Twelve-week of sofosbuvir/velpatasvir therapeutic regimen for chronic hepatitis C patients in northwest region of China: a real-world multicenter clinical study
10.3760/cma.j.cn501113-20201010-00548
- VernacularTitle:12周索磷布韦/维帕他韦方案治疗西北地区慢性丙型肝炎患者：一项真实世界多中心临床研究
- Author:
Qiang XU
1
;
Wei ZHANG
;
Yuxiu MA
;
Caini HE
;
Liting ZHANG
;
Yilihamu ABULITIFU
;
Yu LI
;
Nan WANG
;
Hongli WANG
;
Yunyu ZHAO
;
Xu GAO
;
Peigen GAO
;
Xingyang SU
;
Shen LI
;
Yuanyuan LIU
;
Feng GUO
;
Zhangqian CHEN
;
Hailing LIU
;
Xiaoqin GAO
;
Jianjun FU
;
Guoying YU
;
Xiaozhong WANG
;
Jiuping WANG
;
Yongping ZHANG
;
Fanpu JI
Author Information
1. 新疆医科大学附属中医医院，乌鲁木齐 830000
- Keywords:
Chronic hepatitis C;
Sofosbuvir;
Velpatasvir;
Effectiveness;
Real world;
Genotype 3;
Liver cirrhosis;
Ribavirin
- From:
Chinese Journal of Hepatology
2021;29(11):1046-1052
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To study the real-world outcome of China FDA-approved Sofosbuvir (SOF)/Velpatasvir (VEL) in Northwest China.Methods:In this multicenter, prospective, real-world cohort study, we recruited patients from 10 sites from Northwest China, who were chronically infected with HCV GTs 1-6 from 06/2018 to 09/2019. Patients received SOF (400mg)/VEL (100mg) for 12 weeks, and with ribavirin 900-1200 mg for GT3 cirrhosis and for any genotype decompensated cirrhosis. The primary endpoint was sustained virological response at 12-weeks post-treatment (SVR12) and safety. The secondary endpoint was the change of liver function after the achievement of SVR12.Results:Totally, 143 patients were enrolled in the study, four patients were lost to follow-up and one died during the follow-up, 138 patients were included in per-protocol analysis. Of the 138 patients, the mean age 53 years, 53.6% male, 94.2% Han nationality, 53.6% liver cirrhosis, 10.1% HBsAg +, 6.5% renal dysfunction, 5.1% treatment-experienced, and 16.7% patients received ribavirin treatment. The genotype distribution was as follows: 35.5% GT1, 42.8% GT2, 15.9% GT3, and 5.8% un-typed. The SVR12 rate was 96.5% (138/143, 95% CI: 93.5%-99.6%) for intention-to-treat analysis, and in per-protocol analysis, all 138 patients obtained SVR12 (100%). Compared with baseline, the serum total bilirubin, ALT and AFP levels decreased (all P < 0.05), as well as increased ALB and platelet count (all P < 0.001) at post-treatment 12-weeks. Overall adverse events (AEs) rate is 29.0%, and the most common AEs were anemia (14.5%) and fatigue (8.0%). Severe side effects (edema and fatigue) occurred in 2 patients, one of whom needed a short-term interruption of treatment due to fatigue. Conclusion:In this real-world cohort study, 12-week SOF/VEL regimen with or without ribavirin achieved high SVR12 rates (96.5%-100% overall) with excellent safety profile among patients with HCV GT1/2/3 infection including patients with GT3 and cirrhosis, and led to improvement of liver function.
