Cost-effectiveness of Telaprevir Combination Therapy for Chronic Hepatitis C
Cost-effectiveness of Telaprevir Combination Therapy for Chronic Hepatitis C
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DOI：
10.1371/journal.pone.0090295
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发表时间：
2014-03-06
期刊：
影响因子：
3.7
通讯作者：
Deniz, Baris
中科院分区：
文献类型：
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作者：
Brogan, Anita J.;Talbird, Sandra E.;Deniz, Baris
目的：探索特拉匹韦（TVR）联合聚乙二醇干扰素α-2a和利巴韦林（PR）的预期长期健康和经济结局，在III期研究ADVANCE中，与单独使用PR相比，该方案在慢性基因型1型丙型肝炎病毒（HCV）和代偿性肝病成人患者中显示出持续病毒学应答（SVR）显著增加（初治患者）和实现研究设计：在美国（US），开发了一个决策分析模型来评估TVR+PR与PR的成本效益。方法：患者首先通过模型的72周决策树治疗阶段，然后进入循环马尔可夫治疗后阶段。从ADVANCE和REALIZE获得临床数据（患者特征、SVR率、不良事件发生率和持续时间）。健康状态转移概率、药物和其他成本（以2012/2013年美元计）和效用值来自试验、已发表的研究和公开来源。结果被折扣为3%per year.Results：无论治疗史，接受TVR+PR的患者预计将经历更少的肝脏疾病并发症，更多的生命年，更多的质量调整生命年（QOLS）比接受PR的患者。在以前的复发，TVR+PR占主导地位，总医疗费用较低，更多的QOLS。对于其他患者亚组，每增加一个QALY的增量成本在16，778美元（初治患者）和34，279美元（既往无效应答者）之间。广泛的敏感性分析证实了强大的模型results.Conclusions：在标准的支付意愿阈值，TVR+PR代表了一个具有成本效益的治疗方案相比，PR单独的慢性基因型1型HCV和代偿性肝病患者在美国。需要进一步分析以比较TVR+PR与所有现有HCV治疗方案。
Objective: To explore the expected long-term health and economic outcomes of telaprevir (TVR) plus peginterferon alfa-2a and ribavirin (PR), a regimen that demonstrated substantially increased sustained virologic response (SVR) compared with PR alone in adults with chronic genotype 1 hepatitis C virus (HCV) and compensated liver disease in the Phase III studies ADVANCE (treatment-naive patients) and REALIZE (relapsers, partial responders, and null responders to previous PR treatment).Study Design: A decision-analytic model was developed to assess the cost-effectiveness of TVR+PR vs. PR in the United States (US).Methods: Patients first moved through the 72-week decision-tree treatment phase of the model and then entered the cyclic Markov post-treatment phase. Clinical data (patient characteristics, SVR rates, and adverse event rates and durations) were obtained from ADVANCE and REALIZE. Health-state transition probabilities, drug and other costs (in 2012/2013 US dollars), and utility values were obtained from the trials, published studies, and publicly available sources. Outcomes were discounted at 3% per year.Results: Regardless of treatment history, patients receiving TVR+PR were projected to experience fewer liver-disease complications, more life-years, and more quality-adjusted life-years (QALYs) than patients receiving PR. In prior relapsers, TVR+PR was dominant, with lower total medical costs and more QALYs. For the other patient subgroups, incremental costs per QALY gained were between $16,778 (treatment-naive patients) and $34,279 (prior null responders). Extensive sensitivity analyses confirmed robust model results.Conclusions: At standard willingness-to-pay thresholds, TVR+PR represents a cost-effective treatment option compared with PR alone for patients with chronic genotype 1 HCV and compensated liver disease in the US. Future analyses are needed to compare TVR+PR with all existing HCV treatment options.