The effectiveness of daclatasvir based therapy in European patients with chronic hepatitis C and advanced liver disease

TY - JOUR

T1 - The effectiveness of daclatasvir based therapy in European patients with chronic hepatitis C and advanced liver disease

AU - Young, Jim

AU - Weis, Nina

AU - Hofer, Harald

AU - Irving, William

AU - Weiland, Ola

AU - Giostra, Emiliano

AU - Pascasio, Juan Manuel

AU - Castells, Lluis

AU - Prieto, Martin

AU - Postema, Roelien

AU - Lefevre, Cinira

AU - Evans, David

AU - Bucher, Heiner C.

AU - Calleja, Jose Luis

PY - 2017/1/7

Y1 - 2017/1/7

N2 - Background: 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. Methods: 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. Results: 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. Conclusions: Daclatasvir with sofosbuvir is an effective treatment in clinical practice for hepatitis C genotype 1 patients with decompensated cirrhosis.

AB - Background: 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. Methods: 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. Results: 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. Conclusions: Daclatasvir with sofosbuvir is an effective treatment in clinical practice for hepatitis C genotype 1 patients with decompensated cirrhosis.

KW - Daclatasvir

KW - Direct-acting antivirals

KW - Effectiveness

KW - Hepatitis C

KW - Sofosbuvir

U2 - 10.1186/s12879-016-2106-x

DO - 10.1186/s12879-016-2106-x

M3 - Journal article

C2 - 28061762

AN - SCOPUS:85010211623

SN - 1471-2334

VL - 17

JO - BMC Infectious Diseases

JF - BMC Infectious Diseases

M1 - 45

ER -