About: Efficacy of Oseltamivir-Zanamivir Combination Compared to Each Monotherapy for Seasonal Influenza: A Randomized Placebo-Controlled Trial

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Efficacy of Oseltamivir-Zanamivir Combination Compared to Each Monotherapy for Seasonal Influenza: A Randomized Placebo-Controlled Trial
Creator	Lina, Bruno Andreoletti, Laurent Blanchon, Thierry Mosnier, Anne Leport, Catherine Mentré, France Enouf, Vincent Duval, Xavier Bouscambert-Duchamp, Maude Tibi, Annick Tubach, Florence Vincent, Corine Cile Charlois-Ou, Cé Study, Bivir Van Der Werf, Sylvie
Source	PMC
abstract	BACKGROUND: Neuraminidase inhibitors are thought to be efficacious in reducing the time to alleviation of symptoms in outpatients with seasonal influenza. The objective of this study was to compare the short-term virological efficacy of oseltamivir-zanamivir combination versus each monotherapy plus placebo. METHODS AND FINDINGS: We conducted a randomized placebo-controlled trial with 145 general practitioners throughout France during the 2008–2009 seasonal influenza epidemic. Patients, general practitioners, and outcome assessors were all blinded to treatment assignment. Adult outpatients presenting influenza-like illness for less than 36 hours and a positive influenza A rapid test diagnosis were randomized to oseltamivir 75 mg orally twice daily plus zanamivir 10 mg by inhalation twice daily (OZ), oseltamivir plus inhaled placebo (O), or zanamivir plus oral placebo (Z). Treatment efficacy was assessed virologically according to the proportion of patients with nasal influenza reverse transcription (RT)-PCR below 200 copies genome equivalent (cgeq)/µl at day 2 (primary outcome), and clinically to the time to alleviation of symptoms until day 14. Overall 541 patients (of the 900 planned) were included (OZ, n = 192; O, n = 176; Z, n = 173), 49% male, mean age 39 years. In the intention-to-treat analysis conducted in the 447 patients with RT-PCR-confirmed influenza A, 46%, 59%, and 34% in OZ (n = 157), O (n = 141), and Z (n = 149) arms had RT-PCR<200 cgeq/µl (−13.0%, 95% confidence interval [CI] −23.1 to −2.9, p = 0.025; +12.3%, 95% CI 2.39–22.2, p = 0.028 for OZ/O and OZ/Z comparisons). Mean day 0 to day 2 viral load decrease was 2.14, 2.49, and 1.68 log(10) cgeq/µl (p = 0.060, p = 0.016 for OZ/O and OZ/Z). Median time to alleviation of symptoms was 4.0, 3.0, and 4.0 days (+1.0, 95% CI 0.0–4.0, p = 0.018; +0.0, 95% CI −3.0 to 3.0, p = 0.960 for OZ/O and OZ/Z). Four severe adverse events were observed. Nausea and/or vomiting tended to be more frequent in the combination arm (OZ, n = 13; O, n = 4; and Z, n = 5 patients, respectively). CONCLUSIONS: In adults with seasonal influenza A mainly H3N2 virus infection, the oseltamivir-zanamivir combination appeared less effective than oseltamivir monotherapy, and not significantly more effective than zanamivir monotherapy. Despite the theoretical potential for the reduction of the emergence of antiviral resistance, the lower effectiveness of this combination calls for caution in its use in clinical practice. TRIAL REGISTRATION: www.ClinicalTrials.gov NCT00799760 Please see later in the article for the Editors' Summary
has issue date	2010-11-02(xsd:dateTime)
bibo:doi	10.1371/journal.pmed.1000362
bibo:pmid	21072246
has license	cc-by
sha1sum (hex)	073d9b195e4d3e325a8ec7cd30b9ec23bb0a00a7
schema:url	https://doi.org/10.1371/journal.pmed.1000362
resource representing a document's title	Efficacy of Oseltamivir-Zanamivir Combination Compared to Each Monotherapy for Seasonal Influenza: A Randomized Placebo-Controlled Trial
has PubMed Central identifier	PMC2970549
has PubMed identifier	21072246
schema:publication	PLoS Med
resource representing a document's body	covid:073d9b195e4d3e325a8ec7cd30b9ec23bb0a00a7#body_text
is schema:about of	named entity 'outpatients' named entity 'Influenza' named entity 'ZANAMIVIR' named entity 'OSELTAMIVIR' named entity 'SEASONAL INFLUENZA' named entity 'EFFICACY' named entity 'ZANAMIVIR' named entity 'COMPARED' named entity 'COMBINATION' named entity 'MONOTHERAPY' named entity 'RANDOMIZED PLACEBO-CONTROLLED TRIAL' named entity 'VIROLOGICAL' named entity 'SYMPTOMS' named entity 'SEASONAL INFLUENZA' named entity 'OUTPATIENTS' named entity 'STUDY' named entity 'TO COMPARE' named entity 'OBJECTIVE' named entity 'PLACEBO' named entity 'TIME' named entity 'REDUCING' named entity 'BACKGROUND' named entity 'OSELTAMIVIR' named entity 'MONOTHERAPY' named entity 'SHORT-TERM' named entity 'NEURAMINIDASE INHIBITORS' named entity 'COMBINATION' named entity 'THOUGHT' named entity 'EFFICACY' covid:arg/073d9b195e4d3e325a8ec7cd30b9ec23bb0a00a7 named entity 'Each' named entity 'Trial' named entity 'Neuraminidase inhibitors' named entity 'oseltamivir' named entity 'Seasonal Influenza' named entity 'Oseltamivir' named entity 'viruses' named entity 'virus' named entity 'viruses' named entity 'virological' named entity 'oseltamivir' named entity 'viruses' named entity 'subtyping' named entity 'chills' named entity 'rapid test' named entity 'viruses' named entity 'monotherapy' named entity 'oseltamivir' named entity 'virological' named entity 'specificity and sensitivity' named entity 'neuraminidase inhibitors' named entity 'zanamivir' named entity 'viral shedding' named entity 'zanamivir' named entity 'virological' named entity 'zanamivir' named entity 'infection' named entity 'SmithKline' named entity 'oseltamivir' named entity 'viral shedding' named entity 'primer' named entity 'clinical symptoms' named entity 'oseltamivir' named entity 'influenza' named entity 'vomiting' named entity 'oedema' named entity 'false negative results'

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