title: Boceprevir in genotype 1 chronic hepatitis C: first experiences in Serbia.
abstract: BACKGROUND
  The triple therapy which consists of one of the protease inhibitor plus pegylated interferon and ribavirin (P/R) is the standard of care for the treatment of chronic hepatitis C virus (HCV) genotype 1 (G1) infection both in treatment-naïve and experienced patients.
  
  
  OBJECTIVE
  The aim of this study was to analyze the efficacy and tolerability of this regime in hospital practice in Serbia.
  
  
  METHODS
  From July 2012 to October 2012, 20 previously treated patients with advanced fibrosis and HCV G1 infection were included in the triple antiviral regimen in six referral centers in Serbia. All patients were treated with response guide therapy (RGT) regime according to the boceprevir treatment protocol. During the 4-week lead-in period all patients received peginterferon plus ribavirin. After the lead-in pe- riod boceprevir was added in the dosage of 800 mg three times a day orally.The subsequent treatment varied according to virologic response and fibrosis. During the therapy HCV RNA level was measured at week 4, 8, 12, 24 of the treatment for the assessment of virologic response profile. All patients who completed therapy were assessed at the end of the treatment and at the end of an additional 24-week treatment-free period for a sustained virologic response (SVR).
  
  
  RESULTS
  The total of 20 patients with advanced fibrosis was treated. Among patients with an undetectable HCV RNA level at week 8 the rate of SVR was 100%. No patient with decrease in the HCV RNA level < 1 log 10 IU/ml at treatment week 4 achieved SVR. The overall rate of SVR was 55%. The safety profile of the treatment regimen was good. Anemia was reported in 25% of patients. There was no life-threatening treatment adverse event.
  
  
  CONCLUSIONS
  Boceprevir in combination with P/R achieved fairly good SVR rates in patients that were"most difficult to treat"who failed on dual therapy and was effective among patients with cirrhosis.
authors.forename: Jasmina Simonović
authors.initials: JS
authors.lastname: Babić
authors.forename: Ksenija
authors.initials: K
authors.lastname: Bojović
authors.forename: Milotka
authors.initials: M
authors.lastname: Fabri
authors.forename: Velimir
authors.initials: V
authors.lastname: Kostić
authors.forename: Maja
authors.initials: M
authors.lastname: Jovanović
authors.forename: Zeljko
authors.initials: Z
authors.lastname: Mijailović
authors.forename: Petar
authors.initials: P
authors.lastname: Svorcan
authors.forename: Goran
authors.initials: G
authors.lastname: Janković
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005838:Genotype; D016174:Hepacivirus; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D008103:Liver Cirrhosis; D011392:Proline / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011480:Protease Inhibitors / Q000008:administration & dosage; D012254:Ribavirin / Q000008:administration & dosage; D055771:Serbia
chemical_list: D000998:Antiviral Agents; D011480:Protease Inhibitors; 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