Saab Sammy, Parisé Hélène, Virabhak Suchin, Wang Alice, Marx Steven E, Sanchez Gonzalez Yuri, Misurski Derek, Johnson Scott
a UCLA, Pfleger Liver Institute , Los Angeles , CA , USA ;
b Medicus Economics LLC , Milton , MA, USA ;
J Med Econ. 2016 Aug;19(8):795-805. doi: 10.1080/13696998.2016.1176030. Epub 2016 Apr 24.
This study compared the cost-effectiveness of direct-acting antiviral therapies currently recommended for treating genotypes (GT) 1 and 4 chronic hepatitis C (CHC) patients in the US.
A cost-effectiveness analysis of treatments for CHC from a US payer's perspective over a lifelong time horizon was performed. A Markov model based on the natural history of CHC was used for a population that included treatment-naïve and -experienced patients. Treatment alternatives considered for GT1 included ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin (3D ± R), sofosbuvir + ledipasvir (SOF/LDV), sofosbuvir + simeprevir (SOF + SMV), simeprevir + pegylated interferon/ribavirin (SMV + PR) and no treatment (NT). For GT4 treatments, ombitasvir/paritaprevir/ritonavir + ribavirin (2D + R), SOF/LDV and NT were compared. Transition probabilities, utilities and costs were obtained from published literature. Outcomes included rates of compensated cirrhosis (CC), decompensated cirrhosis (DCC), hepatocellular carcinoma (HCC) and liver-related death (LrD), total costs, life-years and quality-adjusted life-years (QALYs). Costs and QALYs were used to calculate incremental cost-effectiveness ratios.
In GT1 patients, 3D ± R and SOF-containing regimens have similar long-term outcomes; 3D ± R had the lowest lifetime risks of all liver disease outcomes: CC = 30.2%, DCC = 5.0 %, HCC = 6.8%, LT = 1.9% and LrD = 9.2%. In GT1 patients, 3D ± R had the lowest cost and the highest QALYs. As a result, 3D ± R dominated these treatment options. In GT4 patients, 2D + R had lower rates of liver morbidity and mortality, lower cost and more QALYs than SOF/LDV and NT.
While the results are based on input values, which were obtained from a variety of heterogeneous sources-including clinical trials, the findings were robust across a plausible range of input values, as demonstrated in probabilistic sensitivity analyses.
Among currently recommended treatments for GT1 and GT4 in the US, 3D ± R (for GT1) and 2D + R (for GT4) have a favorable cost-effectiveness profile.
本研究比较了目前美国推荐用于治疗基因1型（GT）和4型慢性丙型肝炎（CHC）患者的直接抗病毒疗法的成本效益。
从美国医保支付方的角度，对CHC治疗进行了终身时间跨度的成本效益分析。基于CHC自然病史的马尔可夫模型用于包括初治和经治患者的人群。GT1型考虑的治疗方案包括奥比他韦/帕利哌韦/利托那韦+达沙布韦±利巴韦林（3D±R）、索磷布韦+来迪派韦（SOF/LDV）、索磷布韦+西米普明（SOF+SMV）、西米普明+聚乙二醇干扰素/利巴韦林（SMV+PR）以及不治疗（NT）。对于GT4型治疗，比较了奥比他韦/帕利哌韦/利托那韦+利巴韦林（2D+R）、SOF/LDV和NT。转移概率、效用和成本来自已发表的文献。结果包括代偿期肝硬化（CC）、失代偿期肝硬化（DCC）、肝细胞癌（HCC）和肝脏相关死亡（LrD）的发生率、总成本、生命年和质量调整生命年（QALY）。成本和QALY用于计算增量成本效益比。
在GT1型患者中，3D±R和含SOF的治疗方案具有相似的长期结果；3D±R在所有肝病结局中的终身风险最低：CC=30.2%，DCC=5.0%，HCC=6.8%，肝移植（LT）=1.9%，LrD=9.2%。在GT1型患者中，3D±R成本最低，QALY最高。因此，3D±R优于这些治疗选择。在GT4型患者中，2D+R的肝脏发病率和死亡率较低，成本较低，QALY比SOF/LDV和NT更多。
虽然结果基于从包括临床试验在内的各种异质来源获得的输入值，但如概率敏感性分析所示，在合理的输入值范围内，研究结果是稳健的。
在美国目前推荐的GT1型和GT4型治疗中，3D±R（用于GT1型）和2D+R（用于GT4型）具有良好的成本效益。
