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    BRA 77 Eakkawit

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    This phase III clinical trial evaluated the efficacy and safety of oral ivermectin treatment for dengue infection. 146 patients aged 15 or older with confirmed dengue infection were randomly assigned to receive either a 3-day course of oral ivermectin at 400 μg/kg daily or a placebo. Results showed no difference in plasma viremia clearance times between the two groups. However, NS1 antigen clearance times were significantly shorter and more patients had undetectable NS1 at discharge with ivermectin treatment. No difference was found in fever clearance times. No serious adverse events occurred. This study demonstrates the virological efficacy and safety of short-term ivermectin treatment for dengue,

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    BRA 77 Eakkawit

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    vetma1
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    This phase III clinical trial evaluated the efficacy and safety of oral ivermectin treatment for dengue infection. 146 patients aged 15 or older with confirmed dengue infection were randomly assigned to receive either a 3-day course of oral ivermectin at 400 μg/kg daily or a placebo. Results showed no difference in plasma viremia clearance times between the two groups. However, NS1 antigen clearance times were significantly shorter and more patients had undetectable NS1 at discharge with ivermectin treatment. No difference was found in fever clearance times. No serious adverse events occurred. This study demonstrates the virological efficacy and safety of short-term ivermectin treatment for dengue,

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    This phase III clinical trial evaluated the efficacy and safety of oral ivermectin treatment for dengue infection. 146 patients aged 15 or older with confirmed dengue infection were randomly assigned to receive either a 3-day course of oral ivermectin at 400 μg/kg daily or a placebo. Results showed no difference in plasma viremia clearance times between the two groups. However, NS1 antigen clearance times were significantly shorter and more patients had undetectable NS1 at discharge with ivermectin treatment. No difference was found in fever clearance times. No serious adverse events occurred. This study demonstrates the virological efficacy and safety of short-term ivermectin treatment for dengue,

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    23 views1 page

    BRA 77 Eakkawit

    Uploaded by

    vetma1
    This phase III clinical trial evaluated the efficacy and safety of oral ivermectin treatment for dengue infection. 146 patients aged 15 or older with confirmed dengue infection were randomly assigned to receive either a 3-day course of oral ivermectin at 400 μg/kg daily or a placebo. Results showed no difference in plasma viremia clearance times between the two groups. However, NS1 antigen clearance times were significantly shorter and more patients had undetectable NS1 at discharge with ivermectin treatment. No difference was found in fever clearance times. No serious adverse events occurred. This study demonstrates the virological efficacy and safety of short-term ivermectin treatment for dengue,

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    of 1

    The 34th Annual Meeting The Royal College of Physicians of Thailand

    'Internal Medicine and One Health'


    26th - 28th April 2018, PEACH Royal Cliff Beach Resort, Pattaya, Chonburi, Thailand

    Efficacy and Safety of Ivermectin against Dengue


    Infection: A Phase III, Randomized, Double-blind,
    Placebo-controlled Trial
    Eakkawit Yamasmith1 Fadhil A-hamad Saleh-arong1
    Panisadee Avirutnan2 Nasikarn Angkasekwinai1
    Dumrong Mairiang2 Ekkarat Wongsawat1
    Sawalee Tanrumluk1 Usanee Fongsri1
    Yupin Suputtamongkol1
    1
    Department of Medicine, Faculty of Medicine Siriraj Hospital, Bangkok 10700, Thailand, 2Department of
    Research and Development, Faculty of Medicine Siriraj Hospital, Bangkok 10700, Thailand Medical
    Biotechnology Research Unit, National Center for Genetic Engineering and Biotechnology, National
    Science and Technology Development Agency, Bangkok 12120, Thailand

    Background: Results from the previous phase II study (unpublished data) indicated that 3-day
    treatment with oral ivermectin (400 µg/kg; once daily) is safe in patients with dengue infection.

    Objective: We conducted this phase III clinical trial to determine the virological and clinical
    efficacies and confirm the safety of this treatment regimen in adult patients with dengue infection at
    Siriraj Hospital.

    Methods: This was a randomized, double-blind, placebo-controlled trial of once daily dose of 400
    µg/kg of oral ivermectin for three days compared to placebo for treatment of patients with dengue
    infection, between February 2014 and September 2017. Patients aged 15 years or older, who had
    fever suspected of dengue infection and positive dengue non-structural protein NS1 rapid test, were
    recruited. They were randomly assigned (1:1 in block of four) to placebo or three-day of oral
    ivermectin treatment. The virological outcomes were plasma dengue viremia clearance and dengue
    nonstructural protein 1 (NS1) antigenemia clearance. Clinical efficacies included fever clearance
    and the proportion of patients who developed dengue hemorrhagic fever (DHF) after treatment.

    Results: Overall 146 patients were enrolled. A number of 131 patients were included in the
    modified intention analysis (66 patients in the ivermectin group and 65 patients in the placebo
    group). The median (IQR) plasma dengue viremia clearance were 80.5 (71.7-89.3) hours and 82
    (74.2 -89.8) hours in the ivermectin and the placebo groups, respectively (p=0.766). The median
    (IQR) NS1 clearance times were 90 (70.3-109.8) hours and 102 (76.6-127.4) hours in the
    ivermectin and the placebo groups, respectively (P=0.027). Nineteen patients (74.47%) and 30
    patients (46.15%) had undetectable NS1 at discharge in the ivermectin and the placebo groups
    respectively (P=0.001). The median (IQR) fever clearance times were 79 (73.1-84.9) hours, 79
    (70.7-87.3) hours in the ivermectin and the placebo groups, respectively (P=0.736). There were no
    serious adverse events observed in this study.

    Conclusion: Once daily dose of ivermectin treatment for three days is safe. Virological efficacy is
    demonstrated by significant difference of NS1 clearance time and proportion of patients with NS1
    negative at discharge between the two treatment groups. However there is no clinical efficacy of
    ivermectin shown in this study. The pharmacokinetic and pharmacodynamics study are needed in
    order to modify the dosage regimen of ivermectin treatment to improve the clinical efficacy.
    Keywords: Ivermectin, Dengue infection, Efficacy, Safety

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