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根据德国指南,针对丙型肝炎病毒(HCV)基因型及早期病毒反应,采用聚乙二醇化干扰素α-2b联合利巴韦林定制慢性丙型肝炎治疗方案的临床有效性和成本效益:一项决策分析

Clinical effectiveness and cost effectiveness of tailoring chronic hepatitis C treatment with peginterferon alpha-2b plus ribavirin to HCV genotype and early viral response: a decision analysis based on German guidelines.

作者信息

Siebert Uwe, Sroczynski Gaby, Aidelsburger Pamela, Rossol Siegbert, Wasem Jürgen, Manns Michael P, McHutchison John G, Wong John B

机构信息

Department of Public Health, Medical Decision Making and Health Technology Assessment, UMIT-University of Health Sciences, Medical Informatics and Technology, Hall i.T., Austria.

出版信息

Pharmacoeconomics. 2009;27(4):341-54. doi: 10.2165/00019053-200927040-00006.

Abstract

BACKGROUND

Recently developed German guidelines for antiviral treatment in patients with chronic hepatitis C recommend basing drug dosage, intended treatment duration and early stopping rules on the genotype of the hepatitis C virus and early viral responses to treatment.

OBJECTIVES

To evaluate effectiveness and cost effectiveness of different antiviral treatment strategies including the German guidelines, for chronic hepatitis C.

METHODS

A validated lifetime Markov model was used to project life expectancy, QALYs and lifetime costs for the following strategies: (i) no antiviral therapy (NoAVT); (ii) interferon-alpha-2b plus ribavirin for 48 weeks (IFN + R); (iii) peginterferon-alpha-2b plus weight-based ribavirin for 48 weeks (PEG + R); (iv) peginterferon-alpha-2b plus ribavirin according to German guidelines with genotype-dependent treatment duration, dosage and 12-week viral response evaluation (GUIDE). Clinical and resource utilization data were derived from a clinical trial, the published literature and a survey of German hepatologists. Incremental cost-effectiveness ratios (ICERs) were calculated adopting the German societal perspective. Costs (in euro, year 2005 values) and health outcomes were discounted at 3% annually. Uncertainty was assessed using deterministic and probabilistic sensitivity analyses.

RESULTS

Compared with NoAVT, PEG + R increased undiscounted life expectancy by 5.0 life-years (5.2 QALYs) and GUIDE increased undiscounted life expectancy by 4.9 years (5.1 QALYs). Compared with PEG + R, GUIDE saved 13% of hepatitis C virus-related lifetime costs per patient. GUIDE dominated IFN + R. Compared with NoAVT, discounted ICERs were euro1500 per QALY for GUIDE and euro3200 per QALY for PEG + R.

CONCLUSION

Administering GUIDE should allow tailoring treatment efficiently to genotype, bodyweight and early viral response in patients with chronic hepatitis C, and appears cost effective compared with other well accepted medical interventions.

摘要

背景

最近制定的德国慢性丙型肝炎患者抗病毒治疗指南建议,根据丙型肝炎病毒的基因型以及治疗的早期病毒反应来确定药物剂量、预期治疗疗程和早期停药规则。

目的

评估包括德国指南在内的不同抗病毒治疗策略对慢性丙型肝炎的有效性和成本效益。

方法

使用经过验证的终身马尔可夫模型来预测以下策略的预期寿命、质量调整生命年(QALY)和终身成本:(i)不进行抗病毒治疗(NoAVT);(ii)干扰素-α-2b加利巴韦林治疗48周(IFN + R);(iii)聚乙二醇干扰素-α-2b加基于体重的利巴韦林治疗48周(PEG + R);(iv)根据德国指南使用聚乙二醇干扰素-α-2b加利巴韦林,治疗疗程、剂量取决于基因型,并进行12周病毒反应评估(GUIDE)。临床和资源利用数据来自一项临床试验、已发表的文献以及对德国肝病专家的一项调查。采用德国社会视角计算增量成本效益比(ICER)。成本(以欧元计,2005年的值)和健康结果按每年3%进行贴现。使用确定性和概率敏感性分析评估不确定性。

结果

与NoAVT相比,PEG + R使未贴现的预期寿命增加了5.0年(5.2个QALY),GUIDE使未贴现的预期寿命增加了4.9年(5.1个QALY)。与PEG + R相比,GUIDE使每位患者的丙型肝炎病毒相关终身成本节省了13%。GUIDE优于IFN + R。与NoAVT相比,贴现后的ICER为:GUIDE每QALY 1500欧元,PEG + R每QALY 3200欧元。

结论

采用GUIDE策略应能根据慢性丙型肝炎患者的基因型、体重和早期病毒反应有效地调整治疗方案,并且与其他广泛接受的医学干预措施相比,似乎具有成本效益。

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