Repeated-Dose High-Dose Ivermectin Pharmacokinetics and Safety in Children with Acute Dengue.
Keswadee Lapphra, Dumrong Mairiang, Joel Tarning et al.
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In 30 seconds
This prospective, open-label, sequential dose-escalation study characterized pharmacokinetics and safety of ivermectin given once daily for 3 days in children aged 1–15 years, weighing ≥15 kg, with acute uncomplicated dengue. Twenty-four children received 400 or 600 μg/kg. Median 0–48-h AUC last was 1316.49 and 2129.41 ng·h/mL, respectively, and corresponding C max values were 107.50 and 165.50 ng/mL. Six children (25%) had serious adverse events of grade 4 neutropenia, none assessed as ivermectin-related. Exploratory analyses found no clear exposure-response association with viremia or NS1 trajectories; the study was not designed to assess efficacy.
Key findings
- Median 0–48-h AUC last was 1316.49 ng·h/mL at 400 μg/kg and 2129.41 ng·h/mL at 600 μg/kg; corresponding C max values were 107.50 and 165.50 ng/mL.
- Six participants (25%) experienced serious adverse events consisting of grade 4 neutropenia; none was assessed as related to ivermectin.
- Dose-normalized AUC last and C max showed no clear relationship with body weight across the studied range.
- First-48-h analyses found no clear association between ivermectin exposure and viremia or NS1 trajectories.
Why it matters
Pediatric data on repeated high-dose ivermectin in dengue have been limited. These findings provide dengue-specific pharmacokinetic and safety reference data that may help inform dose selection, interpretation of exposure, and safety monitoring in future studies. The absence of a clear association with viral markers should not be interpreted as evidence for or against antiviral efficacy, which this study was not designed to determine.
What to keep in mind
The study was open-label and sequential dose-escalation, included 24 children, and was not designed or powered to evaluate antiviral efficacy or clinical benefit.