真实世界中不同ALT、AST水平慢性丙型肝炎患者对直接抗病毒药物治疗的病毒学应答及肝纤维化指标变化情况

Virological response to direct-acting antiviral therapy and changes in liver fibrosis indices in chronic hepatitis C patients with different alanine aminotransferase and aspartate aminotransferase levels in a real-world setting

目的探讨真实世界中不同ALT、AST水平的慢性丙型肝炎患者对直接抗病毒药物(DAA)治疗的病毒学应答,以及治疗后肝硬度测定(LSM)值、4项因素的肝纤维化指数(FIB-4)和AST/PLT比值指数(APRI)的变化情况。方法纳入2017年12月—2020年5月在北京大学第一医院感染疾病科门诊就诊的慢性丙型肝炎患者,计算患者治疗病毒学应答率。采用Wilcoxon秩和检验对比不同组间基线及治疗结束第12周LSM、FIB-4和APRI的变化;计数资料组间比较采用χ2检验。结果共纳入48例慢性丙型肝炎患者,其中基线ALT或AST出现异常的患者为33.3%。所有患者DAA治疗第4周病毒学应答率为85.4%,治疗结束时、治疗结束12、24、48周均为100%;治疗结束第12周较基线LSM[6.1(5.1~12.4)kPa vs 8.6(5.7~16.9)kPa,Z=-1.676,P=0.043]、APRI[0.24(0.19~0.48)vs 0.42(0.23~1.17),Z=-2.050,P=0.027]差异有统计学意义。ALT或AST异常的患者治疗结束12周与基线LSM[8.9(5.6~13.1)kPa vs 14.4(8.0~28.2)kPa,Z=-1.679,P=0.047]、APRI[0.44(0.25~0.50)vs 1.29(0.99~2.09),Z=-3.427,P=0.001]差异有统计学意义。结论慢性丙型肝炎患者DAA治疗后持续病毒学应答率高,基线ALT或AST有异常较无异常的患者在治疗后LSM及APRI改善更明显。

Objective To investigate the virologic response to direct-acting antiviral(DAA)therapy and the changes in liver stiffness measurement(LSM),fibrosis-4(FIB-4),and aspartate aminotransferase-to-platelet ratio index(APRI)after treatment in chronic hepatitis C(CHC)patients with different alanine aminotransferase(ALT)and aspartate aminotransferase(AST)levels at baseline in a real-world setting.Methods CHC patients who attended the outpatient service of Department of Infectious Diseases,Peking University First Hospital,from December 2017 to May 2020 were enrolled,and virologic response rate was calculated.The Wilcoxon rank-sum test was used to compare LSM,FIB-4,and APRI between groups at baseline and at 12 weeks after treatment,and the chi-square test was used for comparison of categorical data between groups.Results A total of 48 CHC patients were enrolled,among whom 33.3%had abnormal ALT or AST at baseline.Among these patients,the virologic response rate was 85.4%at week 4 of treatment and 100%at the end of treatment and at 12,24,and 48 weeks after treatment,and there were significant changes from baseline to 12 weeks after treatment in LSM[6.1(5.1-12.4)kPa vs 8.6(5.7-16.9)kPa,Z=-1.676,P=0.043]and APRI[0.24(0.19-0.48)vs 0.42(0.23-1.17),Z=-2.050,P=0.027].From baseline to 12 weeks after treatment,the patients with abnormal ALT or AST at baseline had significant changes in LSM[8.9(5.6-13.1)kPa vs 14.4(8.0-28.2)kPa,Z=-1.679,P=0.047]and APRI[0.44(0.25-0.50)vs 1.29(0.99-2.09),Z=-3.427,P=0.001].Conclusion CHC patients achieve a high sustained virologic response rate after DAA therapy,and the patients with abnormal ALT or AST at baseline tend to have more significant improvements in LSM and APRI than those without such abnormality.