title: Cost-effectiveness of daclatasvir plus sofosbuvir-based regimen for treatment of hepatitis C virus genotype 3 infection in Canada.
abstract: OBJECTIVE
  New regimens for the treatment of chronic hepatitis C virus (HCV) genotype 3 have demonstrated substantial improvement in sustained virologic response (SVR) compared with existing therapies, but are considerably more expensive. The objective of this study was to evaluate the cost-effectiveness of two novel all-oral, interferon-free regimens for the treatment of patients with HCV genotype 3: daclatasvir plus sofosbuvir (DCV + SOF) and sofosbuvir plus ribavirin (SOF + RBV), from a Canadian health-system perspective.
  
  
  METHODS
  A decision analytic Markov model was developed to compare the effect of various treatment strategies on the natural history of the disease and their associated costs in treatment-naïve and treatment-experienced patients. Patients were initially distributed across fibrosis stages F0-F4, and may incur disease progression through fibrosis stages and on to end-stage liver disease complications and death; or may achieve SVR. Clinical efficacy, health-related quality-of-life, costs, and transition probabilities were based on published literature. Probabilistic sensitivity analysis was performed to assess parameter uncertainty associated with the analysis.
  
  
  RESULTS
  In treatment-naive patients, the expected quality-adjusted life years (QALYs) for interferon-free regimens were higher for DCV + SOF (12.37) and SOF + RBV (12.48) compared to that of pINF + RBV (11.71) over a lifetime horizon, applying their clinical trial treatment durations. The expected costs were higher for DCV + SOF ($170,371) and SOF + RBV ($194,776) vs pINF + RBV regimen ($90,905). Compared to pINF + RBV, the incremental cost-effectiveness ratios (ICER) were $120,671 and $135,398 per QALYs for DCV + SOF and SOF + RBV, respectively. In treatment-experienced patients, DCV + SOF regimen dominated the SOF + RBV regimen. Probabilistic sensitivity analysis indicated a 100% probability that a DCV + SOF regimen was cost saving in treatment-experienced patients.
  
  
  CONCLUSIONS
  Daclatasvir plus sofosbuvir is a safe and effective option for the treatment of chronic HCV genotype 3 patients. This regimen could be considered a cost-effective option following a first-line treatment of peg-interferon/ribavirin treatment experienced patients with HCV genotype-3 infection.
authors.affiliation: a a BMS Canada, Market Access and Public Affairs , Saint-Laurent, Quebec , Canada.
authors.forename: A
authors.initials: A
authors.lastname: Moshyk
authors.affiliation: a a BMS Canada, Market Access and Public Affairs , Saint-Laurent, Quebec , Canada.
authors.forename: M-J
authors.initials: MJ
authors.lastname: Martel
authors.affiliation: a a BMS Canada, Market Access and Public Affairs , Saint-Laurent, Quebec , Canada.
authors.forename: A A
authors.initials: AA
authors.lastname: Tahami Monfared
authors.affiliation: b b Goeree Consulting and Professor Emeritus, McMaster University , Hamilton , Ontario , Canada.
authors.forename: R
authors.initials: R
authors.lastname: Goeree
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000191:economics*; D002170:Canada; D002219:Carbamates; D003362:Cost-Benefit Analysis; D004359:Drug Therapy, Combination / Q000191:economics*; D005260:Female; D017048:Health Care Costs; D016174:Hepacivirus / Q000187:drug effects* / Q000235:genetics*; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000191:economics*; D008297:Male; D008390:Markov Chains; D008875:Middle Aged; D011759:Pyrrolidines; D019057:Quality-Adjusted Life Years; D000069474:Sofosbuvir / Q000008:administration & dosage / Q000191:economics*; D014633:Valine / Q000031:analogs & derivatives
chemical_list: D000998:Antiviral Agents; D002219:Carbamates; D007093:Imidazoles; D011759:Pyrrolidines; D014633:Valine; C549273:daclatasvir; D000069474:Sofosbuvir
keywords: Canada; Chronic hepatitis C; Cost-effectiveness; Daclatasvir; Genotype 3; Pegylated interferon; Sofosbuvir