Final results of the telaprevir access program: Fibroscan values predict safety and efficacy in hepatitis c patients with advanced fibrosis or cirrhosis

Antonia Lepida, Massimo Colombo, Inmaculada Fernandez, Djamal Abdurakhmanov, Paulo Abrao Ferreira, Simone I. Strasser, Petr Urbanek, Alessandra Mangia, José L. Calleja, Wafae Iraqi, Ralph DeMasi, Isabelle Lonjon-Domanec, Christophe Moreno, Heiner Wedemeyer

Research output: Contribution to journalArticle

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Abstract

Background: Liver stiffness determined by transient elastography is correlated with hepatic fibrosis stage and has high accuracy for detecting severe fibrosis and cirrhosis in chronic hepatitis C patients. We evaluated the clinical value of baseline FibroScan values for the prediction of safety and efficacy of telaprevir-based therapy in patients with advanced fibrosis and cirrhosis in the telaprevir Early Access Program HEP3002. Methods: 1,772 patients with HCV-1 and bridging fibrosis or cirrhosis were treated with telaprevir plus pegylated interferon-α and ribavirin (PR) for 12 weeks followed by PR alone, the total treatment duration depending on virological response and previous response type. Liver fibrosis stage was determined either by liver biopsy or by non-invasive markers. 1,282 patients (72%) had disease stage assessed by FibroScan; among those 46% were classified as Metavir F3 at baseline and 54% as F4. Results: Overall, 1,139 patients (64%) achieved a sustained virological response (SVR) by intentionto- treat analysis. Baseline FibroScan values were tested for association with SVR and the occurrence of adverse events. By univariate analysis, higher baseline FibroScan values were predictive of lower sustained virological response rates and treatment-related anemia. By multivariate analysis, FibroScan was no longer statistically significant as an independent predictor, but higher FibroScan values were correlated with the occurrence of infections and serious adverse events. Conclusions: FibroScan has a limited utility as a predictor of safety and efficacy in patients treated with telaprevir-based triple therapy. Nevertheless it can be used in association with other clinical and biological parameters to help determine patients who will benefit from the triple regiments.

Original languageEnglish
JournalPLoS One
Volume10
Issue number9
DOIs
Publication statusPublished - Sep 23 2015

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hepatitis
fibrosis
Hepatitis
Fibrosis
Liver
Safety
normal values
liver cirrhosis
Biopsy
Ribavirin
Interferons
chronic hepatitis C
Elasticity Imaging Techniques
Stiffness
therapeutics
liver
Chronic Hepatitis C
interferons
Therapeutics
telaprevir

ASJC Scopus subject areas

  • Agricultural and Biological Sciences(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • Medicine(all)

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Final results of the telaprevir access program : Fibroscan values predict safety and efficacy in hepatitis c patients with advanced fibrosis or cirrhosis. / Lepida, Antonia; Colombo, Massimo; Fernandez, Inmaculada; Abdurakhmanov, Djamal; Ferreira, Paulo Abrao; Strasser, Simone I.; Urbanek, Petr; Mangia, Alessandra; Calleja, José L.; Iraqi, Wafae; DeMasi, Ralph; Lonjon-Domanec, Isabelle; Moreno, Christophe; Wedemeyer, Heiner.

In: PLoS One, Vol. 10, No. 9, 23.09.2015.

Research output: Contribution to journalArticle

Lepida, A, Colombo, M, Fernandez, I, Abdurakhmanov, D, Ferreira, PA, Strasser, SI, Urbanek, P, Mangia, A, Calleja, JL, Iraqi, W, DeMasi, R, Lonjon-Domanec, I, Moreno, C & Wedemeyer, H 2015, 'Final results of the telaprevir access program: Fibroscan values predict safety and efficacy in hepatitis c patients with advanced fibrosis or cirrhosis', PLoS One, vol. 10, no. 9. https://doi.org/10.1371/journal.pone.0138503
Lepida, Antonia ; Colombo, Massimo ; Fernandez, Inmaculada ; Abdurakhmanov, Djamal ; Ferreira, Paulo Abrao ; Strasser, Simone I. ; Urbanek, Petr ; Mangia, Alessandra ; Calleja, José L. ; Iraqi, Wafae ; DeMasi, Ralph ; Lonjon-Domanec, Isabelle ; Moreno, Christophe ; Wedemeyer, Heiner. / Final results of the telaprevir access program : Fibroscan values predict safety and efficacy in hepatitis c patients with advanced fibrosis or cirrhosis. In: PLoS One. 2015 ; Vol. 10, No. 9.
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abstract = "Background: Liver stiffness determined by transient elastography is correlated with hepatic fibrosis stage and has high accuracy for detecting severe fibrosis and cirrhosis in chronic hepatitis C patients. We evaluated the clinical value of baseline FibroScan values for the prediction of safety and efficacy of telaprevir-based therapy in patients with advanced fibrosis and cirrhosis in the telaprevir Early Access Program HEP3002. Methods: 1,772 patients with HCV-1 and bridging fibrosis or cirrhosis were treated with telaprevir plus pegylated interferon-α and ribavirin (PR) for 12 weeks followed by PR alone, the total treatment duration depending on virological response and previous response type. Liver fibrosis stage was determined either by liver biopsy or by non-invasive markers. 1,282 patients (72{\%}) had disease stage assessed by FibroScan; among those 46{\%} were classified as Metavir F3 at baseline and 54{\%} as F4. Results: Overall, 1,139 patients (64{\%}) achieved a sustained virological response (SVR) by intentionto- treat analysis. Baseline FibroScan values were tested for association with SVR and the occurrence of adverse events. By univariate analysis, higher baseline FibroScan values were predictive of lower sustained virological response rates and treatment-related anemia. By multivariate analysis, FibroScan was no longer statistically significant as an independent predictor, but higher FibroScan values were correlated with the occurrence of infections and serious adverse events. Conclusions: FibroScan has a limited utility as a predictor of safety and efficacy in patients treated with telaprevir-based triple therapy. Nevertheless it can be used in association with other clinical and biological parameters to help determine patients who will benefit from the triple regiments.",
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T2 - Fibroscan values predict safety and efficacy in hepatitis c patients with advanced fibrosis or cirrhosis

AU - Lepida, Antonia

AU - Colombo, Massimo

AU - Fernandez, Inmaculada

AU - Abdurakhmanov, Djamal

AU - Ferreira, Paulo Abrao

AU - Strasser, Simone I.

AU - Urbanek, Petr

AU - Mangia, Alessandra

AU - Calleja, José L.

AU - Iraqi, Wafae

AU - DeMasi, Ralph

AU - Lonjon-Domanec, Isabelle

AU - Moreno, Christophe

AU - Wedemeyer, Heiner

PY - 2015/9/23

Y1 - 2015/9/23

N2 - Background: Liver stiffness determined by transient elastography is correlated with hepatic fibrosis stage and has high accuracy for detecting severe fibrosis and cirrhosis in chronic hepatitis C patients. We evaluated the clinical value of baseline FibroScan values for the prediction of safety and efficacy of telaprevir-based therapy in patients with advanced fibrosis and cirrhosis in the telaprevir Early Access Program HEP3002. Methods: 1,772 patients with HCV-1 and bridging fibrosis or cirrhosis were treated with telaprevir plus pegylated interferon-α and ribavirin (PR) for 12 weeks followed by PR alone, the total treatment duration depending on virological response and previous response type. Liver fibrosis stage was determined either by liver biopsy or by non-invasive markers. 1,282 patients (72%) had disease stage assessed by FibroScan; among those 46% were classified as Metavir F3 at baseline and 54% as F4. Results: Overall, 1,139 patients (64%) achieved a sustained virological response (SVR) by intentionto- treat analysis. Baseline FibroScan values were tested for association with SVR and the occurrence of adverse events. By univariate analysis, higher baseline FibroScan values were predictive of lower sustained virological response rates and treatment-related anemia. By multivariate analysis, FibroScan was no longer statistically significant as an independent predictor, but higher FibroScan values were correlated with the occurrence of infections and serious adverse events. Conclusions: FibroScan has a limited utility as a predictor of safety and efficacy in patients treated with telaprevir-based triple therapy. Nevertheless it can be used in association with other clinical and biological parameters to help determine patients who will benefit from the triple regiments.

AB - Background: Liver stiffness determined by transient elastography is correlated with hepatic fibrosis stage and has high accuracy for detecting severe fibrosis and cirrhosis in chronic hepatitis C patients. We evaluated the clinical value of baseline FibroScan values for the prediction of safety and efficacy of telaprevir-based therapy in patients with advanced fibrosis and cirrhosis in the telaprevir Early Access Program HEP3002. Methods: 1,772 patients with HCV-1 and bridging fibrosis or cirrhosis were treated with telaprevir plus pegylated interferon-α and ribavirin (PR) for 12 weeks followed by PR alone, the total treatment duration depending on virological response and previous response type. Liver fibrosis stage was determined either by liver biopsy or by non-invasive markers. 1,282 patients (72%) had disease stage assessed by FibroScan; among those 46% were classified as Metavir F3 at baseline and 54% as F4. Results: Overall, 1,139 patients (64%) achieved a sustained virological response (SVR) by intentionto- treat analysis. Baseline FibroScan values were tested for association with SVR and the occurrence of adverse events. By univariate analysis, higher baseline FibroScan values were predictive of lower sustained virological response rates and treatment-related anemia. By multivariate analysis, FibroScan was no longer statistically significant as an independent predictor, but higher FibroScan values were correlated with the occurrence of infections and serious adverse events. Conclusions: FibroScan has a limited utility as a predictor of safety and efficacy in patients treated with telaprevir-based triple therapy. Nevertheless it can be used in association with other clinical and biological parameters to help determine patients who will benefit from the triple regiments.

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