ic response based on TW 8 HCV-RNA results in subjects who have failed previous therapy. Forty-six percent (74/162) of subjects in the VICTRELIS-RGT arm and 52% (84/161) in the VICTRELIS-PR48 had undetectable HCV-RNA at TW 8 (early responders) compared with 9% (7/80) in the PR48 arm.
Table 13 Sustained Virologic Response (SVR) by HCV-RNA Detectability at TW8 in Subjects Who Have Failed Previous Therapy VICTRELIS-RGT VICTRELIS-PR48 PR48
SVR by TW8 Detectability, % (n/N)* N=146 N=154 N=72
Undetectable 88 (65/74) 88 (74/84) 100 (7/7)
Detectable 40 (29/72) 43 (30/70) 14 (9/65)
*Denominator included only subjects with HCV-RNA results at TW8.
Among subjects with detectable HCV-RNA at TW 8 who attained an undetectable HCV-RNA at TW 12 and completed at least 36 weeks of treatment, the SVR rates were 79% (27/34) in VICTRELIS-RGT arm (4 weeks of PegIntron and REBETOL then 32 weeks of VICTRELIS with PegIntron and REBETOL followed by 12 weeks of PegIntron and REBETOL alone) and 72% (29/40) in VICTRELIS-PR48 arm (4 weeks of PegIntron and REBETOL then 44 weeks of VICTRELIS with PegIntron and REBETOL).
Interferon Responsiveness during Lead-In Therapy with Peginterferon alfa and Ribavirin
Previously Untreated Subjects
In previously untreated subjects eva luated in SPRINT-2, interferon-responsiveness (defined as greater than or equal to 1-log10 decline in viral load at TW 4) was predictive of SVR. VICTRELIS-treated subjects who demonstrated interferon responsiveness at TW 4 achieved SVR rates of 81% (203/252) in VICTRELIS-RGT arm and 79% (200/254) in VICTRELIS-PR48 arm, compared to 52% (134/260) in subjects treated with PegIntron/REBETOL.
VICTRELIS-treated subjects who demonstrated poor interferon responsiveness (defined as less than 1-log10 decline in viral load at TW 4), achieved SVR rates of 28% (27/97) in VICTRELIS-RGT arm and 38% (36/95) in VICTRELIS-PR48 arm, compared to 4% (3/83) in subjects treated with PegIntron/REBETOL. Subjects with less than a 0.5-log10 decline in viral load at TW4 achieved SVR rates of 28% (13/47) in VICTRELIS-RGT arm and 30% (11/37) in VICTRELIS-PR48 arm, compared to 0% (0/25) in subjects treated with PegIntron/REBETOL. Subjects with less than a 0.5-log10 decline in viral load at TW4 with peginterferon alfa plus ribavirin therapy alone are predicted to have a null response (less than 2-log10 viral load decline at TW12) to peginterferon alfa and ribavirin.
Subjects Who Failed Previous Therapy with Peginterferon Alfa and Ribavirin
In subjects who were previous relapsers and partial responders eva luated in RESPOND-2, interferon-responsiveness (defined as greater than or equal to 1-log10 decline in viral load at TW4) was predictive of SVR. VICTRELIS-treated subjects who demonstrated interferon responsiveness at TW4 achieved SVR rates of 74% (81/110) in VICTRELIS-RGT arm and 79% (90/114) in VICTRELIS-PR48 arm, compared to 27% (18/67) in subjects treated with PegIntron/REBETOL. VICTRELIS-treated subjects who demonstrated poor interferon responsiveness (defined as less than 1-log10 decline in viral load at TW4) achieved SVR rates of 33% (15/46) in VICTRELIS-RGT arm and 34% (15/44) in VICTRELIS-PR48 arm, compared to 0% (0/12) in subjects treated with PegIntron/REBETOL.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
VICTRELIS 200 mg capsules are comprised of a red-colored cap with the Merck logo printed in yellow ink, and a yellow-colored body with "314" printed in red ink. The c |