Safety and efficacy of twice daily versus every 8 hour telaprevir with Peginterfepon/Ribavirin (PR) in patients with cirrhosis
P Buggisch, YJ Horsmans, RS Brown, M Buti, K Agarwal, W Sievert, E Janczewska, C Hezode, M Rizzetto, R Parana, S De Meyer, R De Masi, D Luo, J Witek, S Zeuzem · Zeitschrift für Gastroenterologie · 2013 · Heft 08
Bibliografische Angaben
Zusammenfassung
Aims: Non-inferior efficacy of telaprevir (TVR) twice-daily (bid) versus every 8 hours (q8h), in combination with peginterferon/ribavirin (PR) in treatment-naïve patients, has been established across a range of patient baseline characteristics. Here we describe detailed results of TVR bid or q8h across fibrosis/cirrhosis stages. Methods: OPTIMIZE was a randomized, open-label, multicenter, Phase III trial in treatment-naïve patients with chronic HCV genotype 1 infection (NCT01241760). Patients were stratified by liver fibrosis stage (F0-F2 vs. F3/4) and IL28B genotype, and randomized to either TVR 1125 mg bid (N…
