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| 慢性HCV感染DAA应答特点和长期预后观察研究 |
| Slower viral control but similar SVR12 rates with DAA therapy for chronic hepatitis C patients with liver cirrhosis |
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| DOI：10.3969/j.issn.1007-8134.2021.03.003 |
| 中文关键词: 直接抗病毒药物 HCV 慢性丙型肝炎 持续病毒学应答 速率 肝硬化 预测 预后 |
| 英文关键词: direct-acting antiviral agents HCV chronic hepatitis C speed sustained virologic response liver cirrhosis predictor prognosis |
| 基金项目:国家自然科学基金面上项目（81572462）；北京市卫计委首都卫生发展科研专项（2016-2-5031）；国家自然科学基金创新研究群体项目（81721002）；“艾滋病和病毒性肝炎等重大传染病防治”科技重大专项（2017ZX10202201） |
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| 中文摘要: |
| 目的 本研究旨在观察不同疾病进展阶段的HCV感染者直接抗病毒药物（direct-acting antiviral agents, DAA）治疗的应答特点和长期预后。方法 纳入2016年7月—2017年3月就诊于我中心的慢性HCV感染者127例，其中慢性丙型肝炎（chronic hepatitis C, CHC）患者85例，代偿期肝硬化（compensated-liver cirrhosis, CLC）患者32例，失代偿期肝硬化（decompensated-liver cirrhosis, DLC）患者10例。DAA治疗12或24周。比较3组患者HCV RNA转阴时间、停药后12周持续病毒学应答（sustained virologic response 12, SVR12）率以及停药后2年的转归情况。结果 所有CHC、CLC、DLC患者均完成DAA治疗。CHC、CLC和DLC患者的SVR12率分别为98.82%（84/85）、96.88%（31/32）和100%（10/10）；CHC患者HCV RNA转阴时间明显早于CLC和DLC患者（P均＜0.05）。在2年随访期间，1例CLC患者发生病毒学复发，2例DLC患者分别出现肝功能恶化和肝细胞癌。结论 目前常用的DAA治疗方案对CHC、CLC和DLC的患者均有高效的抑制病毒复制的作用，并且SVR12率在96%～100%之间，有很高治愈率。对于肝硬化患者停药后仍须监测肝癌的发生或个别病例HCV复发等情况。 |
| 英文摘要: |
| Objective This study aimed to characterize the virological response on direct-acting antiviral agents (DAA) treatment in chronic hepatitis C (CHC) patients with liver cirrhosis. Methods Eighty-five CHC patients without liver cirrhosis, 32 CHC patients with compensated-liver cirrhosis (CLC), and 10 CHC patients with decompensated-liver cirrhosis (DLC) were enrolled in the study. All patients were administered generic sofosbuvir, ledipasvir-sofosbuvir, or sofosbuvir-daclatasvir with or without 1,000-1,200 mg of ribavirin daily for 12 or 24 weeks, respectively. HCV RNA was detected once a week till undetectable. The efficacy endpoint was sustained virologic response (undetectable HCV RNA) 12 weeks after cessation of treatment (SVR12). Safety and efficacy data were collected. All patients were followed up more than 2 years. Results CHC, CLC and DLC patients achieved undetectable HCV RNA at post-treatment week 1 were 52.94% (45/85), 12.50% (4/32) and 10.00% (1/10), respectively. Kruskal-Wallis H test and Mann-Whitney U test demonstrated that CHC patients had a faster speed of HCV RNA undetectable than CLC and DLC patients (P＜ 0.05). And there was no significant difference for speed of HCV RNA undetectable between CLC and DLC patients. Further analysis found that viral load, genotype of HCV RNA, and HCV treatment experienced with interferon or pegylated-interferon made no difference in speed of viral control. Although the speed of HCV RNA undetectable was different among the groups, the SVR12 rates were similar in CHC, CLC and DLC patients [98.82% (84/85), 96.88% (31/32) and 100% (10/10), respectively]. One CLC patient had viral relapse at 6-month post-treatment, one DLC patient showed liver disfunction, and one DLC patient had hepatocellular carcinoma (HCC) during the 9-month follow-up. Conclusions This study demonstrated that currently DAA regimens are effective and safe among chronic hepatitis C, compensated- and decompensated-liver cirrhosis patients, and SVR rates are as high as 96%-100%, while liver cirrhosis patients require surveillance of HCC and relapse of HCV. |
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