title: Diabetes mellitus and advanced liver fibrosis are risk factors for severe anaemia during telaprevir-based triple therapy.
abstract: OBJECTIVE
  Adding telaprevir to pegylated-interferon and ribavirin increased both response rates and side effects of hepatitis C virus (HCV) treatment. We identified variables associated with severe anaemia during telaprevir-based triple therapy.
  
  
  METHODS
  An observational study was performed on 142 HCV-infected patients between June 2011 and March 2012. All subjects completed 12 weeks of telaprevir-based triple therapy or discontinued early because of anaemia. Severe anaemia was defined by a haemoglobin≤8.9 g/dl; advanced fibrosis was determined by Fib-4≥3.25.
  
  
  RESULTS
  The 47 (33%) patients who developed severe anaemia were similar to those who did not in sex, race, and prior response to dual therapy, but they were more likely to have diabetes (23.4% vs. 6.3%, P<0.01), advanced fibrosis (46.8% vs. 29.5%, P=0.04) and a history of anaemia during previous dual therapy (29.7% vs. 11.4%, P=0.02). Patients developing severe anaemia were older (59 vs. 56 years, P=0.02), had lower baseline platelet counts (134 vs. 163×10(9) /L, P=0.04), haemoglobin (14.0 vs. 15.0 g/dl, P<0.01), estimated glomerular filtration rate (79 vs. 90 ml/min/1.73 m2, P=0.03) and a higher median ribavirin/weight ratio (14.9 vs. 13.2 mg/kg, P<0.01). In multivariable logistic regression, presence of diabetes (OR=5.61, 95% CI: 1.59-19.72), Fib-4≥3.25 (OR=3.09, 95% CI: 1.28-7.46), higher ribavirin/weight ratio (OR=1.31 per mg/kg, 95% CI: 1.13-1.52) and lower baseline haemoglobin (OR=0.57 per g/dl, 95% CI, 0.41-0.80) were independently associated with developing severe anaemia.
  
  
  CONCLUSIONS
  Severe anaemia occurred in one-third of patients receiving telaprevir-based triple therapy. Risk was greater in patients with diabetes, advanced liver fibrosis, higher ribavirin/weight ratio and lower baseline haemoglobin.
authors.affiliation: Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
authors.forename: James F
authors.initials: JF
authors.lastname: Crismale
authors.forename: Valérie
authors.initials: V
authors.lastname: Martel-Laferrière
authors.forename: Kian
authors.initials: K
authors.lastname: Bichoupan
authors.forename: Emily
authors.initials: E
authors.lastname: Schonfeld
authors.forename: Alexis
authors.initials: A
authors.lastname: Pappas
authors.forename: Christina
authors.initials: C
authors.lastname: Wyatt
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Odin
authors.forename: Lawrence U
authors.initials: LU
authors.lastname: Liu
authors.forename: Thomas D
authors.initials: TD
authors.lastname: Schiano
authors.forename: Ponni V
authors.initials: PV
authors.lastname: Perumalswami
authors.forename: Meena
authors.initials: M
authors.lastname: Bansal
authors.forename: Douglas T
authors.initials: DT
authors.lastname: Dieterich
authors.forename: Andrea D
authors.initials: AD
authors.lastname: Branch
mesh_terms: D000740:Anemia / Q000209:etiology*; D003924:Diabetes Mellitus, Type 2 / Q000453:epidemiology*; D006526:Hepatitis C / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use; D008103:Liver Cirrhosis / Q000453:epidemiology*; D016015:Logistic Models; D015999:Multivariate Analysis; D016017:Odds Ratio; D009842:Oligopeptides / Q000009:adverse effects* / Q000627:therapeutic use; D011092:Polyethylene Glycols / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000627:therapeutic use; D012254:Ribavirin / Q000627:therapeutic use; D012307:Risk Factors; D018709:Statistics, Nonparametric
chemical_list: D016898:Interferon-alpha; D009842:Oligopeptides; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C486464:telaprevir; C100416:peginterferon alfa-2a
keywords: anaemia; diabetes mellitus; hepatitis C virus; pegylated-interferon; ribavirin; telaprevir; triple therapy