February 20, 2014

Journal of Hepatology
Volume 60, Issue 3 , Pages 530-537, March 2014

Zobair M. Younossi, Mendel E. Singer, Heshaam M. Mir, Linda Henry, Sharon Hunt

Received 12 August 2013; received in revised form 21 October 2013; accepted 7 November 2013. published online 20 November 2013.

See Focus, pages 471–472

Abstract

Background & Aims
Hepatitis C (HCV) is a common cause of chronic liver disease worldwide. Current standard treatment for genotype-1 patients uses a triple combination of pegylated-interferon alpha (IFN), ribavirin (RBV) and a direct-acting antiviral agent (DAA) with 75–80% sustained virologic response (SVR) rates. The aim is to determine cost-effectiveness of staging-guided vs. treat all HCV genotype-1 patients with interferon-based vs. interferon-free regimens.

Methods
A decision analytic Markov model simulating patients until death compared four strategies for treating HCV genotype-1: Triple therapy (IFN, RBV, DAA) with staging-guidance or treat all, and oral IFN-free regimen with staging-guidance or treat all. Strategies with staging initiated treatment at fibrosis stages F2-F4, with staging repeated every 5years until age 70. The reference case was a treatment-naïve 50-year-old. Analysis was repeated for 50% increase in cost of oral therapy. Effectiveness was measured in quality-adjusted life years (QALYs).

Results
Treatment of all patients with oral IFN-free regimen was the most cost-effective strategy, with an ICER of $15,709/QALY at baseline cost of oral therapy. The ICER remained below $50,000/QALY in sensitivity analyses for baseline and +50% cost of oral therapy scenarios. The treat all strategy was also the most effective strategy; associated with the lowest risk of developing advanced liver disease.

Conclusions
Treating all HCV patients with oral IFN-free regimen reduced the number of patients developing advanced liver disease and increased life expectancy. Additionally, IFN-free regimen without staging may be the most cost-effective approach for treating HCV genotype-1 patients. The efficacy and safety of these regimens must be confirmed using randomized clinical trials.

Abbreviations: HCV, hepatitis C, IFN, pegylated, interferon alpha, RBV, ribavirin, DAA, direct, acting antiviral agent, SVR, sustained virologic response, IFN, BV, DAA, Triple therapy, ICER, incremental cost, effectiveness analysis, QALYs, quality, adjusted life years (a standard metric that incorporates both length and quality of life), CHC, chronic hepatitis C, HIV, immunodeficiency virus, TVR, telaprevir, BOC, boceprevir, GT, genotype, F2 or F4, moderate or advanced fibrosis, F0, F1, mild fibrosis, WAC, wholesale acquisition cost, NADAC, National Average Drug Acquisition Cost, CMS, Centers for Medicare and Medicaid Services

Keywords: Interferon-free oral treatment, Cost-effectiveness analysis, Markov model, HCV, DAA

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