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Predictive value of FIB-4 and APRI versus METAVIR on sustained virologic response in genotype 1 hepatitis C patients

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Abstract

Purpose

Advanced liver fibrosis is a negative predictor of virologic response in genotype 1 chronic hepatitis C (CHC) patients. Biopsy, however, is invasive, costly, and carries some risk of complications.

Methods

Using data from the prospective, international cohort study PROPHESYS, we assessed two alternative noninvasive measures of fibrosis, the FIB-4 and AST-to-platelet ratio index (APRI), to predict virologic response in CHC patients.

Results

CHC genotype 1, monoinfected, treatment-naive patients prescribed peginterferon alfa-2a (40 KD)/ribavirin in accordance with country-specific legal and regulatory requirements and who had baseline METAVIR, FIB-4, and APRI scores (N = 1,592) were included in this analysis. Patients were stratified according to the baseline METAVIR, FIB-4, or APRI score to assess virologic response [hepatitis C virus (HCV) RNA <50 IU/mL] by week 4 of treatment (rapid virologic response) and 24 weeks after untreated follow-up ]sustained virologic response (SVR)]. Baseline predictors of SVR were explored by multiple logistic regression, and the strength of the association between each fibrosis measure and SVR was evaluated. Both FIB-4 and APRI scores increased with increasing levels of biopsy-assessed fibrosis. The association between FIB-4 and SVR (p < 0.1 × 10−30) was stronger than that between METAVIR (p = 3.86 × 10−13) or APRI (p = 5.48 × 10−6) and SVR. Baseline factors significantly associated with SVR included male gender, lower HCV RNA, lower FIB-4 score, no steatosis, and higher alanine aminotransferase ratio.

Conclusion

The FIB-4 index provides a valuable, noninvasive measure of fibrosis and can be used to predict virologic response in patients treated with peginterferon alfa-2a (40  KD)/ribavirin.

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Acknowledgements

This study was supported by F. Hoffmann-La Roche Ltd., Basel, Switzerland. Support for third-party writing assistance for this manuscript was provided by F. Hoffmann-La Roche Ltd., Basel, Switzerland.

Compliance with Ethical Requirements

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008. Informed consent was obtained from all patients for being included in the study.

Conflicts of interest

Peter Ferenci—Global Advisory Board: Roche/Genentech, Merck, Janssen, Boehringer-Ingelheim and Rottapharm-Madaus; Advisor: GSK, Achilleon, Idenix; Speaker’s Bureau: Roche, MSD Austria, Janssen Austria, BMS Austria; Unrestricted Research Grant: Roche Austria and MSD Austria. Kimberly L. Beavers—Anadys, Bristol-Myers Squibb, Genentech, Inhibitex, Johnson and Johnson, Merck, Pharmasset, Roche and Vertex; Speakers Bureau: Genentech, Merck, Vertex. Michael Gschwantler—Speaker: Roche Austria, MSD Austria, Bristol-Myers Squibb and Janssen Austria. Dominique Larrey—Consultant for Roche Anti-viral Agents. Istvan Tornai—Advisory Board Member: Roche, MSD and Janssen-Cilag in Hungary. Mojca Maticic—Speaker and/or Advisor: Bayer Slovenia, Berlin-Chemie Slovenia, GSK Slovenia, Janssen Slovenia, MSD Slovenia, Roche Slovenia, Schering-Plough Slovenia. Diethelm Messinger—Employee of IST GmbH. IST GmbH has a contract with Roche to provide statistical support. Fernando Tatsch—Employee of F. Hoffmann-La Roche and a shareholder in F. Hoffmann-La Roche. Rodrigo Aires, Manuela Curescu, Paulo R. Abrão Ferreira, Massimo Puoti, János Schuller, Stefan Ion, Anna Tusnádi, and Andrzej Horban declare that they have no conflicts of interest.

Author information

Author notes

  1. Fernando Tatsch

    Present address: AbbVie, Chicago, USA

Authors and Affiliations

  1. Internal Medicine 3, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria

    Peter Ferenci

  2. The Goiás Federal University Clinical Hospital, Goiânia, Brazil

    Rodrigo Aires

  3. Asheville Gastroenterology Associates, Asheville, NC, USA

    Kimberly L. Beavers

  4. University of Medicine and Pharmacy of Timisoara, Timisoara, Romania

    Manuela Curescu

  5. Division of Infectious Disease, Federal University of São Paulo, São Paulo, Brazil

    Paulo R. Abrão Ferreira

  6. 4th Department of Internal Medicine, Wilhelminenspital, Vienna, Austria

    Michael Gschwantler

  7. Central Military Hospital, Bucharest, Romania

    Stefan Ion

  8. Liver Unit, Saint Eloi Hospital, Montpelier, France

    Dominique Larrey

  9. University Medical Centre, Ljubljana, Slovenia

    Mojca Maticic

  10. SC Malattie Infettive dell’ AO Ospedale Niguarda Cà Granda, Milan, Italy

    Massimo Puoti

  11. Szent Laszlo Hospital, Budapest, Hungary

    János Schuller

  12. 2nd Department of Internal Medicine, Medical University, Debrecen, Hungary

    Istvan Tornai

  13. Infectology Department, Hetényi Géza Hospital, Szolnok, Hungary

    Anna Tusnádi

  14. IST GmbH, Mannheim, Germany

    Diethelm Messinger

  15. F. Hoffmann-La Roche Ltd, Basel, Switzerland

    Fernando Tatsch

  16. Warsaw Medical University, Warsaw, Poland

    Andrzej Horban

  17. Hospital of Infectious Diseases, Warsaw, Poland

    Andrzej Horban

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  1. Peter Ferenci
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Correspondence to Peter Ferenci.

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Ferenci, P., Aires, R., Beavers, K.L. et al. Predictive value of FIB-4 and APRI versus METAVIR on sustained virologic response in genotype 1 hepatitis C patients. Hepatol Int 8, 83–93 (2014). https://doi.org/10.1007/s12072-013-9484-6

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  • DOI: https://doi.org/10.1007/s12072-013-9484-6

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