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Ivermectin Accelerates Circulating Nonstructural Protein 1 (NS1) Clearance in Adult Dengue Patients: A Combined Phase 2/3 Randomized Double-blinded Placebo Controlled Trial.

AbstractBACKGROUND:
Dengue is the most significant mosquito-borne viral disease; there are no specific therapeutics. The antiparasitic drug ivermectin efficiently inhibits the replication of all 4 dengue virus serotypes in vitro.
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.
AuthorsYupin 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
JournalClinical 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
PMID33462580 (Publication Type: Clinical Trial, Phase II, Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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
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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