Real-World Efficacy and Safety of an 8-Week Glecaprevir/Pibrentasvir Regimen in Children and Adolescents with Chronic Hepatitis C—Results of a Multicenter EpiTer-2 Study

Author:

Pawlowska Malgorzata12ORCID,Dobrowolska Krystyna3ORCID,Moppert Justyna12ORCID,Pokorska-Śpiewak Maria45ORCID,Purzynska Mariola6,Marczynska Magdalena45ORCID,Zarebska-Michaluk Dorota7ORCID,Flisiak Robert8ORCID

Affiliation:

1. Department of Infectious Diseases and Hepatology, Faculty of Medicine, Collegium Medicum Bydgoszcz, Nicolaus Copernicus University, 87-100 Torun, Poland

2. Department of Paediatrics, Infectious Diseases and Hepatology, Voivodeship Infectious Observation Hospital in Bydgoszcz, 85-030 Bydgoszcz, Poland

3. Collegium Medicum, Jan Kochanowski University, 25-317 Kielce, Poland

4. Department of Children’s Infectious Diseases, Medical University of Warsaw, 01-201 Warsaw, Poland

5. Department of Pediatric Infectious Diseases, Regional Hospital of Infectious Diseases in Warsaw, 01-201 Warsaw, Poland

6. Pomeranian Centre of Department of Infectious Diseases and Observation for Children, Smoluchowskiego 18, 80-214 Gdansk, Poland

7. Department of Infectious Diseases and Allergology, Jan Kochanowski University, 25-317 Kielce, Poland

8. Department of Infectious Diseases and Hepatology, Medical University of Białystok, 15-540 Bialystok, Poland

Abstract

The aim of the study was to analyze the effectiveness and safety of anti-HCV treatment based on a pangenotypic direct-acting antiviral (DAA) regimen with glecaprevir/pibrentasvir (GLE/PIB) in children. The multi-center study was conducted in HCV-infected children who were treated in the period from November 2022 to January 2023. The analysis included 23 pediatric patients with a mean (SD) age of 9.61 (3.68) years. The cohort included 13 girls and 10 boys. The most common HCV genotypes were GT1b (n = 9, 39.1%), GT1a (n = 6, 26.1%) and GT3 (n = 5, 21.7%). The SVR was assessed at 12 weeks after the end of treatment and was 100% for both girls and boys. The conducted study showed a very good tolerance of the treatment in the entire analyzed group and confirmed a very high efficacy and safety for 8-week treatment with GLE/PIB in children over three years of age. It seems that our study is the first on the real-world use of an 8-week GLE/PIB pangenotypic therapy in a group of children aged 3–12 years and the first in Europe for adolescents aged 12–17.

Funder

Polish Association of Epidemiologists and Infectiologists

Publisher

MDPI AG

Subject

General Medicine

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