Study of SCY-635, Pegasys and Copegus in Hepatitis C

Objectives: The primary objective of this Phase 2a study was to assess the effect of treatment with SCY-635, used in combination with peginterferon alfa-2a (PegIFN α-2a) and ribavirin (RBV), on hepatitis C viral replication (as measured by quantitative serum HCV RNA) in treatment-naive subjects with chronic genotype 1 infection who have an IL28B genotype of C/T or T/T. The secondary objective of the study was to evaluate the safety and pharmacokinetics (PK) of SCY-635 when given in combination with PegIFN α-2a and RBV. Primary Endpoints: Proportion of subjects in each cohort with an undetectable serum HCV RNA level at Week 4 of treatment Secondary Endpoints: Adverse events and clinical laboratory assessments, including tests of liver function Proportion of subjects achieving complete early virologic response (cEVR, defined as an undetectable serum HCV RNA level at Week 12) Proportion of subjects achieving partial early virologic response (pEVR, defined as a detectable serum HCV RNA level with ≥ 2 log10 reduction in serum HCV RNA from Baseline to Week 12) Proportion of subjects achieving an undetectable serum HCV RNA level at Week 24 Pharmacokinetic assessments of SCY-635 when given in combination with PegIFN α-2a and RBV; trough concentrations of PegIFN α-2a and RB