February 24, 2014

Impact of interferon free regimens on clinical and cost outcomes for chronic hepatitis C genotype 1 patients

J Hepatol. 2014 Mar;60(3):530-7. doi: 10.1016/j.jhep.2013.11.009. Epub 2013 Nov 19.

Younossi ZM1, Singer ME2, Mir HM3, Henry L4, Hunt S4.


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.

Copyright © 2013 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

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

PMID: 24269472 [PubMed - in process]


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