title: A small percentage of patients with hepatitis C receive triple therapy with boceprevir or telaprevir.
abstract: OBJECTIVE
  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 after the Food and Drug Administration approval of boceprevir and telaprevir in the United States.
  
  
  METHODS
  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), who were 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-naive, 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.
  
  
  RESULTS
  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 was approved for treatment of HCV infection in the United States. 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. On the basis of 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.
  
  
  CONCLUSIONS
  Only 18.7% of patients with HCV genotype 1 infection received triple therapy in the 12 months after Food and Drug Administration 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.
authors.affiliation: Division of Digestive and Liver Diseases, Department of Internal Medicine, University of Texas Southwestern Medical School and Parkland Health and Hospital System, Dallas, Texas 75390-8887, USA.
authors.forename: Emerson Y
authors.initials: EY
authors.lastname: Chen
authors.forename: Seth N
authors.initials: SN
authors.lastname: Sclair
authors.forename: Frank
authors.initials: F
authors.lastname: Czul
authors.forename: Betty
authors.initials: B
authors.lastname: Apica
authors.forename: Perry
authors.initials: P
authors.lastname: Dubin
authors.forename: Paul
authors.initials: P
authors.lastname: Martin
authors.forename: William M
authors.initials: WM
authors.lastname: Lee
mesh_terms: D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage*; D003430:Cross-Sectional Studies; D004359:Drug Therapy, Combination / Q000379:methods; D004363:Drug Utilization / Q000706:statistics & numerical data; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000008:administration & dosage*; D011392:Proline / Q000008:administration & dosage / Q000031:analogs & derivatives*; D012189:Retrospective Studies; D012254:Ribavirin / Q000008:administration & dosage*; D014481:United States
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D009842:Oligopeptides; D012254:Ribavirin; C486464:telaprevir; C512204:N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; D011392:Proline
keywords: CI; DAA; Direct-acting Antiviral; HCV; HIV; OR; Outcomes Research; PEG-IFN; RBV; SD; SVR; confidence interval; direct-acting antiviral; hepatitis C virus; human immunodeficiency virus; odds ratio; pegylated interferon; ribavirin; standard deviation; sustained virological response