|
VICTRELIS(boceprevir) capsule(二十四)
|
|
|
|
|
SVR†,§ % |
65 |
68 |
38 |
|
(n/N) |
(228/352) |
(232/342) |
(132/350) |
|
Cohort 1 (non-Black) |
n=316 |
n=311 |
n=311 |
|
SVR† % |
67 |
68 |
40 |
|
Relapse‡ % |
9 |
8 |
23 |
|
(n/N) |
(21/232) |
(18/230) |
(37/162) |
|
Cohort 2 (Black) |
n=52 |
n=55 |
n=52 |
|
SVR† % |
42 |
53 |
23 |
|
Relapse‡ % |
12 |
17 |
14 |
|
(n/N) |
(3/25) |
(6/35) |
(2/14) |
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 lead-in therapy with PegIntron and REBETOL (10/24, 42%) compared to those who received RGT (5/16 , 31%).
Sustained Virologic Response (SVR) Based on TW 8 HCV-RNA Results
Table 11 presents sustained virologic response based on TW 8 HCV-RNA results in previously untreated subjects. Fifty-seven percent (208/368) of subjects in the VICTRELIS-RGT arm and 56% (204/366) of subjects in the VICTRELIS-PR48 arm had undetectable HCV-RNA at TW8 (early responders) compared with 17% (60/363) of subjects in the PR48 arm.
Table 11 Sustained Virologic Response (SVR) by HCV-RNA Detectability at TW8 in Previously Untreated Subjects in the Combined Cohort
|
|
VICTRELIS-RGT |
VICTRELIS-PR48 |
PR48 |
|
|
|
SVR by TW8 Detectability, % (n/N)* |
N=337 |
N=335 |
N=331 |
|
Undetectable |
88 (184/208) |
90 (184/204) |
85 (51/60) |
|
Detectable |
36 (46/129) |
40 (52/131) |
30 (82/271) |
Among subjects with detectable HCV-RNA at TW 8 who had attained undetectable HCV-RNA at TW 24 and completed at least 28 weeks of treatment, the SVR rates were 66% (45/68) in VICTRELIS-RGT arm (4 weeks of PegIntron and REBETOL then 24 weeks of VICTRELIS with PegIntron and REBETOL followed by 20 weeks of PegIntron and REBETOL alone) and 75% (55/73) in VICTRELIS-PR48 arms (4 weeks of PegIntron and REBETOL then 44 weeks of VICTRELIS with PegIntron and REBETOL).
Subjects Who Failed Previous Therapy with Peginterferon Alfa and Ribavirin
RESPOND-2 was a randomized, parallel-group, double-blind study comparing two therapeutic regimens of VICTRELIS 800 mg orally three times daily in combination with PR [PegIntron 1.5 µg/kg/week subcutaneously and weight-based ribavirin (600–1400 mg/day orally divided twice daily)] compared to PR alone in adult subjects with chronic hepatitis C (HCV genotype 1) infection with demonstrated interferon responsiveness (as defined historically by a decrease in HCV-RNA viral load greater than or equal to 2-l |
