Conditions: Hepatitis C Virus (HCV)
Keywords: hepatitis C infection hepatitis C severe kidney disease chronic kidney disease Genotype 1a Genotype 4 treatment experienced interferon IFN pegIFN
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 18
Healthy volunteers: no

Brief summary:
This study evaluates the efficacy and safety of ombitasvir/paritaprevir/ritonavir with or without dasabuvir in adults with hepatitis C virus (HCV) genotype 1a (GT1a) or genotype 4 (GT4) infection and with severe kidney impairment or end-stage kidney disease.

Detailed description:

Arms:
arm 1: Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks. arm 2: Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\]) for 12 weeks.

Interventions: intervention 1: ombitasvir/paritaprevir/ritonavir and dasabuvir intervention 2: ombitasvir/paritaprevir/ritonavir
Intervention descriptions: intervention 1: Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet intervention 2: Tablet; ombitasvir coformulated with paritaprevir and ritonavir

Protocol document: