Telaprevir, Peg-IFN-alfa-2a, and RBV in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C

SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (\<lower limit of quantification) at 12 weeks after last actual dose of study drug. 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).

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

Population: FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.

Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA \>=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by race and by prior response.

Time frame: up to Week 72

Population: FA Set.

AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes SAE as well as Non-SAEs. SAE (subset of AE): 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.

Time frame: Up to Week 52

Population: Safety Set.

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. eRVR was defined as undetectable HCV RNA (\<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.

Time frame: Week 4 and Week 12

Population: FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.

On treatment virologic failure was defined as meeting any futility rule or completing assigned treatment duration and having detectable HCV RNA at EOT. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Futility rules: 1) Virologic breakthrough (at least 1 log10 increase from nadir or confirmed detectable HCV RNA after undetectable HCV RNA) from Day 1 through Week 24 or 48 (depending on treatment duration); 2) HCV RNA \>1000 IU/mL during Weeks 4 to 12, inclusive; 3) Detectable HCV RNA after Week 12. Percentages are calculated by using total number in FA set as denominator, in each category.

Time frame: Week 2, 4, 8, 12, 16, 24, 28, 36, 40, and 48

Population: FA Set.

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Relapse was defined as having undetectable HCV RNA (\<lower limit of quantification) at actual end of treatment (EOT) and followed by detectable HCV RNA (\>=lower limit of quantification) during follow-up.

Time frame: 4 weeks (Wk) (up to Week 52), 12 weeks (up to Week 60) and 24 weeks (up to Week 72) after actual EOT

Population: FA Set. Here number of participants analyzed signifies participants with undetectable HCV RNA (HCV RNA \<lower limit of quantification) at actual EOT and n signifies participants with undetectable HCV RNA at actual EOT for specified category.

SVR24 was defined as an undetectable HCV RNA Levels (\<lower limit of quantification) at 24 weeks after last actual dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL.

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

Population: FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Virologic breakthrough on treatment was defined as an increase of at least 1 log10 from nadir or confirmed detectable HCV RNA (\>=lower limit of quantification) after undetectable HCV RNA (\<lower limit of quantification). Percentages are calculated by using total number in FA set as denominator, in each category.

Time frame: Week 2, 4, 8, and 12

Population: FA Set.

Time frame: 48 weeks

Population: Pharmacokinetic sampling was not performed as per changes in planned analysis (protocol amendment); hence no data was collected.