Z Gastroenterol 2014; 52 - KG141
DOI: 10.1055/s-0034-1386163

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 1, S Christensen 2, N Grüner 3, R Heyne 4, H Hinrichsen 5, D Hüppe 6, MP Manns 7, J Petersen 8, J Schulze-zur-Wiesch 9, U Spengler 10, D Häussinger 11, M Rössle 12, T Berg 13, D Brainard 14, W Symonds 14, J McHutchison 14, L Gallo 15, T Warger 15, N Forestier 15, S Zeuzem 16
  • 1Uniklinik Heidelberg, Heidelberg, Germany
  • 2Schwerpunktpraxis, Münster, Germany
  • 3Klinikum Großhadern, München, Germany
  • 4Schwerpunktpraxis, Berlin, Germany
  • 5Schwerpunktpraxis, Kiel, Germany
  • 6Schwerpunktpraxis, Herne, Germany
  • 7Medizinische Hochschule Hannover, Hannover, Germany
  • 8Ifi Institut für interdisziplinäre Medizin, Hamburg, Germany
  • 9Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany
  • 10Uniklinik Bonn, Bonn, Germany
  • 11Uniklinik Düsseldorf, Düsseldorf, Germany
  • 12Schwerpunktpraxis, Freiburg, Germany
  • 13Uniklinik Leipzig, Leipzig, Germany
  • 14Gilead Sciences, Foster City, United States
  • 15Gilead Sciences, Martinsried, Germany
  • 16Uniklinik Frankfurt, Frankfurt, Germany

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. The predictive value of viral response at Weeks 2 and 4 was calculated; potential viral kinetic (VK) differences in subgroups were evaluated.

Results: 73 patients with HCV genotype 2 and 250 patients with genotype 3 received 12 or 24 weeks of SOF+RBV respectively. The predictive value of viral response at Weeks 2 and 4 will be presented. No difference in VK was noted comparing cirrhosis status, IL28B genotype, or SVR12 outcome.

Conclusions: 12 or 24 weeks of treatment with SOF+RBV was highly efficacious in genotype 2 or 3 HCV-infected patients, respectively. The majority of subjects achieved HCV RNA < LLOQ, TND at Week 4. On-treatment viral kinetics were not predictive of response. Accordingly, there is no role for response guided therapy with these regimens.