Barclay Stephen T, Cooke Graham S, Holtham Elizabeth, Gauthier Aline, Schwarzbard Jeremie, Atanasov Petar, Irving William L
1Walton Liver Clinic, Glasgow Royal Infirmary, Glasgow, UK.
2Division of Infectious diseases, Imperial College London, London, UK.
Hepatol Med Policy. 2016 Apr 14;1:2. doi: 10.1186/s41124-016-0002-z. eCollection 2016.
New interferon (IFN)-free treatments for hepatitis C are more effective, safer but more expensive than current IFN-based therapies. Comparative data of these, versus current first generation protease inhibitors (PI) with regard to costs and treatment outcomes are needed. We investigated the real-world effectiveness, safety and cost per cure of 1st generation PI-based therapies in the UK.
Medical records review of patients within the HCV Research UK database. Patients had received treatment with telaprevir or boceprevir and pegylated interferon and ribavirin (PR). Data on treatment outcome, healthcare utilisation and adverse events (AEs) requiring intervention were collected and analysed overall and by subgroups. Costs of visits, tests, therapies, adverse events and hospitalisations were estimated at the patient level. Total cost per cure was calculated as total median cost divided by SVR rate.
154 patients from 35 centres were analysed. Overall median total cost per cure was £44,852 (subgroup range,: £35,492 to £107,288). Total treatment costs were accounted for by PI: 68.3 %, PR: 26.3 %, AE management: 5.4 %. Overall SVR was 62.3 % (range 25 % to 86.2 %). 36 % of patients experienced treatment-related AEs requiring intervention, 10 % required treatment-related hospitalisation.
This is the first UK multicentre study of outcomes and costs of PI-based HCV treatments in clinical practice. There was substantial variation in total cost per cure among patient subgroups and high rates of treatment-related discontinuations, AEs and hospitalisations. Real world safety, effectiveness and total cost per cure for the new IFN free combinations should be compared against this baseline.
丙型肝炎的新型无干扰素治疗比目前基于干扰素的疗法更有效、更安全，但成本更高。需要这些疗法与当前第一代蛋白酶抑制剂（PI）在成本和治疗结果方面的比较数据。我们调查了英国基于第一代PI疗法的实际疗效、安全性和每治愈一例的成本。
对英国丙型肝炎研究数据库中的患者病历进行回顾。患者接受了特拉匹韦或博赛匹韦与聚乙二醇干扰素和利巴韦林（PR）的联合治疗。收集并分析了治疗结果、医疗资源利用情况以及需要干预的不良事件（AE）的数据，整体及按亚组进行分析。在患者层面估算了就诊、检查、治疗、不良事件和住院的费用。每治愈一例的总成本计算为总中位数成本除以持续病毒学应答（SVR）率。
分析了来自35个中心的154例患者。每治愈一例的总体中位数总成本为44,852英镑（亚组范围：35,492英镑至107,288英镑）。总治疗成本中PI占68.3%，PR占26.3%，AE管理占5.4%。总体SVR为62.3%（范围为25%至86.2%）。36%的患者经历了需要干预的治疗相关AE，10%的患者需要治疗相关住院。
这是英国第一项关于临床实践中基于PI的丙型肝炎治疗结果和成本的多中心研究。患者亚组之间每治愈一例的总成本存在很大差异，治疗相关停药、AE和住院率较高。应将新型无干扰素联合疗法的实际安全性、有效性和每治愈一例的总成本与该基线进行比较。
