Authors
Tania M Welzel, Jörg Petersen, Kerstin Herzer, Peter Ferenci, Michael Gschwantler, Heiner Wedemeyer, Thomas Berg, Ulrich Spengler, Ola Weiland, Marc van der Valk, Jürgen Rockstroh, Markus Peck-Radosavljevic, Yue Zhao, Maria Jesus Jimenez-Exposito, Stefan Zeuzem
Publication date
2016/11/1
Journal
Gut
Volume
65
Issue
11
Pages
1861-1870
Publisher
BMJ Publishing Group
Description
Objective
We assessed the effectiveness and safety of daclatasvir (DCV) plus sofosbuvir (SOF), with or without ribavirin (RBV), in a large real-world cohort, including patients with advanced liver disease.
Design
Adults with chronic HCV infection at high risk of decompensation or death within 12 months and with no available treatment options were treated in a European compassionate use programme. The recommended regimen was DCV 60 mg plus SOF 400 mg for 24 weeks; RBV addition or shorter duration was allowed at physicians' discretion. The primary endpoint was sustained virological response at post-treatment week 12 (SVR12).
Results
Of the 485 evaluable patients, 359 received DCV+SOF and 126 DCV+SOF+RBV. Most patients were men (66%), white (93%) and treatment-experienced (70%). The most frequent HCV genotypes were 1b (36%), 1a (33%) and 3 (21%), and 80% of patients had …
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