title: A real life boceprevir use in treatment-experienced HCV genotype 1 patients with advanced fibrosis.
abstract: BACKGROUND
  A number of high quality randomized clinical trials examining the efficacy and safety of triple therapy in genotype-1 HCV-infected patients have been published. However, these trials included a small number of patients with advanced fibrosis, and selected a population different from that in real-world settings.
  
  
  OBJECTIVE
  To determine the efficacy of boceprevir, pegInterferon and ribavirin regimen in genotype-1 treatment-experienced HCV-infected patients with cirrhosis and bridging fibrosis in real-life setting.
  
  
  METHODS
  167 treatment-experienced patients (85.6% relapsers) out of which 33.5% had cirrhosis, with a mean age of 52.6 years, registered in the Romanian Name Patient Program Database were included into the study.
  
  
  RESULTS
  16.7% of patients had a viral load >100 IU/mL. Undetectable HCV RNA was encountered in 77.3% of patients at week 12. Multiple logistic regression analysis revealed the following independent predictors, measured at week 8, for an HCV RNA ≥100 IU/mL at week 12 of triple therapy: alanine aminotransferase values (p=0.01), hemoglobin level (p=0.04) and <2 log drop of viral load (p<0.0001). A stopping score at 8 weeks was created as the sum of these 3 parameters, with a total of 4 possible points. AUROC of this score was 0.84, with a sensitivity of 75% and a specificity of 86.2%.
  
  
  CONCLUSIONS
  Triple therapy in this cohort of real-life genotype-1 HCV-infected patients with advanced fibrosis showed robust early virological response (EVR) rates. A week 8 model predicting lack of EVR was created, with good clinical utility that can be validated in prospective larger cohorts.
authors.affiliation: Gastroenterology and Hepatology Center, Fundeni Clinical Institute, Bucharest, Romania.
authors.forename: Liana
authors.initials: L
authors.lastname: Gheorghe
authors.affiliation: Gastroenterology and Hepatology Center, Fundeni Clinical Institute, Bucharest, Romania.
authors.forename: Speranta
authors.initials: S
authors.lastname: Iacob
authors.affiliation: Gastroenterology and Hepatology Center, Fundeni Clinical Institute, Bucharest, Romania.
authors.forename: Iulia
authors.initials: I
authors.lastname: Simionov
authors.affiliation: National Institute for Infectious Diseases Prof. Dr. Matei Bals, Bucharest, Romania.
authors.forename: Florin
authors.initials: F
authors.lastname: Caruntu
authors.affiliation: Victor Babes Universitary Hospital of Infectious & Tropical Diseases, Bucharest, Romania.
authors.forename: Adriana
authors.initials: A
authors.lastname: Motoc
authors.affiliation: National Institute for Infectious Diseases Prof. Dr. Matei Bals, Bucharest, Romania.
authors.forename: Victoria
authors.initials: V
authors.lastname: Arama
authors.affiliation: National Institute for Infectious Diseases Prof. Dr. Matei Bals, Bucharest, Romania.
authors.forename: Liliana
authors.initials: L
authors.lastname: Preotescu
authors.affiliation: National Institute for Infectious Diseases Prof. Dr. Matei Bals, Bucharest, Romania.
authors.forename: Ion
authors.initials: I
authors.lastname: Stefan
authors.affiliation: Department of Gastroenterology and Hepatology, University of Medicine and Pharmacy, Timisoara, Romania.
authors.forename: Adrian
authors.initials: A
authors.lastname: Goldis
authors.affiliation: Faculty of Medicine, University of Oradea, Oradea, Romania.
authors.forename: Cristian
authors.initials: C
authors.lastname: Brisc
authors.affiliation: Clinical Hospital of Infectious Diseases, Constanta, Romania.
authors.forename: Sorin
authors.initials: S
authors.lastname: Rugina
authors.affiliation: University of Medicine and Pharmacy, Cluj-Napoca, Romania.
authors.forename: Nicolae
authors.initials: N
authors.lastname: Rednic
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000145:classification / Q000235:genetics / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use; D008103:Liver Cirrhosis / Q000821:virology*; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011392:Proline / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D012254:Ribavirin; 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