Prospective Study
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Mar 14, 2015; 21(10): 3013-3019
Published online Mar 14, 2015. doi: 10.3748/wjg.v21.i10.3013
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
Cristina Stasi, Alessia Piluso, Umberto Arena, Elena Salomoni, Paolo Montalto, Monica Monti, Barbara Boldrini, Giampaolo Corti, Fabio Marra, Giacomo Laffi, Stefano Milani, Anna Linda Zignego
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
Cristina Stasi, Health Agency of Tuscany, 50141 Florence, Italy
Paolo Montalto, Gastrointestinal Endoscopy Unit, Ospedale SS Cosma e Damiano, 51017 Pescia, Italy
Stefano Milani, Department of Biomedical, Experimental and Clinical sciences, University of Florence, 50134 Florence, Italy
Author contributions: Stasi C designed the research study, performed the research, collected and analysed the data, wrote the paper, and reviewed the final version of the manuscript; Piluso A collected data, provided technical support, and revised the manuscript; Monti M collected data and provided technical support; Arena U contributed to performing the research and critically revised the manuscript; Salomoni E, Montalto P, Boldrini B and Corti G performed the research; Marra F, Laffi G and Milani S critically revised it; Zignego AL contributed to the research design, drafted the manuscript, and critically revised the manuscript; all authors read and approved the final manuscript.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Cristina Stasi, MD, PhD, Department of Experimental and Clinical Medicine, University of Florence, Largo Brambilla 3, 50134 Firenze, Italy. cristina.stasi@gmail.com
Telephone: +39-55-7947154 Fax: +39-55-7947154
Received: September 4, 2014
Peer-review started: September 5, 2014
First decision: September 27, 2014
Revised: October 14, 2014
Accepted: December 5, 2014
Article in press: December 8, 2014
Published online: March 14, 2015
Processing time: 192 Days and 23.2 Hours
Abstract

AIM: 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.

CONCLUSION: Pre-treatment liver stiffness may be useful for predicting the response to treatment in patients treated with either dual or triple anti-HCV therapy.

Keywords: Antiviral therapy; Chronic hepatitis C; Fibrosis; Liver stiffness; Sustained virological response

Core tip: Transient elastography is a non-invasive, easy, reproducible technique that is well tolerated for staging non-significant fibrosis or severe fibrosis/cirrhosis. The assessment of liver fibrosis using transient elastography may be useful to reduce the need for a liver biopsy. In this prospective study, liver stiffness values can also be used as a predictor of response to therapy. A liver stiffness value greater than 12 kPa is a negative predictor of response to both dual and triple therapy. Therefore, transient elastography could be used in clinical practice to improve the selection of patient treatment.