艾尔巴韦格拉瑞韦与索磷布韦维帕他韦治疗丙型肝炎的成本-效果分析
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摘要
目的评价艾尔巴韦格拉瑞韦片(EBR/GZR)与索磷布韦维帕他韦片(SOF/VEL)治疗中国人群基因1型(GT1慢性丙型肝炎(CHC)的经济学。方法构建Markov模型估计两种方案的患者终身成本和所获得效用,进行成本-效果分析,并对基础分析结果进行敏感性分析。结果相比SOF/VEL,EBR/GZR对于无肝硬化患者(13.844 2 QALYs vs. 13.782 9QALYs, 82 199.8元vs. 94 470.4元)和肝硬化患者(12.668 7 QALYs vs. 12.557 1 QALYs, 230 026.4元vs. 242 784.5元)均效用更高、成本更低,具有经济学优势。结论对于中国GT 1型CHC患者,不论是否合并肝硬化,基于真实世界研究中的SVR,EBR/GZR方案相对于SOF/VEL方案的经济学更优。
Objectives To conduct cost-effectiveness analysis of elbasvir/grazoprevir(EBR/GZR) versus sofosbuvir/velpatasvir(SOF/VEL) in Chinese hepatitis C patients with genotype 1 infection. Methods Markov cohort state-transition model was performed to conduct cost-effectiveness analysis. Sensitivity analysis was conducted based on base-case analysis. Results EBR/GZR showed higher QALYs and lower costs for noncirrhotic patients(13.8442 QALYs vs 13.7829 QALYs, 82 199.8 RMB vs94 470.4 RMB) and cirrhotic patients(12.6687 QALYs vs 12.5571 QALYs, 230 026.4 RMB vs 242 784.5 RMB) compared with SOF/VEL. Conclusions EBR/GZR regimen was more economic in noncirrhotic and cirrhotic patients compared with SOF/VEL for Chinese patients with hepatitis C virus genotype 1 infection when using the real-world SVR.
Objectives To conduct cost-effectiveness analysis of elbasvir/grazoprevir(EBR/GZR) versus sofosbuvir/velpatasvir(SOF/VEL) in Chinese hepatitis C patients with genotype 1 infection. Methods Markov cohort state-transition model was performed to conduct cost-effectiveness analysis. Sensitivity analysis was conducted based on base-case analysis. Results EBR/GZR showed higher QALYs and lower costs for noncirrhotic patients(13.8442 QALYs vs 13.7829 QALYs, 82 199.8 RMB vs94 470.4 RMB) and cirrhotic patients(12.6687 QALYs vs 12.5571 QALYs, 230 026.4 RMB vs 242 784.5 RMB) compared with SOF/VEL. Conclusions EBR/GZR regimen was more economic in noncirrhotic and cirrhotic patients compared with SOF/VEL for Chinese patients with hepatitis C virus genotype 1 infection when using the real-world SVR.
引文
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[18]Chen GF,Wei L,Chen J,et al.Will Sofosbuvir/Ledipasvir(Harvoni)Be Cost-Effective and Affordable for Chinese Patients Infected with Hepatitis C Virus?An Economic Analysis Using Real-World Data[J].PLoS One,2016,11(6):e155934.
[19]Wei L,Hu S,Hou J,et al.A Novel Estimation of the Impact of Treatment with Entecavir on Long-Term Mortality,Morbidity,and Health Care Costs of Chronic Hepatitis B in China[J].Value Health Reg Issues,2013,2(1):48-56.
[20]Thein HH,Yi Q,Dore GJ,et al.Estimation of stage-specific fibrosis progression rates in chronic hepatitis C virus infection:A metaanalysis and meta-regression[J].Hepatology,2008,48(2):418-431.
[21]Fattovich G,Giustina G,Degos F,et al.Morbidity and mortality in compensated cirrhosis type C:a retrospective follow-up study of384 patients[J].Gastroenterology,1997,112(2):463-472.
[22]van der Meer AJ,Veldt BJ,Feld JJ,et al.Association Between Sustained Virological Response and All-Cause Mortality Among Patients With Chronic Hepatitis C and Advanced Hepatic Fibrosis[J].JAMA,2012,308(24):2584-2593.
[23]Morgan RL1,Baack B,Smith BD,et al.Eradication of hepatitis C virus infection and the development of hepatocellular carcinoma:a meta-analysis of observational studies[J].Ann Intern Med,2013,158(5 Pt 1):329-337.
[24]D'Ambrosio R,Aghemo A,Rumi MG,et al.A morphometric and immunohistochemical study to assess the benefit of a sustained virological response in hepatitis C virus patients with cirrhosis[J].Hepatology,2012,56(2):532-543.
[25]Townsend R,McEwan P,Kim R,et al.Structural Frameworks and Key Model Parameters in Cost-Effectiveness Analyses for Current and Future Treatments of Chronic Hepatitis C[J].Value Health,2011,14(8):1068-1077.
[26]Thein HH,Krahn M,Kaldor JM,et al.Estimation of Utilities for Chronic Hepatitis C from SF-36 Scores[J].Am J Gastroenterol,2005,100(3):643-651.
[27]Levy AR,Kowdley KV,Iloeje U,et al.The impact of chronic hepatitis B on quality of life:a multinational study of utilities from infected and uninfected persons[J].Value Health,2008,11(3):527-538.
[2]疾病预防控制局.2018年全国法定传染病疫情概况[EB/OL].(2019-4-24)[2019-4-25].http://www.nhc.gov.cn/jkj/s3578/201904/050427ff32704a5db64f4ae1f6d57c6c.shtml.
[3]Kenny-Walsh E.Clinical outcomes after hepatitis C infection from contaminated anti-D immune globulin.Irish Hepatology Research Group[J].N Engl J Med,1999,340(16):1228-1233.
[4]Freeman AJ,Dore GJ,Law MG,et al.Estimating progression to cirrhosis in chronic hepatitis C virus infection[J].Hepatology,2001,34(4 pt 1):809-816.
[5]Li JF,Liu S,Ren F,et al.Fibrosis progression in interferon treatment-naive Chinese plasma donors with chronic hepatitis C for20 years:a cohort study[J].Int J Infect Dis,2014(27):49-53.
[6]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更新版)[J].中华传染病杂志,2015,33(12):705-724.
[7]陈平钰,李洪超,马爱霞.艾尔巴韦/格拉瑞韦片治疗基因1b型慢性丙型肝炎的经济学评价[J].中国循证医学杂志,2018,18(12):1352-1358.
[8]Chen PY,Liu Q,Li HC,et al.Cost-Effectiveness of Elbasvir/Grazoprevir Versus Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir(3D Regimen)for Treatment of Chronic Hepatitis C Genotype 1BPatients in China[J].Value in Health,2018,21:S64.
[9]Ahmed H,Abushouk AI,Menshawy A,et al.Meta-analysis of grazoprevir plus elbasvir for treatment of hepatitis C virus genotype 1infection[J].Ann Hepatol,2018,17(1):18-32.
[10]Ahmed H,Abushouk AI,Attia A,et al.Safety and efficacy of sofosbuvir plus velpatasvir with or without ribavirin for chronic hepatitis C virus infection:A systematic review and meta-analysis[J].J Infect Public Health,2018,11(2):156-164.
[11]Milligan S,Khalili M,Fagiuoli S,et al.Global real-world evidence of sofosbuvir/velpatasvir as a simple,effective regimen for the treatment of chronic hepatitis C:Integrated analysis of 12 clinical practice cohorts[C].Vienna:European Association for the Study of the Liver's 54th Annual International Liver Congress,10-14 April 2019.
[12]Tsai N,Bacon B,Curry M,et al.Utilization of DAA therapies ledipasvir/sofosbuvir and sofosbuvir/velpatasvir in patients with genotype 1 HCV:real-world experience from the TRIO network[C].Amsterdam:The International Liver Congress EASL 2017-European Association for the Study of the Liver,2017.
[13]Hernández‐Conde M,Fernández I,PerellóC,et al.Effectiveness and safety of elbasvir/grazoprevir therapy in patients with chronic HCV infection:Results from the Spanish HEPA‐C real‐world cohort[J].J Viral Hepat,2019,26(1):55-64.
[14]Hinrichsen H,Klinker H,Stoehr A,et al.Effectiveness of Elbasvir/Grazoprevir(EBR/GZR)in Genotype 1(GT1)Infected Patients with and without Liver Cirrhosis in German Real-World:Results from the German Hepatitis C Registry(DHC-R)[C].Paris:The International Liver Congress EASL-European Association for the Study of the Liver,2018.
[15]Ogawa E,Furusyo N,Azuma K,et al.Elbasvir plus grazoprevir for patients with chronic hepatitis C genotype 1:A multicenter,real-world cohort study focusing on chronic kidney disease[J].Antiviral Res,2018(159):143-152.
[16]Nwankwo C,Bacon B,Curry MP,et al.Impact of treatment duration and ribavirin(RBV)addition on real-world effectiveness of elbasvir/grazoprevir(EBR/GZR)in select patient subgroups with Genotype 1(GT1)Chronic Hepatitis C(HCV):Retrospective data analyses from the Trio Network.Hepatology[C].Washington DC:The Liver Meeting,2017.
[17]Flamm SL,Bacon B,Curry MP,et al.Real-world use of elbasvir‐grazoprevir in patients with chronic hepatitis C:retrospective analyses from the TRIO network[J].Aliment pharmacol Ther,2018,47(11):1511-1522.
[18]Chen GF,Wei L,Chen J,et al.Will Sofosbuvir/Ledipasvir(Harvoni)Be Cost-Effective and Affordable for Chinese Patients Infected with Hepatitis C Virus?An Economic Analysis Using Real-World Data[J].PLoS One,2016,11(6):e155934.
[19]Wei L,Hu S,Hou J,et al.A Novel Estimation of the Impact of Treatment with Entecavir on Long-Term Mortality,Morbidity,and Health Care Costs of Chronic Hepatitis B in China[J].Value Health Reg Issues,2013,2(1):48-56.
[20]Thein HH,Yi Q,Dore GJ,et al.Estimation of stage-specific fibrosis progression rates in chronic hepatitis C virus infection:A metaanalysis and meta-regression[J].Hepatology,2008,48(2):418-431.
[21]Fattovich G,Giustina G,Degos F,et al.Morbidity and mortality in compensated cirrhosis type C:a retrospective follow-up study of384 patients[J].Gastroenterology,1997,112(2):463-472.
[22]van der Meer AJ,Veldt BJ,Feld JJ,et al.Association Between Sustained Virological Response and All-Cause Mortality Among Patients With Chronic Hepatitis C and Advanced Hepatic Fibrosis[J].JAMA,2012,308(24):2584-2593.
[23]Morgan RL1,Baack B,Smith BD,et al.Eradication of hepatitis C virus infection and the development of hepatocellular carcinoma:a meta-analysis of observational studies[J].Ann Intern Med,2013,158(5 Pt 1):329-337.
[24]D'Ambrosio R,Aghemo A,Rumi MG,et al.A morphometric and immunohistochemical study to assess the benefit of a sustained virological response in hepatitis C virus patients with cirrhosis[J].Hepatology,2012,56(2):532-543.
[25]Townsend R,McEwan P,Kim R,et al.Structural Frameworks and Key Model Parameters in Cost-Effectiveness Analyses for Current and Future Treatments of Chronic Hepatitis C[J].Value Health,2011,14(8):1068-1077.
[26]Thein HH,Krahn M,Kaldor JM,et al.Estimation of Utilities for Chronic Hepatitis C from SF-36 Scores[J].Am J Gastroenterol,2005,100(3):643-651.
[27]Levy AR,Kowdley KV,Iloeje U,et al.The impact of chronic hepatitis B on quality of life:a multinational study of utilities from infected and uninfected persons[J].Value Health,2008,11(3):527-538.