INCIVEK(telaprevir)tablet, film coated(三十三)
|
SVR rate |
|
|
Prior relapsers |
86% (246/286) |
22% (15/68) |
Prior partial responders |
59% (57/97) |
15% (4/27) |
Prior null responders |
32% (47/147) |
5% (2/37) |
Treatment Outcomes for Subjects Without SVR |
|
On-treatment virologic failure† |
|
|
Prior relapsers |
1% (3/286) |
10% (7/68) |
Prior partial responders |
15% (15/97) |
26% (7/27) |
Prior null responders |
50% (74/147) |
22% (8/37) |
Relapse ‡ |
|
|
Prior relapsers |
3% (8/254) |
63% (27/43) |
Prior partial responders |
20% (14/71) |
0% (0/4) |
Prior null responders |
24% (15/62) |
50% (2/4) |
Among prior relapsers, 76% (218/286) achieved an eRVR and of those 95% (208/218) achieved an SVR. In an earlier, dose-finding clinical trial, 78% (52/67) of prior relapsers achieved an eRVR and were treated with 24 weeks of peginterferon alfa and ribavirin (T12/PR24); of those 94% (49/52) achieved an SVR.
For all populations in the study (prior relapsers, prior partial responders, and prior null responders), SVR rates were higher for the T12/PR group than for the Pbo/PR48 group across subgroups by sex, age, ethnicity, body mass index, HCV genotype subtype, baseline HCV-RNA level, and extent of liver fibrosis.
Twenty-three percent of INCIVEK-treated subjects had cirrhosis at baseline. SVR rates among cirrhotic subjects who received INCIVEK combination treatment compared to Pbo/PR48 were: 87% (48/55) compared to 13% (2/15) for prior relapsers, 34% (11/32) compared to 20% (1/5) for prior partial responders, and 14% (7/50) compared to 10% (1/10) for prior null responders.
Four percent (19/530) of treatment experienced subjects who received INCIVEK combination treatment were Black/African Americans; the SVR rate for these subjects was 63% (12/19) compared to 65% (328/503) for Caucasians.
16 HOW SUPPLIED/STORAGE AND HANDLING
INCIVEK™ (telaprevir) is supplied as purple film-coated capsule-shaped tablets containing 375 mg of telaprevir. Each tablet is debossed with the characters "V 375" on one side and is packaged as follows:
28-day packer contains 4 weekly cartons of 7 blister strips each (6 tablets per blister strip) |
NDC 51167-100-01 |
Bottle containing 168 tablets |
NDC 51167-100-02 |
Store at 25ºC (77ºF); excursions permitted to 15-30ºC ( |