Integrated safety analysis of Sofosbuvir-based HCV treatment regimens from phase 3 studies
S Christensen, S Zeuzem, C Eisenbach, N Grüner, R Heyne, H Hinrichsen, D Hüppe, J Petersen, U Spengler, J Schulze-zur-Wiesch, D Häussinger, M Rössle, T Berg, D Brainard, W Symonds, J McHutchison, L Gallo, T Warger, N Forestier, MP Manns · Zeitschrift für Gastroenterologie · 2014 · Heft 08
Bibliografische Angaben
Zusammenfassung
Background and aims: Sofosbuvir (SOF) is an HCV NS5B polymerase inhibitor that has demonstrated high sustained response rates in patients with genotypes 1 – 6 HCV infection. The aim of this analysis was to evaluate the combined safety across the SOF phase 3 studies. Methods: Safety data from patients enrolled in five Phase 3 studies (FISSION, FUSION, POSITRON, VALENCE and NEUTRINO) were reviewed. Adverse events (AEs), serious AEs (SAEs), discontinuations and safety laboratory values were included in the analysis and pooled by treatment regimen. The placebo and PEG + RBV groups are presented as controls. Results:…
