Early viral kinetics do not predict treatment outcome with sofosbuvir+ribavirin for 12 or 24 weeks in HCV genotype 2/3 patients in the valence trial
C Eisenbach, S Christensen, N Grüner, R Heyne, H Hinrichsen, D Hüppe, MP Manns, J Petersen, J Schulze-zur-Wiesch, U Spengler, D Häussinger, M Rössle, T Berg, D Brainard, W Symonds, J McHutchison, L Gallo, T Warger, N Forestier, S Zeuzem · Zeitschrift für Gastroenterologie · 2014 · Heft 08
Bibliografische Angaben
Zusammenfassung
Background: Sofosbuvir (SOF) + ribavirin (RBV) for 12 or 24 weeks led to high SVR rates in genotype 2 or 3 HCV-infected patients, respectively, in the Phase 3 VALENCE study. We analyzed viral kinetics to determine the relationship to SVR12. Methods: Treatment-naïve or treatment-experienced patients infected with HCV genotype 2 or 3 were randomized to receive SOF+RBV for 12 weeks or placebo. The study was amended to extend treatment duration to 24 weeks for patients with genotype 3 infection. HCV RNA was measured using the COBAS TaqMan® HCV Test, v2.0 with the High Pure System. The primary end point was SVR12. Th…
