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

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 5 years 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.

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.