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Sofosbuvir‐based therapies in genotype 2 hepatitis C virus cirrhosis: A real‐life experience with focus on ribavirin dose

This study aimed to investigate the efficacy and safety of sofosbuvir‐based therapies for the treatment of cirrhosis from hepatitis C virus (HCV) genotype 2 infection. Data of all consecutive HCV genotype 2 cirrhotic patients who started sofosbuvir‐based treatments between January 2015 and March 201...

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Autores principales: Smirne, Carlo, D'Avolio, Antonio, Bellan, Mattia, Gualerzi, Alessandro, Crobu, Maria G., Pirisi, Mario
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8214994/
https://www.ncbi.nlm.nih.gov/pubmed/34152088
http://dx.doi.org/10.1002/prp2.811
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author Smirne, Carlo
D'Avolio, Antonio
Bellan, Mattia
Gualerzi, Alessandro
Crobu, Maria G.
Pirisi, Mario
author_facet Smirne, Carlo
D'Avolio, Antonio
Bellan, Mattia
Gualerzi, Alessandro
Crobu, Maria G.
Pirisi, Mario
author_sort Smirne, Carlo
collection PubMed
description This study aimed to investigate the efficacy and safety of sofosbuvir‐based therapies for the treatment of cirrhosis from hepatitis C virus (HCV) genotype 2 infection. Data of all consecutive HCV genotype 2 cirrhotic patients who started sofosbuvir‐based treatments between January 2015 and March 2017 in eight Italian tertiary hospitals were collected retrospectively. Overall, 273 patients (Child A: 94.5%) were enrolled. In the 194 subjects treated with sofosbuvir/ribavirin, median initial ribavirin dosage was 13.9 mg/kg/day, and therapy duration was 16 weeks. Sustained virological response (SVR) rates were 93.8% in intention‐to‐treat (ITT) and 95.3% in per‐protocol (PP) analyses for the 129 treatment‐naïve patients, and 96.9% (ITT) and 98.4% (PP) for the 65 treatment‐experienced subjects. Adverse events were reported in 142 patients (73.2%), but only 1.5% discontinued treatment. Eighty‐eight subjects with treatment‐induced anemia (mild: 34.5%, moderate: 7.7%, severe: 3.1%) had to reduce ribavirin dosage, but SVR rates were comparable to the weight‐based dose group, both in ITT (95.4% and 94.3%) and PP (97.7% and 95.2%) analyses, respectively. Moreover, ITT and PP SVR rates were similar between shorter (<20 weeks) (94.1% and 96.0%, respectively) and prolonged (≥20 weeks) regimens (95.7% and 96.7%, respectively). SVR rates in the 79 subjects treated with sofosbuvir/daclatasvir (without ribavirin) were similar (ITT: 96.2%; PP: 97.4%, respectively), without de novo/worsening anemia. In conclusion, in a real‐life study centered on genotype 2 patients with well‐compensated cirrhosis, sofosbuvir‐based regimens were associated with good SVR and tolerability rates, regardless of previous antiviral treatments, without a significant impact of on treatment ribavirin dose reductions.
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spelling pubmed-82149942021-06-28 Sofosbuvir‐based therapies in genotype 2 hepatitis C virus cirrhosis: A real‐life experience with focus on ribavirin dose Smirne, Carlo D'Avolio, Antonio Bellan, Mattia Gualerzi, Alessandro Crobu, Maria G. Pirisi, Mario Pharmacol Res Perspect Original Articles This study aimed to investigate the efficacy and safety of sofosbuvir‐based therapies for the treatment of cirrhosis from hepatitis C virus (HCV) genotype 2 infection. Data of all consecutive HCV genotype 2 cirrhotic patients who started sofosbuvir‐based treatments between January 2015 and March 2017 in eight Italian tertiary hospitals were collected retrospectively. Overall, 273 patients (Child A: 94.5%) were enrolled. In the 194 subjects treated with sofosbuvir/ribavirin, median initial ribavirin dosage was 13.9 mg/kg/day, and therapy duration was 16 weeks. Sustained virological response (SVR) rates were 93.8% in intention‐to‐treat (ITT) and 95.3% in per‐protocol (PP) analyses for the 129 treatment‐naïve patients, and 96.9% (ITT) and 98.4% (PP) for the 65 treatment‐experienced subjects. Adverse events were reported in 142 patients (73.2%), but only 1.5% discontinued treatment. Eighty‐eight subjects with treatment‐induced anemia (mild: 34.5%, moderate: 7.7%, severe: 3.1%) had to reduce ribavirin dosage, but SVR rates were comparable to the weight‐based dose group, both in ITT (95.4% and 94.3%) and PP (97.7% and 95.2%) analyses, respectively. Moreover, ITT and PP SVR rates were similar between shorter (<20 weeks) (94.1% and 96.0%, respectively) and prolonged (≥20 weeks) regimens (95.7% and 96.7%, respectively). SVR rates in the 79 subjects treated with sofosbuvir/daclatasvir (without ribavirin) were similar (ITT: 96.2%; PP: 97.4%, respectively), without de novo/worsening anemia. In conclusion, in a real‐life study centered on genotype 2 patients with well‐compensated cirrhosis, sofosbuvir‐based regimens were associated with good SVR and tolerability rates, regardless of previous antiviral treatments, without a significant impact of on treatment ribavirin dose reductions. John Wiley and Sons Inc. 2021-06-20 /pmc/articles/PMC8214994/ /pubmed/34152088 http://dx.doi.org/10.1002/prp2.811 Text en © 2021 The Authors. Pharmacology Research & Perspectives published by John Wiley & Sons Ltd, British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Original Articles
Smirne, Carlo
D'Avolio, Antonio
Bellan, Mattia
Gualerzi, Alessandro
Crobu, Maria G.
Pirisi, Mario
Sofosbuvir‐based therapies in genotype 2 hepatitis C virus cirrhosis: A real‐life experience with focus on ribavirin dose
title Sofosbuvir‐based therapies in genotype 2 hepatitis C virus cirrhosis: A real‐life experience with focus on ribavirin dose
title_full Sofosbuvir‐based therapies in genotype 2 hepatitis C virus cirrhosis: A real‐life experience with focus on ribavirin dose
title_fullStr Sofosbuvir‐based therapies in genotype 2 hepatitis C virus cirrhosis: A real‐life experience with focus on ribavirin dose
title_full_unstemmed Sofosbuvir‐based therapies in genotype 2 hepatitis C virus cirrhosis: A real‐life experience with focus on ribavirin dose
title_short Sofosbuvir‐based therapies in genotype 2 hepatitis C virus cirrhosis: A real‐life experience with focus on ribavirin dose
title_sort sofosbuvir‐based therapies in genotype 2 hepatitis c virus cirrhosis: a real‐life experience with focus on ribavirin dose
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8214994/
https://www.ncbi.nlm.nih.gov/pubmed/34152088
http://dx.doi.org/10.1002/prp2.811
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