Department of Infectious Diseases, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Department of Infectious Diseases, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, Shandong, China.
J Gastroenterol Hepatol. 2021 Mar;36(3):767-774. doi: 10.1111/jgh.15192. Epub 2020 Aug 5.
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.
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).
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 naïve, 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).
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.
全球范围内，中国的慢性丙型肝炎（CHC）负担最重，但真实世界中直接作用抗病毒药物（DAA）的数据有限。我们的目的是研究中国大陆已批准的 DAA 治疗方案的真实世界结果，包括基因型（GT）3 的治疗方案。
REAL-C 是一项多国真实世界无干扰素 DAA 治疗 CHC 的登记研究，涵盖了中国大陆和其他亚洲中心的多个中心。我们评估了治疗结束后 12 周时的持续病毒学应答率（SVR12）、不良事件以及对肝功能和纤维化（纤维化-4 指数）的治疗效果。
我们分析了来自中国大陆 12 个中心（3 个直辖市和 9 个省）的 859 例 DAA 治疗的 CHC 患者（2017 年 6 月 1 日至 2019 年 5 月 30 日）：中位年龄 52 岁，49.9%为男性，33.1%为肝硬化，95%为初治患者，2.5%为 HBsAg 。最常见的 GT 是 GT1b（523 例，62.2%），其次是 GT2a（156 例，18.5%）、GT3b（74 例，8.8%）、GT3a（41 例，4.9%）和 GT6（37 例，4.4%）。总的 SVR12 率为 98.0%（95%置信区间 96.9-98.8%），GT1b 为 98.1%，GT2a 为 96.8%，GT3a 为 100%，GT3b 为 97.3%，GT6 为 100%。基线肝硬化和男性，但不是既往治疗史、肾功能不全、年龄和 GT 与 SVR12 相关。对于肝硬化和非肝硬化患者，SVR12 后肝功能试验、甲胎蛋白和纤维化-4 指数均有显著改善。严重不良事件罕见（1.1%），仅有 9 例患者提前停药，贫血是最常见的不良事件（13.1%，大多与利巴韦林有关）。
在真实世界中，中国患有不同 GT 的患者中，中国食品药品监督管理局批准的无干扰素 DAA 治疗耐受性良好，治愈率高（总体为 98.0%），包括 GT3a/3b，且可改善肝功能。
