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. 2023 Nov;12(11):2595-2609.
doi: 10.1007/s40121-023-00872-4. Epub 2023 Oct 19.

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

Rui Hua #  1 , Fei Kong #  1 , Guangming Li  2 , Xiaofeng Wen  3 , Yuexin Zhang  4 , Xingxiang Yang  5 , Chenxin Meng  6 , Wen Xie  7 , Yongfang Jiang  8 , Xiaozhong Wang  9 , Xueji Han  10 , Yan Huang  11 , Qing Mao  12 , Jiefei Wang  13 , Yujuan Guan  14 , Jiayu Chen  15 , Yingjie Ma  16 , Qingfang Xiong  17 , Hong Ma  18 , Xuebing Yan  19 , Huiying Rao  20 , Yingren Zhao  21 , Tong Sun  22 , Liying Zhu  23 , Xiaorong Mao  24 , Jianqi Lian  25 , Guojiong Deng  26 , Yongning Xin  27 , Yifei Wang  28 , Yinong Ye  29 , Bin Xu  30 , Hainv Gao  31 , Youwen Tan  32 , Dongliang Li  33 , Dongliang Yang  34 , Minghua Su  35 , Xiaomeng Zhang  36 , Jie Min  36 , Xinsheng Shi  36 , Lai Wei  37 , Junqi Niu  38
Affiliations

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

Rui Hua et al. Infect Dis Ther. 2023 Nov.

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 < 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.

Keywords: Alfosbuvir; China; Daclatasvir; Hepatitis C virus.

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Conflict of interest statement

Xiaomeng Zhang, Jie Min, and Xinsheng Shi are employees of Nanjing Sanhome Pharmaceutical Co., Ltd. The other authors have no conflict of interest to declare. 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 Xion, 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, Junqi Niu, and Lai Wei have nothing to disclose.

Figures

Fig. 1
Fig. 1
Trial profile
Fig. 2
Fig. 2
Decrease of HCV RNA relative to baseline at different test time points
See this image and copyright information in PMC

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