Sylvie Deuffic-Burban1, Michaël Schwarzinger2, Dorothée Obach2, Vincent Mallet3, Stanislas Pol4, Georges-Philippe Pageaux5, Valérie Canva6, Pierre Deltenre7, Françoise Roudot-Thoraval8, Dominique Larrey5, Daniel Dhumeaux9, Philippe Mathurin10, Yazdan Yazdanpanah11. 1. 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. 2. Inserm, IAME, UMR 1137, F-75018 Paris, France; Univ Paris Diderot, Sorbonne Paris Cité, F-75018 Paris, France. 3. 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. 4. 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. 5. Service des Maladies de l'Appareil digestif, Hôpital Saint Eloi, Montpellier, France. 6. Service des Maladies de l'Appareil digestif et de la Nutrition, Hôpital Huriez, CHRU Lille, France. 7. Service de gastro-entérologie et d'hépatologie, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland. 8. Service Santé publique, Hôpital Henri Mondor, Créteil, France. 9. Inserm U955, Physiopathologie et Thérapeutique des Hépatites virales chroniques, Hôpital Henri-Mondor, Créteil, France. 10. 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. 11. 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.
Abstract
BACKGROUND & AIMS: 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.
BACKGROUND & AIMS: 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.
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