Alfosbuvir plus Daclatasvir for Treatment of Chronic Hepatitis C Virus Infection in China
Autor: | 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 |
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Jazyk: | angličtina |
Rok vydání: | 2023 |
Předmět: | |
Zdroj: | Infectious Diseases and Therapy, Vol 12, Iss 11, Pp 2595-2609 (2023) |
Druh dokumentu: | article |
ISSN: | 2193-8229 2193-6382 |
DOI: | 10.1007/s40121-023-00872-4 |
Popis: | Abstract 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 |
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