Younossi Z M, Park H, Saab S, Ahmed A, Dieterich D, Gordon S C
Department of Medicine, Center for Liver Diseases, Inova Fairfax Hospital, Falls Church, VA, USA.
Aliment Pharmacol Ther. 2015 Mar;41(6):544-63. doi: 10.1111/apt.13081. Epub 2015 Jan 26.
An all-oral, pegylated interferon (pegIFN)-free and ribavirin (RBV)-free single-tablet of ledipasvir (LDV) and sofosbuvir (SOF) is now approved for the treatment of patients infected with hepatitis C virus (HCV) genotype 1.
To estimate the health economic outcomes for LDV/SOF compared with current treatments in US patients infected with HCV genotype 1.
A hybrid decision-tree and Markov state-transition model was developed. For a cohort of 10,000 patients, the model captured outcomes for several pairings of LDV/SOF with comparators, including long-term health outcomes, number need to treat, life-years gained, quality-adjusted life-years (QALYS) gained, incremental cost-effectiveness ratios and costs per sustained virologic response (SVR). Patients with different levels of treatment experience and different cirrhosis stages were included.
LDV/SOF decreased the number of advanced liver disease cases by 0-93% compared with current regimens or no treatment in treatment-naïve patients. In treatment-experienced [pegIFN plus ribavirin (PR) or protease inhibitor (PI) + PR] patients, treatment with LDV/SOF decreased the incidence of advanced liver disease complications in most of the cases analysed, except SOF + SMV. For all patient sub-cohorts, LDV/SOF was associated with the lowest 1-year costs per SVR and, with regard to lifetime incremental costs per QALY gained, was either dominant or the most cost-effective treatment. Overall, treatment initiation at earlier stages of liver fibrosis resulted in improved health economic outcomes.
LDV/SOF is associated with more favourable short- and long-term health economic outcomes compared with current therapies for patients across all levels of treatment experience and cirrhosis stages.
一种不含聚乙二醇化干扰素（pegIFN）和利巴韦林（RBV）的全口服单片剂，由来迪派韦（LDV）和索磷布韦（SOF）组成，现已获批用于治疗丙型肝炎病毒（HCV）基因1型感染患者。
评估LDV/SOF与美国HCV基因1型感染患者目前治疗方案相比的健康经济结果。
建立了一个混合决策树和马尔可夫状态转移模型。对于10,000名患者的队列，该模型捕捉了LDV/SOF与对照方案几种组合的结果，包括长期健康结果、需治疗人数、获得的生命年数、获得的质量调整生命年（QALY）、增量成本效益比以及每例持续病毒学应答（SVR）的成本。纳入了不同治疗经验水平和不同肝硬化阶段的患者。
与初治患者的现有方案或不治疗相比，LDV/SOF可使晚期肝病病例数减少0 - 93%。在经治患者[聚乙二醇化干扰素联合利巴韦林（PR）或蛋白酶抑制剂（PI）+ PR]中，除SOF + SMV外，在大多数分析病例中，LDV/SOF治疗可降低晚期肝病并发症的发生率。对于所有患者亚队列，LDV/SOF每例SVR的1年成本最低，就每获得一个QALY的终生增量成本而言，要么占主导地位，要么是最具成本效益的治疗方案。总体而言，在肝纤维化早期开始治疗可改善健康经济结果。
与目前针对所有治疗经验水平和肝硬化阶段患者的疗法相比，LDV/SOF具有更有利的短期和长期健康经济结果。
