艾尔巴韦/格拉瑞韦治疗基因1型慢性丙型肝炎效果的真实世界研究

夏阳; 黄晶; 吴树铎; 李剑萍; 陈文莉; 谢志伟; 关玉娟

doi:10.3969/j.issn.1001-5256.2020.12.012

艾尔巴韦/格拉瑞韦治疗基因1型慢性丙型肝炎效果的真实世界研究

DOI: 10.3969/j.issn.1001-5256.2020.12.012

1. 广州医科大学附属市八人民医院
2. 广东省人民医院感染科
3. 广东省中医院肝病科

基金项目:

白求恩医学研究基金资助项目（SG066DS）；

详细信息

中图分类号: R512.63
计量
- 文章访问数: 4458
- HTML全文浏览量: 100
- PDF下载量: 115
- 被引次数: 0
出版历程
- 收稿日期: 2020-06-02
- 出版日期: 2020-12-20

Efficacy of elbasvir/grazoprevir in treatment of genotype 1 chronic hepatitis C: A real-world study

Department of Hepatology,Guangzhou Eighth People's Hospital,Guangzhou Medical University
Department of Infectious Diseases,Guangdong General Hospital
Department of Hepatology,Guangdong Provincial Hospital of Traditional Chinese Medicine

Research funding:

摘要

摘要:
目的评估艾尔巴韦/格拉瑞韦在丙型肝炎基因1型患者真实世界中的疗效和安全性。方法选取2018年8月-2019年3月就诊于广州市第八人民医院、广东省中医医院、广东省人民医院接受艾尔巴韦/格拉瑞韦治疗的丙型肝炎患者35例,治疗12周,停药后随访12周。观察停药后12周持续病毒学应答（SVR12）、生化学应答和治疗随访期间的不良事件发生率。非正态分布的计量资料组间比较采用Kruskal-Wallis H检验,组内进一步两两比较采用Mann-Whitney U检验;计数资料的组间比较采用χ2检验。采用logistic回归分析探讨影响丙型肝炎病毒学应答的危险因素。结果 35例HCV患者中97. 1%（34/35）为HCV基因1b型,2. 9%（1/35）为HCV基因1a型,28例（80. 0%）为慢性丙型肝炎非肝硬化患者,7例（20. 0%）为代偿期肝硬化患者。治疗结束时的病毒应答率为100%（28/28）,SVR12率为94. 74%（18/19）。另外,年龄、性别、HCV RNA基线载量、初治或经治、是否存在肝硬化、肾功能情况、是否合并其他疾病均不影响疗效（P值均> 0. 05）。患者的...
- 丙型肝炎,慢性 /
- 抗病毒药 /
- 治疗学
Abstract:
Objective To investigate the efficacy and safety of elbasvir/grazoprevir in patients with genotype 1 hepatitis C in the real world.Methods A total of 35 patients with hepatitis C who received elbasvir/grazoprevir treatment in Guangzhou Eighth People's Hospital,Guangdong Provincial Hospital of Traditional Chinese Medicine,and Guangdong General Hospital from August 2018 to March 2019 were enrolled,treated for 12 weeks,and then followed up for 12 weeks after drug withdrawal. The patients were observed in terms of sustained virologic response at week 12 after drug withdrawal( SVR12),biochemical response,and incidence rate of adverse events during treatment and follow-up. The Kruskal-Wallis H test was used for comparison of non-normally distributed continuous data between groups,and the Mann-Whitney U test was used for further comparison between two groups; the chi-square test was used for comparison of categorical data between groups. A logistic regression analysis was used to investigate the risk factors for virologic response in patients with hepatitis C.Results Among the 35 patients with HCV infection,97. 1%( 34/35) had genotype 1 b HCV and 2. 9%( 1/35) had genotype 1 a HCV; of all patients,28( 80%) were non-cirrhotic patients with chronic hepatitis C and 7( 20%) had compensated liver cirrhosis. At the end of treatment,the virologic response rate of 100%( 28/28) and SVR12 was 94. 74%( 18/19). In addition,age,sex,baseline HCV RNA load,previous treatment history,presence or absence of liver cirrhosis,renal function,and presence or absence of other diseases did not affect the treatment outcome( all P > 0. 05). There were significant changes in the levels of alanine aminotransferase,aspartate aminotransferase,gamma-glutamyl transpeptidase,and albumin from baseline to the end of 12-week treatment( Z =-7. 131,-6. 797,-3. 060,and-2. 875,all P < 0. 05). No patient experienced drug withdrawal during treatment. Conclusion This study confirms that elbasvir/grazoprevir has good efficacy and safety in the treatment of hepatitis C in domestic real-world studies.
- hepatitis C,chronic /
- antiviral agents /
- therapeutics

HTML全文

参考文献(21)

[1] WANG X,GAO F,YUAN G,et al. Ten-year follow-up analysis of chronic hepatitis C patients after getting sustained virological response to pegylated interferon-αand ribavirin therapy[J]. J Viral Hepat,2016,23(12):971-976.

[2] 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.

[3] YOO ER,PERUMPAIL RB,CHOLANKERIL G,et al. expanding treatment access for chronic hepatitis C with task-shifting in the era of direct-acting antivirals[J]. J Clin Transl Hepatol,2017,5(2):130-133.

[4] WEI L,WANG FS,ZHANG MX,et al. Daclatasvir plus asunaprevir in treatment-nave patients with hepatitis C virus genotype 1b infection[J]. World J Gastroenterol,2018,24(12):1361-1372.

[5] HAYES CN,IMAMURA M,CHAYAMA K. The practical management of chronic hepatitis C infection in Japan-dual therapy of daclatasvir+asunaprevir[J]. Expert Rev Gastroenterol Hepatol,2017,11(2):103-113.

[6] MORIO K,IMAMURA M,KAWAKAMI Y,et al. Real-world efficacy and safety of daclatasvir and asunaprevir therapy for hepatitis C virus-infected cirrhosis patients[J]. J Gastroenterol Hepatol,2017,32(3):645-650.

[7] World Health Organization. Guidelines for the screening care and treatment of persons with chronic hepatitis C infection:Updated version[R]. Geneva:World Health Organization,2016.

[8] ZEUZEM S,GHALIB R,REDDY KR,et al. Grazoprevir-elbasvir combination therapy for treatment-naive cirrhotic and noncirrhotic patients with chronic hepatitis C virus genotype 1,4,or 6 infection:A randomized trial[J]. Ann Intern Med,2015,163(1):1-13.

[9] MANNS MP,von HAHN T. Novel therapies for hepatitis C-one pill fits all?[J]. Nat Rev Drug Discov,2013,12(8):595-610.

[10] 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.

[11] SOKOLR R. Sofosbuvir/velpatasvir(Epclusa)for hepatitis C[J]. Am Fam Physician,2017,95(10):664-666.

[12] ROTH D,NELSON DR,BRUCHFELD A,et al. Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease(the C-SURFER study):A combination phase 3study[J]. Lancet,2015,386(10003):1537-1545.

[13] 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.

[14] 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.

[15] LYNCH SM,WU GY. Hepatitis C virus:A review of treatment guidelines,cost-effectiveness,and access to therapy[J]. J Clin Transl Hepatol,2016,4(4):310-319.

[16] ROTH D,NELSON DR,BRUCHFELD A,et al. Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4-5 chronic kidney disease(the C-SURFER study):A combination phase 3study[J]. Lancet,2015,386(10003):1537-1545.

[17] REDDY KR,ROTH D,BRUCHFELD A,et al. Elbasvir/grazoprevir does not worsen renal function in patients with hepatitis C virus infection and pre-existing renal disease[J]. Hepatol Res,2017,47(12):1340-1345.

[18] ELBAZ T,EL-KASSAS M,ESMAT G. New era for management of chronic hepatitis C virus using direct antiviral agents:A review[J]. J Adv Res,2015,6(3):301-310.

[19] DUSHEIKO GM,MANNS MP,VIERLING JM. Safety and tolerability of elbasvir/grazoprevir in patients with chronic hepatitis C(HCV)infection:Integrated analysis of phase 2-3 trials[J]. Hepatology,2015,62(Suppl 1):562A.

[20] CURRY MP,O’LEARY JG,BZOWEJ N,et al. Sofosbuvir and vel-patasvir for HCV in patients with decompensated cirrhosis[J]. N Engl J Med,2015,373(27):2618-2628.

[21] TSAI TC,DENG ST,HSU CW. The efficacy and safety of elbasvir/grazoprevir treatment in HCV genotype 1 patients in Taiwan[J]. J Med Virol,2020,92(2):219-226.

施引文献

资源附件(0)

访问统计