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Ann Hepatol. 2019 Apr 15. pii: S1665-2681(19)30045-6. doi: 10.1016/j.aohep.2018.09.005. [Epub ahead of print]

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

Author information

1
Liver and Infectious Diseases, Lazzaro Spallanzani National Institute for Infectious Disease, Rome, Italy. Electronic address: raffaella.lionetti@inmi.it.
2
Internal Medicine Unit, Fatebenefratelli Hospital Isola Tiberina, Rome, Italy; Liver Unit, Tor Vergata University Hospital, Rome, Italy.
3
Liver Unit, Tor Vergata University Hospital, Rome, Italy.
4
Gastroenterology and Liver Unit, Policlinico Gemelli, Catholic University, Rome, Italy.
5
Liver and Infectious Diseases, Lazzaro Spallanzani National Institute for Infectious Disease, Rome, Italy.
6
Gastroenterology and Liver Unit, Policlinico Umberto I, Sapienza University, Rome, Italy.
7
Medicina Protetta-Infectious Diseases, Belcolle Hospital, Viterbo, Italy.
8
Infectious Diseases, Policlinico Umberto I, Sapienza University, Rome, Italy.
9
Liver Unit, Sant'Andrea University Hospital, Rome, Italy.
10
Laboratory of Virology, Lazzaro Spallanzani National Institute for Infectious Disease, Rome, Italy.

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.

KEYWORDS:

Advanced fibrosis; Antiviral therapy; Tolerability

PMID:
31023614
DOI:
10.1016/j.aohep.2018.09.005
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