Trial Outcomes & Findings for A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy (NCT NCT00535847)

Last Updated: 2014-08-05

Results Overview

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

117 participants

Primary outcome timeframe

24 weeks after the completion of treatment (up to Week 72)

Results posted on

2014-08-05

Participant Flow

Subjects randomized to placebo control group in parent studies VX05-950-104 (NCT00336479), VX05-950-104EU (NCT00372385) and VX06-950-106 (NCT00420784) who had discontinued treatment in the parent study due to an inadequate response to treatment or relapsed after treatment were eligible to participate in this study VX06-950-107 (NCT00535847).

Participant milestones

Participant milestones
Measure	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks.	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.	Other Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 \[NCT00535847\]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 \[NCT00336479\], VX05-950-104EU \[NCT00372385\] or VX06-950-106 \[NCT00420784\]) were included in "Other" reporting group.
Overall Study STARTED	81	34	2
Overall Study COMPLETED	59	20	0
Overall Study NOT COMPLETED	22	14	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks.	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.	Other Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 \[NCT00535847\]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 \[NCT00336479\], VX05-950-104EU \[NCT00372385\] or VX06-950-106 \[NCT00420784\]) were included in "Other" reporting group.
Overall Study Adverse Event	5	3	2
Overall Study Non compliance	1	1	0
Overall Study Protocol-defined Virologic Stopping Rule	16	10	0

Baseline Characteristics

A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week n=81 Participants Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks.	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week n=34 Participants Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.	Other n=2 Participants Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 \[NCT00535847\]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 \[NCT00336479\], VX05-950-104EU \[NCT00372385\] or VX06-950-106 \[NCT00420784\]) were included in "Other" reporting group.	Total n=117 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
Age, Categorical Between 18 and 65 years	81 Participants n=5 Participants	34 Participants n=7 Participants	2 Participants n=5 Participants	117 Participants n=4 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
Age, Continuous	50.0 years STANDARD_DEVIATION 7.7 • n=5 Participants	51.2 years STANDARD_DEVIATION 5.9 • n=7 Participants	49.0 years STANDARD_DEVIATION 0.0 • n=5 Participants	50.3 years STANDARD_DEVIATION 7.2 • n=4 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	8 Participants n=7 Participants	0 Participants n=5 Participants	36 Participants n=4 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	26 Participants n=7 Participants	2 Participants n=5 Participants	81 Participants n=4 Participants
Region of Enrollment North America	64 participants n=5 Participants	26 participants n=7 Participants	2 participants n=5 Participants	92 participants n=4 Participants
Region of Enrollment Europe	17 participants n=5 Participants	8 participants n=7 Participants	0 participants n=5 Participants	25 participants n=4 Participants

PRIMARY outcome

Timeframe: 24 weeks after the completion of treatment (up to Week 72)

Population: The FA set included all enrolled subjects who received at least 1 dose of study drug in this study (VX06-950-107 \[NCT00535847\]).

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week n=81 Participants Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks.	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week n=34 Participants Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.	Other n=2 Participants Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 \[NCT00535847\]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 \[NCT00336479\], VX05-950-104EU \[NCT00372385\] or VX06-950-106 \[NCT00420784\]) were included in "Other" reporting group.	Did Not Achieve eRVR/Did Not Achieve SVR All subjects in "Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week", "Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week" and "Other" reporting groups who neither achieved eRVR nor SVR in this study (VX06-950-107 \[NCT00535847\]).
Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment	60.5 percentage of participants Interval 49.0 to 71.2	52.9 percentage of participants Interval 35.1 to 70.2	100.0 percentage of participants Interval 15.8 to 100.0	—

PRIMARY outcome

Timeframe: Baseline through Week 48

Population: The FA set included all enrolled subjects who received at least 1 dose of study drug in this study (VX06-950-107 \[NCT00535847\]).

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.

