Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Department of Virology and Liver Unit, Graduate School of Medical Sciences, Nagoya City University, Nagoya, Japan.
Hepatol Int. 2019 Sep;13(5):587-598. doi: 10.1007/s12072-019-09974-z. Epub 2019 Aug 28.
One-third of the global hepatitis C virus (HCV) burden is found in Asia. Real-world data from diverse East Asian cohorts remain limited. This study addressed the real-world status of direct-acting antiviral (DAA) therapy among patients from East Asia.
Chronic hepatitis C (CHC) patients from clinical sites in Japan, Taiwan, South Korea, and Hong Kong were recruited in the REAL-C registry, an observational chart review registry. The primary outcome was sustained virologic response (SVR12, HCV RNA PCR < 25 IU/mL 12 week post-therapy).
A total of 6287 CHC patients were enrolled. Compared to other East Asian patients, patients from Japan were older (66.3 vs. 61.5 years, p < 0.0001), had lower body mass indices (22.9 kg/m vs. 24.6 kg/m, p < 0.001), and were more likely to have non-liver malignancy history (12.2% vs. 5.0%, p < 0.001).The overall SVR12 rate was 96.4%, similar to patients both inside and outside Japan (96.6% vs. 96%, p = 0.21). The SVR12 rate ranged from 91.1 to 99.4% except treatment-experienced cirrhotic HCV genotype-1 patients who received daclatasvir/asunaprevir (85.9%) and the treatment-experienced cirrhotic HCV genotype-2 patients treated with sofosbuvir/ribavirin (87%). The overall rate of drug discontinuation was 1.9%, also similar across regions. On multivariate regression analyses, there was no significant association between geographic region and SVR outcomes.
In this large multinational CHC cohort from the East Asia, oral DAAs were highly effective and well tolerated across the region. Policies should encourage treatment for all CHC patients with DAAs in Asia with its heavy burden of HCV.
全球三分之一的丙型肝炎病毒(HCV)负担发生在亚洲。来自东亚不同队列的真实世界数据仍然有限。本研究旨在了解东亚患者直接作用抗病毒(DAA)治疗的真实世界状况。
从日本、中国台湾、韩国和中国香港的临床中心招募慢性丙型肝炎(CHC)患者,参与 REAL-C 注册研究,这是一项观察性图表审查注册研究。主要结局是持续病毒学应答(SVR12,治疗后 12 周 HCV RNA PCR<25 IU/mL)。
共纳入 6287 例 CHC 患者。与其他东亚患者相比,来自日本的患者年龄更大(66.3 岁比 61.5 岁,p<0.0001),体重指数更低(22.9 kg/m 比 24.6 kg/m,p<0.001),且更有可能有非肝脏恶性肿瘤病史(12.2%比 5.0%,p<0.001)。总体 SVR12 率为 96.4%,与日本内外的患者相似(96.6%比 96%,p=0.21)。除接受达卡他韦/阿舒瑞韦治疗的经治肝硬化 HCV 基因型 1 患者(85.9%)和接受索非布韦/利巴韦林治疗的经治肝硬化 HCV 基因型 2 患者(87%)外,SVR12 率范围为 91.1%至 99.4%。总的停药率为 1.9%,各地区也相似。多变量回归分析显示,地理位置与 SVR 结局之间无显著关联。
在这项来自东亚的大型多国 CHC 队列中,口服 DAA 在整个地区均具有高度疗效和良好耐受性。鉴于亚洲 HCV 负担沉重,政策应鼓励对所有 CHC 患者使用 DAA 进行治疗。