title: Low-density lipoprotein and other predictors of response with telaprevir-based therapy in treatment-experienced HCV genotype 1 patients: REALIZE study.
abstract: OBJECTIVE
  Predictors of response to treatment with peginterferon plus ribavirin are well established. In these post-hoc analyses of the REALIZE study, we sought to identify predictors of response for telaprevir-based triple therapy.
  
  
  METHODS
  Patients from the REALIZE study with baseline data for all predictors evaluated (including baseline disease characteristics and demographics, prior treatment response and baseline laboratory assessments) were included in the post-hoc analyses (n = 465). Univariate and multivariate analyses were used to evaluate factors predicting treatment outcomes.
  
  
  RESULTS
  Sustained viral response (SVR) rates were 86% in prior relapsers, 63% in prior partial responders and 32% in prior null-responders. In the final multivariate analysis, baseline factors predicting SVR were prior response to treatment [Odds ratio (OR) = 2.80; 95% confidence interval (CI), 2.13-3.69], low-density lipoprotein (LDL) (≥2.6 mmol/L) (OR = 2.11; 95% CI, 1.52-2.93), HCV genotype (OR = 0.58; 95% CI, 0.36-0.93), and maximum alanine amino transferase and aspartate amino transferase (OR = 0.62; 95% CI, 0.40-0.97).
  
  
  CONCLUSIONS
  Prior response to peginterferon plus ribavirin treatment and LDL levels are the main independent predictive markers of response with telaprevir-based triple therapy.
authors.affiliation: Universitätsklinikum Leipzig, Sektion Hepatologie, Klinik für Gastroenterologie und Rheumatologie, Leipzig, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Berg
authors.forename: Pietro
authors.initials: P
authors.lastname: Andreone
authors.forename: Stanislas
authors.initials: S
authors.lastname: Pol
authors.forename: Stuart
authors.initials: S
authors.lastname: Roberts
authors.forename: Zobair
authors.initials: Z
authors.lastname: Younossi
authors.forename: Moises
authors.initials: M
authors.lastname: Diago
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Lawitz
authors.forename: Roberto
authors.initials: R
authors.lastname: Focaccia
authors.forename: Graham R
authors.initials: GR
authors.lastname: Foster
authors.forename: Andrzej
authors.initials: A
authors.lastname: Horban
authors.forename: Isabelle
authors.initials: I
authors.lastname: Lonjon-Domanec
authors.forename: Ralph
authors.initials: R
authors.lastname: DeMasi
authors.forename: Gaston
authors.initials: G
authors.lastname: Picchio
authors.forename: Donghan
authors.initials: D
authors.lastname: Luo
authors.forename: Sandra
authors.initials: S
authors.lastname: De Meyer
authors.forename: Stefan
authors.initials: S
authors.lastname: Zeuzem
mesh_terms: D015415:Biomarkers / Q000097:blood*; D004359:Drug Therapy, Combination; D016174:Hepacivirus / Q000235:genetics*; D006526:Hepatitis C / Q000188:drug therapy* / Q000235:genetics; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use; D008077:Lipoproteins, LDL / Q000097:blood*; D016017:Odds Ratio; D009842:Oligopeptides / Q000627:therapeutic use*; D011092:Polyethylene Glycols / Q000627:therapeutic use; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins / Q000627:therapeutic use; D012044:Regression Analysis; D012254:Ribavirin / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D016898:Interferon-alpha; D008077:Lipoproteins, LDL; D009842:Oligopeptides; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C486464:telaprevir; C100416:peginterferon alfa-2a
keywords: HCV; LDL; REALIZE; predictors; response; telaprevir