Conditions: Chronic Hepatitis C Hepatitis C Virus HCV Direct-Acting Antiviral Agent (DAA)-Experienced
Keywords: Hepatitis C HCV Genotype 6 HCV GT1 Interferon (IFN) free HCV Genotype 5 HCV HCV GT4 HCV Genotype 4 Chronic Hepatitis C Chronic HCV Hepatitis C Genotype 1 HCV GT5 HCV Genotype 1
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 141
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the efficacy and safety of ABT-493 and ABT-530 with or without ribavirin (RBV) in participants with chronic hepatitis C virus, (HCV)-infection who previously failed treatment with a direct acting antiviral (DAA)-containing regimen.

Detailed description:

Arms:
arm 1: ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis. arm 2: ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus ribavirin (RBV) for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis. arm 3: ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis. arm 4: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks in HCV genotypes 1- or 4-6- infected participants with or without cirrhosis. arm 5: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 16 weeks in HCV genotype 1- or 4-6- infected participants with or without cirrhosis.

Interventions: intervention 1: ABT-493, ABT-530 intervention 2: ribavirin (RBV) intervention 3: ABT-493/ABT-530
Intervention descriptions: intervention 1: ABT-493 (tablet) dosed with ABT-530 (tablet) intervention 2: Tablet intervention 3: Tablet; ABT-493 coformulated with ABT-530

Protocol document: