真实世界中艾尔巴韦/格拉瑞韦治疗慢性丙型肝炎的临床效果

刘芳; 梁静; 韩涛; 张亚萍; 吕洪敏; 曹颖颖; 史利利

doi:10.3969/j.issn.1001-5256.2020.10.010

真实世界中艾尔巴韦/格拉瑞韦治疗慢性丙型肝炎的临床效果

DOI: 10.3969/j.issn.1001-5256.2020.10.010

天津市第三中心医院消化肝病科天津市肝胆疾病研究所天津市人工细胞重点实验室

详细信息

中图分类号: R512.63
计量
- 文章访问数: 1295
- HTML全文浏览量: 13
- PDF下载量: 98
- 被引次数: 0
出版历程
- 收稿日期: 2020-03-18
- 出版日期: 2020-10-20

Clinical effect of elbasvir/grazoprevir in treatment of chronic hepatitis C in the real world

Department of Gastroenterology,Tianjin Third Central Hospital & Tianjin Institute of Hepatobiliary Disease & Tianjin Key Laboratory of Artificial Cells

摘要

摘要: 目的观察慢性丙型肝炎基因1b型患者应用艾尔巴韦/格拉瑞韦治疗的临床效果。方法纳入2018年12月至2019年10月在天津市第三中心医院接受12周艾尔巴韦/格拉瑞韦治疗的99例基因1b型慢性丙型肝炎及代偿期肝硬化患者,均完成治疗及12周随访。收集治疗基线、治疗结束及停药后12周临床数据、血清学指标、病毒学指标及肝硬度值,观察慢性丙型肝炎患者病毒学应答的情况,分析治疗结束时及停药后12周病毒学应答率及肝功能、肝硬度变化,评价艾尔巴韦/格拉瑞韦治疗的安全性。多组间比较应用Friedman检验,进一步两两比较应用Wilcoxon符号秩和检验。结果在99例艾尔巴韦/格拉瑞韦治疗12周的患者中治疗结束时及停药后12周HCV RNA低于检测下限比例分别为100%、99%;治疗结束时ALT、AST较基线明显下降（Z值分别为-5.857、-5.941,P值均<0.05）,肝硬度在停药12周明显降低,由基线10.5 k Pa降至8.0 kPa（Z=-4.036,P <0.05）;其中24例代偿期肝硬化患者在治疗结束时、停药后12周的病毒学应答率均达到100%,ALT、AST较基线均明显减低（P...
- 丙型肝炎,慢性 /
- 肝硬化 /
- 抗病毒药
Abstract: Objective To investigate the clinical effect of elbasvir/grazoprevir in the treatment of patients with genotype 1 b chronic hepatitis C( CHC). Methods A total of 99 patients with genotype 1 b CHC and compensated cirrhosis who received elbasvir/grazoprevir treatment for 12 weeks and completed treatment and follow-up for 12 weeks after drug withdrawal in Tianjin Third Central Hospital from December2018 to October 2019 were enrolled. Related clinical data,serological markers,virological indices,and liver stiffness measurement were collected at baseline,at the end of treatment,and at week 12 after drug withdrawal,and virologic response was observed. The Friedman test and Wilcoxon signed rank sum test were used to observe virologic response rate and the changes in liver function and liver stiffness measurement at the end of treatment and at week 12 after drug withdrawal,and the safety of elbasvir/grazoprevir was evaluated. Results For the 99 patients treated with elbasvir/grazoprevir for 12 weeks,the proportion of patients with HCV RNA below the lower limit of detection was100% at the end of treatment and 99% at week 12 after drug withdrawal. There were significant reductions in alanine aminotransferase( ALT) and aspartate aminotransferase( AST) from baseline to the end of treatment( Z =-5. 857 and-5. 941,both P < 0. 05). Liver stiffness measurement decreased from 10. 5 kPa at baseline to 8. 0 kPa at week 12 after drug withdrawal( Z =-4. 036,P < 0. 05). Among the 99 patients,24 patients with compensatory cirrhosis reached a virologic response rate of 100% at the end of treatment and at week 12 after drug withdrawal,as well as significant reductions in ALT and AST from baseline( both P < 0. 05),and liver stiffness measurement decreased from 21. 1 kPa at baseline to 17. 5 k Pa at the end of treatment( Z =-1. 832,P = 0. 067) and 13. 6 k Pa at week 12 after drug withdrawal( Z =-3. 182,P = 0. 001). Compared with the non-liver cirrhosis group,the liver cirrhosis group had significantly greater reductions in liver stiffness measurement( P < 0. 05). The patients had good tolerance throughout the treatment,and 4 patients reported mild adverse events during the treatment. Conclusion Patients with genotype 1 b CHC have a high virologic response rate to elbasvir/grazoprevir in the real world,with significant improvements in liver function and liver stiffness measurement and good tolerance.
- hepatitis C,chronic /
- liver cirrhosis /
- antiviral agents

HTML全文

参考文献(21)

[1] MAO XR,ZHANG LT,JIANG N,et al. Distribution of HCV genotypes in Chinese Han population with chronic hepatitis C[J]. J Zhejiang Univ(Med Sci),2015,44(4):417-422.(in Chinese)毛小荣，张立婷，蒋妮，等．丙型肝炎病毒基因型在中国大陆汉族慢性丙型肝炎患者中的分布特征[J]．浙江大学学报医学版，2015,44(4):417-422.

[2] JU W,YANG S,FENG S,et al. Hepatitis C virus genotype and subtype distribution in Chinese chronic hepatitis C patients:Nationwide spread of HCV genotypes 3 and 6[J]. Virol J,2015,12:109.

[3] WEI L,JIA JD,WANG FS,et al. Efficacy and safety of elbasvir/grazoprevir in participants with hepatitis C virus genotype1,4,or 6 infection from the Asia-Pacific region and Russia:Final results from the randomized C-CORAL study[J]. J Gastroenterol Hepatol,2019,34(1):12-21.

[4] JACOBSON IM,LAWITZ E,KWO PY,et al. Safety and efficacy of Elbasvir/Grazoprevir in patients with hepatitis C virus infection and compensated cirrhosis:An integrated analysis[J]. Gastroenterology,2017,152(6):1372-1382. e2.

[5] KWO P,GANE EJ,PENG CY,et al. Effectiveness of Elbasvir and Grazoprevir combination,with or without Ribavirin, for treatment-experienced patients with chronic hepatitis C infection[J]. Gastroenterology,2017,152(1):164-175. e4.

[6] KRAMER J,PUENPATOM A,ERICKSON K,et al. Real world experience with elbasvir/grazoprevir in the Veterans Affairs healthcare system[J]. J Hepatol,2017,66:Abstract PS-095.

[7] Chinese Society of Hepatology and Chinese Society of Infectious Diseases,Chinese Medical Association. The guideline of prevention and treatment for hepatitis C:A 2015 update[J]. J Clin Hepatol,2015,31(12):1961-1979.(in Chinese)中华医学会肝病学分会，中华医学会感染病学分会．丙型肝炎防治指南(2015年更新版)[J]．临床肝胆病杂志，2015,31(12):1961-1979.

[8] LEE MH,YANG HI,LU SN,et al. Hepatitis C virus seromarkers and subsequent risk of hepatocellular carcinoma:Longterm predictors from a community-based cohort study[J]. J Clin Oncol,2010,28(30):4587-4593.

[9] LEE MH,YANG HI,LU SN,et al. Hepatitis C virus genotype1b increases cumulative lifetime risk of hepatocellular carcinoma[J]. Int J Cancer,2014,135(5):1119-1126.

[10] WEI L,KUMADA H,PERUMALSWAMI PV,et al. Safety and efficacy of elbasvir/grazoprevir in Asian participants with hepatitis C virus genotypes 1 and 4 infection[J]. J Gastroenterol Hepatol,2019,34(9):1597-1603.

[11] KUMADA H,SUZUKI Y,KARINO Y,et al. The combination of elbasvir and grazoprevir for the treatment of chronic HCV infection in Japanese patients:A randomized phase II/III study[J]. J Gastroenterol,2017,52(4):520-533.

[12] OMRAN D,ZAYED RA,NABEEL MM,et al. Evaluating diagnostic accuracy of noninvasive tests in assessment of significant liver fibrosis in chronic hepatitis C egyptian patients[J].Viral Immunol,2018,31(4):315-320.

[13] MUELLER S,ENGLERT S,SEITZ HK,et al. Inflammationadapted liver stiffness values for improved fibrosis staging in patients with hepatitis C virus and alcoholic liver disease[J].Liver Int,2015,35(12):2514-2521.

[14] PONS M,SANTOS B,SIMN-TALERO M,et al. Rapid liver and spleen stiffness improvement in compensated advanced chronic liver disease patients treated with oral antivirals[J].Therap Adv Gastroenterol,2017,10(8):619-629.

[15] KNOP V,MAUSS S,GOESER T,et al. Dynamics of liver stiffness by transient elastography in patients with chronic hepatitis C virus infection receiving direct-acting antiviral therapy-Results from the German Hepatitis C-Registry[J]. J Viral Hepat,2020,27(7):690-698.

[16] KOHLA M,FAYOUMI AE,AKL M,et al. Early fibrosis regression by shear wave elastography after successful direct-acting antiHCV therapy[J]. Clin Exp Med,2020,20(1):143-148.

[17] ATTIA D,DETERDING K,CORNBERG J,et al. Different kinetics of liver stiffness using shear wave elastography in patients with chronic hepatitis C infection treated with interferon-free regimens[J]. Eur J Gastroenterol Hepatol,2019,31(1):67-74.

[18] TADA T,KUMADA T,TOYODA H,et al. Improvement of liver stiffness in patients with hepatitis C virus infection who received direct-acting antiviral therapy and achieved sustained virological response[J]. J Gastroenterol Hepatol,2017,32(12):1982-1988.

[19] KANDA T,LAU G,WEI L,et al. APASL clinical practice recommendation:How to treat HCV-infected patients with renal impairment?[J]. Hepatol Int,2019,13(2):103-109.

[20] LENS S,RODRIGUEZ S,LLOVET L,et al. Treating hepatitis C in patients with renal failure[J]. Dig Dis,2017,35:339-346.

[21] ATSUKAWA M,TSUBOTA A,TOYODA H,et al. Efficacy and safety of elbasvir/grazoprevir for Japanese patients with genotype 1b chronic hepatitis C complicated by chronic kidney disease,including those undergoing hemodialysis:A post hoc analysis of a multicenter study[J]. J Gastroenterol Hepatol,2019,34(2):364-369.

施引文献

资源附件(0)

访问统计