Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease

AbbVie

Status and phase: Completed; Phase 3

Conditions: Severe Renal Impairment; Compensated Cirrhosis; Hepatitis C Virus; End-stage Renal Disease; Chronic Hepatitis C

Treatments: Drug: dasabuvir; Drug: Ribavirin; Drug: ombitasvir/paritaprevir/ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02207088

M14-226

2014-001527-77 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Positive for anti-HCV Ab (Antibody) and HCV RNA >1,000 IU/mL at Screening.
2. Screening laboratory result indicating HCV genotype 1 infection.
3. Subject has never received antiviral treatment for hepatitis C infection (treatment-naive subject) or subject has received previous treatment with peginterferon with or without RBV with non-response (HCV RNA quantifiable at end of treatment or relapsed after end of treatment).
4. Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m^2 as estimated by the Modification of Diet in Renal Disease (MDRD) method.

Exclusion criteria

1. Women who are pregnant or breastfeeding.
2. Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency Virus (HIV Ab).
3. Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation such as ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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68 participants in 1 patient group

3-DAA (Direct Acting Antivirals) with or without RBV

Experimental group

Description:

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

Treatment:

Drug: ombitasvir/paritaprevir/ritonavir

Drug: Ribavirin

Drug: dasabuvir