A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. Two results are reported: 1) Protocol defined SVR: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72); 2) SVR as per FDA guidance (snapshot analysis): undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used.

Time frame: 24 weeks after last planned dose of study treatment (up to Week 72)

Population: The full analysis (FA) set included all randomized subjects who received at least 1 dose of any study drug.

Criteria for grading severity (toxicity) of ALT and AST: Grade 0 (\<1.25\*upper limit of normal \[ULN\]); Grade 1 (mild=1.25 to 2.5\*ULN); Grade 2 (moderate=2.6 to 5.0\*ULN); Grade 3 (severe= greater than 5.0 to 20.0\*ULN); Grade 4 (life-threatening= greater than 20.0\*ULN). Number of subjects with Grade 3 shift (from Grade 0, Grade 1 or Grade 2 baseline) and Grade 4 shift (from Grade 0, Grade 1, Grade 2 or Grade 3 baseline) are reported. If a subject experienced more than 1 severity grade shifts during post baseline assessments, the maximum severity grade shift was considered.

Time frame: Baseline up to Week 48

Population: The FA set included all randomized subjects who received at least 1 dose of any study drug.

FSS was a 9-item questionnaire where each item was scored on a scale of 1 to 7 (higher scores indicated higher influence of fatigue). FSS total score was calculated as the average of individual items on the questionnaire and FSS total score ranged from 1 to 7, where higher score indicated higher influence of fatigue.

Time frame: Baseline, Week 4, 12, 24, 36, 48, 72

Population: The FA set included all randomized subjects who received at least 1 dose of any study drug. Here n signifies those participants who were evaluable for this measure at given time points for each group, respectively.

FibroTest analysis was a biomarker analysis test used to generate a score that was correlated with the degree of liver damage. The FibroTest score was calculated from the results of a six-parameter blood test, combining six serum markers (alpha-2-macroglobulin, haptoglobin, apolipoprotein A1, gamma-glutamyl transpeptidase, total bilirubin, and alanine transaminase). The FibroTest score (F score) may range from 0.00 (Grade F0) to 1.00 (Grade F4), where F0= no fibrosis and F4=cirrhosis. Results were presented separately for subjects who achieved SVR at 24 weeks after the last planned dose of study treatment and those who did not achieve SVR at 24 weeks after the last planned dose of study treatment. Improvement was defined as decrease of at least 1 grade relative to baseline.

Time frame: Baseline through 24 weeks after last planned dose of study treatment (up to Week 72)

Population: The FA set included all randomized subjects who received at least 1 dose of any study drug. Here number of participants analyzed signifies those subjects who were evaluable for FibroTest Analysis and n signifies those subjects who were evaluable for FibroTest Analysis in specified category for each treatment arm, respectively.

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both Week 4 and Week 12.

Time frame: Week 4 and Week 12

Population: The FA set included all randomized subjects who received at least 1 dose of any study drug.

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment.

Time frame: Week 4

Population: The FA set included all randomized subjects who received at least 1 dose of any study drug.

AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study.

Time frame: Baseline up to Week 48

Population: The FA set included all randomized subjects who received at least 1 dose of any study drug.

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.

Time frame: 12 weeks after last planned dose of study treatment (up to Week 60)

Population: The FA set included all randomized subjects who received at least 1 dose of any study drug.

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.

Time frame: 24 weeks after last actual dose of study treatment (up to Week 72)

Population: The FA set included all randomized subjects who received at least 1 dose of any study drug.

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.

Time frame: End of treatment (up to Week 48)

Population: The FA set included all randomized subjects who received at least 1 dose of any study drug.

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.

Time frame: Week 12

Population: The FA set included all randomized subjects who received at least 1 dose of any study drug.

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL.

Time frame: Week 72 (24 weeks after last dose for subjects with a planned treatment duration of 48 weeks and 48 weeks after last dose for subjects with planned treatment duration of 24 weeks)

Population: The FA set included all randomized subjects who received at least 1 dose of any study drug.

Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. For viral relapse, 2 analyses were performed: planned and actual. The planned analyses was measured from the end of treatment (EOT) visit to 24 weeks after the last planned dose of study treatment. The actual analyses was measured from the EOT visit to 24 weeks after the last actual dose of study treatment.

Time frame: After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)

Population: Analysis population included subjects who completed their assigned study drug treatment and had undetectable HCV RNA at the completion of treatment (up to Week 48).