Trial Outcomes & Findings for A Phase 2a Study to Evaluate Viral Kinetics and Safety of Telaprevir in Participants With Genotype 2 or 3 Hepatitis C Infection (NCT NCT00561015)

Last Updated: 2013-06-17

Results Overview

Level of HCV RNA in plasma was measured using COBAS TaqMan HCV test v2.0 (an in vitro nucleic acid amplification test for quantitation of HCV RNA genotypes 1 through 6 in human serum or plasma, using the COBAS AmpliPrep Total Nucleic Acid Isolation Kit (TNAI) for preparation of highly purified total nucleic acid from serum or plasma and automated amplification and detection on TaqMan 48 Analyzer). Lower limit of quantification was 25 international units/milliliter (IU/ml) and limit of detection was 10 IU/ml. Assay used was reverse transcription-polymerase chain reaction (RT-PCR) methodology.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

52 participants

Primary outcome timeframe

Baseline, Pre-dose (Day 15)

Results posted on

2013-06-17

Participant Flow

Out of 26 participants infected with genotype 2 hepatitis C virus (HCV) who were randomly assigned to treatment, only 23 participants received treatment. 2 participants withdrew and 1 participant was infected with HCV genotype 4. All the 26 participants infected with genotype 3 HCV received treatment.

Participant milestones

Participant milestones
Measure	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 Participants who were never treated for chronic hepatitis (inflammation of liver) C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a+ RBV (Pbo/PR24) - Genotype 2 Participants who were never treated for chronic hepatitis C genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
Overall Study STARTED	9	5	9	8	9	9
Overall Study COMPLETED	5	5	9	7	8	6
Overall Study NOT COMPLETED	4	0	0	1	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 Participants who were never treated for chronic hepatitis (inflammation of liver) C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
Overall Study Adverse Event	0	0	1	0
Overall Study Lost to Follow-up	2	1	0	3
Overall Study Participant non-compliance	2	0	0	0

Baseline Characteristics

A Phase 2a Study to Evaluate Viral Kinetics and Safety of Telaprevir in Participants With Genotype 2 or 3 Hepatitis C Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 n=9 Participants Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 n=5 Participants Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 n=9 Participants Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 n=8 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 n=9 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 n=9 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Total n=49 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants	8 Participants n=4 Participants	9 Participants n=21 Participants	9 Participants n=10 Participants	49 Participants n=115 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age Continuous	42.3 years STANDARD_DEVIATION 10.63 • n=5 Participants	56.6 years STANDARD_DEVIATION 5.13 • n=7 Participants	49.8 years STANDARD_DEVIATION 10.33 • n=5 Participants	43.4 years STANDARD_DEVIATION 9.62 • n=4 Participants	42.4 years STANDARD_DEVIATION 7.75 • n=21 Participants	39.8 years STANDARD_DEVIATION 13.76 • n=10 Participants	44.9 years STANDARD_DEVIATION 10.97 • n=115 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	14 Participants n=115 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	8 Participants n=21 Participants	9 Participants n=10 Participants	35 Participants n=115 Participants
Region of Enrollment France	7 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants	3 participants n=4 Participants	4 participants n=21 Participants	3 participants n=10 Participants	28 participants n=115 Participants
Region of Enrollment Italy	1 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	1 participants n=10 Participants	4 participants n=115 Participants
Region of Enrollment Sweden	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=10 Participants	1 participants n=115 Participants
Region of Enrollment United Kingdom	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	5 participants n=4 Participants	5 participants n=21 Participants	5 participants n=10 Participants	16 participants n=115 Participants

PRIMARY outcome

Timeframe: Baseline, Pre-dose (Day 15)

Population: Full analysis set (FAS) population included all randomly assigned participants who received at least 1 dose of TVR or placebo.

Outcome measures

Outcome measures
Measure	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 n=9 Participants Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 n=5 Participants Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 n=9 Participants Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 n=8 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 n=9 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 n=9 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15 Change at Day 15	-3.66 log10 IU/ml Interval -5.4 to -0.9	-5.51 log10 IU/ml Interval -6.0 to -4.6	-4.83 log10 IU/ml Interval -6.0 to -0.2	-0.54 log10 IU/ml Interval -1.0 to -0.1	-4.85 log10 IU/ml Interval -6.1 to -2.3	-4.72 log10 IU/ml Interval -6.1 to -3.2
Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15 Baseline	6.61 log10 IU/ml Interval 4.4 to 7.3	6.21 log10 IU/ml Interval 5.3 to 7.3	6.15 log10 IU/ml Interval 5.5 to 7.4	6.65 log10 IU/ml Interval 5.8 to 7.1	6.79 log10 IU/ml Interval 5.4 to 7.4	6.92 log10 IU/ml Interval 3.9 to 7.3

PRIMARY outcome

Timeframe: Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hour [hr])

Population: The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure.

The Cmax is defined as the maximum observed analyte concentration. The Cmax was measured in nanogram/milliliter (ng/ml).

Outcome measures

Outcome measures
Measure	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 n=9 Participants Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 n=5 Participants Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 n=7 Participants Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 n=8 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
Maximum Plasma Concentration (Cmax) for Telaprevir on Day 1	1886 ng/ml Standard Deviation 1043	2462 ng/ml Standard Deviation 761	1497 ng/ml Standard Deviation 435	1588 ng/ml Standard Deviation 1090	—	—

PRIMARY outcome

Timeframe: Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr)

The Tmax is defined as the actual sampling time to reach maximum observed analyte concentration. The analyte concentration associated with Tmax is referred to as Cmax.

Outcome measures

Outcome measures
Measure	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 n=9 Participants Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 n=5 Participants Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 n=7 Participants Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 n=8 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
Time to Reach Maximum Plasma Concentration (Tmax) for Telaprevir on Day 1	3.0 hr Interval 0.5 to 6.0	4.0 hr Interval 2.1 to 4.2	4.0 hr Interval 3.0 to 6.0	4.0 hr Interval 3.0 to 8.0	—	—

PRIMARY outcome

Timeframe: Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr)

The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method.

Outcome measures

Outcome measures
Measure	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 n=9 Participants Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 n=5 Participants Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 n=7 Participants Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 n=8 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 1	7980 ng*hr/ml Standard Deviation 4658	11248 ng*hr/ml Standard Deviation 3810	6938 ng*hr/ml Standard Deviation 1828	6979 ng*hr/ml Standard Deviation 5011	—	—

SECONDARY outcome

Timeframe: Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)

The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method.

Outcome measures

Outcome measures
Measure	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 n=8 Participants Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 n=4 Participants Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 n=6 Participants Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 n=6 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 15	20144 ng*hr/ml Standard Deviation 11129	26588 ng*hr/ml Standard Deviation 10908	18480 ng*hr/ml Standard Deviation 3011	20895 ng*hr/ml Standard Deviation 6242	—	—

SECONDARY outcome

Timeframe: Baseline and Week 24/26

Levels of HCV RNA in plasma were measured using COBAS TaqMan HCV test v2.0. Lower limit of quantification was 25 IU/ml and limit of detection was 10 IU/ml. The assay used real time RT-PCR methodology. End of treatment (EOT) for group T2 \& PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.

Outcome measures

Outcome measures
Measure	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 n=7 Participants Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 n=5 Participants Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 n=9 Participants Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 n=8 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 n=7 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 n=9 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Week 24 and Week 26	-5.91 log10 IU/ml Interval -6.6 to -3.7	-5.51 log10 IU/ml Interval -6.6 to -4.6	-5.45 log10 IU/ml Interval -6.7 to 0.7	-5.71 log10 IU/ml Interval -6.4 to -0.9	-5.50 log10 IU/ml Interval -6.7 to -4.7	-6.22 log10 IU/ml Interval -6.6 to -3.2

SECONDARY outcome

Timeframe: Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)

The Cmax is defined as the maximum observed analyte concentration. The Cmax is measured in ng/ml.

Outcome measures

Outcome measures
Measure	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 n=8 Participants Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 n=4 Participants Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 n=6 Participants Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 n=6 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
Maximum Plasma Concentration (Cmax) for Telaprevir on Day 15	3261 ng/ml Standard Deviation 1818	4318 ng/ml Standard Deviation 1518	2898 ng/ml Standard Deviation 423	3358 ng/ml Standard Deviation 377	—	—

SECONDARY outcome

Timeframe: Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)

The Cmin is defined as minimum plasma concentration between 0 hr and dosing interval. The Cmin is measured in ng/ml.

Outcome measures

Outcome measures
Measure	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 n=8 Participants Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 n=4 Participants Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 n=6 Participants Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 n=6 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
Minimum Plasma Concentration (Cmin) for Telaprevir on Day 15	1605 ng/ml Standard Deviation 1106	2164 ng/ml Standard Deviation 1398	1800 ng/ml Standard Deviation 375	2002 ng/ml Standard Deviation 659	—	—

SECONDARY outcome

Timeframe: Baseline, Day 12, 15, Week 4, 6, 14 and EOT (Week 24/26 or early discontinuation)

Population: The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'n' included those participants who were evaluable for this measure at specific time points.

Virological response was defined as having HCV RNA level less than a particular threshold that is less than 10 IU/ml (undetectable).

