Journal article
FibroTest is an independent predictor of virologic response in chronic hepatitis C patients retreated with pegylated interferon alfa-2b and ribavirin in the EPIC3 program
Journal of hepatology, Vol.54(2), pp.227-235
2011
DOI: 10.1016/j.jhep.2010.06.038
PMID: 21056496
Abstract
Background & aims: EPIC-3 is a prospective, international study that has demonstrated the efficacy of PEG-IFN alfa-2b plus weight-based ribavirin in patients with chronic hepatitis C and significant fibrosis who previously failed any interferon-alfa/ribavirin therapy. The aim of the present study was to assess FibroTest (FT), a validated non-invasive marker of fibrosis in treatment-naive patients, as a possible alternative to biopsy as the baseline predictor of subsequent early virologic (EVR) and sustained virologic response (SVR) in previously treated patients.
Methods: Of 2312 patients enrolled, 1459 had an available baseline FT, biopsy, and complete data. Uni- (UV) and multi-variable (MV) analyses were performed using FT and biopsy.
Results: Baseline characteristics were similar as in the overall population; METAVIR stage: 28% F2, 29% F3, and 43% F4, previous relapsers 29%, previous PEG-IFN regimen 41%, high baseline viral load (BVL) 64%. 506 patients (35%) had undetectable HCV-RNA at TW12 (TW12neg), with 58% achieving SVR. The accuracy of FT was similar to that in naive patients: AUROC curve for the diagnosis of F4 vs F2=0.80 (p<0.00001). Five baseline factors were associated (p<0.001) with SVR in UV and MV analyses (odds ratio: UV/MV): fibrosis stage estimated using FT (4.5/5.9) or biopsy (1.5/1.6), genotype 2/3 (4.5/5.1), BVL (1.5/1.3), prior relapse (1.6/1.6), previous treatment with non-PEG-IFN (2.6/2.0). These same factors were associated (p ≤ 0.001) with EVR. Among patients TW12neg, two independent factors remained highly predictive of SVR by MV analysis (p ≤ 0.001): genotype 2/3 (odds ratio=2.9), fibrosis estimated with FT (4.3) or by biopsy (1.5).
Conclusions: FibroTest at baseline is a possible non-invasive alternative to biopsy for the prediction of EVR at 12 weeks and SVR, in patients with previous failures and advanced fibrosis, retreated with PEG-IFN alfa-2b and ribavirin.
Details
- Title: Subtitle
- FibroTest is an independent predictor of virologic response in chronic hepatitis C patients retreated with pegylated interferon alfa-2b and ribavirin in the EPIC3 program
- Creators
- Thierry POYNARD - APHP-UPMC Liver Center, Paris, FranceMona MUNTEANU - APHP-UPMC Liver Center, Paris, FranceThomas BERG - Charité, Campus Virchow Klinikum, Universitätsmedizin Berlin, GermanyThomas MCGARRITY - Milton S. Hershey Medical Center, Hershey, PA, United StatesE. Jenny HEATHCOTE - University Health Network, Toronto, ON, CanadaFernando GONCALES - Department of Medical Clinical, Faculty of Medical Sciences, University of Campinas, Campinas, BrazilMoises DIAGO - Hospital General Universitario de Valencia, Valencia, SpainAntonio CRAXI - GI and Liver Unit, DIBIMIS, University of Palermo, Palermo, ItalyMarcelo SILVA - Hospital Universitario Austral, Pilar, ArgentinaNavdeep BOPARAI - Schering-Plough Research Institute, Kenilworth, NJ, United StatesLouis GRIFFEL - Schering-Plough Research Institute, Kenilworth, NJ, United StatesMargaret BURROUGHS - Schering-Plough Research Institute, Kenilworth, NJ, United StatesMassimo COLOMBO - Rirst Division of Gastroenterology, Fondazione IRCCS Maggiore Hospital, University of Milan, Milan, ItalyClifford BRASS - Schering-Plough Research Institute, Kenilworth, NJ, United StatesJanice ALBRECHT - Schering-Plough Research Institute, Kenilworth, NJ, United StatesJordi BRUIX - Centro de Investigación Biomédica en Red de Enfermedades Hepaticas y Digestivas, Liver Unit, Hospital Clinic, University of Barcelona, Barcelona, SpainEugene SCHIFF - University of Miami School of Medicine, Miami, FL, United StatesRuben TERG - Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo, Capital Federal, ArgentinaSteven FLAMM - Northwestern University, Chicago, IL, United StatesRicardo MORENO-OTERO - Hospital Universitario de la Princesa and Centro de Investigación Biomédica en Red de Enfermedades Hepaticas y Digestivas (Instituto de Salud Carlos III), Madrid, SpainFlair CARRILHO - Department of Gastroenterology, University of São Paulo School of Medicine, São Paulo, BrazilWarren SCHMIDT - University of Iowa Hospitals and Clinics, Iowa City, IA, United States
- Resource Type
- Journal article
- Publication Details
- Journal of hepatology, Vol.54(2), pp.227-235
- Publisher
- Elsevier
- DOI
- 10.1016/j.jhep.2010.06.038
- PMID
- 21056496
- ISSN
- 0168-8278
- eISSN
- 1600-0641
- Language
- English
- Date published
- 2011
- Academic Unit
- Gastroenterology and Hepatology; Internal Medicine
- Record Identifier
- 9984094617802771
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