Liver Unit, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
CIBERehd, Instituto Carlos III, Barcelona, Spain.
PLoS One. 2022 Dec 1;17(12):e0278544. doi: 10.1371/journal.pone.0278544. eCollection 2022.
The treatment of chronic hepatitis C virus (HCV) with direct-acting antivirals has undergone a spectacular revolution and added significant value to healthcare systems and patients. The aim of the study was to evaluate the efficiency and value of Sofosbuvir (SOF)-based regimens for a target population of 85,959 chronic HCV patients treated in Spain during 2015-2019, compared to previous therapeutic strategies (peginterferon/ and ribavirin in double/triple therapy with telaprevir or boceprevir).
A previously developed lifetime Markov model was adapted to simulate the disease HCV evolution. In SOF-based regimens, all patients (100%) were treated regardless with sustained virological response (SVR) of 93-98%, obtained from real-world data. In previous therapeutic, only ≥F2 patients were treated according to clinical practice (38%) with an average SVR of 61% taken from published literature. The value was measured as clinical and economic impact in terms of avoided HCV-related mortality and liver complications; total costs and quality-adjusted life years (QALYs) applying an annual 3% discount rate.
Compared to previous therapeutic, during lifetime, SOF-based regimens reduced decompensated cirrhosis by 89%, hepatocellular carcinoma by 77% and liver transplant by 84%, decreasing the cost associated to liver complications management in €770 million. SOF-based regimens also decreased liver-related mortality by 82%. Besides, SOF-based regimens gained 310,765/QALYs, saving €274 million (considering drugs, monitoring, and HCV management).
For Spain, SOF-based regimens offer value for HCV patients in terms of lowering HCV-related liver disease burden and generating significant cost savings for the health system, contributing to the WHO goal.
直接作用抗病毒药物治疗慢性丙型肝炎病毒（HCV）取得了巨大的突破，为医疗保健系统和患者带来了巨大的价值。本研究旨在评估索磷布韦（SOF）为西班牙在 2015 年至 2019 年期间治疗的 85959 例慢性 HCV 患者的目标人群提供的方案的疗效和价值，与之前的治疗策略（聚乙二醇干扰素/利巴韦林联合特拉泼维或博赛泼维的双重/三重治疗）相比。
先前开发的终生马尔可夫模型进行了调整，以模拟 HCV 疾病的演变。在 SOF 为基础的方案中，所有患者（100%）都接受治疗，无论是否获得了真实世界数据中 93-98%的持续病毒学应答（SVR）。在之前的治疗中，只有≥F2 患者根据临床实践进行治疗（38%），平均 SVR 为 61%，取自已发表的文献。该值通过避免 HCV 相关死亡率和肝脏并发症的临床和经济影响来衡量；总成本和质量调整生命年（QALYs），应用每年 3%的贴现率。
与之前的治疗相比，SOF 为基础的方案在患者的一生中降低了失代偿性肝硬化 89%、肝细胞癌 77%和肝移植 84%，降低了与肝脏并发症管理相关的费用 7.70 亿欧元。SOF 为基础的方案还降低了与肝脏相关的死亡率 82%。此外，SOF 为基础的方案获得了 310765 个 QALYs，为卫生系统节省了 2.74 亿欧元（考虑药物、监测和 HCV 管理）。
对于西班牙而言，SOF 为基础的方案为 HCV 患者提供了价值，降低了 HCV 相关肝脏疾病负担，并为卫生系统节省了大量成本，有助于实现世界卫生组织的目标。
