摘要
背景慢性丙型肝炎(chronic hepatitis C,CHC)是全球公共卫生问题,随着直接抗病毒药(direct antiviral therapy,DAA)在中国的应用,DAA药物成为目前国内慢性丙型肝炎抗病毒一线方案,但目前真实世界DAA治疗后长期疗效数据尚少.目的观察慢性丙型肝炎患者接受直接抗病毒药物抗病毒治疗后48 wk病毒学应答及临床疗效.方法连续收集2018-04-01/2020-04-30在天津市第三中心医院接受DAA治疗的初治CHC患者,评估治疗基线、治疗结束、治疗后12 wk及48 wk的病毒学应答及肝肾功能、肝硬度、APRI及临床结局.结果共收集291例应用DAA治疗的CHC患者,纳入145例完成抗病毒治疗及随访的CHC患者进入本研究.其中肝硬化患者占28.3%,基因型1b、2a、3a、6a分别占78.0%、17.2%、2.8%、2.0%.DAA治疗结束、治疗后12 wk及48 wk获得持续病毒学应答(sustained virological response,SVR)比例分别为100%、97.9%和97.2%,其中基因型1b、2a、3a、6a的SVR48分别为97.3%、96%、100%、100%.治疗结束后48 wk与基线相比较,丙氨酸氨基转移酶、天冬氨酸氨基转移酶、总胆红素及白蛋白的复常率分别为93.2%、91.7%、73.3%及97.7%.治疗结束后48 wk肝硬度(liver stiffness measurement,LSM)及APRI与基线水平相比均明显下降(LSM 12.5 vs 10.2kpa P<0.01;APRI 0.34 vs 0.13 P<0.01),肝硬化组及非肝硬化组患者均有明显下降(P<0.05).48 wk随访期间,其中4例(2.8%)CHC患者进展为肝硬化,8例(5.6%)肝硬化患者进展为肝硬化失代偿,3例(2.1%)肝硬化患者发生新发肝细胞癌(hepatocellular carcinoma,HCC).结论本研究真实世界中慢性丙型肝炎患者应用DAA治疗后48 wk,总体病毒持续应答率较高,肝功能、肝硬度及APRI值均明显改善.2.1%患者出现新发HCC.
BACKGROUND Chronic hepatitis C is a global public health problem.With the application of direct acting antiviral(DAA)drugs in China,DAA therapy has become the first-line antiviral regimen for chronic hepatitis C(CHC)in China.However,there is a lack of real-world long-term efficacy data after DAA treatment.AIM To observe the virological response and clinical efficacy of DAA therapy in patients with CHC.METHODS Patients with newly diagnosed chronic hepatitis C who received DAA treatment at Tianjin Third Central Hospital from April 1,2018 to April 30,2020 were collected continu-ously.The virological response,liver function,creatinine,liver stiffness,aspartate aminotransferase(AST)-platelet ratio index(APRI),and clinical outcomes were evaluated at baseline,12 and 48 wk after treatment,and the end of treatment.RESULTS A total of 291 patients with CHC treated with DAA were collected,of whom 145 completed antiviral therapy and were followed for 48 wk.The patients with liver cirrhosis accounted for 28.3%,and those infected by genotypes 1b,2a,3a,and 6A accounted for 78.0%,17.2%,2.8%,and 2.0%,respectively.The proportion of patients with sustained virological response(SVR)was 97.9%,97.2%,and 100%at 12 and 48-week after treatment and at the end of DAA treatment,respectively.The SVR at 48 wk in patients infected by genotypes 1b,2a,3a,and 6A was 97.3%,96%,100%,and 100%,respectively.Compared with baseline values,the normalization rates of alanine aminotransferase(ALT),AST,total bilirubin(TBIL),and albumin(ALB)were 93.2%,91.7%,73.3%,and 97.7%,respectively.After 48 wk of treatment,liver stiffness(LSM)and APRI were significantly decreased compared with baseline values(LSM:12.5 kpa vs 10.2 kpa,P<0.01;APRI:0.34 vs 0.13,P<0.01),and decreased significantly in both the cirrhotic group and non-cirrhotic group(P<0.05).During the 48-wk follow-up period,four(2.8%)patients with CHC progressed to cirrhosis,eight(5.6%)with cirrhosis progressed to decompensated cirrhosis,and three(2.1%)with cirrhosis developed hepatocellular carcinoma(HCC).CONCLUSION The overall SVR rate to 48 wk of DAA treatment in patients with chronic hepatitis C in the real world is higher,and liver function,liver stiffness,and APRI value can be significantly improved.A small portion of patients may develop HCC.
作者
刘刚
刘芳
向慧玲
张亚苹
史利利
叶青
吕洪敏
梁静
Gang Liu;Fang Liu;Hui-Ling Xiang;Ya-Ping Zhang;Li-Li Shi;Qing Ye;Hong-Min Lv;Jing Liang(Department of Gastroenterology,Tianjin Nankai District Santan Hospital,Tianjin 300190,China,The Third Central Clinical College of Tianjin Medical University,Tianjin 300170,China;Department of Hepatology,The Third Central Clinical College of Tianjin Medical University,,Tianjin Third Central Hospital,Tianjin 300170,China)
出处
《世界华人消化杂志》
CAS
2022年第1期49-55,共7页
World Chinese Journal of Digestology
关键词
慢性丙型肝炎
直接抗病毒药
病毒应答率
肝硬度
Chronic hepatitis C
Direct acting antiviral drugs
Sustained virus response rate
Liver stiffness
