|
VICTRELIS(boceprevir) capsule(二十六)
|
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.
|
|
|
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) |
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 virologic 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) |
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, interf |
