title: Virological outcomes and treatment algorithms utilisation in observational study of patients with chronic hepatitis C treated with boceprevir or telaprevir.
abstract: BACKGROUND
  HCV-TARGET is a longitudinal observational study of chronic hepatitis C virus (HCV) patients treated with direct-acting anti-viral agents (DAAs) in a US consortium of 90 academic and community medical centres.
  
  
  OBJECTIVE
  To assess utilisation of response-guided therapy (RGT) and sustained virological response (SVR) of a large cohort of patients.
  
  
  METHODS
  Patients received peginterferon (PEG-IFN), ribavirin and either telaprevir or boceprevir. Demographical, clinical and virological data were collected during treatment and follow-up. RGT and treatment futility stopping rules was assessed at key time points.
  
  
  RESULTS
  Of 2084 patients, 38% had cirrhosis and 56% had received prior treatment for HCV. SVR rates were 31% (95% CI: 24-40) and 50% (95% CI: 44-56) in boceprevir patients with and without cirrhosis, respectively. SVR rates were 46% (95% CI: 42-50) and 60% (95% CI: 57-64) in telaprevir patients with and without cirrhosis, respectively. Early clearance of virus, IL28B genotype, platelet counts and diabetes were identified as predictors of SVR among boceprevir patients, while early clearance of virus, IL28B, cirrhosis, HCV subtype, age, haemoglobin, bilirubin and albumin levels were identified as predictors of SVR for telaprevir patients.
  
  
  CONCLUSIONS
  In academic and community centres, triple therapy including boceprevir or telaprevir led to SVR rates somewhat lower than those noted in large phase 3 clinical trials. Response rates were consistently higher among patients without cirrhosis compared to those with cirrhosis regardless of DAA used and prior treatment response. Trial registration clinicaltrials.gov NCT01474811.
authors: Virginia Commonwealth University Health System, Richmond, VA, USA.
authors: R K
authors: RK
authors: Sterling
authors: A
authors: A
authors: Kuo
authors: V K
authors: VK
authors: Rustgi
authors: M S
authors: MS
authors: Sulkowski
authors: T G
authors: TG
authors: Stewart
authors: J M
authors: JM
authors: Fenkel
authors: H
authors: H
authors: El-Genaidi
authors: M A
authors: MA
authors: Mah'moud
authors: G M
authors: GM
authors: Abraham
authors: P W
authors: PW
authors: Stewart
authors: L
authors: L
authors: Akushevich
authors: D R
authors: DR
authors: Nelson
authors: M W
authors: MW
authors: Fried
authors: A M
authors: AM
authors: Di Bisceglie
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D055815:Young Adult; D000367:Age Factors; D000465:Algorithms; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D015415:Biomarkers; D015897:Comorbidity; D004359:Drug Therapy, Combination; D005838:Genotype; D019698:Hepatitis C, Chronic / Q000188:drug therapy; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use; D008103:Liver Cirrhosis / Q000188:drug therapy; D008137:Longitudinal Studies; D009842:Oligopeptides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D011092:Polyethylene Glycols / Q000627:therapeutic use; D011392:Proline / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000627:therapeutic use; D012254:Ribavirin / Q000627:therapeutic use
chemical_list: D000998:Antiviral Agents; D015415:Biomarkers; D000077190:Interferon alpha-2; D016898:Interferon-alpha; 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; D009842:Oligopeptides; C100416:peginterferon alfa-2a; C417083:peginterferon alfa-2b; D011092:Polyethylene Glycols; D011392:Proline; D011994:Recombinant Proteins; D012254:Ribavirin; C486464:telaprevir
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