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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| Vydáno v: | Clinical therapeutics Ročník 47; číslo 3; s. 244 - 247 |
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01.03.2025
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| Abstract | •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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| AbstractList | 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. •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. Highlights•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.PURPOSEGlecaprevir/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.METHODSThis 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.FINDINGSSix 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.IMPLICATIONSThis 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. Purpose 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. Methods 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. Findings 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. Implications 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. |
| Author | Caiazzo, Roberta Musto, Francesca Cibarelli, Alessandro Stracuzzi, Marta Garcia, Marc Lorenzo David, Daniela Valentino, Maria Sole Giacomet, Vania Coppola, Crescenzo Di Tonno, Raffaella |
| Author_xml | – sequence: 1 givenname: Francesca surname: Musto fullname: Musto, Francesca email: musto.francesca@asst-fbf-sacco.it organization: Paediatric Infectious Disease Unit, Department of Paediatrics, Luigi Sacco Hospital Milan, University of Milan (UniMi), Milan, Italy – sequence: 2 givenname: Marta surname: Stracuzzi fullname: Stracuzzi, Marta organization: Paediatric Infectious Disease Unit, Department of Paediatrics, Luigi Sacco Hospital Milan, University of Milan (UniMi), Milan, Italy – sequence: 3 givenname: Alessandro surname: Cibarelli fullname: Cibarelli, Alessandro organization: Paediatric Infectious Disease Unit, Department of Paediatrics, University of Milan (UniMi), Milan, Italy – sequence: 4 givenname: Crescenzo surname: Coppola fullname: Coppola, Crescenzo organization: Paediatric Infectious Disease Unit, Department of Paediatrics, University of Milan (UniMi), Milan, Italy – sequence: 5 givenname: Roberta surname: Caiazzo fullname: Caiazzo, Roberta organization: Paediatric Infectious Disease Unit, Department of Paediatrics, University of Milan (UniMi), Milan, Italy – sequence: 6 givenname: Daniela surname: David fullname: David, Daniela organization: Paediatric Infectious Disease Unit, Department of Paediatrics, University of Milan (UniMi), Milan, Italy – sequence: 7 givenname: Raffaella surname: Di Tonno fullname: Di Tonno, Raffaella organization: Paediatric Infectious Disease Unit, Department of Paediatrics, University of Milan (UniMi), Milan, Italy – sequence: 8 givenname: Marc Lorenzo surname: Garcia fullname: Garcia, Marc Lorenzo organization: Paediatric Infectious Disease Unit, Department of Paediatrics, University of Milan (UniMi), Milan, Italy – sequence: 9 givenname: Maria Sole surname: Valentino fullname: Valentino, Maria Sole organization: Paediatric Infectious Disease Unit, Department of Paediatrics, University of Milan (UniMi), Milan, Italy – sequence: 10 givenname: Vania surname: Giacomet fullname: Giacomet, Vania organization: Paediatric Infectious Disease Unit, Department of Paediatrics, Luigi Sacco Hospital Milan, University of Milan (UniMi), Milan, Italy |
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| Cites_doi | 10.1016/j.jpeds.2013.04.044 10.1093/cid/ciac255 10.1002/jmv.24573 10.1002/hep.30840 10.1097/MPG.0000000000002900 10.1097/MPG.0b013e3182774cae 10.1016/S2468-1253(21)00472-6 10.1016/j.jhep.2018.11.013 10.1007/s00535-023-01968-x 10.1016/S2468-1253(19)30385-1 10.1093/cid/ciu447 10.1097/MPG.0000000000002710 10.1155/2012/785627 10.1007/s12519-022-00612-7 10.1097/MPG.0000000000001872 10.1002/jmv.23384 10.1002/hep.31841 |
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| References_xml | – reference: American Association for the Study of Liver Diseases. HCV guidance: recommendations for testing, managing, and treating hepatitis C. – volume: 70 start-page: 371 year: 2019 end-page: 378 ident: bib0006 article-title: Epidemiology and natural history of hepatitis C virus infection among children and young people publication-title: J Hepatol – reference: . Accessed March 29, 2024. – reference: World Health Organization. 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| Snippet | •Optimal real-life efficacy of glecaprevir/pibrentasvir pediatric formulation for chronic Hepatitis C infection in children aged 3 to 12 years.•Real-life... Highlights•Optimal real-life efficacy of glecaprevir/pibrentasvir pediatric formulation for chronic Hepatitis C infection in children aged 3 to 12 years.... 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... Purpose Glecaprevir/pibrentasvir (GLE/PIB) has been approved by the European Medicines Agency and by US Food and Drug Administration for the treatment of... |
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| Title | 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 |
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