Sezione di Gastroenterologia, Di.Bi.M.I.S., University of Palermo, Palermo, Italy.
Hepatology. 2014 May;59(5):1692-705. doi: 10.1002/hep.27010. Epub 2014 Apr 1.
We assessed the cost-effectiveness of sofosbuvir (SOF)-based triple therapy (TT) compared with boceprevir (BOC)- and telaprevir (TVR)-based TT in untreated genotype 1 (G1) chronic hepatitis C (CHC) patients discriminated according to IL28B genotype, severity of liver fibrosis, and G1 subtype. The available published literature provided the data source. The target population was made up of untreated Caucasian patients, aged 50 years, with G1CHC and these were evaluated over a lifetime horizon by Markov model. The study was carried out from the perspective of the Italian National Health Service. Outcomes included discounted costs (in euros at 2013 value), life-years gained (LYG), quality-adjusted life year (QALY), and incremental cost-effectiveness ratio (ICER). Cost of SOF was assumed to be € 3,500 per week, i.e., the price generating a willingness-to-pay threshold of € 25,000 per LYG compared with TVR in the entire population of untreated G1 patients. The robustness of the results was evaluated by one-way deterministic and multivariate probabilistic sensitivity analyses. SOF was cost-effective compared with BOC in all strategies with the exception of cirrhosis and IL28B CC patients. In comparison with TVR-based strategies, SOF was cost-effective in IL28B CT/TT (ICER per LYG € 22,229) and G1a (€ 19,359) patients, not cost-effective in IL28B CC (€45,330), fibrosis F0-F3 (€ 26,444), and in cirrhosis (€ 34,906) patients, and dominated in G1b patients. The models were sensitive to SOF prices and to likelihood of sustained virological response.
In untreated G1 CHC patients, SOF-based TT may be a cost-effective alternative to first-generation protease inhibitors depending on pricing. The cost-effectiveness of SOF improved in IL28B CT/TT and G1a patients. SOF was dominated by TVR in G1b patients even if, in clinical practice, this issue could be counterbalanced by the good tolerability profile of SOF and by the shorter treatment duration.
我们评估了索非布韦(SOF)为基础的三联疗法(TT)与博赛泼维(BOC)和特拉泼维(TVR)为基础的 TT 在未经治疗的基因型 1(G1)慢性丙型肝炎(CHC)患者中的成本效益,这些患者根据 IL28B 基因型、肝纤维化严重程度和 G1 亚型进行了区分。现有已发表的文献提供了数据来源。目标人群是未经治疗的、年龄为 50 岁的高加索人,患有 G1CHC,并通过马尔可夫模型在一生中进行评估。这项研究是从意大利国家卫生服务的角度进行的。结果包括折扣成本(以 2013 年的欧元计算)、生命年获益(LYG)、质量调整生命年(QALY)和增量成本效益比(ICER)。SOF 的成本假设为每周 3500 欧元,即与 TVR 相比,在未经治疗的所有 G1 患者中,生成 25000 欧元/LYG 的意愿支付阈值。通过单因素确定性和多变量概率敏感性分析评估了结果的稳健性。SOF 在除肝硬化和 IL28B CC 患者之外的所有策略中都比 BOC 具有成本效益。与 TVR 为基础的策略相比,SOF 在 IL28B CT/TT(每 LYG 的 ICER 为 22229 欧元)和 G1a(19359 欧元)患者中具有成本效益,在 IL28B CC(45330 欧元)、纤维化 F0-F3(26444 欧元)和肝硬化(34906 欧元)患者中不具有成本效益,并且在 G1b 患者中被主导。模型对 SOF 价格和持续病毒学应答的可能性敏感。
在未经治疗的 G1 CHC 患者中,SOF 为基础的 TT 可能是第一代蛋白酶抑制剂的一种具有成本效益的替代方案,这取决于定价。在 IL28B CT/TT 和 G1a 患者中,SOF 的成本效益得到了提高。SOF 在 G1b 患者中被 TVR 主导,即使在临床实践中,SOF 的良好耐受性和较短的治疗时间也可以抵消这一问题。