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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
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.