Conditions: HCV Hepatitis C Infection Genotype 4
Keywords: Genotype 4 non-responder treatment experienced HCV naive relapser hepatitis infection compensated cirrhosis hepatitis c Cirrhosis Egypt null responder partial responder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 160
Healthy volunteers: no

Brief summary:
This study evaluates the efficacy and safety of ABT-450/r/ABT-267 with RBV in treatment-naive and treatment-experienced HCV GT4 subjects without or with compensated cirrhosis.

Detailed description:
Non-cirrhotic subjects were directly enrolled into Arm A. Cirrhotic subjects were randomized to either Arm B (12 weeks of treatment) or Arm C (24 weeks of treatment).

Arms:
arm 1: ABT-450/r/ABT-267 (paritaprevir/ritonavir/ombitasvir; 2 direct acting antiviral agent \[DAA\]) plus Ribavirin (RBV) for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants without cirrhosis. arm 2: ABT-450/r/ABT-267 plus RBV for 12 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis. arm 3: ABT-450/r/ABT-267 plus RBV for 24 weeks in treatment-naïve and treatment-experienced (with pegylated interferon and ribavirin) participants with compensated cirrhosis.

Interventions: intervention 1: 2 DAA intervention 2: RBV
Intervention descriptions: intervention 1: ABT-450/r/ABT-267 tablets intervention 2: Ribavirin tablets

Protocol document: