A phase Ⅲ clinical study to evaluate the efficacy and safety profile of antaitasvir phosphate combined with yiqibuvir in the treatment of adults with chronic hepatitis C
- VernacularTitle:一项评估磷酸安泰他韦联合英强布韦治疗成人慢性丙型肝炎疗效和安全性的Ⅲ期临床研究
- Author:
Lai WEI
1
;
Jia SHANG
;
Xuan AN
;
Guoqiang ZHANG
;
Yujuan GUAN
;
Hongxin PIAO
;
Jinglan JIN
;
Lang BAI
;
Xingxiang YANG
;
Daokun YANG
;
Xinhua LUO
;
Shufang YUAN
;
Yingren ZHAO
;
Yingjie MA
;
Guangming LI
;
Feng LIN
;
Xiaoping WU
;
Jiawei GENG
;
Guizhou ZOU
;
Jiabao CHANG
;
Zuojiong GONG
;
Xiaorong MAO
;
Jing ZHU
;
Wentao GUO
;
Qingwei HE
;
Lin LUO
;
Yulei ZHUANG
;
Hongming XIE
;
Yingjun ZHANG
Author Information
- Publication Type:Journal Article
- Keywords: Chronic hepatitis C; Therapeutic; Antaitasvir phosphate; Yiqibuvir; Efficacy; Safety
- From: Chinese Journal of Hepatology 2025;33(6):560-569
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To assess the efficacy and safety profile of antaitasvir phosphate combined with yiqibuvir in the treatment of chronic hepatitis C (CHC) of various genotypes, without cirrhosis or with compensated cirrhosis.Methods:394 cases with CHC from 22 centers were collected from October 2021 to April 2023. They were randomly assigned to receive either the experimental drugs (antaitasvir phosphate 100 mg+yiqibuvir 600 mg) or placebo treatment in a 3∶1 ratio. The patients were administered drugs once a day for 12 consecutive weeks, and then followed up for 24 weeks after treatment cessation. All subjects were unblinded at the four-week follow-up following drug discontinuation, with the experimental drug group continuing to complete subsequent post-discontinuation follow-up. The placebo group was switched to receive the experimental drugs for a repeated 12-week treatment period and followed up for another 24 weeks after discontinuation of the drug (placebo delayed treatment phase).The sustained virologic response rate (SVR12) was observed for subjects in the double-blind phase and the placebo delayed-treatment phase at 12 weeks after treatment cessation.Virological resistance analysis was performed on subjects who failed treatment. The primary efficacy endpoint was SVR12. The number and percentage of subjects who achieved "HCV RNA
