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; Regimen; Sofosbuvir; Clinical endpoint

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 development the of infection. We conducted phase 3 study to evaluate efficacy safety alfosbuvir combination daclatasvir Chinese All received 600 mg tablets plus 60 once daily 12 weeks. The primary endpoint was sustained virological response weeks after end (SVR12). follow-up visit done at week 4 12, those who achieved SVR12 were followed up post-treatment 24. Of 326 least one dose drug, 320 (98.2% [95% confidence interval (CI): 96.5%–99.5%]) (SVR12), which superior historical rate 88% (p < 0.0001). rates similar regardless most baseline characteristics. common adverse event (AE) (≥ 10%) hypercholesterolemia. Serious events (SAEs) reported 25 (7.7%) patients, none judged be related drug. majority AEs mild moderate severity. highly safe infected genotype 1, 2, 3, or 6, suggesting that this could promising option China irrespective genotype. ClinicalTrial.gov identifier, NCT04070235.