School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, 205 Kapoor Hall, Buffalo, NY 14214, USA.
Pharmacoeconomics. 2013 Sep;31(9):739-51. doi: 10.1007/s40273-013-0073-2.
Chronic hepatitis C virus (HCV) infection, a blood-borne virus, is the leading cause of chronic liver disease and liver transplantation worldwide. Chronic HCV infection is usually asymptomatic in the early stages of the disease, making an estimation of the total population affected difficult to elicit. The gold standard treatment option to date has been a combination of pegylated interferon and ribavirin. Recent developments have led to the introduction of two protease inhibitors for use in chronic HCV-boceprevir and telaprevir. Phase III studies have shown both agents have the potential to significantly increase the probability of attaining a sustained virologic response (the primary outcome of interest in chronic HCV) in genotype 1 infections. However, the added cost of these agents also presents the need for decision makers to determine their place on drug formularies. The protease inhibitors are to be administered as triple therapy with the existing gold standard. However, significant variation exists as to the proposed duration of triple therapy, use of lead-in pegylated interferon and ribavirin and subsequent pegylated interferon therapy after finishing the course of triple therapy. Treatment algorithms also exist for the use of stopping rules in the case of early non-responders.The aim of this review is to highlight the current understanding of the economic impact protease inhibitors may have on health care systems and considerations required in the treatment of HCV. Economic and health-related quality of life issues are addressed from multiple viewpoints. The major aspects of the economic evaluations, to date, that included triple therapy as an alternative in the treatment of chronic HCV are brought to light. Future economic evaluations in alternative settings would be useful. The review also emphasizes the challenges for future research. This includes the potential for new therapies to no longer require inclusion of pegylated interferon and/or ribavirin, as well as the use of protease inhibitors in non-genotype 1 patients or those with significant co-morbidities such as HIV/AIDS.
慢性丙型肝炎病毒（HCV）感染是一种血源性病毒，是全球慢性肝病和肝移植的主要原因。慢性 HCV 感染在疾病早期通常无症状，因此难以准确估计受影响的总人群。迄今为止，金标准治疗选择一直是聚乙二醇干扰素和利巴韦林联合治疗。最近的发展导致了两种蛋白酶抑制剂在慢性 HCV 中被引入——博赛泼维（boceprevir）和特拉泼维（telaprevir）。III 期研究表明，这两种药物都有可能显著提高基因型 1 感染患者获得持续病毒学应答（慢性 HCV 主要关注的终点）的概率。然而，这些药物的附加成本也需要决策者确定它们在药物处方中的位置。蛋白酶抑制剂与现有的金标准联合使用作为三联疗法。然而，在三联疗法的建议持续时间、使用引介性聚乙二醇干扰素和利巴韦林以及在完成三联疗法后随后的聚乙二醇干扰素治疗方面存在显著差异。在早期无应答者的情况下，也存在使用停药规则的治疗算法。本综述的目的是强调蛋白酶抑制剂对卫生保健系统可能产生的经济影响的当前理解，并考虑到 HCV 治疗所需的考虑因素。从多个角度解决了经济和健康相关生活质量问题。迄今为止，包括作为替代方案治疗慢性 HCV 的三联疗法的经济评估的主要方面被揭示出来。在替代治疗方案中进行未来的经济评估将是有用的。该综述还强调了未来研究的挑战。这包括新疗法可能不再需要包含聚乙二醇干扰素和/或利巴韦林，以及在非基因型 1 患者或有重大合并症（如 HIV/AIDS）的患者中使用蛋白酶抑制剂。
