5 REALIZE TRIAL FINAL RESULTS: TELAPREVIR-BASED REGIMEN FOR GENOTYPE 1 HEPATITIS C VIRUS INFECTION IN PATIENTS WITH PRIOR NULL RESPONSE, PARTIAL RESPONSE OR RELAPSE TO PEGINTERFERON/RIBAVIRIN

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5 REALIZE TRIAL FINAL RESULTS: TELAPREVIR-BASED REGIMEN FOR GENOTYPE 1 HEPATITIS C VIRUS INFECTION IN PATIENTS WITH PRIOR NULL RESPONSE, PARTIAL RESPONSE OR RELAPSE TO PEGINTERFERON/RIBAVIRIN S. Zeuzem, P. Andreone, S. Pol, E.J. Lawitz, M. Diago, S. Roberts, R. Focaccia, Z.M. Younossi, G.R. Foster, A. Horban, P.J. Pockros, R. Van Heeswijk, S. de Meyer, D. Luo, G. Picchio, M. Beumont. Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany; Universita di Bologna, Bologna, Italy; Universite Paris Descartes, INSERM Unite 567, and Assistance Publique-Hopitaux de Paris, Cochin Hospital, Paris, France; Alamo Medical Resarch, San Antonio, TX, USA; Hospital General de Valencia, Valencia, Spain; Department of Gasteroenterology, Alfred Hospital, Melbourne, VIC, Australia; Emilio Ribas Infectious Diseases Institute, Sao Paulo, Brazil; Center for Liver Disease, Inova Fairfax Hospital, Falls Church, VA, USA; Institute of Cell and Molecular Science, Queen Mary University of London, London, UK; Medical University of Warsaw, Warsaw, Poland; Scripps Clinic and The Scripps Research Institute, La Jolla, CA, USA; Tibotec BVBA, Beerse, Belgium; Tibotec Inc., Titusville, NJ, USA E-mail: zeuzem@em.uni-frankfurt.de Background: The Phase 3 study REALIZE evaluated telaprevir (T) in combination with pegylated-IFN alfa-2a (P) and ribavirin (R) in well-characterised prior PR treatment-failure patients. Methods: REALIZE was a randomised, international, multicentre, double-blind, placebo-controlled trial to evaluate the efficacy, safety and tolerability of T (750mg q8h) plus P (180mg/w) and R (1000– 1200mg/d) compared with PR alone in G1 HCV-infected patients with prior PR treatment failure including non-responders (nulland partial-responders) and relapsers. The treatment arms (randomised 2:2:1, stratified by viral load and type of prior response) were: 1) T/PR for 12 weeks, followed by PR for 36 weeks (T12/PR48); 2) PR for 4 weeks followed by T/PR for 12 weeks, then PR for 32 weeks (Lead-in T12/PR48); 3) PR for 48 weeks (Pbo/PR48). The primary objective was to evaluate the superior efficacy of the T/PR arms for non-responders and relapsers. Secondary objectives included the evaluation of a lead-in and efficacy in prior nulland partialresponders separately. HCVRNA was quantified with the COBAS TaqMan v2.0 assay (LLOQ=25 IU/mL). ESAs were not allowed for anaemia management. Results: 833 patients were screened, 663 randomised, and 662 treated. 70% of patients were male, 93% were Caucasian, 26% had cirrhosis, and 89% had baseline HCVRNA ≥800,000 IU/mL.