Safety and efficacy of DCV-based DAAs therapy for chronic HCV infection in China
10.3760/cma.j.issn.1007-3418.2018.12.011
- VernacularTitle: 达拉他韦为基础的直接抗病毒药治疗中国HCV感染者的疗效及安全性
- Author:
Jinyuan WEI
1
;
Dengna LIN
;
Zhebin WU
;
Jianyun ZHU
;
Zhixin ZHAO
;
Yongyu MEI
;
Chaoshuang LIN
;
Juan ZHANG
;
Xiaohong ZHANG
Author Information
1. Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou 510630, China
- Publication Type:Journal Article
- Keywords:
Hepatitis C, chronic;
Therapy;
Safety;
Direct-acting antiviral agent;
Daclatasvir
- From:
Chinese Journal of Hepatology
2018;26(12):933-939
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the efficacy and safety of DCV-based DAAs therapy for chronic HCV infected Chinese patients.
Methods:An open-label, non-randomized, prospective study was designed. Fifty-two patients with chronic HCV infection were enrolled. Among them, there was one patient after liver transplantation, 2 patients after kidney transplantation, 3 patients with hepatocellular carcinoma, and 4 patients with HBV infection. Thirteen cases with chronic hepatitis C (one compensated cirrhosis) who were negative for resistance-related variants [NS5A RAS (-)] of gene 1b and NS5A were treated with daclatasvir (DCV) + asunaprevir (ASV) for 24 weeks. Twenty-five cases of CHC (six compensated cirrhosis) with GT 1b, 2a, 3a, 3b, 6a were treated with DCV + SOF ± RBV for 24 weeks. 8 cases with decompensated cirrhosis of gene 1b and NS5A RAS(-) were given DCV + SOF + RBV regimen for 12 weeks. Six cases with decompensated cirrhosis, of gene 2a, 1b, 2a, 3a, 3b, were given DCV + SOF + RBV regimen for 24 weeks. HCV RNA, blood routine test, liver and kidney function, and upper abdominal ultrasound/MRI were measured at baseline, 4 weeks of treatment, end of treatment, and 12 weeks of follow-up. The incidence of adverse events and laboratory abnormalities during treatment were recorded. A t-test was used to compare the measurement data between two groups, and analysis of variance was used to compare the measurement data between multiple groups.
Results:Sixteen patients (100%) achieved SVR12 after treatment, with 0% recurrence rate. Rapid virological response (RVR) of the four treatment regimens were 76.92%, 54.17%, 87.50%, and 83.33%, respectively, and 32 patients achieved 100% virological response after the completion of treatment. The incidence of adverse events of chronic hepatitis C with cirrhosis and decompensated cirrhosis was 62.5% and 64.29%, respectively. The most common adverse event was fatigue in CHC (25.00%), and elevated indirect bilirubin in decompensated cirrhosis (42.86%). No serious adverse drug events, deaths or adverse reactions occurred.
Conclusion:DCV-based DAAs regimen is promising option for the treatment of HCV genotypes, compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, and HCV infection after liver/kidney transplantation in china. Above all, it has high SVR12 with good tolerability and safety profile.
