Department of Internal Medicine, Division of Digestive and Liver Diseases, University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas, TX; Department of Medicine, Division of Hepatology, University of Miami Miller School of Medicine, Miami, FL.
BACKGROUND & AIMS:
Protease inhibitor triple therapy for hepatitis C virus (HCV) infection (boceprevir or telaprevir with pegylated interferon and ribavirin) has been shown to increase rates of sustained virologic response in phase 3 trials. We investigated the proportion of patients who began therapy with this regimen in the 12 months following the Food and Drug Administration (FDA) approval of boceprevir and telaprevir in the US.
We performed a retrospective cross-sectional study of 487 patients with HCV genotype 1 infection (396 did not receive triple therapy and 91 had begun triple therapy with boceprevir or telaprevir), seen at hepatology practices in Dallas and Miami from June 2011 through February 2012. The subjects were predominantly middle-aged, non-Hispanic white, and privately insured; 50% were treatment-naïve, and most had advanced fibrosis. We compared features of patients who initiated triple therapy with those who deferred it. Treated patients were followed to determine the discontinuation rate in the first 12 weeks of treatment.
Of patients assessed, only 18.7% began triple therapy-the same percentage as those receiving dual therapy (pegylated interferon and ribavirin) before boceprevir or telaprevir were approved for treatment of HCV infection in the US. Reasons for deferring treatment included relative contraindications (50.5%), patient choice (22.5%), and less-advanced liver disease (17.4%). Among treated patients, 15% discontinued prematurely because of serious adverse events. Based on multivariate analysis, factors associated with initiation of triple therapy included prior treatment relapse (odds ratio [OR] 4.6; 95% confidence interval [CI], 2.1-9.9) and liver fibrosis of stage 3 (OR, 9.1; 95% CI, 3.1-27) or stage 4 (OR, 9.0; 95% CI, 3.3-25) but not hepatic decompensation.
Only 18.7% of patients with HCV genotype 1 infection received triple therapy in the 12 months following FDA approval of boceprevir and telaprevir. This low percentage might result from concerns of side effects and recognition that more effective medications could be available in the future.