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索磷布韦、聚乙二醇干扰素和利巴韦林治疗慢性丙型肝炎患者的成本效益分析:纤维化初期的早期治疗与晚期纤维化的延迟治疗对比

[Cost-effectiveness analysis of sofosbuvir, peginterferon and ribavirin in patients with chronic hepatitis C: Early treatment in the initial stage of fibrosis vs. delayed treatment in advanced fibrosis].

作者信息

Buti María, Domínguez-Hernández Raquel, Oyagüez Itziar, Casado Miguel Ángel

机构信息

Unidad de Hepatología, Hospital Universitario Vall d'Hebron, Barcelona, España; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), España.

Pharmacoeconomics & Outcomes Research Iberia, Madrid, España.

出版信息

Gastroenterol Hepatol. 2016 Aug-Sep;39(7):449-57. doi: 10.1016/j.gastrohep.2016.03.006. Epub 2016 Apr 12.

DOI:10.1016/j.gastrohep.2016.03.006
PMID:27084669
Abstract

AIMS

Cost-effectiveness analysis of sofosbuvir combined with peginterferon alpha-2a and ribavirin (SOF/Peg-IFN/RBV) in early versus advanced fibrosis in previously untreated patients with chronic hepatitis C genotype 1 (CHC-GT1), from the perspective of the Spanish National Health System (NHS).

METHODS

A Markov model was developed to compare lifetime costs and outcomes (life years gained [LYGs] and quality-adjusted life years [QALYs]) of 2 treatment strategies: SOF/Peg-IFN/RBV administered during early fibrosis (mild-moderate fibrosis; F2-F3) or advanced fibrosis (cirrhosis; F4). Efficacy (sustained virologic response), annual transition probabilities, disease management costs and utilities were obtained from the literature. Costs and outcomes were discounted annually at 3%. Direct costs were considered, expressed in Euros (€, 2014). Probabilistic sensitivity analysis (PSA) was also performed.

RESULTS

SOF/Peg-IFN/RBV therapy at F2-F3 was more effective (19.12 LYGs and 14.14 QALYs) compared to F4. In a cohort of 1,000 patients, SOF/Peg-IFN/RBV prevented 66 cases of decompensated cirrhosis, 60 hepatocellular carcinomas and 4 liver transplantations compared with therapy in advanced fibrosis. The total lifetime cost of early therapy (€43,263) was less than the cost of treatment in the advanced stage (€49,018). Early therapy was a dominant strategy, more effective and less costly in all simulations. In the PSA analysis, administration of SOF/PEG-IFN/RBV at F2-F3 was dominant in all simulations.

CONCLUSIONS

Starting SOF/Peg-IFN/RBV therapy at F2-F3, compared with therapy at F4, reduced the incidence of liver disease complications and was associated with cost savings for the Spanish NHS in CHC-GT1 patients.

摘要

目的

从西班牙国家卫生系统(NHS)的角度,对索磷布韦联合聚乙二醇干扰素α-2a和利巴韦林(SOF/Peg-IFN/RBV)治疗初治慢性丙型肝炎基因1型(CHC-GT1)患者早期与晚期纤维化的成本效益进行分析。

方法

建立马尔可夫模型,比较两种治疗策略的终身成本和结局(获得的生命年数[LYGs]和质量调整生命年数[QALYs]):在早期纤维化(轻度至中度纤维化;F2-F3)或晚期纤维化(肝硬化;F4)期间给予SOF/Peg-IFN/RBV。疗效(持续病毒学应答)、年度转移概率、疾病管理成本和效用值均来自文献。成本和结局按每年3%进行贴现。考虑直接成本,以欧元(€,2014年)表示。还进行了概率敏感性分析(PSA)。

结果

与F4期相比,F2-F3期的SOF/Peg-IFN/RBV治疗更有效(19.12个LYGs和14.14个QALYs)。在1000例患者队列中,与晚期纤维化治疗相比,SOF/Peg-IFN/RBV预防了66例失代偿期肝硬化、60例肝细胞癌和4例肝移植。早期治疗的终身总成本(43,263欧元)低于晚期治疗成本(49,018欧元)。在所有模拟中,早期治疗是一种占优策略,更有效且成本更低。在PSA分析中,F2-F3期给予SOF/PEG-IFN/RBV在所有模拟中均占优。

结论

在F2-F3期开始SOF/Peg-IFN/RBV治疗,与F4期治疗相比,降低了肝病并发症的发生率,并为西班牙NHS的CHC-GT1患者节省了成本。

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