聚乙二醇干扰素α-2a与利巴韦林联合用药对比干扰素α-2b与利巴韦林治疗慢性丙型肝炎患者的成本效益分析

Cost-effectiveness of combination peginterferon alpha-2a and ribavirin compared with interferon alpha-2b and ribavirin in patients with chronic hepatitis C.

作者信息

Sullivan S D, Jensen D M, Bernstein D E, Hassanein T I, Foster G R, Lee S S, Cheinquer H, Craxi A, Cooksley Graham, Klaskala W, Pettit K, Patel K K, Green J

机构信息

University of Washington, Seattle WA 98195, USA.

出版信息

Am J Gastroenterol. 2004 Aug;99(8):1490-6. doi: 10.1111/j.1572-0241.2004.30286.x.

DOI:10.1111/j.1572-0241.2004.30286.x

PMID:15307866

Abstract

BACKGROUND

Sustained virological response (SVR) is the primary objective in the treatment of chronic hepatitis C (CHC). Results from a recent clinical trial of patients with previously untreated CHC demonstrate that the combination of peginterferon alpha-2a and ribavirin produces a greater SVR than interferon alpha-2b and ribavirin combination therapy. However, the cost-effectiveness of peginterferon alpha-2a plus ribavirin in the U.S. setting has not been investigated.

METHODS

A Markov model was developed to investigate cost-effectiveness in patients with CHC using genotype to guide treatment duration. SVR and disease progression parameters were derived from the clinical trials and epidemiologic studies. The impact of treatment on life expectancy and costs were projected for a lifetime. Patients who had an SVR were assumed to remain virus-free for the rest of their lives. In genotype 1 patients, the SVRs were 46% for peginterferon alpha-2a plus ribavirin and 36% for interferon alpha-2b plus ribavirin. In genotype 2/3 patients, the SVRs were 76% for peginterferon alpha-2a plus ribavirin and 61% for interferon alpha-2b plus ribavirin. Quality of life and costs were based on estimates from the literature. All costs were based on published U.S. medical care costs and were adjusted to 2003 U.S. dollars. Costs and benefits beyond the first year were discounted at 3%.

RESULTS

In genotype 1, peginterferon alpha-2a plus ribavirin increases quality-adjusted life expectancy (QALY) by 0.70 yr compared to interferon alpha-2b plus ribavirin, producing a cost-effectiveness ratio of $2,600 per QALY gained. In genotype 2/3 patients, peginterferon alpha-2a plus ribavirin increases QALY by 1.05 yr in comparison to interferon alpha-2b plus ribavirin. Peginterferon alpha-2a combination therapy in patients with HCV genotype 2 or 3 is dominant (more effective and cost saving) compared to interferon alpha-2b plus ribavirin. Results weighted by genotype prevalence (75% genotype 1; 25% genotype 2 or 3) also show that peginterferon alpha-2a plus ribavirin is dominant. Peginterferon alpha-2a and ribavirin remained cost-effective (below $16,500 per QALY gained) under sensitivity analyses on key clinical and cost parameters.

CONCLUSION

Peginterferon alpha-2a in combination with ribavirin with duration of therapy based on genotype, is cost-effective compared with conventional interferon alpha-2b in combination with ribavirin when given to treatment-naïve adults with CHC.

摘要

背景

持续病毒学应答（SVR）是慢性丙型肝炎（CHC）治疗的主要目标。一项针对既往未接受治疗的CHC患者的近期临床试验结果表明，聚乙二醇化干扰素α-2a与利巴韦林联合使用比干扰素α-2b与利巴韦林联合治疗产生更高的SVR。然而，聚乙二醇化干扰素α-2a加利巴韦林在美国环境下的成本效益尚未得到研究。

方法

开发了一个马尔可夫模型，以利用基因型指导治疗持续时间来研究CHC患者的成本效益。SVR和疾病进展参数源自临床试验和流行病学研究。预测了治疗对预期寿命和成本的终生影响。假设获得SVR的患者在其余生中保持无病毒状态。在基因1型患者中，聚乙二醇化干扰素α-2a加利巴韦林的SVR为46%，干扰素α-2b加利巴韦林的SVR为36%。在基因2/3型患者中，聚乙二醇化干扰素α-2a加利巴韦林的SVR为76%，干扰素α-2b加利巴韦林的SVR为61%。生活质量和成本基于文献估计。所有成本均基于已公布的美国医疗保健成本，并调整为2003年美元。第一年之后的成本和效益按3%进行贴现。

结果

在基因1型中，与干扰素α-2b加利巴韦林相比，聚乙二醇化干扰素α-2a加利巴韦林使质量调整生命年（QALY）增加0.70年，每获得一个QALY的成本效益比为2600美元。在基因2/3型患者中，与干扰素α-2b加利巴韦林相比，聚乙二醇化干扰素α-2a加利巴韦林使QALY增加1.05年。与干扰素α-2b加利巴韦林相比，聚乙二醇化干扰素α-2a联合疗法在HCV基因2或3型患者中具有优势（更有效且节省成本）。按基因型患病率（75%基因1型；25%基因2或3型）加权的结果也表明，聚乙二醇化干扰素α-2a加利巴韦林具有优势。在对关键临床和成本参数进行敏感性分析时，聚乙二醇化干扰素α-2a和利巴韦林仍具有成本效益（每获得一个QALY低于16500美元）。