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Multicenter Study
. 2025 Apr;45(4):e16180.
doi: 10.1111/liv.16180. Epub 2024 Nov 21.

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

Mariangela Stinco  1 , Chiara Rubino  1 , Elisa Bartolini  1 , Federica Nuti  2 , Giulia Paolella  2 , Gabriella Nebbia  2 , Erika Silvestro  3 , Silvia Garazzino  3 , Emanuele Nicastro  4 , Lorenzo D'Antiga  4 , Chiara Zanchi  5 , Laura Morra  6 , Raffaele Iorio  7 , Fabiola Di Dato  7 , Giuseppe Maggiore  8 , Maria Rita Sartorelli  8 , Donatella Comparcola  8 , Marta Stracuzzi  9 , Vania Giacomet  9 , Francesca Musto  9 , Michele Pinon  10 , Pierluigi Calvo  10 , Ines Carloni  11 , Federica Zallocco  11 , Mara Cananzi  12 , Sandra Trapani  13   14 , Giuseppe Indolfi  1   15
Affiliations
Multicenter Study

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

Mariangela Stinco et al. Liver Int. 2025 Apr.

Abstract

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.

Keywords: child; direct‐acting antivirals; hepatitis C virus; pan‐genotypic regimen; sustained virological response.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Virological responses at the different treatment week. °Out of 44 tested patients. °°Out of 50 teste patients. *End of treatment; **Sustained Virologic Response (SVR) 12.
FIGURE 2
FIGURE 2
Comparison between median ALT and AST levels before, during and after glecaprevir/pibrentasvir treatment. *p < 0.0001.
See this image and copyright information in PMC

References

    1. 2023 Update of The World Health Organisation , WHO Global Hepatitis Report, 2017 (Geneva: World Health Organization, 2017), https://www.who.int/news‐room/fact‐sheets/detail/hepatitis‐c.
    1. Indolfi G., Easterbrook P., Dusheiko G., et al., “Hepatitis C Virus Infection in Children and Adolescents,” Lancet Gastroenterology & Hepatology 4 (2019): 477–487. - PubMed
    1. Indolfi G., Mangone G., Bartolini E., Moriondo M., Azzari C., and Resti M., “Hepatitis C Viraemia After Apparent Spontaneous Clearance in a Vertically Infected Child,” Lancet 387 (2016): 1967–1968. - PubMed
    1. European Paediatric Hepatitis C Virus Network , “Three Broad Modalities in the Natural History of Vertically Acquired Hepatitis C Virus Infection,” Clinical Infectious Diseases 41 (2005): 45–51. - PubMed
    1. Resti M., Jara P., Hierro L., et al., “Clinical Features and Progression of Perinatally Acquired Hepatitis C Virus Infection,” Journal of Medical Virology 70 (2003): 373–377. - PubMed

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