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Sofosbuvir-based therapies in genotype 2 hepatitis C virus cirrhosis: A real-life experience with focus on ribavirin dose.
- Source :
-
Pharmacology research & perspectives [Pharmacol Res Perspect] 2021 Aug; Vol. 9 (4), pp. e00811. - Publication Year :
- 2021
-
Abstract
- 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.<br /> (© 2021 The Authors. Pharmacology Research & Perspectives published by John Wiley & Sons Ltd, British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics.)
- Subjects :
- Adult
Aged
Aged, 80 and over
Antiviral Agents adverse effects
Carbamates adverse effects
Drug Therapy, Combination
Female
Genotype
Hepatitis C, Chronic complications
Hepatitis C, Chronic virology
Humans
Imidazoles adverse effects
Liver Cirrhosis etiology
Liver Cirrhosis virology
Male
Middle Aged
Pyrrolidines adverse effects
RNA, Viral genetics
Retrospective Studies
Ribavirin adverse effects
Sofosbuvir adverse effects
Treatment Outcome
Valine administration & dosage
Valine adverse effects
Antiviral Agents administration & dosage
Carbamates administration & dosage
Hepacivirus genetics
Hepatitis C, Chronic drug therapy
Imidazoles administration & dosage
Liver Cirrhosis drug therapy
Pyrrolidines administration & dosage
Ribavirin administration & dosage
Sofosbuvir administration & dosage
Valine analogs & derivatives
Subjects
Details
- Language :
- English
- ISSN :
- 2052-1707
- Volume :
- 9
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Pharmacology research & perspectives
- Publication Type :
- Academic Journal
- Accession number :
- 34152088
- Full Text :
- https://doi.org/10.1002/prp2.811