| Title: |
Effectiveness and Safety of Glecaprevir/Pibrentasvir in Italian Children and Adolescents With Chronic Hepatitis C: A Real‐Word, Multicenter Study |
| Authors: |
Stinco, Mariangela; Rubino, Chiara; Bartolini, Elisa; Nuti, Federica; Paolella, Giulia; Nebbia, Gabriella; Silvestro, Erika; Garazzino, Silvia; Nicastro, Emanuele; D'Antiga, Lorenzo; Zanchi, Chiara; Morra, Laura; Iorio, Raffaele; Di Dato, Fabiola; Maggiore, Giuseppe; Sartorelli, Maria Rita; Comparcola, Donatella; Stracuzzi, Marta; Giacomet, Vania; Musto, Francesca; Pinon, Michele; Calvo, Pierluigi; Carloni, Ines; Zallocco, Federica; Cananzi, Mara; Trapani, Sandra; Indolfi, Giuseppe |
| Contributors: |
M. Stinco; C. Rubino; E. Bartolini; F. Nuti; G. Paolella; G. Nebbia; E. Silvestro; S. Garazzino; E. Nicastro; L. D'Antiga; C. Zanchi; L. Morra; R. Iorio; F. Di Dato; G. Maggiore; M.R. Sartorelli; D. Comparcola; M. Stracuzzi; V. Giacomet; F. Musto; M. Pinon; P. Calvo; I. Carloni; F. Zallocco; M. Cananzi; S. Trapani; G. Indolfi |
| Publisher Information: |
John Wiley and Sons Inc |
| Publication Year: |
2025 |
| Collection: |
The University of Milan: Archivio Istituzionale della Ricerca (AIR) |
| Subject Terms: |
child; direct‐acting antiviral; hepatitis C viru; pan‐genotypic regimen; sustained virological response; Settore MEDS-20/A - Pediatria generale e specialistica |
| Description: |
Background & Aims: Glecaprevir/Pibrentasvir (GLE/PIB) has been approved by the European Medicine Agency (EMA) and by the US Food and Drug Administration (US-FDA) for the treatment of children and adolescents from 3 years of age with chronic hepatitis C virus (CHC) infection. The aim of this study was to confirm the real-world effectiveness and safety of GLE/PIB in children and adolescents (3 to < 18 years old) with CHC. Methods: This prospective, multicentre study involved 11 Italian centres. Children and adolescents (from 3 to < 18 years of age) received a weight-based dose (up to 300/120 mg) of GLE/PIB once daily for 8 weeks. The effectiveness endpoint was sustained virological response 12 weeks after the end of treatment (SVR12). Safety was assessed by adverse events (AE) and clinical/laboratory data. Results: Sixty-one patients (median age 12 years, interquartile range 5) were enrolled and treated between June 2020 and October 2023. Genotype distribution was as follows: 24/61 genotype 1 (39.4%), 13/61 genotype 2 (21.3%), 18/61 genotype 3 (29.5%) and 6/61 genotype 4 (9.8%). Sixty (98.4%) patients completed treatment and follow-up. SVR12 was obtained by 60/61 patients (98.4%). One patient died because of an oncological illness while on treatment. AE occurred in 13.1% of the patients, were mild and no patients prematurely stopped treatment. Conclusions: This study confirmed the real-life effectiveness and safety of the 8-week therapy with GLE/PIB for treatment of CHC in children and adolescents. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/39569493; info:eu-repo/semantics/altIdentifier/wos/WOS:001361311800001; volume:45; issue:4; firstpage:1; lastpage:7; numberofpages:7; journal:LIVER INTERNATIONAL; https://hdl.handle.net/2434/1156871 |
| DOI: |
10.1111/liv.16180 |
| Availability: |
https://hdl.handle.net/2434/1156871; https://doi.org/10.1111/liv.16180 |
| Rights: |
info:eu-repo/semantics/openAccess ; license:Creative commons ; license uri:http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| Accession Number: |
edsbas.1B88AFC7 |
| Database: |
BASE |