• Subjects with undetectable HCV-RNA at TW 8 (early responders) and who were also negative through TW24 discontinued therapy and entered follow-up at the TW 28 visit.
• Subjects with detectable HCV-RNA at TW 8 or any subsequent treatment week but subsequently negative at TW 24 (late responders) were changed in a blinded fashion to placebo at the TW 28 visit and continued therapy with PegIntron + REBETOL for an additional 20 weeks, for a total treatment duration of 48 weeks.

All subjects with detectable HCV-RNA in plasma at TW24 were discontinued from treatment. Sustained Virologic Response (SVR) was defined as plasma HCV-RNA undetectable at Follow-up Week 24. Plasma HCV-RNA results at Follow-up Week 12 were used if plasma HCV-RNA results at Follow-up Week 24 were missing.

Mean age of subjects randomized was 49 years. The racial distribution of subjects was as follows: 82% White, 14% Black, and 4% others. The distribution of subjects by gender was 60% men and 40% women.

The addition of VICTRELIS to PegIntron and REBETOL significantly increased the SVR rates compared to PegIntron and REBETOL alone in the combined cohort (63% to 66% VICTRELIS-containing arms vs. 38% PR48 control) for randomized subjects who received at least one dose of any study medication (Full-Analysis-Set population). SVR rates for Blacks in a predefined analysis who received the combination of VICTRELIS with PegIntron and REBETOL were 42% to 53% (see Table 10).