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Abstract
BackgroundThere 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.MethodsA 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.ResultsThe 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.ConclusionsDaclatasvir with sofosbuvir is an effective treatment in clinical practice for hepatitis C genotype 1 patients with decompensated cirrhosis.
Highlights
There is limited evidence for the effectiveness of daclatasvir in patients whose hepatitis C threatens their life expectancy
Of these 242 patients, 13 died prior to 12 weeks after treatment, one was lost to follow up during treatment and a response was missing for three patients so that the SVR12 as-treated analysis was of 225 patients
This study shows that 24 weeks of daclatasvir and sofosbuvir is an effective treatment for hepatitis C virus (HCV) in patients with advanced liver disease, with estimated rates of SVR12 of 87% and 97% in intent-to-treat and as-treated analyses respectively
Summary
There is limited evidence for the effectiveness of daclatasvir in patients whose hepatitis C threatens their life expectancy. 50% or less in patients infected with HCV genotype 1 [4], SVR rates were as high as 60 to 80% in genotypes 2, 3 and 6 [4, 5]. This treatment caused potentially serious side effects and was contraindicated in patients with decompensated cirrhosis [4]. There is limited evidence for the effectiveness of this treatment
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