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 journalArticlepeer-review

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

Keywords

  • Advanced fibrosis
  • Antiviral therapy
  • Tolerability

ASJC Scopus subject areas

  • Hepatology

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