Conditions: Hepatitis C
Keywords: Genotype 1
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 117
Healthy volunteers: no

Brief summary:
To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.

Detailed description:

Arms:
arm 1: 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. arm 2: 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. arm 3: 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.

Interventions: intervention 1: Telaprevir intervention 2: Ribavirin intervention 3: Pegylated interferon alfa 2a
Intervention descriptions: intervention 1: Tablet intervention 2: Tablet intervention 3: Solution for Injection

Protocol document: