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

• Telaprevir (Drug), also known as VX-950: Tablet
• Ribavirin (Drug): Tablet
• Pegylated interferon alfa 2a (Drug): Solution for Injection

Primary outcomes

• Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment [24 weeks after the completion of treatment (up to Week 72)]: 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).
• Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline through Week 48]: 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.

Secondary outcomes

• Percentage of Prior Relapsers With Undetectable HCV RNA [24 weeks after the completion of treatment (up to Week 72)]: 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).
• Percentage of Subjects With End of Treatment Response [End of treatment (up to Week 48)]: 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).
• Percentage of Subjects With Undetectable HCV RNA at Week 48 After Completion of Treatment Among Subjects Who Completed Assigned Treatment [48 weeks after completion of treatment (up to Week 96)]: 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).
• Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response [Baseline up to Week 72]: 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.

Sex: All, ages: 18 Years to 70 Years

Inclusion Criteria:

* Enrolled in the control arm of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479) or VX05-950-104EU (NCT00372385)

Participant flow

Outcome results

• Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment (Primary), Number, percentage of participants: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week 60.5 (49.0 to 71.2); Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week 52.9 (35.1 to 70.2); Other 100.0 (15.8 to 100.0)
• Percentage of Prior Relapsers With Undetectable HCV RNA (Secondary), Number, percentage of participants: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week 96.0 (79.6 to 99.9); Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week 100.0 (29.2 to 100.0); Other 100.0 (2.5 to 100.0)
• Percentage of Subjects With End of Treatment Response (Secondary), Number, percentage of participants: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week 72.8 (61.8 to 82.1); Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week 64.7 (46.5 to 80.3); Other 100.0 (15.8 to 100.0)
• Percentage of Subjects With Undetectable HCV RNA at Week 48 After Completion of Treatment Among Subjects Who Completed Assigned Treatment (Secondary), Number, percentage of participants: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week 83.1 (71.0 to 91.6); Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week 70.0 (45.7 to 88.1); Other
• Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response (Secondary), Number, participants: Achieved eRVR/Achieved SVR 12; Achieved eRVR/Did Not Achieve SVR 5; Did Not Achieve eRVR/Achieved SVR 7; Did Not Achieve eRVR/Did Not Achieve SVR 27
• Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Primary), Number, participants: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week 77; Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week 31; Other 2

Adverse events

Time frame: Adverse Events during Overall Treatment Phase (Baseline through Week 48)

Serious adverse events by term

Other adverse events by term

• Nathalie Adda, MD, Study director, Vertex Pharmaceuticals Incorporated