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

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

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。

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.