Daclatasvir plus sofosbuvir, with or without ribavirin, achieved high sustained virological response rates in patients with HCV infection and advanced liver disease in a real-world cohort

  • 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 cirrhosis (42% Child–Pugh B/C; 46% Model for End-Stage Liver Disease score >10). SVR12 (modified intention-to-treat) was achieved by 91% of patients (419/460); 1 patient had virological breakthrough and 13 patients relapsed. Virological failure was not associated with treatment group (adjusted risk difference DCV+SOF minus DCV+SOF+RBV: 1.06%; 95% CI −2.22% to 4.35%). High SVR12 was observed regardless of HCV genotype or cirrhosis, liver transplant or HIV/HCV coinfection status. Twenty eight patients discontinued treatment due to adverse events (n=18) or death (n=10) and 18 died during follow-up. Deaths and most safety events were associated with advanced liver disease and not considered treatment related. Conclusions DCV+SOF with or without RBV achieved high SVR12 and was well tolerated in a diverse cohort of patients with severe liver disease. Trial registration number NCT0209966.

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Author:Tania Mara WelzelGND, Jörg Petersen, Kerstin Herzer, Peter FerenciORCiDGND, Michael Gschwantler, Heiner WedemeyerORCiDGND, Thomas BergORCiDGND, Ulrich SpenglerORCiDGND, Ola Weiland, Marc van der Valk, Jürgen RockstrohORCiDGND, Markus Peck-Radosavljevic, Yue Zhao, Maria Jesus Jimenez-Exposito, Stefan ZeuzemORCiDGND
Pubmed Id:https://pubmed.ncbi.nlm.nih.gov/27605539
Parent Title (German):Gut
Publisher:BMJ Publishing Group
Place of publication:London
Document Type:Article
Date of Publication (online):2016/11/24
Date of first Publication:2016/09/07
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Release Date:2016/12/21
Tag:antiviral therapy; chronic viral hepatitis; cirrhosis; hepatitis c
Page Number:10
First Page:1861
Last Page:1870
Institutes:Medizin / Medizin
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Licence (English):License LogoCreative Commons - Namensnennung-Nicht kommerziell 4.0