title: Cost-effectiveness of combination daclatasvir-sofosbuvir for treatment of genotype 3 chronic hepatitis C infection in the United States.
abstract: BACKGROUND
  A phase III trial evaluated the efficacy and safety of Daklinza (daclatasvir or DCV) in combination with sofosbuvir (SOF) for treatment of genotype (GT) 3 hepatitis C virus (HCV) patients.
  
  
  OBJECTIVE
  This study evaluated the cost-effectiveness of DCV + SOF vs SOF in combination with ribavirin (RBV) over a 20-year time horizon from the perspective of a United States (US) payer.
  
  
  METHODS
  A published Markov model was adapted to reflect US demographic characteristics, treatment patterns, costs of drug acquisition, monitoring, disease and adverse event management, and mortality risks. Clinical inputs came from the ALLY-3 and VALENCE trials. The primary outcome was the incremental cost-utility ratio. Life-years, incidence of complications, number of patients achieving sustained virological response (SVR), and the total cost per SVR were secondary outcomes. Costs (2014 USD) and quality-adjusted life years (QALYs) were discounted at 3% per year. Deterministic, probabilistic, and scenario sensitivity analyses were conducted.
  
  
  RESULTS
  DCV + SOF was associated with lower costs and better effectiveness than SOF + RBV in the base case and in almost all scenarios (i.e. treatment-experienced, non-cirrhotic, time horizons of 5, 10, and 80 years). DCV + SOF was less costly, but also slightly less effective than SOF + RBV in the cirrhotic and treatment-naïve population scenarios. Results were sensitive to variations in the probability of achieving SVR for both treatment arms. DCV + SOF costs less than $50,000 per QALY gained in 79% of all probabilistic iterations compared with SOF + RBV.
  
  
  CONCLUSIONS
  DCV + SOF is a dominant option compared with SOF + RBV in the US for the overall GT 3 HCV patient population.
authors.affiliation: a Evidera , Montreal , QC , Canada.
authors.forename: Catherine
authors.identifier: http://orcid.org/0000-0002-5415-1045
authors.initials: C
authors.lastname: Saint-Laurent Thibault
authors.affiliation: b QuickPivot , Boston , MA , USA.
authors.forename: Divya
authors.initials: D
authors.lastname: Moorjaney
authors.affiliation: c Evidera , Waltham , MA , USA.
authors.forename: Michael L
authors.identifier: http://orcid.org/0000-0002-9702-2999
authors.initials: ML
authors.lastname: Ganz
authors.affiliation: d Bristol-Myers Squibb , Hartford , CT , USA.
authors.forename: Bruce
authors.initials: B
authors.lastname: Sill
authors.affiliation: e Bristol-Myers Squibb , Plainsboro , NJ , USA.
authors.forename: Shalini
authors.initials: S
authors.lastname: Hede
authors.affiliation: e Bristol-Myers Squibb , Plainsboro , NJ , USA.
authors.forename: Yong
authors.initials: Y
authors.lastname: Yuan
authors.affiliation: f GlaxoSmithKline , Upper Providence , PA , USA.
authors.forename: Boris
authors.initials: B
authors.lastname: Gorsh
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D002219:Carbamates; D003362:Cost-Benefit Analysis; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D007093:Imidazoles / Q000191:economics / Q000627:therapeutic use; D008297:Male; D008390:Markov Chains; D008875:Middle Aged; D018803:Models, Economic; D011759:Pyrrolidines; D019057:Quality-Adjusted Life Years; D000069474:Sofosbuvir / Q000191:economics / Q000627:therapeutic use; D016019:Survival Analysis; D014481:United States; D014633:Valine / Q000031:analogs & derivatives
chemical_list: D000998:Antiviral Agents; D002219:Carbamates; D007093:Imidazoles; D011759:Pyrrolidines; D014633:Valine; C549273:daclatasvir; D000069474:Sofosbuvir
keywords: Cost-benefit analysis; Cost-effectiveness; Daclatasvir; Hepatitis C; Sofosbuvir