Abstract: Objectiv To observe the efficacy and safety of sofosbuvir/daclatasvir in the treatment of patients with chronic hepatitis C （CHC） and hepatitis C cirrhosis （LC）. Methods 311 patients with CHC and 129 patients with LC were recruited in this real-world study in our hospital between May 2016 and May 2017,and they were treated with sofosbuvir/daclatasvir or combination of sofosbuvir/daclatasvir and ribavirin respectively,for 12 weeks. All patients were followed-up for 12 weeks at the end of discontinuation of the regimen. Sustained virological response at the end of 12 weeks（SVR12）,biochemical response,liver stiffness measurement and adverse reactions were observed. Results At the end of two week treatment,serum bilirubin,ALT and AST levels in patients with LC were（18.10±3.46） μmol/L,（32.48±9.97） IU/L and（31.99±6.65） IU/L,significantly lower than （20.98±28.64）μmol/L,（97.76±106.43） IU/L and （72.47±80.81） IU/L at baseline （P<0.05）; serum bilirubin, ALT and AST levels in patients with CHC were （20.15±3.48） μmol/L,（35.18±18.47） IU/L and AST （35.05±13.22） IU/L,significantly lower than （24.07±18.12） μmol/L,（91.42±54.56） IU/L and （81.06±40.45） IU/L at baseline （P<0.05）;serum HCV RNA load in patients with CHC was（1.83±2.88） lg IU/ml,in patients with LC was （1.67±2.34）lg IU/ml,both significantly lower than（6.12±1.19）lg IU/ml and （5.91±1.17） lg IU/ml at baseline （P<0.01）;LSM in patients with CHC was（8.09±0.90） kPa,and in patients with LC was（13.32±1.47） kPa,both significantly lower than （11.81±3.33） kPa and （17.56±9.86） kPa at baseline（P<0.01）;all patients no matter with any HCV genotype infection in both groups got 94% or over of SVR12;Logistic analysis showed that the baseline cirrhosis and relapse patients non-response to PR therapy were the independent risk factors for failed SVR12;the main adverse reactions were fatigue and headache. Conclusion The application of sofosbuvir/daclatasvir regimen in treatment of patients with CHC or hepatitis C cirrhosis might achieve a very high SVR12,biochemical response rate and improved liver fibrosis with a good safety.

Key words: Hepatitis C, Sofosbuvir, Daclatasvir, Direct acting antiviral agents, Treatment