral shedding in titers. RESULTS: In the prophylaxis study, 8 (67%) of 12 placebo and 8 (38%) of 21 oseltamivir recipients became infected (P = .16; efficacy, 61%); 6 (50%) placebo compared with 0 oseltamivir recipients shed virus (P<.001; efficacy, 100%), and 33% of placebo but no oseltamivir recipient had infection-related respiratory illness (P<.01). Among infected subjects in the treatment study (n = 69), the viral titer area under the curve of the combined oseltamivir groups (n = 56) was lower (median [interquartile range [IQR]], 80 [23-151] vs 273 [79-306] log10 tissue culture-infective doses50 per milliliter x hour; P = .02) than the placebo group (n = 13), and the median (IQR) duration of viral shedding with therapy was reduced from 107 (83-131) to 58 (35-59) hours (P = .003). Oseltamivir treatment also reduced symptom scores (median [IQR] score-hours, 225 [97-349] vs 400 [189-645]; P = .05), and nasal proinflammatory cytokine levels. Transient mild to moderate nausea after dosing was observed in 15 (17%) of 88 oseltamivir and 2 (7%) of 29 placebo recipients (95% confidence interval for difference, -11% to 68%), which was largely prevented by ingestion with food. CONCLUSIONS: In these trials, prophylaxis and early treatment with oral oseltamivir were both associated with significant antiviral and clinical effects in experimental human influenza.

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Authors: Hayden, F. G., Treanor, J. J., Fritz, R. S., Lobo, M., Betts, R. F., Miller, M., Kinnersley, N., Mills, R. G., Ward, P., & Straus, S. E.
Affiliations: University of Virginia (US)
ORCID: Hayden, Frederick G.
Kinnersley, Nelson
Mills, Roger G.
Ward, Penelope
Venue: JAMA
Publisher: American Medical Association (AMA)
Published: 1999-10-06
Volume: 282
Issue: 13
Pages: 1240
ISSN: 0002-9955 (ISSN-L)
0098-7484
DOI: 10.1001/jama.282.13.1240
OpenAlex: W2072658090
Cited by: 550
References: 30
Citations by year: 2026: 10 · 2025: 11 · 2024: 8 · 2023: 10 · 2022: 17 · 2021: 14 · 2020: 17 · 2019: 8 · 2018: 12 · 2017: 16 · 2016: 22 · 2015: 13 · 2014: 23 · 2013: 22 · 2012: 22
FWCI: 30.45
Type: journal article
Language: en
Open access: closed
Locations: JAMA (publishedVersion)
PubMed (publishedVersion)
Funders: National Institutes of Health (n01co056000-057)
National Cancer Institute (N01 CO 56000)
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 A virus, antiviral prophylaxis, antiviral therapy, viral shedding, H1N1 influenza, drug safety and tolerability, dose comparison, zanamivir, influenza C, influenza D virus, influenza E
MeSH terms: Administration, Oral, Adolescent, Adult, Amines, Dose-Response Relationship, Drug, Double-Blind Method, Enzyme Inhibitors, Female, Humans, Influenza, Human, Male, Nausea, Neuraminidase, Nose, Influenza A virus, Area Under Curve, Oseltamivir

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Use of the Oral Neuraminidase Inhibitor Oseltamivir in Experimental Human Influenza: Randomized Controlled Trials for Prevention and Treatment

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