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J Viral Hepat. 2018 Jan;25(1):56-62. doi: 10.1111/jvh.12765. Epub 2017 Aug 30.

A different perspective on sofosbuvir-ledipasvir treatment of patients with HCV genotype 1b cirrhosis: The ital-c network study.

Author information

1
Department of Emergency and Organ Transplantation, Section of Gastroenterology, AOU Policlinico, University of Bari, Bari, Italy.
2
Division of Gastroenterology, "Casa Sollievo Sofferenza" Hospital, IRCCS, San Giovanni Rotondo, Italy.
3
Clinics of Infectious Diseases, "Federico II" University of Naples, Naples, Italy.
4
Division of Gastroenterology, Department of Clinical Medicine and Surgery, "Federico II" University of Naples, Naples, Italy.
5
Clinics of Infectious Diseases, University of Bari, Bari, Italy.
6
Infectious and Tropical Diseases Unit, S. Anna and S. Sebastiano Hospital, Caserta, Italy.
7
Department of Medical Sciences, University of Turin, Turin, Italy.
8
Department of Gastroenterology and Hepatology, Azienda Ospedaliera Cittàdella Salute e della Scienza, Turin, Italy.
9
Department of Medical and Surgical Sciences (DIMEC), Centre for the Study of Hepatitis, University of Bologna, Bologna, Italy.
10
Internal Medicine, Hospital of Ostuni, Ostuni, Italy.
11
Clinics of Infectious Diseases, University of Foggia, Foggia, Italy.
12
Division of Infectious Diseases, Hospital of Galatina, Galatina, Italy.
13
Clinics of Internal Medicine "G. Baccelli", University of Bari, Bari, Italy.
14
Clinics of Internal Medicine "C. Frugoni", University of Bari, Bari, Italy.
15
Hepatology and Liver Transplantation Unit, University of Tor Vergata, Rome, Italy.
16
Liver Unit, Hospital of Castellaneta, Castellaneta, Italy.
17
Unit of Infectious Diseases, Hospital of Bisceglie, Bisceglie, Italy.
18
Department of Emergency and Organ Transplantation, Section of Nephrology, AOU Policlinico, University of Bari, Bari, Italy.

Abstract

The effectiveness of a 12-week course of sofosbuvir-ledipasvir in treatment-experienced HCV genotype 1b-infected patients with cirrhosis is still under debate. Our primary endpoint was to compare the sustained virological response at post-treatment week 12 (SVR12) of sofosbuvir-ledipasvir in combination with ribavirin for 12 weeks, and sofosbuvir-ledipasvir alone for 24 weeks. This was a prospective observational study that enrolled 424 (195 naive, 229 experienced; 164 treated for 12 weeks with Ribavirin and 260 with sofosbuvir-ledipasvir alone for 24 weeks) consecutive HCV genotype 1b-infected patients with cirrhosis. The SVR12 rates were 93.9% and 99.2% in patients treated for 12 and 24 weeks, respectively (P = .002). The baseline characteristics of patients treated for 12 weeks were significantly different from those treated for 24 weeks as regards their younger age (P = .002), prevalence of Child-Pugh class A (P = .002), lower MELD scores (P = .001) and smaller number of nonresponders (P = .04). The shorter treatment was significantly associated with a lower SVR12 in univariate and multivariate analyses (P = .007 and P = .008, respectively). The SVR rate was unaffected by age, gender, BMI, Child-Pugh class, MELD score or previous antiviral treatment. Patients receiving ribavirin experienced more episodes of ascites and headache but less recurrence of hepatocellular carcinoma (HCC), and were prescribed more diuretics and cardiopulmonary drugs. No patient discontinued treatment. The therapeutic regimen of sofosbuvir-ledipasvir plus ribavirin administered for 12 weeks was less effective than sofosbuvir-ledipasvir alone given for 24 weeks. At odds with European guidelines, the recommended 12-week treatment with sofosbuvir-ledipasvir alone might be suboptimal for this setting of patients.

KEYWORDS:

antiviral therapy; direct-acting antivirals; hepatitis C; liver cirrhosis

PMID:
28787102
DOI:
10.1111/jvh.12765
[Indexed for MEDLINE]

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