visit.
•Subjects with a detectable HCV-RNA at TW 8 but subsequently undetectable at TW 12 (late responders) were changed in a blinded fashion to placebo at the TW 36 visit and continued treatment with PegIntron + REBETOL for an additional 12 weeks, for a total treatment duration of 48 weeks.
•PegIntron + REBETOL for 4 weeks followed by VICTRELIS 800 mg three times daily + PegIntron + REBETOL for 44 weeks (VICTRELIS-PR48).
All subjects with detectable HCV-RNA in plasma at TW 12 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 53 years. The racial distribution of subjects was as follows: 85% White, 12% Black, and 3% others. The distribution of subjects by gender was 67% men and 33% women.
The addition of VICTRELIS to the PegIntron and REBETOL therapy significantly increased the SVR rates compared to PegIntron/REBETOL alone (59% to 66% VICTRELIS-containing arms vs. 23% PR48 control) for randomized subjects who received at least one dose of any study medication (Full-Analysis-Set population) (see Table 12).
Table 12 Sustained Virologic Response (SVR)* , † and Relapse‡ Rates for Subjects Who have Failed Previous Therapy with Peginterferon Alfa and Ribavirin VICTRELIS-RGT VICTRELIS-PR48 PR48
Previous Partial Responder = subject who failed to achieve SVR after at least 12 weeks of previous treatment with peginterferon alfa and ribavirin, but demonstrated a ≥2-log10 reduction in HCV-RNA by Week 12.
Previous Relapser = subject who failed to achieve SVR after at least 12 weeks of previous treatment with peginterferon alfa and ribavirin, but had undetectable HCV-RNA at the end of treatment.
N=162 N=161 N=80
SVR† % 59 66 23
Relapse‡ % 14 12 28
(n/N) (16/111) (14/121) (7/25)
SVR (subjects without cirrhosis) § 62 65 26
(n/N) (90/145) (90/139) (18/70)
SVR by Response to Previous Peginterferon and Ribavirin Therapy
Previous Response Relapser, % (n/N) 70 (73/105) 75 (77/103) 31 (16/51)
Partial responder, % (n/N) 40 (23/57) 52 (30/58) 7 (2/29)
*The Full Analysis Set (FAS) consisted of all randomized subjects (N=403) who received at least one dose of any study medication (PegIntron, REBETOL, or VICTRELIS).
†Sustained Virologic Response (SVR): reported as plasma HCV-RNA < 25 IU/mL at follow-up week (FW) 24. The last available HCV RNA value in the period at or after FW24 was used. If HCV RNA value at FW24 was missing, the FW12 value was carried forward.
‡Relapse rate was the proportion of subjects with undetectable HCV-RNA at End of Treatment (EOT) and detectable HCV-RNA (≥ 25 IU/mL) at End of Follow-up (EOF) among subjects who were undetectable at EOT and not missing End of Follow-up (EOF) data.
§Includes subjects with missing baseline data regarding cirrhosis as diagnosed by liver biopsy.
In subjects with cirrhosis at baseline, sustained virologic response was higher in those who received treatment with the combination of VICTRELIS with PegIntron and REBETOL for 44 weeks after 4 weeks of lead-in therapy with PegIntron and REBETOL (17/22, 77%) compared to those who received RGT (6/17, 35%).
Sustained Virologic Response (SVR) Based on TW8 HCV-RNA Results
Table 13 presents sustained virolog |
