Effectiveness and Safety of Glecaprevir/Pibrentasvir in Italian Children and Adolescents With Chronic Hepatitis C: A Real-Word, Multicenter Study.

Autor: Stinco M; Liver Unit, Meyer Children's Hospital IRCCS, Florence, Italy., Rubino C; Liver Unit, Meyer Children's Hospital IRCCS, Florence, Italy., Bartolini E; Liver Unit, Meyer Children's Hospital IRCCS, Florence, Italy., Nuti F; Pediatric Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy., Paolella G; Pediatric Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy., Nebbia G; Pediatric Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy., Silvestro E; Pediatric Infectious Diseases Unit, Regina Margherita Children's Hospital, University of Turin, Turin, Italy., Garazzino S; Pediatric Infectious Diseases Unit, Regina Margherita Children's Hospital, University of Turin, Turin, Italy., Nicastro E; Hepatology, Gastroenterology and Transplantation Unit, Hospital Papa Giovanni XXIII, Bergamo, Italy., D'Antiga L; Hepatology, Gastroenterology and Transplantation Unit, Hospital Papa Giovanni XXIII, Bergamo, Italy., Zanchi C; Institute for Maternal and Child Health-IRCCS Burlo Garofolo, Trieste, Italy., Morra L; Pediatric Department, University of Trieste, Trieste, Italy., Iorio R; Department of Translational Medical Science, School of Medicine and Surgery, University of Naples Federico II, Naples, Italy., Di Dato F; Department of Translational Medical Science, School of Medicine and Surgery, University of Naples Federico II, Naples, Italy., Maggiore G; Hepatology, Gastroenterology, Nutrition and Liver Transplantation Unit, Bambino Gesù Children's Hospital IRCCS, Rome, Italy., Sartorelli MR; Hepatology, Gastroenterology, Nutrition and Liver Transplantation Unit, Bambino Gesù Children's Hospital IRCCS, Rome, Italy., Comparcola D; Hepatology, Gastroenterology, Nutrition and Liver Transplantation Unit, Bambino Gesù Children's Hospital IRCCS, Rome, Italy., Stracuzzi M; Pediatric Infectious Disease Unit, Department of Pediatrics, Luigi Sacco Hospital, University of Milan, Milan, Italy., Giacomet V; Pediatric Infectious Disease Unit, Department of Pediatrics, Luigi Sacco Hospital, University of Milan, Milan, Italy., Musto F; Pediatric Infectious Disease Unit, Department of Pediatrics, Luigi Sacco Hospital, University of Milan, Milan, Italy., Pinon M; Pediatric Gastroenterology Unit, Regina Margherita Children's Hospital, University of Turin, Turin, Italy., Calvo P; Pediatric Gastroenterology Unit, Regina Margherita Children's Hospital, University of Turin, Turin, Italy., Carloni I; Pediatric Infectious Disease Unit, Salesi Children Hospital, Ancona, Italy., Zallocco F; Pediatric Infectious Disease Unit, Salesi Children Hospital, Ancona, Italy., Cananzi M; Unit of Gastroenterology, Digestive Endoscopy, Hepatology and Care of Children with Liver Transplantation, University Hospital of Padova, Padova, Italy., Trapani S; Pediatric Unit, Meyer Children's Hospital IRCCS, Florence, Italy.; Department of Health Sciences, University of Florence, Florence, Italy., Indolfi G; Liver Unit, Meyer Children's Hospital IRCCS, Florence, Italy.; Department of NEUROFARBA, University of Florence, Florence, Italy.
Jazyk: angličtina
Zdroj: Liver international : official journal of the International Association for the Study of the Liver [Liver Int] 2024 Nov 21. Date of Electronic Publication: 2024 Nov 21.
DOI: 10.1111/liv.16180
Abstrakt: 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.
(© 2024 The Author(s). Liver International published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
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