Evidence map›Paper›PMID 39569493›Full record

ArticleLiver international : official journal of the International Association for the Study of the Liver2025

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

Mariangela Stinco, Chiara Rubino, Elisa Bartolini, Federica Nuti, Giulia Paolella, Gabriella Nebbia, Erika Silvestro, Silvia Garazzino, Emanuele Nicastro, Lorenzo D'Antiga and 17 more

Abstract readMulticenter Study
In one paragraph

Article in Liver international : official journal of the International Association for the Study of the Liver, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors.

Mariangela StincoLiver Unit, Meyer Children's Hospital IRCCS, Florence, Italy.ORCID 0000-0003-3970-5000
Chiara RubinoLiver Unit, Meyer Children's Hospital IRCCS, Florence, Italy.
Elisa BartoliniLiver Unit, Meyer Children's Hospital IRCCS, Florence, Italy.
Federica NutiPediatric Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Giulia PaolellaPediatric Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Gabriella NebbiaPediatric Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Erika SilvestroPediatric Infectious Diseases Unit, Regina Margherita Children's Hospital, University of Turin, Turin, Italy.
Silvia GarazzinoPediatric Infectious Diseases Unit, Regina Margherita Children's Hospital, University of Turin, Turin, Italy.
Emanuele NicastroHepatology, Gastroenterology and Transplantation Unit, Hospital Papa Giovanni XXIII, Bergamo, Italy.
Lorenzo D'AntigaHepatology, Gastroenterology and Transplantation Unit, Hospital Papa Giovanni XXIII, Bergamo, Italy.ORCID 0000-0001-7150-3148
Chiara ZanchiInstitute for Maternal and Child Health-IRCCS Burlo Garofolo, Trieste, Italy.
Laura MorraPediatric Department, University of Trieste, Trieste, Italy.
Raffaele IorioDepartment of Translational Medical Science, School of Medicine and Surgery, University of Naples Federico II, Naples, Italy.
Fabiola Di DatoDepartment of Translational Medical Science, School of Medicine and Surgery, University of Naples Federico II, Naples, Italy.
Giuseppe MaggioreHepatology, Gastroenterology, Nutrition and Liver Transplantation Unit, Bambino Gesù Children's Hospital IRCCS, Rome, Italy.
Maria Rita SartorelliHepatology, Gastroenterology, Nutrition and Liver Transplantation Unit, Bambino Gesù Children's Hospital IRCCS, Rome, Italy.
Donatella ComparcolaHepatology, Gastroenterology, Nutrition and Liver Transplantation Unit, Bambino Gesù Children's Hospital IRCCS, Rome, Italy.
Marta StracuzziPediatric Infectious Disease Unit, Department of Pediatrics, Luigi Sacco Hospital, University of Milan, Milan, Italy.
Vania GiacometPediatric Infectious Disease Unit, Department of Pediatrics, Luigi Sacco Hospital, University of Milan, Milan, Italy.
Francesca MustoPediatric Infectious Disease Unit, Department of Pediatrics, Luigi Sacco Hospital, University of Milan, Milan, Italy.ORCID 0000-0002-4965-2689
Michele PinonPediatric Gastroenterology Unit, Regina Margherita Children's Hospital, University of Turin, Turin, Italy.
Pierluigi CalvoPediatric Gastroenterology Unit, Regina Margherita Children's Hospital, University of Turin, Turin, Italy.
Ines CarloniPediatric Infectious Disease Unit, Salesi Children Hospital, Ancona, Italy.
Federica ZalloccoPediatric Infectious Disease Unit, Salesi Children Hospital, Ancona, Italy.ORCID 0000-0003-3842-2228
Mara CananziUnit of Gastroenterology, Digestive Endoscopy, Hepatology and Care of Children with Liver Transplantation, University Hospital of Padova, Padova, Italy.ORCID 0000-0002-7177-2847
Sandra TrapaniPediatric Unit, Meyer Children's Hospital IRCCS, Florence, Italy.
Giuseppe IndolfiLiver Unit, Meyer Children's Hospital IRCCS, Florence, Italy.ORCID 0000-0003-3830-9823

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND &

aimsGlecaprevir/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.

methodsThis 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.

resultsSixty-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.

conclusionsThis study confirmed the real-life effectiveness and safety of the 8-week therapy with GLE/PIB for treatment of CHC in children and adolescents.

Indexed as

Antiviral AgentsBenzimidazolesHepatitis C, ChronicPyrrolidinesQuinoxalinesSulfonamidesAdolescentAminoisobutyric AcidsChildChild, PreschoolCyclopropanesDrug CombinationsFemaleHepacivirusHumansItalyAminoisobutyric AcidsAntiviral AgentsBenzimidazolesCyclopropanesDrug Combinationsglecaprevirglecaprevir and pibrentasvirLactams, MacrocyclicLeucinepibrentasvirProlinePyrrolidinesQuinoxalinesSulfonamideschilddirect‐acting antiviralshepatitis C viruspan‐genotypic regimensustained virological response

Identifiers

PMID39569493
PMCPMC11897846

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.