title: Cost-effectiveness of elbasvir/grazoprevir use in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and chronic kidney disease in the United States.
abstract: Among patients with chronic kidney disease (CKD) in the United States, HCV infection causes significant morbidity and mortality and results in substantial healthcare costs. A once-daily oral regimen of elbasvir/grazoprevir (EBR/GZR) for 12 weeks was found to be a safe and efficacious treatment for HCV in patients with CKD. We evaluated the cost-effectiveness of EBR/GZR in treatment-naïve and treatment-experienced CKD patients compared with no treatment (NoTx) and pegylated interferon plus ribavirin (peg-IFN/RBV) using a computer-based model of the natural history of chronic HCV genotype 1 infection, CKD and liver disease. Data on baseline characteristics of the simulated patients were obtained from NHANES, 2000-2010. Model inputs were estimated from published studies. Cost of treatment with EBR/GZR and peg-INF/RBV were based on wholesale acquisition cost. All costs were from a third-party payer perspective and were expressed in 2015 U.S. dollars. We estimated lifetime incidence of liver-related complications, liver transplantation, kidney transplantation, end-stage live disease mortality and end-stage renal disease mortality; lifetime quality-adjusted life years (QALY); and incremental cost-utility ratios (ICUR). The model predicted that EBR/GZR will significantly reduce the incidence of liver-related complications and prolong life in patients with chronic HCV genotype 1 infection and CKD compared with NoTx or use of peg-IFN/RBV. EBR/GZR-based regimens resulted in higher average remaining QALYs and higher costs (11.5716, $191 242) compared with NoTx (8.9199, $156 236) or peg-INF/RBV (10.2857, $186 701). Peg-IFN/RBV is not cost-effective, and the ICUR of EBR/GZR compared with NoTx was $13 200/QALY. Treatment of a patient on haemodialysis with EBR/GZR resulted in a higher ICUR ($217 000/QALY). Assuming a threshold of $100 000 per QALY gained for cost-effectiveness, use of elbasvir/grazoprevir to treat an average patient with CKD can be considered cost-effective in the United States.
authors.affiliation: Merck & Co., Inc., Kenilworth, NJ, USA.
authors.forename: E
authors.initials: E
authors.lastname: Elbasha
authors.affiliation: Merck & Co., Inc., Kenilworth, NJ, USA.
authors.forename: W
authors.initials: W
authors.lastname: Greaves
authors.affiliation: University of Miami Miller School of Medicine, Miami, FL, USA.
authors.forename: D
authors.initials: D
authors.lastname: Roth
authors.affiliation: Merck & Co., Inc., Kenilworth, NJ, USA.
authors.forename: C
authors.initials: C
authors.lastname: Nwankwo
mesh_terms: D000577:Amides; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000191:economics; D001572:Benzofurans / Q000008:administration & dosage* / Q000191:economics; D002219:Carbamates; D003198:Computer Simulation; D003362:Cost-Benefit Analysis; D003521:Cyclopropanes; D005838:Genotype; D016174:Hepacivirus / Q000145:classification* / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000191:economics / Q000821:virology; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage* / Q000191:economics; D016898:Interferon-alpha / Q000008:administration & dosage / Q000191:economics; D011810:Quinoxalines / Q000008:administration & dosage* / Q000191:economics; D051436:Renal Insufficiency, Chronic / Q000150:complications*; D012254:Ribavirin / Q000008:administration & dosage / Q000191:economics; D013449:Sulfonamides; D014481:United States; D047029:Lactams, Macrocyclic
chemical_list: D000577:Amides; D000998:Antiviral Agents; D001572:Benzofurans; D002219:Carbamates; D003521:Cyclopropanes; D007093:Imidazoles; D016898:Interferon-alpha; D011810:Quinoxalines; D012254:Ribavirin; D013449:Sulfonamides; C578009:grazoprevir; D047029:Lactams, Macrocyclic; C000589335:elbasvir
keywords: 
  CKD
  ; 
  HCV
  ; chronic hepatitis C; chronic kidney disease; cost-effectiveness analysis; elbasvir/grazoprevir