Daclatasvir, sofosbuvir with or without ribavirin for 24 weeks in hepatitis C genotype 3 cirrhosis: A real-life study

Raffaella Lionetti, Paola Piccolo, Ilaria Lenci, Massimo Siciliano, Ubaldo Visco-Comandini, Adriano De Santis, Maurizio Pompili, Martina Milana, Chiara Taibi, Serena Dell'Isola, Marzia Montalbano, Claudio Mastroianni, Paola Begini, Anna Rosa Garbuglia, Mario Angelico, Gianpiero D'Offizi

Research output: Contribution to journalArticle

Abstract

INTRODUCTION AND AIM: Cirrhotic patients with hepatitis C virus genotype 3 infection show unsatisfactory outcomes after 12 weeks' treatment with direct antiviral agents. The National Italian Drug Agency allows 24 weeks of therapy in difficult-to-treat patients, including genotype 3 cirrhotics. Aim of this study was to evaluate efficacy and safety of a 24-week course of sofosbuvir plus daclatasvir±ribavirin in this population. MATERIALS AND METHODS: 106 consecutive cirrhotics (70.8% males, mean age 55.3±7.6 years) in 8 tertiary hepatology centers received sofosbuvir plus daclatasvir for 24 weeks. Ribavirin was administered in 85 (80.2%) based expected tolerability, at a mean dose of 964±202mg/day. Baseline Child-Pugh class was A 91.5%, B 6.6%, C 1.9%; mean baseline MELD was 8.5±2.7. RESULTS: All patients completed 12-week follow-up post-treatment, and 104 (98.1%) obtained sustained virological response (100% in ribavirin -treated patients vs. 90.4% without ribavirin; p=0.04). No worsening in renal and liver function was observed, no serious adverse events occurred. Two virological failures showed resistance associated variants (Y93H and S282T). CONCLUSION: An extended 24-week treatment with sofosbuvir plus daclatasvir+ribavirin obtained 100% efficacy in genotype 3 hepatitis C cirrhosis, with very limited side effects. The role of ribavirin seems crucial in this setting and should be administered if clinically feasible.

Original languageEnglish
Pages (from-to)434-438
Number of pages5
JournalAnnals of Hepatology
Volume18
Issue number3
DOIs
Publication statusPublished - May 1 2019

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Ribavirin
Hepatitis C
Fibrosis
Genotype
Gastroenterology
Therapeutics
Hepacivirus
Antiviral Agents
Sofosbuvir
BMS-790052
Kidney
Safety
Liver
Infection
Pharmaceutical Preparations
Population

Keywords

  • Advanced fibrosis
  • Antiviral therapy
  • Tolerability

ASJC Scopus subject areas

  • Hepatology

Cite this

Daclatasvir, sofosbuvir with or without ribavirin for 24 weeks in hepatitis C genotype 3 cirrhosis : A real-life study. / Lionetti, Raffaella; Piccolo, Paola; Lenci, Ilaria; Siciliano, Massimo; Visco-Comandini, Ubaldo; De Santis, Adriano; Pompili, Maurizio; Milana, Martina; Taibi, Chiara; Dell'Isola, Serena; Montalbano, Marzia; Mastroianni, Claudio; Begini, Paola; Garbuglia, Anna Rosa; Angelico, Mario; D'Offizi, Gianpiero.

In: Annals of Hepatology, Vol. 18, No. 3, 01.05.2019, p. 434-438.

Research output: Contribution to journalArticle

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abstract = "INTRODUCTION AND AIM: Cirrhotic patients with hepatitis C virus genotype 3 infection show unsatisfactory outcomes after 12 weeks' treatment with direct antiviral agents. The National Italian Drug Agency allows 24 weeks of therapy in difficult-to-treat patients, including genotype 3 cirrhotics. Aim of this study was to evaluate efficacy and safety of a 24-week course of sofosbuvir plus daclatasvir±ribavirin in this population. MATERIALS AND METHODS: 106 consecutive cirrhotics (70.8{\%} males, mean age 55.3±7.6 years) in 8 tertiary hepatology centers received sofosbuvir plus daclatasvir for 24 weeks. Ribavirin was administered in 85 (80.2{\%}) based expected tolerability, at a mean dose of 964±202mg/day. Baseline Child-Pugh class was A 91.5{\%}, B 6.6{\%}, C 1.9{\%}; mean baseline MELD was 8.5±2.7. RESULTS: All patients completed 12-week follow-up post-treatment, and 104 (98.1{\%}) obtained sustained virological response (100{\%} in ribavirin -treated patients vs. 90.4{\%} without ribavirin; p=0.04). No worsening in renal and liver function was observed, no serious adverse events occurred. Two virological failures showed resistance associated variants (Y93H and S282T). CONCLUSION: An extended 24-week treatment with sofosbuvir plus daclatasvir+ribavirin obtained 100{\%} efficacy in genotype 3 hepatitis C cirrhosis, with very limited side effects. The role of ribavirin seems crucial in this setting and should be administered if clinically feasible.",
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T1 - Daclatasvir, sofosbuvir with or without ribavirin for 24 weeks in hepatitis C genotype 3 cirrhosis

