School of International Pharmaceutical Business, China Pharmaceutical University, No. 639 Longmian Road, Jiangning District, Nanjing, 211198, People's Republic of China.
Clin Drug Investig. 2018 Nov;38(11):1031-1039. doi: 10.1007/s40261-018-0702-9.
New direct-acting antivirals (DAAs) have high efficacy and tolerability in the treatment of hepatitis C virus (HCV) infection. The objective of this study was to assess the cost-effectiveness of elbasvir/grazoprevir (EBR/GZR) versus daclatasvir plus asunaprevir (DCV + ASV) in Chinese patients with chronic HCV genotype (GT) 1b infection stratified by cirrhosis status and treatment history.
A cohort state-transition model was constructed to simulate the course of chronic HCV infection in patients stratified by cirrhosis status and treatment history. The model projected lifetime outcomes and costs in terms of HCV treatment, laboratory tests, clinical procedures, and hospitalizations. Mean age of the study cohort at baseline was 45 years, based on published sources. Sustained virologic response (SVR) rates were derived from clinical trials. Healthcare resource utilization and health utilities were extracted or estimated from published studies in Chinese populations. The stability of the base-case analysis was validated by deterministic and probabilistic sensitivity analyses.
In each subpopulation of Chinese patients, treatment with EBR/GZR dominated treatment with DCV + ASV, with lower costs and higher quality-adjusted life-years (QALYs). Sensitivity analysis demonstrated that EBR/GZR was the cost-effective option compared to DCV + ASV in 77.4-97.4% or 94.1-100% of model simulations in Chinese treatment-naïve or treatment-experienced patients, respectively, as the cost-effectiveness threshold changed from zero to US$24,150/QALY (three times GDP per capita in China).
Treatment with EBR/GZR was the cost-effective option for patients with chronic HCV GT1b infection in China, regardless of cirrhosis status or treatment history.
新型直接作用抗病毒药物（DAA）在治疗丙型肝炎病毒（HCV）感染方面具有高疗效和良好耐受性。本研究旨在评估 Elbasvir/grazoprevir（EBR/GZR）与达卡他韦联合asunaprevir（DCV+ASV）在伴有或不伴有肝硬化的中国慢性 HCV 基因 1b 型感染患者中的成本效益。
构建了一个队列状态转移模型，以模拟伴有或不伴有肝硬化的患者中慢性 HCV 感染的进程。该模型预测了终生 HCV 治疗、实验室检测、临床程序和住院治疗的成本和结果。根据已发表的资料，研究队列的基线平均年龄为 45 岁。从临床试验中获得持续病毒学应答（SVR）率。从中国人群发表的研究中提取或估算医疗资源利用和健康效用。通过确定性和概率敏感性分析验证了基础分析的稳定性。
在中国患者的每个亚组中，EBR/GZR 治疗均优于 DCV+ASV 治疗，具有更低的成本和更高的质量调整生命年（QALY）。敏感性分析表明，在治疗初治或经治中国患者时，当成本效益阈值从 0 美元/QALY 增加到 24150 美元/QALY（是中国人均 GDP 的三倍）时，EBR/GZR 治疗均为更具成本效益的选择，在 77.4%97.4%或 94.1%100%的模型模拟中。
对于中国慢性 HCV GT1b 感染患者，无论是否伴有肝硬化或治疗史，EBR/GZR 治疗都是一种具有成本效益的选择。
