FibroTest is an independent predictor of virologic response in chronic hepatitis C patients retreated with pegylated interferon alfa-2b and ribavirin in the EPIC 3 program

Thierry Poynard, Mona Munteanu, Massimo Colombo, Jordi Bruix, Eugene Schiff, Ruben Terg, Steven Flamm, Ricardo Moreno-Otero, Flair Carrilho, Warren Schmidt, Thomas Berg, Thomas McGarrity, E. Jenny Heathcote, Fernando Gonales, Moises Diago, Antonio Craxi, Marcelo Silva, Navdeep Boparai, Louis Griffel, Margaret BurroughsClifford Brass, Janice Albrecht

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13 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)227-235
Number of pages9
JournalJournal of Hepatology
Volume54
Issue number2
DOIs
StatePublished - Feb 1 2011

Keywords

  • Biomarkers
  • Cirrhosis
  • Early virologic response
  • Fibrosis
  • Hepatitis C
  • Non-responder
  • Relapser
  • Treatment failure

ASJC Scopus subject areas

  • Hepatology

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    Poynard, T., Munteanu, M., Colombo, M., Bruix, J., Schiff, E., Terg, R., Flamm, S., Moreno-Otero, R., Carrilho, F., Schmidt, W., Berg, T., McGarrity, T., Heathcote, E. J., Gonales, F., Diago, M., Craxi, A., Silva, M., Boparai, N., Griffel, L., ... Albrecht, J. (2011). FibroTest is an independent predictor of virologic response in chronic hepatitis C patients retreated with pegylated interferon alfa-2b and ribavirin in the EPIC 3 program. Journal of Hepatology, 54(2), 227-235. https://doi.org/10.1016/j.jhep.2010.06.038