Outcome measures

Outcome measures
Measure	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week n=81 Participants Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks.	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week n=34 Participants Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.	Other n=2 Participants Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 \[NCT00535847\]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 \[NCT00336479\], VX05-950-104EU \[NCT00372385\] or VX06-950-106 \[NCT00420784\]) were included in "Other" reporting group.	Did Not Achieve eRVR/Did Not Achieve SVR All subjects in "Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week", "Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week" and "Other" reporting groups who neither achieved eRVR nor SVR in this study (VX06-950-107 \[NCT00535847\]).
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	77 participants	31 participants	2 participants	—
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	7 participants	3 participants	1 participants	—

SECONDARY outcome

Timeframe: 24 weeks after the completion of treatment (up to Week 72)

Population: Analysis population included all enrolled subjects who were prior relapsers in parent study (VX05-950-104 \[NCT00336479\], VX05-950-104EU \[NCT00372385\] or VX06-950-106 \[NCT00420784\]) and received at least 1 dose of study drug in this study (VX06-950-107 \[NCT00535847\]).

Prior relapsers: subjects who had undetectable HCV RNA at the end of treatment in parent study but reverted to detectable levels of HCV RNA after stopping treatment in parent study were categorized as prior relapsers. Percentage of prior relapsers with undetectable HCV RNA 24 weeks after the completion of treatment in this study were presented. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week n=25 Participants Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks.	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week n=3 Participants Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.	Other n=1 Participants Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 \[NCT00535847\]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 \[NCT00336479\], VX05-950-104EU \[NCT00372385\] or VX06-950-106 \[NCT00420784\]) were included in "Other" reporting group.	Did Not Achieve eRVR/Did Not Achieve SVR All subjects in "Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week", "Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week" and "Other" reporting groups who neither achieved eRVR nor SVR in this study (VX06-950-107 \[NCT00535847\]).
Percentage of Prior Relapsers With Undetectable HCV RNA	96.0 percentage of participants Interval 79.6 to 99.9	100.0 percentage of participants Interval 29.2 to 100.0	100.0 percentage of participants Interval 2.5 to 100.0	—

SECONDARY outcome

Timeframe: End of treatment (up to Week 48)

Population: The FA set included all enrolled subjects who received at least 1 dose of study drug in this study (VX06-950-107 \[NCT00535847\]).

Subjects were considered to have an end of treatment response if they completed the assigned treatment regimen and had undetectable HCV RNA at end of treatment or prematurely discontinued the assigned treatment regimen and had undetectable HCV RNA at the time of discontinuation. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week n=81 Participants Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks.	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week n=34 Participants Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.	Other n=2 Participants Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 \[NCT00535847\]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 \[NCT00336479\], VX05-950-104EU \[NCT00372385\] or VX06-950-106 \[NCT00420784\]) were included in "Other" reporting group.	Did Not Achieve eRVR/Did Not Achieve SVR All subjects in "Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week", "Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week" and "Other" reporting groups who neither achieved eRVR nor SVR in this study (VX06-950-107 \[NCT00535847\]).
Percentage of Subjects With End of Treatment Response	72.8 percentage of participants Interval 61.8 to 82.1	64.7 percentage of participants Interval 46.5 to 80.3	100.0 percentage of participants Interval 15.8 to 100.0	—

SECONDARY outcome

Timeframe: 48 weeks after completion of treatment (up to Week 96)

Population: Analysis population included subjects who completed assigned treatment in this study (VX06-950-107 \[NCT00535847\]).

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week n=59 Participants Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks.	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week n=20 Participants Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.	Other Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 \[NCT00535847\]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 \[NCT00336479\], VX05-950-104EU \[NCT00372385\] or VX06-950-106 \[NCT00420784\]) were included in "Other" reporting group.	Did Not Achieve eRVR/Did Not Achieve SVR All subjects in "Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week", "Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week" and "Other" reporting groups who neither achieved eRVR nor SVR in this study (VX06-950-107 \[NCT00535847\]).
Percentage of Subjects With Undetectable HCV RNA at Week 48 After Completion of Treatment Among Subjects Who Completed Assigned Treatment	83.1 percentage of participants Interval 71.0 to 91.6	70.0 percentage of participants Interval 45.7 to 88.1	—	—

SECONDARY outcome

Timeframe: Baseline up to Week 72

Population: The FA set included subjects who received at least 1 dose of study drug in this study (VX06-950-107 \[NCT00535847\]). Data was presented for overall subjects based on eRVR and SVR status as per planned analysis.

Cross tabulation of number of subjects with eRVR/SVR status in present study was presented with respect to prior response status of subjects in parent studies. eRVR=undetectable HCV RNA at Week 4 and Week 12, SVR=undetectable HCV RNA at end of treatment (EOT) and at 24 weeks after last dose of study treatment without any confirmed detectable HCV RNA in between. Prior response=subjects were categorized into following categories based on their viral response in the parent study: Null Response (less than \[\<\] 1-log10 decrease in HCV RNA at Week 4 or \<2-log10 decrease in HCV RNA at Week 12), Partial Response (greater than \[\>\] 2-log10 decrease in HCV RNA at Week 12, but detectable HCV RNA at Week 24), Viral Breakthrough (detectable HCV RNA during treatment after achieving undetectable HCV RNA), Relapse (undetectable HCV RNA at EOT but detectable HCV RNA during viral follow-up). Plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay; lower limit of detection=10 IU/mL.

Outcome measures

Outcome measures
Measure	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week n=57 Participants Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks.	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week n=12 Participants Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.	Other n=12 Participants Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 \[NCT00535847\]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 \[NCT00336479\], VX05-950-104EU \[NCT00372385\] or VX06-950-106 \[NCT00420784\]) were included in "Other" reporting group.	Did Not Achieve eRVR/Did Not Achieve SVR n=36 Participants All subjects in "Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week", "Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week" and "Other" reporting groups who neither achieved eRVR nor SVR in this study (VX06-950-107 \[NCT00535847\]).
Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response Prior Viral Breakthrough	6 participants	0 participants	0 participants	2 participants
Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response Prior Relapse	24 participants	0 participants	4 participants	1 participants
Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response Prior Null Response	12 participants	5 participants	7 participants	27 participants
Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response Prior Partial Response	15 participants	7 participants	1 participants	6 participants

Adverse Events

Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week

Serious events: 7 serious events

Other events: 77 other events

Deaths: 0 deaths

Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week

Serious events: 3 serious events

Other events: 31 other events

Deaths: 0 deaths

Other

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week n=81 participants at risk Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks.	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week n=34 participants at risk Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.	Other n=2 participants at risk Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 \[NCT00535847\]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 \[NCT00336479\], VX05-950-104EU \[NCT00372385\] or VX06-950-106 \[NCT00420784\]) were included in "Other" reporting group.
Skin and subcutaneous tissue disorders Rash generalised	1.2% 1/81 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	0.00% 0/34 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	50.0% 1/2 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
Skin and subcutaneous tissue disorders Drug rash with eosinophilia and systemic symptoms	1.2% 1/81 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	0.00% 0/34 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	0.00% 0/2 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/81 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	2.9% 1/34 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	0.00% 0/2 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
Skin and subcutaneous tissue disorders Urticaria	1.2% 1/81 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	0.00% 0/34 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	0.00% 0/2 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
Blood and lymphatic system disorders Anaemia	3.7% 3/81 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	0.00% 0/34 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	0.00% 0/2 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
Cardiac disorders Angina pectoris	0.00% 0/81 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	2.9% 1/34 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	0.00% 0/2 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
Gastrointestinal disorders Abdominal pain lower	1.2% 1/81 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	0.00% 0/34 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	0.00% 0/2 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
General disorders Non-cardiac chest pain	0.00% 0/81 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	2.9% 1/34 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	0.00% 0/2 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
Infections and infestations Bursitis infective	1.2% 1/81 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	0.00% 0/34 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	0.00% 0/2 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
Musculoskeletal and connective tissue disorders Costochondritis	1.2% 1/81 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	0.00% 0/34 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	0.00% 0/2 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
Nervous system disorders Headache	0.00% 0/81 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	2.9% 1/34 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	0.00% 0/2 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
Respiratory, thoracic and mediastinal disorders Pleurisy	1.2% 1/81 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	0.00% 0/34 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	0.00% 0/2 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.
Vascular disorders Hypertension	0.00% 0/81 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	2.9% 1/34 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.	0.00% 0/2 • Adverse Events during Overall Treatment Phase (Baseline through Week 48) In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.

Other adverse events

Additional Information

Jeff Chodakewitz, M.D.

Vertex Pharmaceuticals Incorporated

Phone: 617-341-6777

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60