Outcome measures

Outcome measures
Measure	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 n=9 Participants Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 n=5 Participants Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 n=9 Participants Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 n=8 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 n=9 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 n=9 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) Day 12 (n=8,5,9,8,9,9)	0.00 percentage of participants	60.0 percentage of participants	0.00 percentage of participants	0.00 percentage of participants	11.1 percentage of participants	22.2 percentage of participants
Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) Day 15 (n=9,5,9,8,9,9)	0.00 percentage of participants	40.0 percentage of participants	22.2 percentage of participants	0.00 percentage of participants	22.2 percentage of participants	11.1 percentage of participants
Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) Week 4 (n=7,5,9,8,9,9)	71.4 percentage of participants	80.0 percentage of participants	44.4 percentage of participants	0.00 percentage of participants	33.3 percentage of participants	66.7 percentage of participants
Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) Week 6 (n=7,5,9,8,9,9)	71.4 percentage of participants	100.0 percentage of participants	77.8 percentage of participants	37.5 percentage of participants	66.7 percentage of participants	100 percentage of participants
Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) Week 14 (n=7,5,9,8,9,9)	100 percentage of participants	100.0 percentage of participants	88.9 percentage of participants	75.0 percentage of participants	100 percentage of participants	100 percentage of participants
Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) Week 24/ Week 26 (n=7,5,9,8,7,9)	100 percentage of participants	100.0 percentage of participants	88.9 percentage of participants	75.0 percentage of participants	100 percentage of participants	100 percentage of participants
Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) EOT (n=9,5,9,8,9,9)	88.9 percentage of participants	100.0 percentage of participants	88.9 percentage of participants	75.0 percentage of participants	100 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to EOT

Population: The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo.

Virological response was defined as having HCV RNA level less than a particular threshold which is either less than 10 IU/ml (undetectable) or less than 25 IU/ml (unquantifiable).Time to virological response was defined as the number of days from the start of medication intake necessary to go for the first time below the threshold value. The EOT for group T2 \& PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.

Outcome measures

Outcome measures
Measure	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 n=9 Participants Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 n=5 Participants Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 n=9 Participants Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 n=8 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 n=9 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 n=9 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
Median Time to Virological Response (HCV RNA Level < 10 IU/ml)	31.0 days Interval 29.0 to 45.0	12.0 days Interval 8.0 to 29.0	43.0 days Interval 29.0 to 45.0	99.0 days Interval 46.0 to 185.0	43.0 days Interval 15.0 to 99.0	29.0 days Interval 29.0 to 39.0

SECONDARY outcome

Timeframe: Baseline, Day 12, 15 and Week 24/26

Population: The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo.

Viral breakthrough was defined as an increase in HCV RNA levels by more than 1 log10 in HCV RNA level from the lowest level reached, or a value of HCV RNA \> 100 IU/ml in participants whose HCV RNA had previously become undetectable (\< 10 IU/ml) or unquantifiable (\< 25 IU/ml) during the considered treatment phase. It was considered as confirmed when the criterion for viral breakthrough is fulfilled at two or more consecutive time points or at the last observed time point in case of trial termination. The EOT for group T2 \& PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.

Outcome measures

Outcome measures
Measure	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 n=9 Participants Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 n=5 Participants Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 n=9 Participants Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 n=8 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 n=9 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 n=9 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
Percentage of Participants With Viral Breakthrough Day 12	11.1 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	37.5 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Viral Breakthrough Day 15	66.7 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	37.5 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Viral Breakthrough Week 24/ Week 26	66.7 percentage of participants	0.0 percentage of participants	11.1 percentage of participants	37.5 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 24 weeks after EOT

Relapse was defined as confirmed detectable HCV RNA (\>=10 IU/ml) during the follow-up period up to 24 weeks after last medication intake and after previous undetectable HCV RNA (\< 10 IU/ml) at EOT. No relapse was defined as having no confirmed detectable HCV RNA (\>=10 IU/ml) during the follow-up period and after previous undetectable HCV RNA (\< 10 IU/ml) at EOT. Missing follow-up means no HCV RNA measurements during the follow-up period and after previous undetectable HCV RNA (\< 10 IU/ml) at EOT. The EOT for group T2 \& PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.

Outcome measures

Outcome measures
Measure	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 n=8 Participants Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 n=5 Participants Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 n=8 Participants Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 n=6 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.	TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 n=9 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.	Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 n=9 Participants Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
Percentage of Participants Who Demonstrated Virological Relapse 24 weeks after EOT	12.5 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	33.3 percentage of participants	33.3 percentage of participants	22.2 percentage of participants
Percentage of Participants Who Demonstrated Virological Relapse Missing follow-up	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	11.1 percentage of participants

SECONDARY outcome

Timeframe: Week 12, 24 after EOT

Population: The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo.

The SVR was defined as having HCV RNA undetectable at EOT, not showing relapse up to follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), and HCV RNA undetectable at follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), respectively. The EOT for group T2 \& PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.