|
INCIVEK(telaprevir)tablet, film coated(三十一)
|
12/363) |
8% (29/361) |
|
SVR in eRVR subjects |
92% (195/212) |
93% (27/29) |
|
No eRVR |
42% (151/363) |
92% (332/361) |
|
SVR in no eRVR subjects |
60% (90/151) |
42% (139/332) |
|
Outcome for Subjects without SVR |
|
On-treatment virologic failure* |
7% (26/363) |
29% (105/361) |
|
Relapse† |
4% (11/298) |
24% (53/220) |
|
Other‡ |
11% (41/363) |
10% (37/361) |
In the T8/PR group, the overall SVR rate was 72%. The eRVR rate was 57% and the SVR rate for eRVR subjects was 87%. The SVR rate for no eRVR subjects was 52%. More subjects in the T8/PR group experienced virologic breakthrough after Week 12 while receiving peginterferon alfa and ribavirin alone, 16% compared to 10% in T12/PR group.
SVR rates were higher (absolute difference of at least 22%) for the T12/PR group than for the Pbo/PR48 group across subgroups by sex, age, race, ethnicity, body mass index, HCV genotype subtype, baseline HCV-RNA (less than 800,000, greater than or equal to 800,000 IU/mL), and extent of liver fibrosis. However, there were small numbers of subjects enrolled in some key subgroups. In the T12/PR group:
-
Twenty-one subjects had cirrhosis at baseline and the overall SVR in these subjects was 62% (13/21). Among subjects with cirrhosis, 43% (9/21) achieved an eRVR and of those 78% (7/9) achieved SVR.
-
Twenty-six subjects were Black/African Americans. The overall SVR among Black/African American subjects was 62% (16/26). Among these subjects, 31% (8/26) achieved an eRVR and of those 89% (8/9) achieved SVR.
Study 111 (ILLUMINATE)
Study 111 was a randomized, open-label trial conducted in treatment-naïve subjects. The study was designed to compare SVR rates in subjects achieving eRVR who were treated with INCIVEK for 12 weeks in combination with Peg-IFN-alfa-2a/RBV for either 24 weeks (T12/PR24 regimen) or 48 weeks (T12/PR48 regimen).
The 540 enrolled subjects had a median age of 51 years (range: 19 to 70); 60% were male; 32% had a body mass index greater than or equal to 30 kg/m2; 14% were Black; 10% were Hispanic or Latino; 82% had baseline HCV-RNA levels greater than 800,000 IU/mL; 16% had bridging fibrosis; 11% had cirrhosis; 72% had HCV genotype 1a; and 27% had HCV genotype 1b.
The SVR rate for all subjects enrolled in the trial was 74%. A total of 352 (65%) subjects achieved eRVR and of those 322 (60%) were randomized to 24 weeks (T12/PR24, n=162) or 48 weeks (T12/PR48, n=160) of treatment. The SVR rates were similar at 92% (T12/PR24) and 90% (T12/PR48), respectively. Again, small numbers of subjects were enrolled in some key subgroups:
-
Sixty-one (11%) of subjects had cirrhosis at baseline. Among subjects with cirrhosis, 30 (49%) achieved an eRVR: 18 were randomized to T12/PR24 and 12 to T12/PR48. The SVR rates were 67% (12/18) for the T12/PR24 group and 92% (11/12) for the T12/PR48 group.
-
Blacks/African Americans comprised 14% (73/5
|
