The lead-in and immediate start regimens produced comparable SVR and no SVR rates, so data from these two groups were pooled (Table 11).

Table 11: Response Rates: Study C216  Treatment Outcome All T12/PR48*
% (n/N) Pbo/PR48
% (n/N)
*
Lead-in and immediate start T12/PR regimens pooled
†
On-treatment virologic 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.
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 (59-86ºF) [see USP Controlled Room Temperature]. Once the bottle is opened use within 28 days. Keep bottle tightly closed.

17 PATIENT COUNSELING INFORMATION
[See FDA-Approved Patient Labeling (Medication Guide).]

17.1Pregnancy
Ribavirin must not be used by women who are pregnant or by men whose f