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Glecaprevir/pibrentasvir in patients aged 3-17 years with chronic hepatitis C: Real-life data from the POLAC project

Anna Dobrzeniecka1,2, Ewa Talarek1,2, Małgorzata Aniszewska1,2

  • 1Department of Children's Infectious Diseases, Medical University of Warsaw, Warsaw, Poland.

Journal of Pediatric Gastroenterology and Nutrition
|October 22, 2025
PubMed

Insights

The pangenotypic regimen glecaprevir/pibrentasvir (GLE/PIB) demonstrated high efficacy and safety in children with chronic hepatitis C. An 8-week treatment resulted in a 98% sustained virologic response rate with mild adverse events.

Area of Science:

  • Hepatology
  • Virology
  • Pediatric Gastroenterology

Background:

  • Chronic hepatitis C (HCV) infection in children poses long-term health risks.
  • Pangenotypic antiviral regimens offer a promising treatment option for pediatric HCV.

Purpose of the Study:

  • To evaluate the efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) in children aged 3-17 years with chronic hepatitis C.
  • To assess the sustained virologic response at 12 weeks posttreatment (SVR12) in pediatric patients receiving an 8-week GLE/PIB regimen.

Main Methods:

  • A nonrandomized, open-label therapeutic program (POLAC project) involving 63 children aged 3-17 years.
  • Patients received either GLE/PIB tablets (≥12 years) or a weight-adjusted granule formula (<12 years) for 8 weeks.
  • Sustained virologic response at 12 weeks posttreatment (SVR12) was the primary efficacy endpoint.

Main Results:

  • 98% of patients (62/63) achieved SVR12, indicating high treatment efficacy.
  • The majority of patients (68%) had genotype 1 HCV; 94% acquired infection vertically.
  • Adverse events were reported in 51% of patients, predominantly mild (e.g., abdominal pain, fatigue, pruritus).

Conclusions:

  • An 8-week GLE/PIB regimen is highly effective and safe for treating chronic hepatitis C in children.
  • GLE/PIB represents a valuable therapeutic option for pediatric patients with chronic HCV infection.
Abstract

Keywords:
direct acting antiviralshepatitis C viruspediatric hepatologysustained virological response

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