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 Burroughs & 2 others Clifford Brass, Janice Albrecht

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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

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Ribavirin
Chronic Hepatitis C
Fibrosis
Biopsy
Viral Load
Odds Ratio
Genotype
peginterferon alfa-2b
Interferon-alpha
Therapeutics
Sustained Virologic Response
Prospective Studies
RNA
Weights and Measures
Recurrence
Population

All Science Journal Classification (ASJC) codes

  • Hepatology

Cite this

Poynard, Thierry ; Munteanu, Mona ; Colombo, Massimo ; Bruix, Jordi ; Schiff, Eugene ; Terg, Ruben ; Flamm, Steven ; Moreno-Otero, Ricardo ; Carrilho, Flair ; Schmidt, Warren ; Berg, Thomas ; McGarrity, Thomas ; Heathcote, E. Jenny ; Gonales, Fernando ; Diago, Moises ; Craxi, Antonio ; Silva, Marcelo ; Boparai, Navdeep ; Griffel, Louis ; Burroughs, Margaret ; Brass, Clifford ; Albrecht, Janice. / 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. In: Journal of Hepatology. 2011 ; Vol. 54, No. 2. pp. 227-235.
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title = "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",
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.",
author = "Thierry Poynard and Mona Munteanu and Massimo Colombo and Jordi Bruix and Eugene Schiff and Ruben Terg and Steven Flamm and Ricardo Moreno-Otero and Flair Carrilho and Warren Schmidt and Thomas Berg and Thomas McGarrity and Heathcote, {E. Jenny} and Fernando Gonales and Moises Diago and Antonio Craxi and Marcelo Silva and Navdeep Boparai and Louis Griffel and Margaret Burroughs and Clifford Brass and Janice Albrecht",
year = "2011",
month = "2",
day = "1",
doi = "10.1016/j.jhep.2010.06.038",
language = "English (US)",
volume = "54",
pages = "227--235",
journal = "Journal of Hepatology",
issn = "0168-8278",
publisher = "Elsevier",
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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, EJ, Gonales, F, Diago, M, Craxi, A, Silva, M, Boparai, N, Griffel, L, Burroughs, M, Brass, C & 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, vol. 54, no. 2, pp. 227-235. https://doi.org/10.1016/j.jhep.2010.06.038

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

In: Journal of Hepatology, Vol. 54, No. 2, 01.02.2011, p. 227-235.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 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

AU - Poynard, Thierry

AU - Munteanu, Mona

AU - Colombo, Massimo

AU - Bruix, Jordi

AU - Schiff, Eugene

AU - Terg, Ruben

AU - Flamm, Steven

AU - Moreno-Otero, Ricardo

AU - Carrilho, Flair

AU - Schmidt, Warren

AU - Berg, Thomas

AU - McGarrity, Thomas

AU - Heathcote, E. Jenny

AU - Gonales, Fernando

AU - Diago, Moises

AU - Craxi, Antonio

AU - Silva, Marcelo

AU - Boparai, Navdeep

AU - Griffel, Louis

AU - Burroughs, Margaret

AU - Brass, Clifford

AU - Albrecht, Janice

PY - 2011/2/1

Y1 - 2011/2/1

N2 - 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.

AB - 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.

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