Real-Life Efficacy and Safety of Glecaprevir/Pibrentasvir Pediatric Formulation for Chronic Hepatitis C Infection in Children Aged 3 to 12 Years: A Case Series of 6 Patients

•Optimal real-life efficacy of glecaprevir/pibrentasvir pediatric formulation for chronic Hepatitis C infection in children aged 3 to 12 years.•Real-life palatability and compliance of glecaprevir/pibrentasvir pediatric formulation.•Good safety of glecaprevir/pibrentasvir pediatric formulation.•Cons...

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Published in:Clinical therapeutics Vol. 47; no. 3; pp. 244 - 247
Main Authors: Musto, Francesca, Stracuzzi, Marta, Cibarelli, Alessandro, Coppola, Crescenzo, Caiazzo, Roberta, David, Daniela, Di Tonno, Raffaella, Garcia, Marc Lorenzo, Valentino, Maria Sole, Giacomet, Vania
Format: Journal Article
Language:English
Published: United States Elsevier Inc 01.03.2025
Elsevier Limited
Subjects:
Adverse events
Aminoisobutyric Acids
Antiviral Agents - administration & dosage
Antiviral Agents - adverse effects
Antiviral Agents - therapeutic use
Antiviral drugs
Benzimidazoles - administration & dosage
Benzimidazoles - adverse effects
Benzimidazoles - therapeutic use
Child
Child, Preschool
Childhood
Children
Children & youth
Childrens health
Chronic hepatitis C
Chronic infection
Cyclopropanes
Drug Combinations
Drug dosages
Female
Gastroenterology
Genotype
Genotype & phenotype
Genotypes
Glecaprevir/pibrentasvir
Hepacivirus - drug effects
Hepacivirus - genetics
Hepatitis C
Hepatitis C, Chronic - drug therapy
Hepatitis C, Chronic - virology
Hepatology
Humans
Infections
Internal Medicine
Lactams, Macrocyclic
Leucine - analogs & derivatives
Male
Nutrition
Patients
Pediatric population
Pediatrics
Proline - analogs & derivatives
Pyrrolidines - administration & dosage
Pyrrolidines - adverse effects
Quinoxalines - administration & dosage
Quinoxalines - adverse effects
Quinoxalines - therapeutic use
Sulfonamides - administration & dosage
Sulfonamides - adverse effects
Sustained Virologic Response
Teenagers
Therapy
Treatment Outcome
Viral Load - drug effects
United States > US
Italy
Therapy
Glecaprevir/pibrentasvir
Chronic hepatitis C
Pediatric population
ISSN:0149-2918, 1879-114X, 1879-114X
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Summary:•Optimal real-life efficacy of glecaprevir/pibrentasvir pediatric formulation for chronic Hepatitis C infection in children aged 3 to 12 years.•Real-life palatability and compliance of glecaprevir/pibrentasvir pediatric formulation.•Good safety of glecaprevir/pibrentasvir pediatric formulation.•Consideration about reducing time of treatment in patients with low viral load. Glecaprevir/pibrentasvir (GLE/PIB) has been approved by the European Medicines Agency and by US Food and Drug Administration for the treatment of children and adolescents aged 3 to 12 years with chronic hepatitis C (CHC) virus infection. The aim of this study was to confirm the real-world effectiveness and safety of GLE/PIB pediatric formulations in children aged 3 to 12 years with CHC. This case series describes a pediatric population (3 to ≤12 years of age) treated with a weight-based dose of GLE/PIB pediatric formulation once daily for 8 weeks. The effectiveness end point was a sustained virologic response 12 weeks after the end of treatment. Safety was assessed on adverse events and clinical/laboratory data. Six patients (median age 6 years; interquartile range, 3 years) were enrolled and treated between March 2023 and December 2023. Genotype distribution was as follows: 4 of 6 genotype 1 (60%), 1 of 6 genotype 2 (20%), and 1 of 6 genotype 3 (20%). Median viral load at baseline was 541,000 IU/mL (interquartile range, 641,000 IU/mL). All (100%) patients completed treatment. Sustained virologic response (SVR) 12 weeks after the end of treatment was 100%. No virologic relapse or breakthrough was observed. No adverse events occurred. This study confirmed the real-life effectiveness and safety profile of an 8-week treatment with GLE/PIB for CHC in children aged 3 to 12 years.
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ISSN:0149-2918
1879-114X
1879-114X
DOI:10.1016/j.clinthera.2024.12.011