Conditions: Chronic Hepatitis C Infection
Keywords: Chronic Hepatitis C Interferon Free Hepatitis C Treatment Naive Hepatitis C Virus Hepatitis C Genotype 1
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 311
Healthy volunteers: no

Brief summary:
This is a study to evaluate the efficacy and safety of three experimental drugs compared with telaprevir (a licensed product) in people with hepatitis C virus infection who have not had treatment before.

Detailed description:
The primary purpose of this study is to demonstrate that treatment with ABT-450/ritonavir (r)/ABT-267 and ABT-333 administered with or without ribavirin (RBV) has non-inferior efficacy compared to treatment with telaprevir and pegylated interferon alpha-2a (pegIFN) and RBV and to compare the safety of these regimens in treatment-naive hepatitis C virus (HCV) genotype (GT) 1a- and 1b-infected adults.

Arms:
arm 1: ABT-450/r/ABT-267 150 mg/100 mg/25 mg once daily (QD) and ABT-333 250 mg twice daily (BID) and weight-based RBV for 12 weeks (3 direct-acting antivirals \[DAAs\] with RBV in GT1a) arm 2: Telaprevir (TPV) 750 mg every 8 hours (q8h) and pegIFN 180 µg/week and weight-based RBV (PR) for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight-based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a) arm 3: ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b) arm 4: ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b) arm 5: Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight-based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)

Interventions: intervention 1: ABT-450/r/ABT-267, ABT-333 intervention 2: Ribavirin intervention 3: Telaprevir intervention 4: Pegylated Interferon alpha 2-a (PegIFN)
Intervention descriptions: intervention 1: Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet intervention 2: Tablet intervention 3: Film-coated tablet intervention 4: Pre-filled syringe

Protocol document: