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1、Cost-effectiveness of Nucleoside Analogs Therapy for Hepatitis B: Markov cohort analyses in ChinaBin Wu 1, Jinfang Shen1,21Department of Pharmacy, Renji Hospital, affliated to School of Medicine, Shanghai Jiaotong University, Shanghai, China.2Address correspondence to: Prof. Jinfang Shen, Department
2、 of Pharmacy, Renji Hospital, affliated to School of Medicine, Shanghai Jiaotong University, Dongfang Road 1600, Shanghai, China. Email: sjfsjtuyahoo This work was supported by the grant from Ministry of Science and Technology of the Peoples Republic of China (NO.2008ZX09312-007)ABSTRACTObjectives:
3、Chronic hepatitis B (CHB) resulted in heavy financial burden in China because of the 112 million people infected with hepatitis B. Current guidelines (ie, by AASLD, EASL and APASL) do not take into account the cost-effectiveness of nucleoside analogs therapy for Hepatitis B, several economic studies
4、 were conducted by the researchers from North America or Western Europe. The main purpose of the current study is to investigate the economic consequences of nucleoside analogs therapy (lamivudine, adefovir, telbivudine and entecavir) for Hepatitis B in China.Methods: The cost-utility analysis for H
5、BeAg-positive and HBeAg-negative CHB was conducted from a third payer perspective over a lifetime time horizon using a Markov model, wihch tracked yearly patients transitions between different health states: chronic hepatitis B, HBeAg seroconversion (HBeAg-positive CHB has this special health state)
6、, CHB with resistance, virologic response, compensated cirrhosis, decompensated cirrhosis, hapetocelluar carcinoma, liver transplantation and death. The transition parameters were derived from systematic literature reviews or previous economic studies, and the cost and utility data were come from th
7、e studies based on Chinese CHB cohort. A 3% yearly discount rate was applied to both costs and health benefits.One-way sensitivity analyses, second-order Monte-Carlo and probabilistic sensitivity analyses were performed. Results: The entecavir strategy obtained the highest quality adjusted life year
8、s (QALY) for both HBeAg-positive and HBeAg-negative patients in comparisons with no treatment,lamivudine, adefovir and telbivudine strategies, the complications and mortality risks were also most decreased. In economic analysis, The no treatment strategy was least effective yet least expensive, and
9、entecavir strategy was the most cost-effective option, followed by telbivudine and lamivudine strategy.The probabilistic sensitivity analysis showed that entecavir strategy would result in 90% cost-effective cases at a $ US20k per QALY threshold. In one-way sensitivity analyses, the most influential
10、 parameters impacted on the robustness of the model were the utility of CHB and virologic response health state.Conclusions: Based on the results of this model-based economic analysis, entecavir strategy is the most cost-effective option in comparisons with lamivudine, adefovir and telbivudine strat
11、egies for HBeAg-positive and HBeAg-negative CHB in China.Keywords: cost-effectiveness；chronic hepatitis B；nucleoside analogs.核苷类药物治疗慢性乙肝的药物经济学研究：基于中国人群的Markov队列分析 吴斌1, 沈金芳1, *1上海交通大学医学院附属仁济医院药剂科（上海市东方路1630号），*通讯作者本项工作得到了科技部“重大新药创制”科技重大专项十一五计划第一批课题的支持（项目编号：NO.2008ZX09312-007）第一作者简介：吴斌，主要研究方向为药物的合理应用。
12、目前承担多项课题研究，迄今发表第一作者SCI论文4篇。E-mail：wbnmuyahoo ，联系 ：021-68383427， ：200127通讯作者简介：沈金芳 ，硕士生导师。主要从事中药复方的质量控制、有效组分分析、药动学与药效学研究。2003年到2004年主持参与上海市科委项目 “利心舒的预临床研究（批准号：02DZ19133）”，完成了利心舒重要复方胶囊的质量控制和标准化研究。近年来，近年参与主编及编写专著3部，在在国家级期刊公开发表文章40余篇，其中以第一作者发表论著20余篇，并有数篇被EI及SCI收录，并应邀为中国药房、中国新药与临床等统计源期刊的投稿论文审稿。E-mail：sjf
13、sjtuyahoo ，联系 ：021-68383427， ：200127目的:评估核苷类药物治疗慢性乙肝的长期经济学效果，为慢性乙肝患者治疗选择提供依据。方法:从第三方支付的角度分别评价HBeAg(+)与HBeAg(-)的慢性乙肝患者接受核苷类药物治疗的成本与效益，根据慢性乙肝自然史建立Markov状态转移模型，包含的状态为：慢性乙肝、HBeAg血清学转换（此状态为HBeAg(+)慢性乙肝患者所独有）、乙肝药物抵抗、病毒反应、代偿性肝纤维化、失代偿性肝纤维化、肝癌、肝移植与死亡。状态之间的年转移概率来自于公开发表的文献，成本与效用数据来自基于中国慢性乙肝人群的研究，年折扣率为3%。在此基础上分
14、别进行一维敏感性、Mnote Carlo模拟与概率敏感性分析。结果：同无治疗、拉米夫定、阿德福韦与替比夫定治疗方案相比， HBeAg(+)与HBeAg(-)的慢性乙肝患者使用恩替卡韦治疗方案后均获得了最高的质量调整生命年(QALY)，同时最大程度的降低了并发症与死亡的风险。无治疗方案成本最低，但获得的效益也最小，恩替卡韦方案的成本-效益比最高，随后依次为替比夫定与拉米夫定方案。概率敏感性分析显示，当每个QALY的支付额度为2万美元的时候，恩替卡韦方案可使超过90%的患者达到较好的成本-效益比。在一维敏感性分析显示，对模型的稳定性有较大影响的是慢性乙肝与病毒反应两种状态下患者的生存效用。结论：对
15、于中国HBeAg(+)与HBeAg(-)的慢性乙肝患者，恩替卡韦治疗方案是较为经济的治疗选择。关键词：成本-效益；慢性乙肝；核苷类药物IntroductionChronic hepatitis B (CHB) infection is a global public health problem, which affects 350400 million people worldwide and is particularly prevalent in China. Epidemiological surveys indicate that approximately 112 million
16、Chinese people are chronically infected with HBV1, 2. Persistent HBV infection is a significant cause of cirrhosis, hepatocellular carcinoma (HCC), and liver failure. These advanced complications of CHB increase the risk of morbidity and mortality, and resulted in expensive healthcare cost 1. The ultimate goal of treatment of CHB is to completely eradicate the hepatitis B virus (H
