Sofosbuvir Plus Simeprevir for the Treatment of HCV Genotype 4 Patients With Advanced Fibrosis or Compensated Cirrhosis is Highly Efficacious in Real Life

S. B. Willemse; L. C. Baak; S. D. Kuiken; A. van der Sluys Veer; K. D. Lettinga; J. T. M. van der Meer; A. C. T. M. Depla; H. Tuynman; C. M. J. van Nieuwkerk; C. J. Schinkel; D. Kwa; H. W. Reesink; M. van der Valk

Disclosures

J Viral Hepat. 2016;23(12):950-954. 

In This Article

Abstract and Introduction

Abstract

Chronic hepatitis C virus (HCV) infection is a major cause of chronic liver disease and liver-related death. Recently, multiple regimens of different direct-acting antiviral agents (DAAs) have been registered. Although treatment with sofosbuvir (SOF) and simeprevir (SMV) is registered for the treatment of genotype 4 patients in some countries, data on efficacy of this combination are lacking. We aimed to assess the efficacy of SOF and SMV with or without RBV during 12 weeks in a real-life cohort of genotype 4 HCV patients. A retrospective multicentre observational study was conducted in 4 hospitals in Amsterdam, the Netherlands, including patients with advanced liver fibrosis or liver cirrhosis treated with SOF plus SMV with or without RBV during 12 weeks for a genotype 4 chronic HCV infection from 1 January 2015 to 1 August 2015. Sustained viral response (SVR) was established at week 12 after end of treatment. A total of 53 patients with genotype 4 HCV infection, treatment naïve and experienced, were included. SVR was achieved in 49 of 53 patients (92%). The four failures all had a virological relapse and did not receive ribavirin. Three were nonresponder to earlier interferon-based treatment, and one was treatment naive. In this real-life cohort of patients with HCV genotype 4 infection and advanced liver fibrosis/cirrhosis, we show that treatment with SOF and SMV is effective. The addition of RBV could be considered in treatment-experienced patients as recommended in guidelines.

Introduction

Chronic hepatitis C virus (HCV) infection is a major cause of chronic liver disease. It causes liver fibrosis and may ultimately lead to liver cirrhosis, hepatocellular carcinoma and death.[1] It is estimated that there are around 80 million people worldwide with chronic HCV infection.[2]

Recently, new potent all-oral antiviral treatment regimens resulting in very high cure rates in all HCV genotypes were registered. For patients with hepatitis C genotype 4, the combination of sofosbuvir (SOF) and simeprevir (SMV) is recommended in European guidelines as one of the treatment indications.[3] Although various studies in genotype 1 chronic hepatitis C (CHC) patients reported sustained viral response (SVR) rates of >90% after treatment with SOF and SMV for 12 weeks with or without ribavirin (RBV), data in genotype 4 CHC are lacking.[4–6] This recommendation in the guidelines is based on study results from SOF or SMV combined with both peginterferon (PegIFN) and RBV and SOF/RBV showing similar results in HCV genotype 1 and 4 patients.[7–13] EASL recommendations state that given the effectiveness of both SOF and SMV against HCV genotype 4, it is likely that the results of combination therapy with SOF and SMV in HCV genotype 1 patients can be extrapolated.[3] This statement has also been followed in the Dutch guidelines.[14] Whether RBV should be added to this treatment regimen is unknown. Recent studies in HCV genotype 1 cirrhotic patients treated with SOF/SMV with or without ribavirin, contradicted each other in the value of the addition of RBV.[15,16]

Our aim was to assess in real life the efficacy of combination treatment of SOF and SMV with or without RBV during 12 weeks for HCV genotype 4 patients.

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