title: Safety profile of boceprevir and telaprevir in chronic hepatitis C: real world experience from HCV-TARGET.
abstract: OBJECTIVE
  The safety profiles of boceprevir and telaprevir in the treatment of chronic hepatitis C, administered in academic and community centres across the United States, were evaluated.
  
  
  METHODS
  In 90 medical centres, patients with chronic HCV received pegylated interferon, ribavirin, and either telaprevir or boceprevir per local standard of care. Demographic, adverse event, clinical, and virological data were collected during treatment and follow-up.
  
  
  RESULTS
  A total of 2084 patients (97% HCV genotype 1) received at least one dose of a protease inhibitor. At baseline, 38% of patients had cirrhosis, and 57% had received at least one prior treatment for hepatitis C. Serious adverse events occurred in 12% of patients receiving protease inhibitor therapy. Overall, 66% of patients experienced anaemia, leading to frequent ribavirin dose reductions (42%) and erythropoietin use (37%); 11% received blood transfusion. More than 90% of patients had adverse events that led to a prescription, treatment, or dosage change, and 39% of patients discontinued treatment early, most commonly because of adverse events (18%) or lack of efficacy (16%). Hepatic decompensation events occurred in 3% of all patients. Age, female gender, cirrhosis, HCV genotype 1 subtype, creatinine clearance, platelet levels, albumin levels and haemoglobin levels were independent predictors of anaemia. Five deaths occurred. Overall, 52% of all patients achieved a sustained virologic response.
  
  
  CONCLUSIONS
  In academic and community centres, where chronic hepatitis C patients commonly have advanced liver disease, triple therapy was associated with a high rate of adverse events and involved frequent treatment modifications and adverse event management.
authors.affiliation: Department of Internal Medicine, Division of Gastroenterology-Hepatology, Henry Ford Hospital, Detroit, MI, USA. Electronic address: sgordon3@hfhs.org.
authors.forename: Stuart C
authors.initials: SC
authors.lastname: Gordon
authors.affiliation: Gastroenterology and Hepatology Research Group, Duke Clinical Research Institute, Durham, NC, USA.
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Muir
authors.affiliation: Yale Liver Center, Yale University School of Medicine, New Haven, CT, USA.
authors.forename: Joseph K
authors.initials: JK
authors.lastname: Lim
authors.affiliation: Center for Hepatitis C, Atlanta Medical Center, Atlanta, GA, USA.
authors.forename: Brian
authors.initials: B
authors.lastname: Pearlman
authors.affiliation: University of Virginia, Charlottesville, VA, USA.
authors.forename: Curtis K
authors.initials: CK
authors.lastname: Argo
authors.affiliation: Columbia Memorial Hospital, Hudson, NY, USA.
authors.forename: Ananthakrishnan
authors.initials: A
authors.lastname: Ramani
authors.affiliation: Strong Memorial Hospital/University of Rochester, Rochester, NY, USA.
authors.forename: Benedict
authors.initials: B
authors.lastname: Maliakkal
authors.affiliation: Austin Hepatitis Center, Austin, TX, USA.
authors.forename: Imtiaz
authors.initials: I
authors.lastname: Alam
authors.affiliation: UNC Liver Center, University of North Carolina, Chapel Hill, NC, USA.
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Stewart
authors.affiliation: UNC Liver Center, University of North Carolina, Chapel Hill, NC, USA.
authors.forename: Monika
authors.initials: M
authors.lastname: Vainorius
authors.affiliation: University of Florida, Division of Gastroenterology, Hepatology and Nutrition, Gainesville, FL, USA.
authors.forename: Joy
authors.initials: J
authors.lastname: Peter
authors.affiliation: University of Florida, Division of Gastroenterology, Hepatology and Nutrition, Gainesville, FL, USA.
authors.forename: David R
authors.initials: DR
authors.lastname: Nelson
authors.affiliation: UNC Liver Center, University of North Carolina, Chapel Hill, NC, USA.
authors.forename: Michael W
authors.initials: MW
authors.lastname: Fried
authors.affiliation: University of Pennsylvania, Philadelphia, PA, USA. Electronic address: rajender.reddy@uphs.upenn.edu.
authors.forename: K Rajender
authors.initials: KR
authors.lastname: Reddy
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage; D004279:DNA, Viral / Q000235:genetics; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000008:administration & dosage*; D011392:Proline / Q000008:administration & dosage / Q000031:analogs & derivatives*; D012189:Retrospective Studies; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D009842:Oligopeptides; 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: Anaemia; Boceprevir; Cirrhosis; Hepatic decompensation; Hepatitis C; Telaprevir