Shortening overall treatment to 12 weeks of Simeprevir (SMV) plus PEG-IFN/RBV in treatment-naïve chronic Hepatitis C (CHC) Genotype 1 patients: assessment of baseline and week 2 o…
M Gschwantler, T Asselah, C Moreno, C Sarrazin, GR Foster, A Craxi, P Buggisch, R Ryan, O Lenz, G Van Dooren, I Lonjon-Domanec, M Schlag, M Buti · Zeitschrift für Gastroenterologie · 2015 · Heft 05
Bibliografische Angaben
Zusammenfassung
Purpose: To assess whether Week-2 response with SMV+Peg-IFN/RBV can allow shortening treatment to 12 weeks, irrespective of baseline and on-treatment factors. Design: Phase-3, open-label study in treatment-naïve CHC genotype 1-patients with no-to-moderate fibrosis (METAVIR F0-F2). In patients with HCV-RNA < 25 IU/mL (detectable/undetectable [Roche COBAS® Taqman® LLOQ: 25 IU/mL, LLOD: 15 IU/mL]) at Week 2 and undetectable at Weeks 4 and 8, all treatments were stopped at Week 12. If these criteria were not met, Peg-IFN/RBV was continued to Week 24. Concordance of response between Roche and Abbott RealTime assays w…