T2 - A real-life study

AU - Lionetti, Raffaella

AU - Piccolo, Paola

AU - Lenci, Ilaria

AU - Siciliano, Massimo

AU - Visco-Comandini, Ubaldo

AU - De Santis, Adriano

AU - Pompili, Maurizio

AU - Milana, Martina

AU - Taibi, Chiara

AU - Dell'Isola, Serena

AU - Montalbano, Marzia

AU - Mastroianni, Claudio

AU - Begini, Paola

AU - Garbuglia, Anna Rosa

AU - Angelico, Mario

AU - D'Offizi, Gianpiero

PY - 2019/5/1

Y1 - 2019/5/1

N2 - INTRODUCTION AND AIM: Cirrhotic patients with hepatitis C virus genotype 3 infection show unsatisfactory outcomes after 12 weeks' treatment with direct antiviral agents. The National Italian Drug Agency allows 24 weeks of therapy in difficult-to-treat patients, including genotype 3 cirrhotics. Aim of this study was to evaluate efficacy and safety of a 24-week course of sofosbuvir plus daclatasvir±ribavirin in this population. MATERIALS AND METHODS: 106 consecutive cirrhotics (70.8% males, mean age 55.3±7.6 years) in 8 tertiary hepatology centers received sofosbuvir plus daclatasvir for 24 weeks. Ribavirin was administered in 85 (80.2%) based expected tolerability, at a mean dose of 964±202mg/day. Baseline Child-Pugh class was A 91.5%, B 6.6%, C 1.9%; mean baseline MELD was 8.5±2.7. RESULTS: All patients completed 12-week follow-up post-treatment, and 104 (98.1%) obtained sustained virological response (100% in ribavirin -treated patients vs. 90.4% without ribavirin; p=0.04). No worsening in renal and liver function was observed, no serious adverse events occurred. Two virological failures showed resistance associated variants (Y93H and S282T). CONCLUSION: An extended 24-week treatment with sofosbuvir plus daclatasvir+ribavirin obtained 100% efficacy in genotype 3 hepatitis C cirrhosis, with very limited side effects. The role of ribavirin seems crucial in this setting and should be administered if clinically feasible.

AB - INTRODUCTION AND AIM: Cirrhotic patients with hepatitis C virus genotype 3 infection show unsatisfactory outcomes after 12 weeks' treatment with direct antiviral agents. The National Italian Drug Agency allows 24 weeks of therapy in difficult-to-treat patients, including genotype 3 cirrhotics. Aim of this study was to evaluate efficacy and safety of a 24-week course of sofosbuvir plus daclatasvir±ribavirin in this population. MATERIALS AND METHODS: 106 consecutive cirrhotics (70.8% males, mean age 55.3±7.6 years) in 8 tertiary hepatology centers received sofosbuvir plus daclatasvir for 24 weeks. Ribavirin was administered in 85 (80.2%) based expected tolerability, at a mean dose of 964±202mg/day. Baseline Child-Pugh class was A 91.5%, B 6.6%, C 1.9%; mean baseline MELD was 8.5±2.7. RESULTS: All patients completed 12-week follow-up post-treatment, and 104 (98.1%) obtained sustained virological response (100% in ribavirin -treated patients vs. 90.4% without ribavirin; p=0.04). No worsening in renal and liver function was observed, no serious adverse events occurred. Two virological failures showed resistance associated variants (Y93H and S282T). CONCLUSION: An extended 24-week treatment with sofosbuvir plus daclatasvir+ribavirin obtained 100% efficacy in genotype 3 hepatitis C cirrhosis, with very limited side effects. The role of ribavirin seems crucial in this setting and should be administered if clinically feasible.

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KW - Antiviral therapy

KW - Tolerability

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