肝脏 ›› 2018, Vol. 23 ›› Issue (7): 587-590.

• 论 著 • 上一篇    下一篇

索非布韦/达拉他韦加利巴韦林治疗丙型肝炎肝硬化的疗效及安全性

刘立, 李俊义, 杜映荣, 刘春云, 李卫昆, 王辉, 李惠敏, 常丽仙, 祁燕伟   

  1. 650041 昆明市第三人民医院肝三科
  • 收稿日期:2018-02-10 发布日期:2020-04-28
  • 通讯作者: 刘立,Email:liuli197210@163.com
  • 作者简介:共同第一作者:李俊义,杜映英,刘春云

Efficacy and safety of sofosbuvir / daclatasvir with ribavirin in the treatment of hepatitis C cirrhosis: a real-world study

LIU Li, LI Jun-yi, DU Ying-rong, LIU Chun-yun, LI Wei-kun, WANG Hui, LI Hui-min, CHANG Li-xian, QI Yan-wei   

  1. Department of Liver Disease, the Third People's Hospital of Kunming, Yunnan 650041, China
  • Received:2018-02-10 Published:2020-04-28

摘要: 目的 观察索非布韦/达拉他韦加利巴韦林治疗丙型肝炎肝硬化患者的疗效和安全性。方法 纳入2016年5月至2017年5月就诊于昆明市第三人民医院肝病科的丙型肝炎肝硬化患者129例,给予索非布韦/达拉他韦加利巴韦林抗病毒治疗12周,治疗后随访12周,观察治疗结束12周后持续性病毒学应答(SVR12)、生化学应答、肝纤维化改善和治疗期间的不良反应。结果 129例患者HCV RNA基线水平为(5.91±1.33) lgIU/mL,治疗2周时为(1.67±1.24) lgIU/mL,治疗2周75.78%患者HCV RNA达到检测下限;治疗12周时93.44%患者HCV RNA检测不到。129例患者基线的FibroScan值为(17.57±9.86);治疗12周时的FibroScan值为(8.32±1.47) kPa(与基线相比,t=15.852,P=0.000);TBil、ALT、AST基线时分别为(24.07±18.12) μmol/L、(91.42±54.56) U/L和(81.06±40.45) U/L,治疗2周时TBil、ALT、AST均显著下降(t=2.408,P=0.017;t=11.054,P=0.000;t=12.227,P=0.000),生化学应答达100%。6例未取得SVR12的患者多因素回归分析显示,复治是独立预测因子。主要不良反应为乏力和头痛,无严重不良反应发生。结论 丙型肝炎肝硬化患者索非布韦/达拉他韦加利巴韦林方案可获得较高的SVR12率和生化学应答率,肝纤维化改善明显,且具有良好的安全性。

关键词: 丙型肝炎肝硬化, 抗病毒药, 治疗

Abstract: Objective To observe the efficacy and safety of sofosbuvir / daclatasvir with ribavirin in the treatment of hepatitis C cirrhosis. Methods From May 2016 to May 2017 in our hospital, there were 129 patients with hepatitis C cirrhosis receiving 12-week sofosbuvir / daclatasvir with ribavirin therapy. Patients were followed up for 12 weeks after antiviral treatment, and sustained virologic response at week 12 post-treatment (SVR12), biochemical response, improvement of hepatic fibrosis and adverse reactions during treatment were observed. Results HCV RNA of the 129 patients was (5.9±1.33) lgIU/mL at baseline and (1.67±1.24) lgIU/mL after 2-week treatment. Among the patients, HCV RNA was undetectable in 75.78% patients after 2-week treatment and in 93.44% patients after 12-week treatment. FibroScan measurement of the patients was (17.57±9.86) at baseline and decreased to (8.32±1.47) at week 12 (t=15.852, P=0.000). Serum levels of total bilirubin (TBil), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were significantly decreased at week 2 compared to those at baseline, respectively (t=2.408, P=0.017; t=11.054, P=0.000; t=12.227, P=0.000). Besides, biochemical response reached 100%. Multivariate regression analysis of 6 patients without SVR12 showed that retreatment was an independent predictor. No serious adverse reactions occurred with fatigue and headache being the main adverse reactions. Conclusion The patients with hepatitis C cirrhosis who received sofosbuvir / daclatasvir with ribavirin therapy achieved very high SVR12 rate, high biochemical response rate and significant improvement of liver fibrosis with good safety.

Key words: Hepatitis C cirrhosis, Antiviral drugs, Treatment