title: Effect of fibrosis on adverse events in patients with hepatitis C treated with telaprevir.
abstract: BACKGROUND
  Data about adverse events are needed to optimise telaprevir-based therapy in a broad spectrum of patients.
  
  
  OBJECTIVE
  To investigate adverse events of telaprevir-based therapy in patients with and without advanced fibrosis or cirrhosis in a real-world setting.
  
  
  METHODS
  Data on 174 hepatitis C-infected patients initiating telaprevir-based therapy at Mount Sinai and Montefiore medical centres were collected. Biopsy data and FIB-4 scores identified patients with advanced fibrosis. Multivariable fully adjusted models were built to assess the effect of advanced fibrosis on specific adverse events and discontinuation of treatment due to an adverse event.
  
  
  RESULTS
  Patients with (n = 71) and without (n = 103) advanced fibrosis were similar in BMI, ribavirin exposure, gender, prior treatment history, haemoglobin and creatinine, but differed in race. Overall, 47% of patients completed treatment and 40% of patients achieved SVR. Treated patients with and without advanced fibrosis or cirrhosis had similar rates of adverse events; advanced fibrosis, however, was independently associated with ano-rectal discomfort (P = 0.03). Three patients decompensated and had advanced fibrosis. The discontinuation of all treatment medications due to an adverse event was significantly associated with older age (P = 0.01), female gender (P = 0.01) and lower platelets (P = 0.03).
  
  
  CONCLUSIONS
  Adverse events were common, but were not significantly related to the presence of advanced fibrosis or cirrhosis. More critical monitoring in older and female patients with low platelets throughout treatment may reduce adverse event-related discontinuations.
authors.affiliation: Division of Liver Diseases, Icahn School of Medicine at the Mount Sinai Medical Center, New York, NY, USA.
authors.forename: K
authors.initials: K
authors.lastname: Bichoupan
authors.forename: J M
authors.initials: JM
authors.lastname: Schwartz
authors.forename: V
authors.initials: V
authors.lastname: Martel-Laferriere
authors.forename: E R
authors.initials: ER
authors.lastname: Giannattasio
authors.forename: K
authors.initials: K
authors.lastname: Marfo
authors.forename: J A
authors.initials: JA
authors.lastname: Odin
authors.forename: L U
authors.initials: LU
authors.lastname: Liu
authors.forename: T D
authors.initials: TD
authors.lastname: Schiano
authors.forename: P
authors.initials: P
authors.lastname: Perumalswami
authors.forename: M
authors.initials: M
authors.lastname: Bansal
authors.forename: P J
authors.initials: PJ
authors.lastname: Gaglio
authors.forename: H
authors.initials: H
authors.lastname: Kalia
authors.forename: D T
authors.initials: DT
authors.lastname: Dieterich
authors.forename: A D
authors.initials: AD
authors.lastname: Branch
authors.forename: J F
authors.initials: JF
authors.lastname: Reinus
mesh_terms: D000740:Anemia / Q000139:chemically induced; D000998:Antiviral Agents / Q000009:adverse effects* / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D019698:Hepatitis C, Chronic / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects* / Q000627:therapeutic use; D008103:Liver Cirrhosis / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000009:adverse effects* / Q000627:therapeutic use; D010976:Platelet Count; D011092:Polyethylene Glycols / Q000009:adverse effects* / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012254:Ribavirin / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D009842:Oligopeptides; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C486464:telaprevir; C417083:peginterferon alfa-2b; C100416:peginterferon alfa-2a