title: [Cost-effectiveness analysis of sofosbuvir, peginterferon and ribavirin in patients with chronic hepatitis C: Early treatment in the initial stage of fibrosis vs. delayed treatment in advanced fibrosis].
abstract: OBJECTIVE
  Cost-effectiveness analysis of sofosbuvir combined with peginterferon alpha-2a and ribavirin (SOF/Peg-IFN/RBV) in early versus advanced fibrosis in previously untreated patients with chronic hepatitis C genotype 1 (CHC-GT1), from the perspective of the Spanish National Health System (NHS).
  
  
  METHODS
  A Markov model was developed to compare lifetime costs and outcomes (life years gained [LYGs] and quality-adjusted life years [QALYs]) of 2 treatment strategies: SOF/Peg-IFN/RBV administered during early fibrosis (mild-moderate fibrosis; F2-F3) or advanced fibrosis (cirrhosis; F4). Efficacy (sustained virologic response), annual transition probabilities, disease management costs and utilities were obtained from the literature. Costs and outcomes were discounted annually at 3%. Direct costs were considered, expressed in Euros (€, 2014). Probabilistic sensitivity analysis (PSA) was also performed.
  
  
  RESULTS
  SOF/Peg-IFN/RBV therapy at F2-F3 was more effective (19.12 LYGs and 14.14 QALYs) compared to F4. In a cohort of 1,000 patients, SOF/Peg-IFN/RBV prevented 66 cases of decompensated cirrhosis, 60 hepatocellular carcinomas and 4 liver transplantations compared with therapy in advanced fibrosis. The total lifetime cost of early therapy (€43,263) was less than the cost of treatment in the advanced stage (€49,018). Early therapy was a dominant strategy, more effective and less costly in all simulations. In the PSA analysis, administration of SOF/PEG-IFN/RBV at F2-F3 was dominant in all simulations.
  
  
  CONCLUSIONS
  Starting SOF/Peg-IFN/RBV therapy at F2-F3, compared with therapy at F4, reduced the incidence of liver disease complications and was associated with cost savings for the Spanish NHS in CHC-GT1 patients.
authors.affiliation: Unidad de Hepatología, Hospital Universitario Vall d'Hebron, Barcelona, España; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), España.
authors.forename: María
authors.initials: M
authors.lastname: Buti
authors.affiliation: Pharmacoeconomics & Outcomes Research Iberia, Madrid, España. Electronic address: rdominguez@porib.com.
authors.forename: Raquel
authors.initials: R
authors.lastname: Domínguez-Hernández
authors.affiliation: Pharmacoeconomics & Outcomes Research Iberia, Madrid, España.
authors.forename: Itziar
authors.initials: I
authors.lastname: Oyagüez
authors.affiliation: Pharmacoeconomics & Outcomes Research Iberia, Madrid, España.
authors.forename: Miguel Ángel
authors.initials: MÁ
authors.lastname: Casado
mesh_terms: D000998:Antiviral Agents / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use; D003198:Computer Simulation; D003362:Cost-Benefit Analysis; D016527:Drug Costs / Q000706:statistics & numerical data; D004359:Drug Therapy, Combination; D005102:Health Expenditures / Q000706:statistics & numerical data; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use; D008103:Liver Cirrhosis / Q000188:drug therapy / Q000209:etiology / Q000517:prevention & control; D008390:Markov Chains; D018803:Models, Economic; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use; D019057:Quality-Adjusted Life Years; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use; D012254:Ribavirin / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use; D000069474:Sofosbuvir / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use; D013030:Spain
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a; D000069474:Sofosbuvir
keywords: Chronic hepatitis C; Cost-effectiveness; Coste-efectividad; Genotipo 1; Genotype 1; Hepatitis C crónica; Sofosbuvir