Alfosbuvir plus Daclatasvir for Treatment of Chronic Hepatitis C Virus Infection in China

• DOI: 10.1007/s40121-023-00872-4
• Publication Date: 2023-10-19T04:02:13Z
• Authors: Rui Hua; Fei Kong; Guangming Li; Xiaofeng Wen; Yuexin Zhang; Xingxiang Yang; Chenxin Meng; Wen Xie; Yongfang Jiang; Xiaozhong Wang; Xueji Han; Yan Huang; Qing Mao; Jiefei Wang; Yujuan Guan; Jiayu Chen; Yingjie Ma; Qingfang Xiong; Hong Ma; Xuebing Yan; Huiying Rao; Yingren Zhao; Tong Sun; Liying Zhu; Xiaorong Mao; Jianqi Lian; Guojiong Deng; Yongning Xin; Yifei Wang; Yinong Ye; Bin Xu; Hainv Gao; Youwen Tan; Dongliang Li; Dongliang Yang; Minghua Su; Xiaomeng Zhang; Jie Min; Xinsheng Shi; Lai Wei; Junqi Niu
• Keywords: Daclatasvir; China; Alfosbuvir; Hepatitis C virus; Infectious and parasitic diseases; RC109-216; 3. Good health; Original Research

Abstract Background and aims 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 a sustained virologic 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 treatment, 321 (98.5% [95% CI 96.5–99.5%]) achieved 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 (≥ 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 treatment. The majority of adverse events (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 this regimen could be a promising option for HCV treatment in China irrespective of genotype.