or therapy for HCV, including interferon or pegylated interferon monotherapy). INCIVEK was given for the first 8 weeks of treatment (T8/PR regimen) or the first 12 weeks of treatment (T12/PR regimen) in combination with Peg-IFN-alfa-2a/RBV for either 24 or 48 weeks. Subjects who had undetectable HCV-RNA at weeks 4 and 12 (extended Rapid Virologic Response [eRVR]) received 24 weeks of Peg-IFN-alfa-2a/RBV treatment, and subjects who did not have undetectable HCV-RNA at weeks 4 and 12 (no eRVR) received 48 weeks of Peg-IFN-alfa-2a/RBV treatment. The control regimen (Pbo/PR48) had a fixed treatment duration, with telaprevir-matching placebo for the first 12 weeks and Peg-IFN-alfa-2a/RBV for 48 weeks.
The 1088 enrolled subjects had a median age of 49 years (range: 18 to 69); 59% of the subjects were male; 23% had a body mass index greater than or equal to 30 kg/m2; 9% were Black; 11% were Hispanic or Latino; 77% had baseline HCV-RNA levels greater than 800,000 IU/mL; 15% had bridging fibrosis; 6% had cirrhosis; 59% had HCV genotype 1a; and 40% had HCV genotype 1b.
Table 10 shows the response rates for the T12/PR and Pbo/PR48 groups.
Table 10: Response Rates: Study 108 Treatment Outcome T12/PR
N = 363
n/N (%) Pbo/PR48
N = 361
n/N (%)
*
On-treatment failure includes subjects who met a protocol-defined virologic stopping rule or who had detectable HCV-RNA at the time of their last dose of INCIVEK and subjects who had viral breakthrough on peginterferon alfa/ribavirin.
†
Relapse rates are calculated with a denominator of subjects with undetectable HCV-RNA at the end of treatment.
‡
Other includes subjects with detectable HCV-RNA at the time of their last study drug but who did not have viral breakthrough, and subjects with a missing SVR assessment.
Overall SVR 79% (285/363) 46% (166/361)
eRVR 58% (212/363) 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 compa
