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索磷布韦和维帕他韦治疗失代偿期肝硬化慢性丙型肝炎患者的成本效果分析。

Cost-effectiveness analysis of sofosbuvir and velpatasvir in chronic hepatitis C patients with decompensated cirrhosis.

机构信息

Faculty of Science, School of Pharmacy, University of Waterloo, Kitchener, ON, Canada.

Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, ON, Canada.

出版信息

J Viral Hepat. 2021 Feb;28(2):260-267. doi: 10.1111/jvh.13419. Epub 2020 Nov 15.

DOI:10.1111/jvh.13419
PMID:33065774
Abstract

BACKGROUND

Current literature indicates that direct-acting antivirals (DAAs) are cost-effective to treat compensated cirrhotic patients with hepatitis C. Although already funded by public payers, it is unknown whether it is economical to reimburse DAAs within the more advanced decompensated cirrhosis population.

METHODS

A state-transition model was developed to conduct a cost-utility analysis of sofosbuvir-velpatasvir (SOF/VEL) plus ribavirin regimen for 12 weeks. The evaluated cohort had a mean age of 58 years and Child-Turcotte-Pugh (CTP) class B cirrhosis with decompensated symptoms. A scenario analysis was performed on CTP C patients. We used a payer perspective, a lifetime time horizon and a 1.5% annual discount rate.

RESULTS

While SOF/VEL plus ribavirin treatment for 12 weeks increased costs by $156 676, it provided an extra 4.00 quality-adjusted life years (QALYs) compared to best supportive care (no DAA therapy). With an incremental cost-effectiveness ratio of $39 169 per QALY, SOF/VEL plus ribavirin was determined to be cost-effective at a willingness to pay of $50 000 per QALY. SOF/VEL reduced liver-related deaths and reduced progression to CTP C cirrhosis by 20.4% and 21.9%, respectively. On the contrary, SOF/VEL regimen resulted in increases in liver transplants and hepatocellular carcinoma (HCC) by 54.0% and 42.5%, respectively. Similar results were found for CTP C patients.

CONCLUSION

This analysis informs payers that SOF/VEL should continue to be reimbursed in decompensated hepatitis C patients. It also supports the recommendations by the American Association for the Study of Liver Diseases to continue screening for HCC in decompensated cirrhotic patients who have achieved sustained virologic response.

摘要

背景

目前的文献表明,直接作用抗病毒药物(DAAs)在治疗代偿性丙型肝炎肝硬化患者方面具有成本效益。尽管已经得到公共支付者的资助,但在更晚期失代偿性肝硬化人群中报销 DAA 是否具有经济性尚不清楚。

方法

开发了一个状态转换模型,对索磷布韦-维帕他韦(SOF/VEL)联合利巴韦林治疗 12 周的方案进行成本-效用分析。评估队列的平均年龄为 58 岁,Child-Turcotte-Pugh(CTP)B 级肝硬化伴失代偿症状。对 CTP C 患者进行了情景分析。我们采用支付者视角、终生时间范围和 1.5%的年度贴现率。

结果

SOF/VEL 联合利巴韦林治疗 12 周增加了 156676 美元的成本,但与最佳支持治疗(无 DAA 治疗)相比,提供了额外的 4.00 个质量调整生命年(QALYs)。SOF/VEL 联合利巴韦林的增量成本-效果比为每 QALY 39169 美元,在支付意愿为每 QALY 50000 美元时被认为具有成本效益。SOF/VEL 降低了肝相关死亡率并将进展为 CTP C 肝硬化的风险分别降低了 20.4%和 21.9%。相反,SOF/VEL 方案导致肝移植和肝细胞癌(HCC)的发生率分别增加了 54.0%和 42.5%。CPT C 患者也得到了类似的结果。

结论

该分析为支付者提供了信息,表明 SOF/VEL 应继续在失代偿性丙型肝炎患者中报销。它还支持美国肝病研究协会的建议,即在达到持续病毒学应答的失代偿性肝硬化患者中继续筛查 HCC。

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