title: The effectiveness of daclatasvir based therapy in European patients with chronic hepatitis C and advanced liver disease.
abstract: There is limited evidence for the effectiveness of daclatasvir in patients whose hepatitis C threatens their life expectancy. The Named Patient Program in Europe included patients with advanced chronic hepatitis C, a life expectancy of less than 12 months and no other treatment options.
  
  
  
  A retrospective multi-country cohort of patients with chronic hepatitis C who received daclatasvir as part of the Named Patient Program in Austria, Denmark, Spain, Sweden, Switzerland and the United Kingdom. Treatment response was defined as a sustained virologic response (unquantifiable hepatitis C RNA) at 12 weeks post treatment. We summarised the characteristics of the patients in this cohort and estimated the rate of sustained virologic response for patients receiving daclatasvir and sofosbuvir with or without ribavirin using hierarchical Bayesian modelling.
  
  
  
  The 249 patients included had a median age of 56 years; most were male (78%), hepatitis C genotype 1 (75%), treatment experienced (65%) and with decompensated cirrhosis (59%). Many had had a liver transplant before receiving daclatasvir (40%). Of the 249 patients, 242 patients received daclatasvir and sofosbuvir and either reached 12 weeks post treatment or died during (n = 9) or after treatment (n = 4) or were lost to follow up during treatment (n = 1). The estimated rate of sustained virologic response at 12 weeks post treatment was 87% (95% credible interval 75 to 94%) for previously treated genotype 1 patients with decompensated cirrhosis.
  
  
  
  Daclatasvir with sofosbuvir is an effective treatment in clinical practice for hepatitis C genotype 1 patients with decompensated cirrhosis.
authors.affiliation: Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Spitalstrasse 12, CH-4031, Basel, Switzerland. james.young@usb.ch.
authors.forename: Jim
authors.initials: J
authors.lastname: Young
authors.affiliation: Department of Infectious Diseases, Copenhagen University Hospital, Hvidovre, Denmark.
authors.forename: Nina
authors.initials: N
authors.lastname: Weis
authors.affiliation: Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria.
authors.forename: Harald
authors.initials: H
authors.lastname: Hofer
authors.affiliation: NIHR Nottingham Digestive Diseases Biomedical Research Unit, University of Nottingham, Nottingham, UK.
authors.forename: William
authors.initials: W
authors.lastname: Irving
authors.affiliation: Division of Infectious Diseases, Department of Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden.
authors.forename: Ola
authors.initials: O
authors.lastname: Weiland
authors.affiliation: Service de Gastroentérologie et Hépatologie, Hôpitaux universitaires de Genève, Geneva, Switzerland.
authors.forename: Emiliano
authors.initials: E
authors.lastname: Giostra
authors.affiliation: Hospital Universitario Virgen del Rocío, Seville, Spain.
authors.forename: Juan Manuel
authors.initials: JM
authors.lastname: Pascasio
authors.affiliation: Liver Unit, Internal Medicine Department, Hospital Universitari Vall Hebron, Barcelona, Spain.
authors.forename: Lluis
authors.initials: L
authors.lastname: Castells
authors.affiliation: Hepatology Unit, Hospital Universitario y Politécnico La Fe, Valencia, Spain.
authors.forename: Martin
authors.initials: M
authors.lastname: Prieto
authors.affiliation: Worldwide Health Economics and Outcomes Research, Bristol-Myers Squibb, Uxbridge, United Kingdom.
authors.forename: Roelien
authors.initials: R
authors.lastname: Postema
authors.affiliation: Worldwide Health Economics and Outcomes Research, Bristol-Myers Squibb, Rueil-Malmaison, France.
authors.forename: Cinira
authors.initials: C
authors.lastname: Lefevre
authors.affiliation: Worldwide Health Economics and Outcomes Research, Bristol-Myers Squibb, Rueil-Malmaison, France.
authors.forename: David
authors.initials: D
authors.lastname: Evans
authors.affiliation: Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Spitalstrasse 12, CH-4031, Basel, Switzerland.
authors.forename: Heiner C
authors.initials: HC
authors.lastname: Bucher
authors.affiliation: Liver Unit, Hospital Universitario Puerta de Hierro, Universidad Autonoma de Madrid, Madrid, Spain.
authors.forename: Jose Luis
authors.initials: JL
authors.lastname: Calleja
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use*; D001499:Bayes Theorem; D002219:Carbamates; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D005060:Europe; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D008103:Liver Cirrhosis / Q000188:drug therapy / Q000821:virology; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D011759:Pyrrolidines; D012189:Retrospective Studies; D012254:Ribavirin / Q000627:therapeutic use; D000069474:Sofosbuvir / Q000627:therapeutic use; D016896:Treatment Outcome; D014633:Valine / Q000031:analogs & derivatives
chemical_list: D000998:Antiviral Agents; D002219:Carbamates; D007093:Imidazoles; D011759:Pyrrolidines; D012254:Ribavirin; D014633:Valine; C549273:daclatasvir; D000069474:Sofosbuvir
keywords: Daclatasvir; Direct-acting antivirals; Effectiveness; Hepatitis C; Sofosbuvir