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Published on: October 20, 2021

Safety, efficacy and pharmacokinetics of peginterferon alpha2a (40 kd) in children with chronic hepatitis C

Kathleen B Schwarz1, Parvathi Mohan, Michael R Narkewicz

  • 1Division of Pediatric Gastroenterology and Nutrition, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA. kschwarz@jhmi.edu

Journal of Pediatric Gastroenterology and Nutrition
|October 13, 2006
PubMed

Insights

Peginterferon alfa-2a (pegINF-alpha2a) showed therapeutic potential in children with chronic hepatitis C. This study investigated its pharmacokinetics, efficacy, and safety in young patients, offering a basis for further pediatric research.

Area of Science:

  • Hepatology
  • Pediatric Infectious Diseases
  • Pharmacology

Background:

  • Chronic hepatitis C virus (HCV) infection poses a global health challenge for children.
  • Standard interferon (INF) treatments have limited efficacy in pediatric patients, especially with genotype 1 HCV.
  • Pegylated interferons demonstrate improved efficacy in adults, suggesting potential benefits for pediatric populations.

Purpose of the Study:

  • To investigate the pharmacokinetics, efficacy, and safety of peginterferon alfa-2a (pegINF-alpha2a) in children aged 2 to 8 years with chronic hepatitis C.
  • To determine if body surface area (BSA)-based dosing achieves therapeutically adequate drug concentrations in pediatric patients.
  • To evaluate the sustained virological response (SVR) and adverse events associated with pegINF-alpha2a treatment in this cohort.

Main Methods:

  • A cohort of 14 children (ages 2-8) with chronic hepatitis C received once-weekly subcutaneous injections of pegINF-alpha2a for 48 weeks.
  • Drug dosage was calculated using the formula: BSA (m2)/(1.73 m2) x 180 microg.
  • Viral load and pharmacokinetic parameters were monitored throughout the study and follow-up period.

Main Results:

  • Pharmacokinetic analysis indicated therapeutically adequate drug concentrations, with mean trough concentrations approximately 20% below adult values and area under the curve 20% above adult values at week 24.
  • Six out of 14 patients (43%), all with genotype 1 HCV, achieved a sustained virological response (SVR).
  • Adverse events were consistent with interferon-based therapies and were not deemed serious.

Conclusions:

  • Peginterferon alfa-2a, dosed by BSA, achieves adequate therapeutic concentrations in children with chronic hepatitis C.
  • The study provides preliminary evidence for the efficacy and safety of pegINF-alpha2a in pediatric patients, warranting further investigation.
  • Findings support larger trials to evaluate pegINF-alpha2a, alone or with ribavirin, for treating chronic hepatitis C in children.

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