Effectiveness and Safety of Glecaprevir/Pibrentasvir in Italian Children and Adolescents With Chronic Hepatitis C: A Real-Word, Multicenter Study
| Title: | Effectiveness and Safety of Glecaprevir/Pibrentasvir in Italian Children and Adolescents With Chronic Hepatitis C: A Real-Word, Multicenter Study |
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| Authors: | STINCO M; RUBINO C; BARTOLINI E; NUTI F; PAOLELLA G; NEBBIA G; SILVESTRO E; GARAZZINO S; NICASTRO E; D'ANTIGA L; ZANCHI C; MORRA L; IORIO R; DI DATO F; MAGGIORE G; SARTORELLI MR; COMPARCOLA D; STRACUZZI M; GIACOMET V; MUSTO F; PINON M; CALVO P; CARLONI I; ZALLOCCO F; CANANZI M; TRAPANI S; INDOLFI G. |
| Contributors: | Stinco, M; Rubino, C; Bartolini, E; Nuti, F; Paolella, G; Nebbia, G; Silvestro, E; Garazzino, S; Nicastro, E; D'Antiga, L; Zanchi, C; Morra, L; Iorio, R; DI DATO, F; Maggiore, G; Sartorelli, Mr; Comparcola, D; Stracuzzi, M; Giacomet, V; Musto, F; Pinon, M; Calvo, P; Carloni, I; Zallocco, F; Cananzi, M; Trapani, S; Indolfi, G. |
| Publisher Information: | WILEY |
| Publication Year: | 2025 |
| Collection: | Padua Research Archive (IRIS - Università degli Studi di Padova) |
| Subject Terms: | child; direct-acting antiviral; hepatitis C viru; pan-genotypic regimen; sustained virological response |
| 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 genot. |
| 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; journal:LIVER INTERNATIONAL; https://hdl.handle.net/11577/3553678 |
| DOI: | 10.1111/liv.16180 |
| Availability: | https://hdl.handle.net/11577/3553678; https://doi.org/10.1111/liv.16180 |
| Accession Number: | edsbas.CC9C6AD5 |
| Database: | BASE |