Conditions: Chronic Hepatitis C Hepatitis C (HCV) Hepatitis C Genotype 1a
Keywords: Treatment naive HCV Interferon free Hepatitis C Genotype 1a Chronic Hepatitis C Hepatitis C
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 46
Healthy volunteers: no

Brief summary:
To evaluate the effect of ribavirin on second phase plasma hepatitis C virus (HCV) ribonucleic acid (RNA) decline in participants who receive ombitasvir/ABT-450/ritonavir and dasabuvir with full dose ribavirin, low dose ribavirin or without ribavirin for 2 weeks in treatment-naive HCV genotype (GT) 1a-infected adults.

Detailed description:

Arms:
arm 1: Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks. arm 2: Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks. arm 3: Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.

Interventions: intervention 1: Ombitasvir/ABT-450/Ritonavir intervention 2: Dasabuvir intervention 3: Ribavirin (RBV)
Intervention descriptions: intervention 1: Ombitasvir/ABT-450/ritonavir combination tablets intervention 2: Dasabuvir tablets intervention 3: Ribavirin tablets

Protocol document: