Ramsey Cheung, Caini He, Shuangsuo Dang, Leslie Y. Kam, Wanhua Ren, Wen Xie, Changqing Zhao, Dachuan Cai, Junqi Niu, Sally Tran, Hongying Pan, Qiang Zhu, Yu Li, Akiko Mizuta, Jia Shang, Hong Ren, Mindie H. Nguyen, Yuemin Nan, Lingdi Liu, Jing Liang, Qiang Xu, Qing Ye, Li Liu, Junping Liu, Wenjun Wang, Rui Huang, Chao Wu, Jiajie Zhang, Mingyuan Zhang, Zongfang Li, Fengmei Wang, Qi Wang, Fanpu Ji, Jie Li, Feng Guo, Xiaozhong Wang, Mayumi Maeda, and Junyi Li
Background and aim Globally, China has the highest chronic hepatitis C (CHC) burden, but its real-world direct-acting antiviral (DAA) data are limited. Our aim is to investigate the real-world outcome of China Food and Drug Administration-approved DAA therapies across mainland China including those with genotype (GT) 3. Methods The REAL-C is a multinational real-world interferon-free DAA-treated CHC registry of several mainland China and other Asian centers. We evaluated the sustained virological response rate 12 weeks after end of treatment (SVR12), adverse events, and treatment effect on liver function and fibrosis (fibrosis-4 index). Results We analyzed 859 DAA-treated CHC patients (6/1/2017-5/30/2019) from 12 mainland China centers (three municipalities and nine provinces): median age 52, 49.9% male, 33.1% cirrhosis, 95% treatment naive, and 2.5% HBsAg+ . The most common GT was GT1b (523, 62.2%), followed by GT2a (156, 18.5%), GT3b (74, 8.8%), GT3a (41, 4.9%), and GT6 (37, 4.4%). SVR12 rates were 98.0% overall (95% confidence interval 96.9-98.8%), 98.1% for GT1b, 96.8% GT2a, 100% GT3a, 97.3% GT3b, and 100% GT6. Baseline cirrhosis and male sex but not prior treatment history, renal dysfunction, age, and GTs were associated with SVR12. For both cirrhotic and non-cirrhotic patients, there were significant improvement in liver function tests, alpha fetoprotein, and fibrosis-4 index with SVR12. Serious adverse events were rare (1.1%) with only nine patients discontinuing therapy prematurely and anemia being the most common adverse event (13.1%, mostly with ribavirin). Conclusions In real-world Chinese patients with diverse GTs, Chinese Food and Drug Administration-approved interferon-free DAAs were well tolerated, provided high cure rates (98.0% overall) including GT3a/3b, and led to improvement of liver function.