A Rollover Protocol of Telaprevir (VX-950) in Combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106 Who did not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 5

Inclusion Criteria

- Subjects randomized in the control arm (Group A) of Study VX06-950-106 are eligible to participate. In addition, these subjects must have discontinued treatment in that study because of the following criteria:
* Week 4 Nonresponder, defined as not having a > or <= 1-log10 decrease from baseline in HCV RNA.
* Viral breakthrough between Week 4 and Week 24. Subjects discontinued study treatment if, on 2 consecutive occasions, the results of HCV RNA testing indicated viral breakthrough. Viral breakthrough is defined as (1) an increase in HCV RNA of >1 log10 compared to the lowest recorded on-treatment value or (2) an HCV RNA level of >100 IU/mL in a subject who had undetectable HCV RNA at a prior time point.
* Week 12 (EVR) Nonresponder, defined as not having achieved an early viral response (EVR, a *2 log10 reduction from baseline in HCV RNA).
* Week 24 Nonresponder, defined as subjects who had detectable HCV RNA at Week 24.
* Week 26 to Week 48 Nonresponder; defined as subjects who had detectable HCV RNA between Weeks 26 and 48.
* Subjects who had detectable HCV RNA during the 24-week post-treatment period.
- Subjects must agree to use 2 methods of contraception, including 1 barrier method, during and for 24 weeks after the last dose of study drug. Female subjects of childbearing potential must have a negative pregnancy test at all visits prior to the first dose.
- Subjects must be willing to refrain from the concomitant use of any medications, substances or foods noted in Section 18 of the protocol.
- Subjects must be able to read and understand the Informed Consent Form (ICF) and willing to sign the ICF and abide by the study restrictions.
- Subjects must agree not to participate in other clinical studies for the duration of their participation in this trial.

Exclusion Criteria

- Subjects who discontinued prior Peg-IFN or RBV for adverse events or for any other reason other than failure to respond to therapy and for whom repeated treatment would be inappropriate.
- Women who are pregnant or breast-feeding.
- Male partners of women who are pregnant or breast-feeding.
- Subjects who have taken any of the prohibited medications identified in Section 18 within 30 days of Day 1.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To provide access to a telaprevir-based treatment to subjects of the Control<br /><br>Group (Group A) of Study VX06-950-106 who stopped treatment due to inadequate<br /><br>response to treatment . Safety, tolerability, and HCV RNA levels will be<br /><br>collected.</p><br>

Secondary Outcome Measures