Peter Ferenci1, Rodrigo Aires2, Kimberly L Beavers3, Manuela Curescu4, Paulo R Abrão Ferreira5, Michael Gschwantler6, Stefan Ion7, Dominique Larrey8, Mojca Maticic9, Massimo Puoti10, János Schuller11, Istvan Tornai12, Anna Tusnádi13, Diethelm Messinger14, Fernando Tatsch15,16, Andrzej Horban17,18. 1. Internal Medicine 3, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. peter.ferenci@meduniwien.ac.at. 2. The Goiás Federal University Clinical Hospital, Goiânia, Brazil. rsaires@uol.com.br. 3. Asheville Gastroenterology Associates, Asheville, NC, USA. kimberly.beavers.MD@ashevillegastro.com. 4. University of Medicine and Pharmacy of Timisoara, Timisoara, Romania. manuela.curescu@gmail.com. 5. Division of Infectious Disease, Federal University of São Paulo, São Paulo, Brazil. paulo.abrao.ferreira@gmail.com. 6. 4th Department of Internal Medicine, Wilhelminenspital, Vienna, Austria. Michael.Gschwantler@wienkav.at. 7. Central Military Hospital, Bucharest, Romania. drstefanion@gmail.com. 8. Liver Unit, Saint Eloi Hospital, Montpelier, France. dom-larrey@chu-montpellier.fr. 9. University Medical Centre, Ljubljana, Slovenia. mojca.maticic@kclj.si. 10. SC Malattie Infettive dell' AO Ospedale Niguarda Cà Granda, Milan, Italy. massimopuoti@libero.it. 11. Szent Laszlo Hospital, Budapest, Hungary. schuller@lamb.hu. 12. 2nd Department of Internal Medicine, Medical University, Debrecen, Hungary. itornai@med.unideb.hu. 13. Infectology Department, Hetényi Géza Hospital, Szolnok, Hungary. a.tusnadi@chello.hu. 14. IST GmbH, Mannheim, Germany. diethelm.messinger@istgmbh.com. 15. F. Hoffmann-La Roche Ltd, Basel, Switzerland. fernando.tatsch@roche.com. 16. AbbVie, Chicago, USA. fernando.tatsch@roche.com. 17. Warsaw Medical University, Warsaw, Poland. ahorban@zakazny.pl. 18. Hospital of Infectious Diseases, Warsaw, Poland. ahorban@zakazny.pl.
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.
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 CHCpatients. 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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