Corman Shelby, Elbasha Elamin H, Michalopoulos Steven N, Nwankwo Chizoba
Pharmerit International, Bethesda, MD, USA.
Merck & Co., Inc., North Wales, PA, USA.
Value Health. 2017 Sep;20(8):1110-1120. doi: 10.1016/j.jval.2017.05.003. Epub 2017 Jun 20.
To evaluate the cost-utility of treatment with elbasvir/grazoprevir (EBR/GZR) regimens compared with ledipasvir/sofosbuvir (LDV/SOF), ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin (3D ± RBV), and sofosbuvir/velpatasvir (SOF/VEL) in patients with chronic hepatitis C genotype (GT) 1 infection.
A Markov cohort state-transition model was constructed to evaluate the cost-utility of EBR/GZR ± RBV over a lifetime time horizon from the payer perspective. The target population was patients infected with chronic hepatitis C GT1 subtypes a or b (GT1a or GT1b), stratified by treatment history (treatment-naive [TN] or treatment-experienced), presence of cirrhosis, baseline hepatitis C virus RNA (< or ≥6 million IU/mL), and presence of NS5A resistance-associated variants. The primary outcome was incremental cost-utility ratio for EBR/GZR ± RBV versus available oral direct-acting antiviral agents. One-way and probabilistic sensitivity analyses were performed to test the robustness of the model.
EBR/GZR ± RBV was economically dominant versus LDV/SOF in all patient populations. EBR/GZR ± RBV was also less costly than SOF/VEL and 3D ± RBV, but produced fewer quality-adjusted life-years in select populations. In the remaining populations, EBR/GZR ± RBV was economically dominant. One-way sensitivity analyses showed varying sustained virologic response rates across EBR/GZR ± RBV regimens, commonly impacted model conclusions when lower bound values were inserted, and at the upper bound resulted in dominance over SOF/VEL in GT1a cirrhotic and GT1b TN noncirrhotic patients. Results of the probabilistic sensitivity analysis showed that EBR/GZR ± RBV was cost-effective in more than 99% of iterations in GT1a and GT1b noncirrhotic patients and more than 69% of iterations in GT1b cirrhotic patients.
Compared with other oral direct-acting antiviral agents, EBR/GZR ± RBV was the economically dominant regimen for treating GT1a noncirrhotic and GT1b TN cirrhotic patients, and was cost saving in all other populations.
评估艾尔巴韦/格拉瑞韦（EBR/GZR）方案与来迪派韦/索磷布韦（LDV/SOF）、奥比他韦/帕立普韦/利托那韦+达沙布韦±利巴韦林（3D±RBV）以及索磷布韦/维帕他韦（SOF/VEL）治疗慢性丙型肝炎基因（GT）1型感染患者的成本效益。
构建马尔可夫队列状态转换模型，从支付方角度评估EBR/GZR±RBV方案在患者终身时间范围内的成本效益。目标人群为感染慢性丙型肝炎GT1a或GT1b亚型（GT1a或GT1b）的患者，按治疗史（初治[TN]或经治）、肝硬化情况、基线丙型肝炎病毒RNA（<或≥600万IU/mL）以及NS5A耐药相关变异的存在情况进行分层。主要结局是EBR/GZR±RBV方案与现有口服直接抗病毒药物相比的增量成本效益比。进行单因素和概率敏感性分析以检验模型的稳健性。
在所有患者群体中，EBR/GZR±RBV方案相对于LDV/SOF方案具有经济优势。EBR/GZR±RBV方案的成本也低于SOF/VEL和3D±RBV方案，但在部分人群中产生的质量调整生命年较少。在其余人群中，EBR/GZR±RBV方案具有经济优势。单因素敏感性分析显示，EBR/GZR±RBV方案的持续病毒学应答率各不相同，当插入下限值时通常会影响模型结论，而在上限值时导致在GT1a肝硬化和GT1b TN非肝硬化患者中优于SOF/VEL方案。概率敏感性分析结果显示，在GT1a和GT1b非肝硬化患者中，EBR/GZR±RBV方案在超过99%的迭代中具有成本效益，在GT1b肝硬化患者中超过69%的迭代具有成本效益。
与其他口服直接抗病毒药物相比，EBR/GZR±RBV方案是治疗GT1a非肝硬化和GT1b TN肝硬化患者的经济优势方案，在所有其他人群中具有成本节约效果。
