Sullivan Sean D, Craxi Antonio, Alberti Alfredo, Giuliani Giovanni, De Carli Claudio, Wintfeld Neil, Patel Kavita K, Green Jesse
University of Washington, Seattle, Washington, USA.
Pharmacoeconomics. 2004;22(4):257-65. doi: 10.2165/00019053-200422040-00004.
In adults with previously untreated chronic hepatitis C (CHC), the combination of peginterferon alpha-2a plus ribavirin produces a higher rate of sustained virological response (SVR) than interferon alpha-2b plus ribavirin, but it is still unproven whether this increase is cost effective. The objective of this study was to determine if the gain in SVR with peginterferon alpha-2a plus ribavirin is worth the incremental cost.
We constructed a Markov model of disease progression in which cohorts of patients received peginterferon alpha-2a plus ribavirin or interferon alpha-2b plus ribavirin for 48 weeks (hepatitis C virus [HCV] genotype 1 and non-1 patients with fibrosis) or 24 weeks (genotype non-1 patients without fibrosis), and were followed for their expected lifetimes. The reference patient was a 45-year-old male with CHC without cirrhosis. The SVRs with peginterferon alpha-2a plus ribavirin and interferon alpha-2b plus ribavirin used to populate the model were 46% and 36% for patients infected with HCV genotype 1 and 76% and 61% for patients infected with HCV non-1 genotypes, respectively. QOL and costs for each health state were based on literature estimates and on Italian treatment patterns. Costs were in 2002 euros and benefits were discounted at 3%. Sensitivity analyses on key clinical and economic parameters were performed. The analysis was reported from the perspective of the Italian National Health Service.
In patients infected with HCV genotype 1, peginterferon alpha-2a plus ribavirin increased life-years (LYs) by 0.78 years and QALYs by 0.67 years, compared with interferon alpha-2b and ribavirin. The incremental cost per LY and QALY gained was euro9433 and euro10 894, respectively. In patients infected with HCV non-1 genotypes, peginterferon alpha-2a plus ribavirin increased LYs by 1.17 and QALY by 1.01 years, compared with interferon alpha-2b plus ribavirin. The incremental cost per LY and QALY gained was euro3261 and euro3766, respectively. Using genotype distribution estimates, the weighted average ICER for all genotypes was euro6811 per LY gained and euro7865 per QALY gained.
Our model suggests that peginterferon alpha-2a plus ribavirin is cost effective compared with conventional interferon alpha-2b plus ribavirin for treatment of naive adults with CHC, regardless of HCV genotype, under a wide range of assumptions regarding treatment effectiveness and costs.
在既往未经治疗的慢性丙型肝炎（CHC）成人患者中，聚乙二醇化干扰素α-2a联合利巴韦林比干扰素α-2b联合利巴韦林产生更高的持续病毒学应答（SVR）率，但这种增加是否具有成本效益仍未得到证实。本研究的目的是确定聚乙二醇化干扰素α-2a联合利巴韦林在SVR方面的获益是否值得其增加的成本。
我们构建了一个疾病进展的马尔可夫模型，其中患者队列接受聚乙二醇化干扰素α-2a联合利巴韦林或干扰素α-2b联合利巴韦林治疗48周（丙型肝炎病毒[HCV]基因型1及有纤维化的非1型患者）或24周（无纤维化的非1型基因型患者），并随访其预期寿命。参考患者为一名45岁无肝硬化的CHC男性。用于填充模型的聚乙二醇化干扰素α-2a联合利巴韦林和干扰素α-2b联合利巴韦林的SVR，HCV基因型1感染患者分别为46%和36%，HCV非1基因型感染患者分别为76%和61%。每个健康状态的生活质量（QOL）和成本基于文献估计和意大利的治疗模式。成本以2002年欧元计，效益按3%贴现。对关键临床和经济参数进行了敏感性分析。该分析从意大利国家卫生服务的角度进行报告。
与干扰素α-2b联合利巴韦林相比，聚乙二醇化干扰素α-2a联合利巴韦林使HCV基因型1感染患者的生命年（LYs）增加0.78年，质量调整生命年（QALYs）增加0.67年。每获得1个LY和1个QALY的增量成本分别为9433欧元和10894欧元。与干扰素α-2b联合利巴韦林相比，聚乙二醇化干扰素α-2a联合利巴韦林使HCV非1基因型感染患者的LYs增加1.17年，QALY增加1.01年。每获得1个LY和1个QALY的增量成本分别为3261欧元和3766欧元。使用基因型分布估计，所有基因型的加权平均增量成本效果比（ICER）为每获得1个LY6811欧元，每获得1个QALY7865欧元。
我们的模型表明相对于传统的干扰素α-2b联合利巴韦林，聚乙二醇化干扰素α-2a联合利巴韦林治疗初治的CHC成人患者具有成本效益，无论HCV基因型如何，在关于治疗有效性和成本的广泛假设下均如此。
