Efficacy of Oseltamivir-Zanamivir Combination Compared to Each Monotherapy for Seasonal Influenza: A Randomized Placebo-Controlled Trial
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  • {"files"=>["https://ndownloader.figshare.com/files/409147", "https://ndownloader.figshare.com/files/409180", "https://ndownloader.figshare.com/files/409205", "https://ndownloader.figshare.com/files/409229", "https://ndownloader.figshare.com/files/409246", "https://ndownloader.figshare.com/files/409303"], "description"=>"<div><h3>Background</h3><p>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.</p><h3>Methods and Findings</h3><p>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, <em>n</em> = 192; O, <em>n</em> = 176; Z, <em>n</em> = 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 (<em>n</em> = 157), O (<em>n</em> = 141), and Z (<em>n</em> = 149) arms had RT-PCR<200 cgeq/µl (−13.0%, 95% confidence interval [CI] −23.1 to −2.9, <em>p</em> = 0.025; +12.3%, 95% CI 2.39–22.2, <em>p</em> = 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<sub>10</sub> cgeq/µl (<em>p</em> = 0.060, <em>p</em> = 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, <em>p</em> = 0.018; +0.0, 95% CI −3.0 to 3.0, <em>p</em> = 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, <em>n</em> = 13; O, <em>n</em> = 4; and Z, <em>n</em> = 5 patients, respectively).</p><h3>Conclusions</h3><p>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.</p><h3>Trial registration</h3><p><a href=\"http://www.ClinicalTrials.gov\">www.ClinicalTrials.gov</a><a href=\"http://www.clinicaltrials.gov/ct2/results?term=NCT00799760\">NCT00799760</a></p><h3></h3><p><em>Please see later in the article for the Editors' Summary</em></p></div>", "links"=>[], "tags"=>["efficacy", "oseltamivir-zanamivir", "compared", "monotherapy", "seasonal", "randomized", "placebo-controlled"], "article_id"=>140808, "categories"=>["Cancer"], "users"=>["Xavier Duval", "Sylvie van der Werf", "Thierry Blanchon", "Anne Mosnier", "Maude Bouscambert-Duchamp", "Annick Tibi", "Vincent Enouf", "Cécile Charlois-Ou", "Corine Vincent", "Laurent Andréoletti", "Florence Tubach", "Bruno Lina", "France Mentré", "Catherine Leport"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1000362.s001", "https://dx.doi.org/10.1371/journal.pmed.1000362.s002", "https://dx.doi.org/10.1371/journal.pmed.1000362.s003", "https://dx.doi.org/10.1371/journal.pmed.1000362.s004", "https://dx.doi.org/10.1371/journal.pmed.1000362.s005", "https://dx.doi.org/10.1371/journal.pmed.1000362.s006"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Efficacy_of_Oseltamivir_Zanamivir_Combination_Compared_to_Each_Monotherapy_for_Seasonal_Influenza_A_Randomized_Placebo_Controlled_Trial/140808", "title"=>"Efficacy of Oseltamivir-Zanamivir Combination Compared to Each Monotherapy for Seasonal Influenza: A Randomized Placebo-Controlled Trial", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2010-11-02 00:13:28"}
  • {"files"=>["https://ndownloader.figshare.com/files/820444"], "description"=>"<p>Trial flow chart.</p>", "links"=>[], "tags"=>["infectious diseases/antimicrobials and drug resistance", "infectious diseases/viral infections"], "article_id"=>490799, "categories"=>["Infectious Diseases", "Virology"], "users"=>["Xavier Duval", "Sylvie van der Werf", "Thierry Blanchon", "Anne Mosnier", "Maude Bouscambert-Duchamp", "Annick Tibi", "Vincent Enouf", "Cécile Charlois-Ou", "Corine Vincent", "Laurent Andréoletti", "Florence Tubach", "Bruno Lina", "France Mentré", "Catherine Leport"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1000362.g001"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Trial_flow_chart_/490799", "title"=>"Trial flow chart.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2010-11-02 00:13:19"}
  • {"files"=>["https://ndownloader.figshare.com/files/820649"], "description"=>"<p>Log-rank test for oseltamivir-zanamivir versus oseltamivir-placebo: <i>p</i> = 0.025 and for oseltamivir-zanamivir versus zanamivir-placebo: <i>p</i> = 0.036). Alleviation of symptoms defined by the presence of no symptoms of nasal stuffiness, sore throat, cough, muscle aches, tiredness-fatigue, feverishness, and headache or only mild ones, for at least 24 h.</p>", "links"=>[], "tags"=>["447", "influenza", "a-infected", "patients", "alleviation", "symptoms", "treated", "oseltamivir-zanamivir", "oseltamivir", "placebo", "zanamivir"], "article_id"=>490981, "categories"=>["Infectious Diseases", "Virology"], "users"=>["Xavier Duval", "Sylvie van der Werf", "Thierry Blanchon", "Anne Mosnier", "Maude Bouscambert-Duchamp", "Annick Tibi", "Vincent Enouf", "Cécile Charlois-Ou", "Corine Vincent", "Laurent Andréoletti", "Florence Tubach", "Bruno Lina", "France Mentré", "Catherine Leport"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1000362.g002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Proportion_of_the_447_influenza_A_infected_patients_with_alleviation_of_symptoms_when_treated_with_combined_oseltamivir_zanamivir_plain_line_oseltamivir_plus_placebo_dotted_line_or_zanamivir_plus_placebo_dashed_line_/490981", "title"=>"Proportion of the 447 influenza A-infected patients with alleviation of symptoms when treated with combined oseltamivir-zanamivir (plain line), oseltamivir plus placebo (dotted line), or zanamivir plus placebo (dashed line).", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2010-11-02 00:16:21"}
  • {"files"=>["https://ndownloader.figshare.com/files/820731"], "description"=>"a<p>Sum of the severity of the seven day 0 influenza symptoms (feverishness, nasal stuffiness, sore throat, cough, muscle aches, tiredness-fatigue, and headache) using a four-point scale <a href=\"http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1000362#pmed.1000362-Hayden1\" target=\"_blank\">[2]</a>,<a href=\"http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1000362#pmed.1000362-Hayden2\" target=\"_blank\">[14]</a>.</p>b<p>The score is expressed as a percentage of the maximal score of 21.</p>", "links"=>[], "tags"=>["541", "patients", "enrolled", "447", "influenza", "a-infected"], "article_id"=>491071, "categories"=>["Infectious Diseases", "Virology"], "users"=>["Xavier Duval", "Sylvie van der Werf", "Thierry Blanchon", "Anne Mosnier", "Maude Bouscambert-Duchamp", "Annick Tibi", "Vincent Enouf", "Cécile Charlois-Ou", "Corine Vincent", "Laurent Andréoletti", "Florence Tubach", "Bruno Lina", "France Mentré", "Catherine Leport"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1000362.t001"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Characteristics_of_the_541_patients_enrolled_in_the_study_and_of_the_447_influenza_A_infected_patients_according_to_treatment_arms_/491071", "title"=>"Characteristics of the 541 patients enrolled in the study and of the 447 influenza A-infected patients according to treatment arms.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2010-11-02 00:17:51"}
  • {"files"=>["https://ndownloader.figshare.com/files/820778"], "description"=>"a<p>Exploratory analysis.</p>", "links"=>[], "tags"=>["arms", "541", "enrolled"], "article_id"=>491126, "categories"=>["Infectious Diseases", "Virology"], "users"=>["Xavier Duval", "Sylvie van der Werf", "Thierry Blanchon", "Anne Mosnier", "Maude Bouscambert-Duchamp", "Annick Tibi", "Vincent Enouf", "Cécile Charlois-Ou", "Corine Vincent", "Laurent Andréoletti", "Florence Tubach", "Bruno Lina", "France Mentré", "Catherine Leport"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1000362.t002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Virological_and_clinical_response_according_to_treatment_arms_in_the_541_enrolled_patients_between_day_0_and_day_2_ITT_analysis_/491126", "title"=>"Virological and clinical response according to treatment arms in the 541 enrolled patients, between day 0 and day 2 (ITT analysis).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2010-11-02 00:18:46"}
  • {"files"=>["https://ndownloader.figshare.com/files/820836"], "description"=>"a<p>Exploratory analysis.</p>", "links"=>[], "tags"=>["arms", "447", "influenza", "a-infected", "patients"], "article_id"=>491185, "categories"=>["Infectious Diseases", "Virology"], "users"=>["Xavier Duval", "Sylvie van der Werf", "Thierry Blanchon", "Anne Mosnier", "Maude Bouscambert-Duchamp", "Annick Tibi", "Vincent Enouf", "Cécile Charlois-Ou", "Corine Vincent", "Laurent Andréoletti", "Florence Tubach", "Bruno Lina", "France Mentré", "Catherine Leport"], "doi"=>["https://dx.doi.org/10.1371/journal.pmed.1000362.t003"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Virological_and_clinical_response_according_to_treatment_arms_in_the_447_influenza_A_infected_patients_between_day_0_and_day_2_ITT_analysis_/491185", "title"=>"Virological and clinical response according to treatment arms in the 447 influenza A-infected patients between day 0 and day 2 (ITT analysis).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2010-11-02 00:19:45"}

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