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Efficacy and Safety of Ergoferon versus Oseltamivir in Adult Outpatients with Seasonal Influenza Virus Infection: A Multicenter Open-Label Randomized Trial

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  • Efficacy and Safety of Ergoferon versus Oseltamivir in Adult Outpatients with Seasonal Influenza Virus Infection: A Multicenter Open-Label Randomized Trial

    Int J Infect Dis. 2016 Sep 8. pii: S1201-9712(16)31157-2. doi: 10.1016/j.ijid.2016.09.002. [Epub ahead of print]
    Efficacy and Safety of Ergoferon versus Oseltamivir in Adult Outpatients with Seasonal Influenza Virus Infection: A Multicenter Open-Label Randomized Trial.

    Rafalsky V1, Averyanov A2, Bart B3, Minina E4, Putilovskiy M5, Andrianova E6, Epstein O7.
    Author information

    Abstract

    OBJECTIVES:

    Ergoferon is antiviral complex drug containing released-active forms of antibodies to interferon gamma, CD4, histamine, which efficacy and safety in treatment of acute respiratory viral infections previously were shown. The aim of the study was to compare Ergoferon vs oseltamivir.
    METHODS:

    A multicenter, open-label, randomized, controlled trial recruited patients aged 18 to 65 years who had tested positive for influenza A or B antigens. A total of 156 patients were enrolled as the intention-to-treat population and randomly assigned to receive either Ergoferon or oseltamivir (n=78 in each group).
    RESULTS:

    The percentages of patients achieving normal body temperature (≤37.0?С) following five days of treatment did not differ significantly between the groups. The mean duration of fever in the Ergoferon and oseltamivir groups was 2.1?1.5 days and 2.3?1.6 days, respectively (p=0.01). The average time to influenza symptom resolution was approximately three days, with no significant between-group differences. Total quality-of-life scores were similar in the groups following five days of drug administration. The incidence of adverse events did not differ significantly between the groups, nor were there any serious adverse events.
    CONCLUSIONS:

    Ergoferon and oseltamivir were equally effective and safe in adult outpatients with seasonal influenza A or B virus infection.
    CLINICAL TRIAL REGISTRATION:

    ClinicalTrials.gov identifier: NCT01804946.
    Copyright ? 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.


    KEYWORDS:

    Influenza; ergoferon; oseltamivir; released-activity

    PMID: 27616034 DOI: 10.1016/j.ijid.2016.09.002
    [PubMed - as supplied by publisher] Free full text
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