1Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Spitalstrasse 12, CH-4031, Basel, Switzerland. email@example.com.
2Department of Infectious Diseases, Copenhagen University Hospital, Hvidovre, Denmark.
3Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria.
4NIHR Nottingham Digestive Diseases Biomedical Research Unit, University of Nottingham, Nottingham, UK.
5Division of Infectious Diseases, Department of Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden.
6Service de Gastroentérologie et Hépatologie, Hôpitaux universitaires de Genève, Geneva, Switzerland.
7Hospital Universitario Virgen del Rocío, Seville, Spain.
8Liver Unit, Internal Medicine Department, Hospital Universitari Vall Hebron, Barcelona, Spain.
9Hepatology Unit, Hospital Universitario y Politécnico La Fe, Valencia, Spain.
10Worldwide Health Economics and Outcomes Research, Bristol-Myers Squibb, Uxbridge, United Kingdom.
11Worldwide Health Economics and Outcomes Research, Bristol-Myers Squibb, Rueil-Malmaison, France.
12Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Spitalstrasse 12, CH-4031, Basel, Switzerland.
13Liver Unit, Hospital Universitario Puerta de Hierro, Universidad Autonoma de Madrid, Madrid, Spain.
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.