Conditions: Chronic Hepatitis C Hepatitis C Virus Genotype 3 Hepatitis C Virus
Keywords: interferon free Hepatitis C daclatasvir Sovaldi HCV Hepatitis C Virus Hepatitis C Genotype 3 Hep C sofosbuvir Chronic Hepatitis C Daklinza
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 506
Healthy volunteers: no

Brief summary:
The purpose of this study was to compare the safety and efficacy of ABT-493/ABT-530 to the combination of sofosbuvir (SOF) and daclatasvir (DCV) in adults with genotype 3 (GT3) chronic hepatitis C virus (HCV) infection.

Detailed description:
This study was a Phase 3, randomized, open-label, active-controlled multicenter study to compare efficacy and safety of ABT-493/ABT-530 to SOF and DCV in treatment-naïve chronic HCV GT3-infected participants without cirrhosis. The study consisted of 2 periods, a treatment period (participants received 8 or 12 weeks of ABT-493/ABT-530 or 12 weeks of SOF with DCV) and a post-treatment period (participants who completed or prematurely discontinued the treatment period were followed for 24 weeks after their last dose of study drug to evaluate efficacy and to monitor HCV RNA and the emergence and persistence of viral variants).

Arms:
arm 1: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. arm 2: Sofosbuvir 400 mg once daily (QD) co-administered with daclatasvir 60 mg QD for 12 weeks. arm 3: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.

Interventions: intervention 1: ABT-493/ABT-530 intervention 2: Sofosbuvir intervention 3: Daclatasvir
Intervention descriptions: intervention 1: Tablet; ABT-493 coformulated with ABT-530 intervention 2: Tablet intervention 3: Tablet

Protocol document: