Abstract | BACKGROUND: METHODS: We conducted 2 consecutive randomized, double-blind, placebo-controlled trials in adult dengue patients to evaluate safety and virological and clinical efficacies of ivermectin. After a phase 2 trial with 2 or 3 days of 1 daily dose of 400 µg/kg ivermectin, we continued with a phase 3, placebo-controlled trial with 3 days of 400 µg/kg ivermectin. RESULTS: The phase 2 trial showed a trend in reduction of plasma nonstructural protein 1 (NS1) clearance time in the 3-day ivermectin group compared with placebo. Combining phase 2 and 3 trials, 203 patients were included in the intention to treat analysis (100 and 103 patients receiving ivermectin and placebo, respectively). Dengue hemorrhagic fever occurred in 24 (24.0%) of ivermectin-treated patients and 32 (31.1%) patients receiving placebo (P = .260). The median (95% confidence interval [CI]) clearance time of NS1 antigenemia was shorter in the ivermectin group (71.5 [95% CI 59.9-84.0] hours vs 95.8 [95% CI 83.9-120.0] hours, P = .014). At discharge, 72.0% and 47.6% of patients in the ivermectin and placebo groups, respectively had undetectable plasma NS1 (P = .001). There were no differences in the viremia clearance time and incidence of adverse events between the 2 groups. CONCLUSIONS: A 3-day 1 daily dose of 400 µg/kg oral ivermectin was safe and accelerated NS1 antigenemia clearance in dengue patients. However, clinical efficacy of ivermectin was not observed at this dosage regimen.
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Authors | Yupin Suputtamongkol, Panisadee Avirutnan, Dumrong Mairiang, Nasikarn Angkasekwinai, Kannika Niwattayakul, Eakkawit Yamasmith, Fadhil A-Hamad Saleh-Arong, Adisak Songjaeng, Tanapan Prommool, Nattaya Tangthawornchaikul, Chunya Puttikhunt, Saowalak Hunnangkul, Chulaluk Komoltri, Suwich Thammapalo, Prida Malasit |
Journal | Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
(Clin Infect Dis)
Vol. 72
Issue 10
Pg. e586-e593
(05 18 2021)
ISSN: 1537-6591 [Electronic] United States |
PMID | 33462580
(Publication Type: Clinical Trial, Phase II, Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: [email protected]. |
Chemical References |
- Antiparasitic Agents
- Viral Nonstructural Proteins
- Ivermectin
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Topics |
- Adult
- Animals
- Antiparasitic Agents
(therapeutic use)
- Dengue
(drug therapy)
- Double-Blind Method
- Humans
- Ivermectin
(therapeutic use)
- Viral Nonstructural Proteins
- Viremia
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