背景:telaprevir或boceprevir三联疗法已被证明可有效治疗慢性丙型肝炎,应答率高达88%。然而,治疗可能与重要的不良反应和高经济影响有关。
目的:评估telaprevir或boceprevir三联疗法治疗慢性丙型肝炎的成本效益和安全性。
方法:回顾性观察研究。我们纳入了所有在7月31日(st)之前开始使用蛋白酶抑制剂治疗的患者,2013.我们评估了持续的病毒学应答,每位患者实现持续病毒学应答的成本,以及与三联疗法相关的不良事件的支持性治疗的费用。
结果:纳入59例患者;35例接受telaprevir治疗(59.3%),24例接受boceprevir治疗(40.7%)。38例(64.4%)患者获得了持续的病毒学应答:telaprevir治疗组24例(68.6%)患者和boceprevir治疗组14例(58.3%)患者。每位持续病毒学应答患者的费用为43,555€(95%CI35,389-51,722€)。使用telaprevir治疗的总成本之间没有统计学上的显着差异,43,494欧元(95%CI34,795欧元-55,092欧元)与boceprevir相比,42,005欧元(95%CI32,122-64,243欧元)。每位患者的平均支持性护理费用为1,500欧元,而最高费用为11,374欧元。由于不良事件,8例(13.6%)患者需要住院,22名(37.3%)患者参加了事故和急诊科,26例(44.1%)患者需要额外的医疗咨询。
结论:telaprevir或boceprevir三联疗法的治疗导致每位患者持续病毒学应答的高成本。由于不良事件,大量患者需要支持治疗,其费用应与三联疗法的费用相加。
BACKGROUND: Triple therapy with telaprevir or boceprevir has proven to be effective in the treatment of chronic hepatitis C with response rates of up to 88%. However, the treatment may be associated with important adverse effects and a high economic impact.
OBJECTIVE: To assess the cost-effectiveness and safety of triple therapy with telaprevir or boceprevir for the treatment of chronic hepatitis C.
METHODS: Retrospective observational study. We included all patients who had started treatment with protease inhibitors before July 31(st), 2013. We evaluated sustained virological response, the cost per patient achieving sustained virological response, and the cost of the supportive treatment for adverse events associated with triple therapy.
RESULTS: Fifty-nine patients were included; 35 had been treated with telaprevir (59.3%) and 24 with boceprevir (40.7%). Sustained virological response was achieved by 38 (64.4%) patients: 24 (68.6%) patients in the telaprevir treatment arm and 14 (58.3%) patients in the boceprevir treatment arm. The cost per patient with sustained virological response was 43,555 € (95% CI 35,389-51,722 €). There were no statistically significant differences between the overall costs of therapy with telaprevir, 43,494 € (95% CI 34,795 €-55,092 €) versus boceprevir, 42,005 € (95% CI 32,122-64,243€). The mean cost of supportive care per patient was 1,500 €, while the maximum cost was 11,374 €. Due to adverse events, 8 (13.6%) patients required hospital admission, 22 (37.3%) patients attended the accident and emergency department, and 26 (44.1%) patients needed additional medical consultations.
CONCLUSIONS: The treatment of triple therapy with telaprevir or boceprevir resulted in high cost per patient with sustained virological response. Due to adverse events, a high number of patients required supportive care, whose costs should be added to those of triple therapy.