Conditions: Chronic Hepatitis C Infection
Keywords: Partial responder Interferon free Treatment-experienced Relapser Hepatitis C Virus Null responder Hepatitis C Genotype 1 paritaprevir ombitasvir dasabuvir ribavirin Viekira PAK Chronic hepatitis C
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 148
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and antiviral activity of 3 direct-acting antiviral agents (DAAs; ABT-450/ritonavir/ABT-267 \[ABT-450/r/ABT-267; ABT-267 also known as ombitasvir\] and ABT-333 \[also known as dasabuvir\]) plus ribavirin (RBV) compared with telaprevir (TPV) with pegylated interferon/ribavirin (pegIFN/RBV) in patients with chronic hepatitis C virus genotype 1 (HCV GT1) infection without cirrhosis who were previously treated with pegylated interferon/ribavirin (pegIFN/RBV).

Detailed description:
A randomized, open-label, parallel-arm, multicenter study to evaluate the safety and antiviral activity of the 3-DAA regimen (ABT-450/ritonavir/ABT-267 \[ABT-450/r/ABT-267\] and ABT-333) plus ribavirin (3-DAA/RBV) compared with the combination of telaprevir (TPV) with RBV and pegIFN (TPV/RBV) in noncirrhotic participants with chronic hepatitis C virus genotype 1 (HCV GT1) infection who were previously treated with pegylated interferon/ribavirin (pegIFN/RBV).

Participants were randomized in a 2:1 ratio to receive 3-DAA/RBV (ABT-450/r/ABT-267 and ABT-333 plus RBV for 12 weeks) or TPV/RBV (TPV co-administered with pegIFN and RBV for 12 weeks, followed by followed by pegIFN and RBV for either 12 or 36 weeks, per local prescribing information).

Arms:
arm 1: 3-DAA (ABT-450/r/ABT-267 \[150 mg/ 100 mg/ 25 mg once daily\] and ABT-333 \[250 mg twice daily\]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks. arm 2: TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously \[SC\] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.

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

Protocol document: