Abstract

Prescription and efficacy of daclatasvir and sofosbuvir ± ribavirin, including patient-reported outcomes, in routine practice in three European countries: the CMPASS-EU cohort study. Objectives: To...

Highlights

  • Despite recent advances in treatment, chronic hepatitis C virus (HCV) infection remains a major public health problem

  • We report the results of an observational cohort study intended to identify the patient characteristics associated with routine prescription of DCV-based regimens in three European countries, and to evaluate the effectiveness, safety and quality-of-life (QoL) changes associated with such regimens in the patients for whom they were prescribed

  • In this study of real-world prescription and outcomes, HCV-infected patients initiating DCV+SOF ±RBV were younger, GT-3 infected, and have more clinically advanced liver disease than those initiating other regimens. Those prescribed DCV included a higher proportion of previous treatment failures on all-oral regimens containing SOF or HCV protease inhibitors, and a higher proportion of illicit drug users (IDU)

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Summary

Introduction

Despite recent advances in treatment, chronic hepatitis C virus (HCV) infection remains a major public health problem. An estimated 184 million people are chronically infected with HCV (Mohd Hanafiah, Groeger, Flaxman, & Wiersma, 2013) and, over a period of 20–30 years, 10–20% will develop cirrhosis and 1–5% hepatocellular carcinoma (European Association for the Study of the Liver, 2014). More than 35,000 new cases of HCV infection were reported across the European Union in 2014, an increase of 29% since 2006. These figures may underestimate the true prevalence, as sources may under-represent high-risk groups, such as intravenous drug users and the prison population (Cornberg et al, 2011). Prior to 2011, pegylated interferon alpha (IFN) combined with ribavirin (RBV) was the cornerstone of HCV therapy despite a high adverse event (AE) burden and an HCV genotype (GT)dependent cure rate of only 50‒75%. Contraindications for IFN—such as severe depression, decompensated cirrhosis and severe cardiovascular disease—restricted treatment uptake (Lauer & Walker, 2001)

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