A phase Ⅱ clinical study of the efficacy and safety of antaitasvir phosphate combined with yiqibuvir for the treatment of chronic hepatitis C in adults
10.3760/cma.j.cn501113-20240307-00116
- VernacularTitle:磷酸安泰他韦联合英强布韦治疗成人慢性丙型肝炎的有效性和安全性——Ⅱ期临床研究
- Author:
Lai WEI
1
;
Hongxin PIAO
;
Jinglan JIN
;
Shufen YUAN
;
Xuan AN
;
Jia SHANG
;
Wenhua ZHANG
;
Jiabao CHANG
;
Tong SUN
;
Yujuan GUAN
;
Bo NING
;
Jing ZHU
;
Wentao GUO
;
Qingwei HE
;
Lin LUO
;
Yulei ZHUANG
;
Hongming XIE
;
Yingjun ZHANG
Author Information
1. 清华大学附属北京清华长庚医院 数智肝胆病学教育部重点实验室（清华大学），北京 102218
- Keywords:
Chronic hepatitis C;
Therapeutic;
Efficacy;
Safety;
Antaitasvir phosphate;
Yiqibuvir
- From:
Chinese Journal of Hepatology
2024;32(7):637-642
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the efficacy and safety of antaitasvir phosphate 100 mg or 200 mg combined with yiqibuvir for 12 weeks in patients with various genotypes of chronic hepatitis C, without cirrhosis or compensated stage cirrhosis.Methods:Patients with chronic hepatitis C (without cirrhosis or compensated stage cirrhosis) were randomly assigned to the antaitasvir phosphate 100 mg+yiqibuvir 600 mg group (100 mg group) or the antaitasvir phosphate 200 mg+yiqibuvir 600 mg group (200 mg group) in a 1∶1 ratio. The drugs were continuously administered once a day for 12 weeks and observed for 24 weeks after drug withdrawal. The drug safety profile was assessed concurrently with the observation of the sustained virological response (SVR12) in the two patient groups 12 weeks following the drug cessation. The intention-to-treat concept was used to define as closely as possible a full analysis set, including all randomized cases who received the experimental drug at least once. The safety set was collected from all subjects who received the experimental drug at least once (regardless of whether they participated in the randomization group) in this study. All efficacy endpoints and safety profile data were summarized using descriptive statistics. The primary efficacy endpoint was SVR12. The primary analysis was performed on a full analysis set. The frequency and proportion of cases were calculated in the experimental drug group (antaitasvir phosphate capsules combined with yiqibuvir tablets) that achieved "HCV RNA
