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OP03 Telaprevir-based therapy in G1 HCV-infected patients with prior null response, partial response or relapse to peginterferon/ribavirin: REALIZE trial final results
  1. G Foster1,
  2. S Zeuzem2,
  3. P Andreone3,
  4. S Pol4,
  5. E Lawitz5,
  6. M Diago6,
  7. S Roberts7,
  8. R Focaccia8,
  9. Z Younossi9,
  10. A H10,
  11. R V Heeswijk11,
  12. S de Meyer11,
  13. D Luo12,
  14. G Picchio12,
  15. M Beumont11
  1. 1Queen Mary University of London, Institute of Cell and Molecular Science, London, UK
  2. 2Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany
  3. 3University‡ di Bologna, Bologna, Italy
  4. 4University Paris Descartes, INSERM UnitÈ 567, and Assistance Publique Hopitaux de Paris, Cochin Hospital Paris, France
  5. 5Alamo Medical Research, San Antonio, Texas, USA
  6. 6Hospital General de Valencia, Valencia, Spain
  7. 7Department of Gastroenterology, Alfred Hospital, Melbourne, Australia
  8. 8Emilio Ribas Infectious Diseases Institute, Sao Paulo, Brazil
  9. 9Center for Liver Disease, Inova Fairfax Hospital, Falls Church, Virginia, USA
  10. 10Medical University of Warsaw, Wolska, Warsaw, Poland
  11. 11Tibotec BVBA, Beerse, Belgium
  12. 12Tibotec Inc., Titusville, New Jersey, USA

Abstract

Introduction This Phase 3 study evaluated telaprevir (T) in combination with pegylated-IFN alfa-2a (P) and ribavirin (R) in well-characterised G1 prior-PR treatment failure patients including prior PR non-responders (null and partial) and relapsers.

Method REALIZE was a randomised, international, multicentre, double-blind, placebo-controlled trial evaluating efficacy, safety and tolerability of T (750 mg q8 h) plus P (180μg/w) and R (1000–1200 mg/d) compared with PR alone. The treatment arms (randomised 2:2:1, stratified by viral load and prior response) were: 12-weeks T/PR, followed by 36-weeks PR (T12PR48); 4-weeks PR followed by 12 weeks T/PR (T delayed start, DS), then 32-weeks PR (T12(DS)/PR48); 48-weeks PR (Pbo/PR48). The primary objective was efficacy of the T/PR arms in non-responders and relapsers. Secondary objectives included evaluation of T DS and efficacy in prior-null and -partial responders. HCV RNA was quantified using COBAS TaqManÆ v2.0 assay (LLOQ=25 IU/ml).

Results 833 patients were screened, and 662 treated. 70% of patients were male, 93% Caucasian, 26% had cirrhosis, and 89% had baseline HCV RNA ≥800 000 IU/ml. AEs reported more frequently in T arms were rash, pruritus, diarrhoea, anorectal disorders and anaemia. 13% of T/PR patients had premature discontinuation (D/C) of T due to AEs: rash (4%) and anaemia (3%) were the most common AEs leading to T D/C.

Conclusion T/PR SVR was significantly superior to PR in all prior-treatment failure populations including null- and partial-responders. A telaprevir delayed start did not have a significant impact on SVR rates. Safety profile of T/PR was consistent with that observed in treatment naive subjects.

Abstract OP03 Table 1

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