Conditions: Chronic Hepatitis C Hepatitis C Virus Compensated Cirrhosis Severe Renal Impairment End-stage Renal Disease
Keywords: Chronic Hepatitis C Hepatitis C End-stage renal disease Hepatitis C Genotype 1 Severe Renal Impairment renal disease Compensated Cirrhosis Renal impairment dialysis Hepatitis C Virus cirrhosis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 68
Healthy volunteers: no

Brief summary:
This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24-week regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in HCV-genotype 1-infected subjects with an Estimated Glomerular Filtration Rate (eGFR) \<30, including those on hemodialysis or peritoneal dialysis.

Detailed description:

Arms:
arm 1: 3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily \[QD\] and dasabuvir 250 mg twice daily \[BID\]) with or without ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks

Interventions: intervention 1: ombitasvir/paritaprevir/ritonavir intervention 2: dasabuvir intervention 3: Ribavirin
Intervention descriptions: intervention 1: tablet intervention 2: tablet intervention 3: tablet

Protocol document: