March 18, 2014

Journal of Hepatology

Article in Press

Sylvie Deuffic-Burban, Michaël Schwarzinger, Dorothée Obach, Vincent Mallet, Stanislas Pol, Georges-Philippe Pageaux, Valérie Canva, Pierre Deltenre, Françoise Roudot-Thoraval, Dominique Larrey, Daniel Dhumeaux, Philippe Mathurin, Yazdan Yazdanpanah

      Received 22 August 2013; received in revised form 4 February 2014; accepted 6 March 2014. published online 18 March 2014.
      Accepted Manuscript
      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 12 weeks of IFN-based new DAAs and two times higher for IFN-free regimens.

    Results

    Treatment with IFN-based new DAAs when fibrosis stage greater than or equal to 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 greater than or equal to 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.

    Abbreviations: G1, genotype 1, HCV, hepatitis C virus, TVR, telaprevir, BOC, boceprevir, DAA, direct-acting antiviral, IFN, interferon, QALYs, quality-adjusted life years, ICER, incremental cost-effectiveness ratio, GDP, gross domestic product, IL28B, interleukin-28B, DRG, diagnosis-related group, SVR, sustained virological response

    Keywords: Boceprevir, Chronic hepatitis C, Cost-effectiveness analysis, Direct-acting antivirals, Genotype 1, Interferon-free regimens, Model-based analysis, Telaprevir, Treatment initiation

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