title: Should we await IFN-free regimens to treat HCV genotype 1 treatment-naive patients? A cost-effectiveness analysis (ANRS 95141).
abstract: OBJECTIVE
  In treatment-naive patients mono-infected with genotype 1 chronic HCV, treatments with telaprevir/boceprevir (TVR/BOC)-based triple therapy are standard-of-care. However, more efficacious direct-acting antivirals (IFN-based new DAAs) are available and interferon-free (IFN-free) regimens are imminent (2015).
  
  
  METHODS
  A mathematical model estimated quality-adjusted life years, cost and incremental cost-effectiveness ratios of (i) IFN-based new DAAs vs. TVR/BOC-based triple therapy; and (ii) IFN-based new DAAs initiation strategies, given that IFN-free regimens are imminent. The sustained virological response in F3-4/F0-2 was 71/89% with IFN-based new DAAs, 85/95% with IFN-free regimens, vs. 64/80% with TVR/BOC-based triple therapy. Serious adverse events leading to discontinuation were taken as: 0-0.6% with IFN-based new DAAs, 0% with IFN-free regimens, vs. 1-10% with TVR/BOC-based triple therapy. Costs were €60,000 for 12weeks of IFN-based new DAAs and two times higher for IFN-free regimens.
  
  
  RESULTS
  Treatment with IFN-based new DAAs when fibrosis stage ⩾F2 is cost-effective compared to TVR/BOC-based triple therapy (€37,900/QALY gained), but not at F0-1 (€103,500/QALY gained). Awaiting the IFN-free regimens is more effective, except in F4 patients, but not cost-effective compared to IFN-based new DAAs. If we decrease the cost of IFN-free regimens close to that of IFN-based new DAAs, then awaiting the IFN-free regimen becomes cost-effective.
  
  
  CONCLUSIONS
  Treatment with IFN-based new DAAs at stage ⩾F2 is both effective and cost-effective compared to TVR/BOC triple therapy. Awaiting IFN-free regimens and then treating regardless of fibrosis is more efficacious, except in F4 patients; however, the cost-effectiveness of this strategy is highly dependent on its cost.
authors.affiliation: Inserm, IAME, UMR 1137, F-75018 Paris, France; Inserm U995, Univ Lille 2 - Lille Nord de France, Lille, France; Univ Paris Diderot, Sorbonne Paris Cité, F-75018 Paris, France. Electronic address: sylvie.burban@inserm.fr.
authors.forename: Sylvie
authors.initials: S
authors.lastname: Deuffic-Burban
authors.affiliation: Inserm, IAME, UMR 1137, F-75018 Paris, France; Univ Paris Diderot, Sorbonne Paris Cité, F-75018 Paris, France.
authors.forename: Michaël
authors.initials: M
authors.lastname: Schwarzinger
authors.affiliation: Inserm, IAME, UMR 1137, F-75018 Paris, France; Univ Paris Diderot, Sorbonne Paris Cité, F-75018 Paris, France.
authors.forename: Dorothée
authors.initials: D
authors.lastname: Obach
authors.affiliation: Unité d'Hépatologie, Assistance Publique - Hôpitaux de Paris, Groupe hospitalier Cochin Saint Vincent de Paul, Université Paris Descartes, Paris, France; Institut Cochin, Université Paris Descartes, Inserm U1016, CNRS UMR 8104, Paris, France; Inserm U1016, Université Paris Descartes, Paris, France; Lingha Systems, Paris Biotech Santé, Paris, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Mallet
authors.affiliation: Unité d'Hépatologie, Assistance Publique - Hôpitaux de Paris, Groupe hospitalier Cochin Saint Vincent de Paul, Université Paris Descartes, Paris, France; Institut Cochin, Université Paris Descartes, Inserm U1016, CNRS UMR 8104, Paris, France; Inserm U1016, Université Paris Descartes, Paris, France.
authors.forename: Stanislas
authors.initials: S
authors.lastname: Pol
authors.affiliation: Service des Maladies de l'Appareil digestif, Hôpital Saint Eloi, Montpellier, France.
authors.forename: Georges-Philippe
authors.initials: GP
authors.lastname: Pageaux
authors.affiliation: Service des Maladies de l'Appareil digestif et de la Nutrition, Hôpital Huriez, CHRU Lille, France.
authors.forename: Valérie
authors.initials: V
authors.lastname: Canva
authors.affiliation: Service de gastro-entérologie et d'hépatologie, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
authors.forename: Pierre
authors.initials: P
authors.lastname: Deltenre
authors.affiliation: Service Santé publique, Hôpital Henri Mondor, Créteil, France.
authors.forename: Françoise
authors.initials: F
authors.lastname: Roudot-Thoraval
authors.affiliation: Service des Maladies de l'Appareil digestif, Hôpital Saint Eloi, Montpellier, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Larrey
authors.affiliation: Inserm U955, Physiopathologie et Thérapeutique des Hépatites virales chroniques, Hôpital Henri-Mondor, Créteil, France.
authors.forename: Daniel
authors.initials: D
authors.lastname: Dhumeaux
authors.affiliation: Inserm U995, Univ Lille 2 - Lille Nord de France, Lille, France; Service des Maladies de l'Appareil digestif et de la Nutrition, Hôpital Huriez, CHRU Lille, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Mathurin
authors.affiliation: Inserm, IAME, UMR 1137, F-75018 Paris, France; Service de Maladies infectieuses et tropicales, Hôpital Bichat Claude Bernard, Paris, France; Univ Paris Diderot, Sorbonne Paris Cité, F-75018 Paris, France.
authors.forename: Yazdan
authors.initials: Y
authors.lastname: Yazdanpanah
mesh_terms: D000998:Antiviral Agents / Q000008:administration & dosage* / Q000191:economics*; D003362:Cost-Benefit Analysis; D003661:Decision Support Techniques; D004359:Drug Therapy, Combination / Q000191:economics; D005602:France; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000191:economics* / Q000821:virology; D006801:Humans; D007372:Interferons / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use; D008103:Liver Cirrhosis / Q000188:drug therapy / Q000191:economics / Q000821:virology; D008875:Middle Aged; D018803:Models, Economic; D009842:Oligopeptides / Q000008:administration & dosage / Q000191:economics; D011392:Proline / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000191:economics; D019057:Quality-Adjusted Life Years; D012254:Ribavirin / Q000008:administration & dosage / Q000191:economics; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D009842:Oligopeptides; D012254:Ribavirin; C486464:telaprevir; C512204:N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; D007372:Interferons; D011392:Proline
keywords: Boceprevir; Chronic hepatitis C; Cost-effectiveness analysis; Direct-acting antivirals; Genotype 1; Interferon-free regimens; Model-based analysis; Telaprevir; Treatment initiation