OPTIMIZE trial: Non-inferiority of twice-daily telaprevir versus administration every 8 hours in treatment-naïve, genotype 1 HCV infected patients
P Buggisch, M Buti, K Agarwal, YJ Horsmans, W Sievert, E Janczewska, RS Brown, C Hezode, M Rizzetto, R Parana, S De Meyer, D Luo, J Witek, S Zeuzem · Zeitschrift für Gastroenterologie · 2013 · Heft 08
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Zusammenfassung
Aims: The ADVANCE study showed that telaprevir (TVR, T) every 8 hours (q8h) combined with peginterferon alfa-2a (P) and ribavirin (R) had superior efficacy to PR alone. Reported here are results from OPTIMIZE, a Phase III, randomized, open-label, international, non-inferiority study comparing twice daily (bid) vs. q8h TVR (NCT01241760). Methods: Treatment-naive patients with genotype 1 (G1) HCV infection were randomized (stratified by fibrosis stage and IL28B genotype) to 750 mg q8h or 1125 mg bid TVR plus P 180 µg/week and R 1000 or 1200 mg/day for 12 weeks (TVR phase), then PR alone for 12 weeks if Week 4 HCV…
