Infectious diseases and therapy · 2023
Alfosbuvir plus Daclatasvir for Treatment of Chronic Hepatitis C Virus Infection in China.
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Hua Rui, Kong Fei, Li Guangming, Wen Xiaofeng, Zhang Yuexin, Yang Xingxiang, Meng Chenxin, Xie Wen, Jiang Yongfang, Wang Xiaozhong, Han Xueji, Huang Yan, Mao Qing, Wang Jiefei, Guan Yujuan, Chen Jiayu, Ma Yingjie, Xiong Qingfang, Ma Hong, Yan Xuebing, Rao Huiying, Zhao Yingren, Sun Tong, Zhu Liying, Mao Xiaorong, Lian Jianqi, Deng Guojiong, Xin Yongning, Wang Yifei, Ye Yinong, Xu Bin, Gao Hainv, Tan Youwen, Li Dongliang, Yang Dongliang, Su Minghua, Zhang Xiaomeng, Min Jie, Shi Xinsheng, Wei Lai, Niu Junqi
Аннотация
INTRODUCTION: A pan-genotypic and effective treatment regimen for patients with chronic hepatitis C virus (HCV) infection remains an unmet medical need in China. Alfosbuvir is a novel potent HCV NS5B polymerase inhibitor in development for the treatment of chronic HCV infection. We conducted a phase 3 study to evaluate the efficacy and safety of alfosbuvir in combination with daclatasvir in Chinese patients with HCV infection.
METHODS: All patients received 600 mg alfosbuvir tablets plus 60 mg daclatasvir tablets once daily for 12 weeks. The primary endpoint was sustained virological response 12 weeks after the end of treatment (SVR12). A follow-up visit was done at week 4 and 12, and those who achieved SVR12 were followed up at post-treatment week 24.
RESULTS: Of the 326 patients who received at least one dose of the study drug, 320 (98.2% [95% confidence interval (CI): 96.5%-99.5%]) achieved sustained virological response at post-treatment week 12 (SVR12), which was superior to the historical SVR12 rate of 88% (p < 0.0001). The SVR12 rates were similar regardless of most baseline characteristics. The most common adverse event (AE) (≥ 10%) was hypercholesterolemia. Serious adverse events (SAEs) were reported in 25 (7.7%) patients, none of which was judged to be related to the study drug. The majority of AEs were mild to moderate in severity.
CONCLUSIONS: Alfosbuvir plus daclatasvir for 12 weeks was highly effective and safe in Chinese patients infected with HCV genotype 1, 2, 3, or 6, suggesting that this regimen could be a promising option for HCV treatment in China irrespective of genotype.
TRIAL REGISTRATION: ClinicalTrial.gov identifier, NCT04070235.
METHODS: All patients received 600 mg alfosbuvir tablets plus 60 mg daclatasvir tablets once daily for 12 weeks. The primary endpoint was sustained virological response 12 weeks after the end of treatment (SVR12). A follow-up visit was done at week 4 and 12, and those who achieved SVR12 were followed up at post-treatment week 24.
RESULTS: Of the 326 patients who received at least one dose of the study drug, 320 (98.2% [95% confidence interval (CI): 96.5%-99.5%]) achieved sustained virological response at post-treatment week 12 (SVR12), which was superior to the historical SVR12 rate of 88% (p < 0.0001). The SVR12 rates were similar regardless of most baseline characteristics. The most common adverse event (AE) (≥ 10%) was hypercholesterolemia. Serious adverse events (SAEs) were reported in 25 (7.7%) patients, none of which was judged to be related to the study drug. The majority of AEs were mild to moderate in severity.
CONCLUSIONS: Alfosbuvir plus daclatasvir for 12 weeks was highly effective and safe in Chinese patients infected with HCV genotype 1, 2, 3, or 6, suggesting that this regimen could be a promising option for HCV treatment in China irrespective of genotype.
TRIAL REGISTRATION: ClinicalTrial.gov identifier, NCT04070235.