对过去五年索非布韦/韦帕他韦(SOF/VEL)在西班牙慢性丙型肝炎患者中的临床和经济价值进行评估

Rafael Esteban , Raquel Domínguez-Hernández , Helena Cantero , Miguel Ángel Casado
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引用次数: 0

摘要

目标用于治疗丙型肝炎病毒(HCV)的直接作用抗病毒药物代表了一种范式的转变。2017年,索非布韦/韦帕他韦(SOF/VEL-Epclusa®)获得批准,该药对所有患者均显示出较高的治愈率,有助于消除HCV。分析旨在量化 SOF/VEL 在西班牙获批后对 HCV 慢性病患者的临床和经济价值。方法采用马尔可夫模型进行经济评估,该模型模拟了自 SOF/VEL 推出(5 年)以来,接受 SOF/VEL 治疗的所有 HCV 慢性病患者(30,488 名患者)的终生疾病进展情况,并与之前的疗法进行了比较。患者进入模型后,在治疗和未治疗的纤维化状态(F0-F4)之间分布。所有患者(100%)均接受了SOF/VEL治疗,无论其纤维化程度如何,49%的患者接受了≥F2的既往疗法。平均持续病毒应答(SVR)率为 98.9% SOF/VEL,而之前的疗法为 61.0%。分析的所有参数均来自真实数据和文献。仅包括与疾病管理相关的直接医疗成本。与之前的疗法相比,SOF/VEL 的价值以避免的肝脏并发症数量及其相关成本和肝脏死亡率来衡量。结果SOF/VEL减少了肝脏并发症的数量,避免了92%的失代偿性肝硬化、80%的肝细胞癌和87%的肝移植,以及85%的肝脏相关死亡率。结论SOF/VEL 增加了 HCV 治疗的相关价值,减轻了疾病的临床和经济负担,有助于在西班牙消除 HCV。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Evaluation of the clinical and economic value of sofosbuvir/velpatasvir (SOF/VEL) in patients with chronic hepatitis C in Spain during the last 5 years

Objective

Direct-acting antivirals for the treatment of hepatitis C virus (HCV) represented a paradigm shift. In 2017, sofosbuvir/velpatasvir (SOF/VEL-Epclusa®) was approved, which showed a high cure rate in all patient, contributing to HCV elimination. The analysis aimed to quantify the clinical and economic value of SOF/VEL in HCV chronic patients since its approval in Spain.

Methods

An economic evaluation was elaborated adapting a Markov model that simulated the lifetime disease progression in of all HCV chronic patients treated with SOF/VEL (30,488 patients) since its launch (5-years), compared to previous therapies. Patients entered the model and were distributed between the fibrosis states (F0-to-F4) in treated and untreated. All patients (100%) were treated with SOF/VEL regardless of their fibrosis, and 49% with previous therapies in ≥F2. The average sustained viral response (SVR) rates 98.9% SOF/VEL versus 61.0% previous therapies. All parameters for the analysis were obtained from real-life data and literature. Only direct healthcare costs associated with disease management were included. The SOF/VEL value was measured as the number of hepatic complications avoided and their associated cost, and hepatic mortality compared to previous therapies. National Health System perspective and a 3% discount rate was applied.

Results

SOF/VEL decreased the number of liver complications, avoiding 92% decompensated cirrhosis, 80% hepatocellular carcinomas, and 87% liver transplants, as well as 85% liver-related mortality. Their cost associated was reduced, amounting to savings of 197 M€.

Conclusion

SOF/VEL adds relevant value to the HCV treatment, reducing the clinical and economic disease burden and contributing to HCV elimination in Spain.
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