title: Evaluation of the prognostic value of liver stiffness in patients with hepatitis C virus treated with triple or dual antiviral therapy: A prospective pilot study.
abstract: OBJECTIVE
  To evaluate the association between liver stiffness (LS) prior to the initiation of dual/triple therapy and viral response.
  
  
  METHODS
  LS was measured in all patients before treatment was administered. The therapeutic approach was based on hepatic, virological, and immunological evaluations and considered the fact that patients with severe fibrosis (F3) or compensated cirrhosis (F4) in Child-Pugh class A are the primary candidates for triple therapy. In total, 65 hepatitis C virus (HCV) patients were treated with Peg-interferon/ribavirin (Peg-IFN/RBV); 24 patients were classified as genotypes 1/4 (36.92%), and 41 patients were classified as genotypes 2/3 (63.08%) (dual therapy). In addition, 20 HCV treatment-experienced genotype 1 patients were treated with PegIFN-RBV and boceprevir (triple therapy). Wilcoxon rank-sum tests were used to compare the groups.
  
  
  RESULTS
  LS significantly differed between dual therapy and triple therapy (P = 0.002). The mean LS value before dual therapy treatment was 8.61 ± 5.79 kPa and was significantly different between patients achieving a sustained virologic response (SVR) 24 weeks after therapy and those who did not (7.23 ± 5.18 kPa vs 11.72 ± 5.99 kPa, respectively, P = 0.0003). The relative risk of non-response to therapy was 4.45 (95%CI: 2.32-8.55). The attributable risk of non-response to therapy was 49%. The mean LS value before triple therapy treatment was 13.29 ± 8.57 kPa and was significantly different between patients achieving and not achieving SVR24 (9.41 ± 5.05 vs 19.11 ± 9.74, respectively; P = 0.008). The relative risk of non-response to therapy was 5.57% (95%CI: 1.50-20.65). The attributable risk of non-response to therapy (70%) was increased compared with dual therapy patients. Pre-treatment stiffness > 12 kPa was significantly associated with non-SVR (P < 0.025) in both groups.
  
  
  CONCLUSIONS
  Pre-treatment liver stiffness may be useful for predicting the response to treatment in patients treated with either dual or triple anti-HCV therapy.
authors.affiliation: Cristina Stasi, Alessia Piluso, Umberto Arena, Elena Salomoni, Monica Monti, Barbara Boldrini, Giampaolo Corti, Fabio Marra, Giacomo Laffi, Anna Linda Zignego, Department of Experimental and Clinical Medicine, University of Florence, 50134 Florence, Italy.
authors.forename: Cristina
authors.initials: C
authors.lastname: Stasi
authors.affiliation: Cristina Stasi, Alessia Piluso, Umberto Arena, Elena Salomoni, Monica Monti, Barbara Boldrini, Giampaolo Corti, Fabio Marra, Giacomo Laffi, Anna Linda Zignego, Department of Experimental and Clinical Medicine, University of Florence, 50134 Florence, Italy.
authors.forename: Alessia
authors.initials: A
authors.lastname: Piluso
authors.affiliation: Cristina Stasi, Alessia Piluso, Umberto Arena, Elena Salomoni, Monica Monti, Barbara Boldrini, Giampaolo Corti, Fabio Marra, Giacomo Laffi, Anna Linda Zignego, Department of Experimental and Clinical Medicine, University of Florence, 50134 Florence, Italy.
authors.forename: Umberto
authors.initials: U
authors.lastname: Arena
authors.affiliation: Cristina Stasi, Alessia Piluso, Umberto Arena, Elena Salomoni, Monica Monti, Barbara Boldrini, Giampaolo Corti, Fabio Marra, Giacomo Laffi, Anna Linda Zignego, Department of Experimental and Clinical Medicine, University of Florence, 50134 Florence, Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Salomoni
authors.affiliation: Cristina Stasi, Alessia Piluso, Umberto Arena, Elena Salomoni, Monica Monti, Barbara Boldrini, Giampaolo Corti, Fabio Marra, Giacomo Laffi, Anna Linda Zignego, Department of Experimental and Clinical Medicine, University of Florence, 50134 Florence, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Montalto
authors.affiliation: Cristina Stasi, Alessia Piluso, Umberto Arena, Elena Salomoni, Monica Monti, Barbara Boldrini, Giampaolo Corti, Fabio Marra, Giacomo Laffi, Anna Linda Zignego, Department of Experimental and Clinical Medicine, University of Florence, 50134 Florence, Italy.
authors.forename: Monica
authors.initials: M
authors.lastname: Monti
authors.affiliation: Cristina Stasi, Alessia Piluso, Umberto Arena, Elena Salomoni, Monica Monti, Barbara Boldrini, Giampaolo Corti, Fabio Marra, Giacomo Laffi, Anna Linda Zignego, Department of Experimental and Clinical Medicine, University of Florence, 50134 Florence, Italy.
authors.forename: Barbara
authors.initials: B
authors.lastname: Boldrini
authors.affiliation: Cristina Stasi, Alessia Piluso, Umberto Arena, Elena Salomoni, Monica Monti, Barbara Boldrini, Giampaolo Corti, Fabio Marra, Giacomo Laffi, Anna Linda Zignego, Department of Experimental and Clinical Medicine, University of Florence, 50134 Florence, Italy.
authors.forename: Giampaolo
authors.initials: G
authors.lastname: Corti
authors.affiliation: Cristina Stasi, Alessia Piluso, Umberto Arena, Elena Salomoni, Monica Monti, Barbara Boldrini, Giampaolo Corti, Fabio Marra, Giacomo Laffi, Anna Linda Zignego, Department of Experimental and Clinical Medicine, University of Florence, 50134 Florence, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Marra
authors.affiliation: Cristina Stasi, Alessia Piluso, Umberto Arena, Elena Salomoni, Monica Monti, Barbara Boldrini, Giampaolo Corti, Fabio Marra, Giacomo Laffi, Anna Linda Zignego, Department of Experimental and Clinical Medicine, University of Florence, 50134 Florence, Italy.
authors.forename: Giacomo
authors.initials: G
authors.lastname: Laffi
authors.affiliation: Cristina Stasi, Alessia Piluso, Umberto Arena, Elena Salomoni, Monica Monti, Barbara Boldrini, Giampaolo Corti, Fabio Marra, Giacomo Laffi, Anna Linda Zignego, Department of Experimental and Clinical Medicine, University of Florence, 50134 Florence, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Milani
authors.affiliation: Cristina Stasi, Alessia Piluso, Umberto Arena, Elena Salomoni, Monica Monti, Barbara Boldrini, Giampaolo Corti, Fabio Marra, Giacomo Laffi, Anna Linda Zignego, Department of Experimental and Clinical Medicine, University of Florence, 50134 Florence, Italy.
authors.forename: Anna Linda
authors.initials: AL
authors.lastname: Zignego
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D054459:Elasticity Imaging Techniques; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics; D006526:Hepatitis C / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use; D008099:Liver / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000821:virology; D008103:Liver Cirrhosis / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011237:Predictive Value of Tests; D011392:Proline / Q000031:analogs & derivatives / Q000627:therapeutic use; D011446:Prospective Studies; D012254:Ribavirin / Q000627:therapeutic use; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; 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
keywords: Antiviral therapy; Chronic hepatitis C; Fibrosis; Liver stiffness; Sustained virological response