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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 Pol1, S Zeuzem2, E Lawitz3, M Diago4, S Roberts5, R Focaccia6, Z Younossi7, G Foster8, A Horban9, P Pockros10, P Andreone11, R van Heeswijk12, S De Meyer12, D Luo13, G Picchio13, M Beumont121Assistance Publique-H˘pitaux de Paris, H˘pital Cochin, Paris, France; 2Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany; 3Alamo Medical Research, San Antonio, Texas, USA; 4Hospital General de Valencia, Valencia, Spain; 5Department of Gastroenterology, Alfred Hospital, Melbourne, VIC, Australia; 6Emilio Ribas Infectious Diseases Institute, SŃo Paulo, Brazil; 7Center for Liver Disease, Inova Fairfax Hospital, Falls Church, Virginia, USA; 8Queen Mary University of London, Institute of Cell and Molecular Science, London, United Kingdom; 9Medical University of Warsaw, Wolska, Warsaw, Poland; 10Scripps Clinic and The Scripps Research Institute, La Jolla, California, USA; 11UniversitÓ di Bologna, Bologna, Italy; 12Tibotec BVBA, Beerse, Belgium; 13Tibotec Inc, Titusville, New Jersey, USA
Aims: REALIZE evaluated telaprevir (T) in combination with peginterferon/ribavirin (PR) in well-characterized prior PR treatment-failure patients, including non-responders (null- and partial-responders) and relapsers.
Methods: REALIZE was a randomized, international, multicentre, double-blind, placebo-controlled trial to evaluate the efficacy, safety and tolerability of T (750 mg q8h) plus P (180 Ág/week) and R (1000-1200 mg/day) compared with PR alone in genotype 1 HCV-infected patients with prior PR treatment failure. The treatment arms (randomized 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 (T12PR48); 2) PR for 4 weeks followed by T/PR for 12 weeks, then PR for 32 weeks (Lead-in T12PR48); 3) PR for 48 weeks (PboPR48). The primary objective was to evaluate the superior efficacy of the T/PR arms for non-responders and relapsers compared to PR. Secondary objectives included the evaluation of a lead-in, and efficacy in prior null- and partial-responders separately. ESAs were not allowed for anemia management.
Results: 70% of patients were male, 93% were Caucasian, 26% had cirrhosis, and 89% had baseline HCV RNA >=800,000 IU/mL. Adverse events (AEs) reported most frequently with telaprevir were fatigue, pruritus, rash, nausea, influenza-like illness, anemia, and diarrhea. The most common reasons for premature telaprevir discontinuation due to AEs were rash (4%) and anemia (3%).
Conclusions: T-based therapy had a superior efficacy than PR in all prior treatment-failure populations studied. A lead-in did not significantly impact SVR rates. The safety profile in prior treatment-failure patients was consistent with that in treatment-naive patients.