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

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection, With Severe Renal Impairment or End-Stage Renal Disease (RUBY-I)

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

Intervention / Treatment
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* Drug: ombitasvir/paritaprevir/ritonavir
* Drug: dasabuvir
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Positive for anti-HCV Ab (Antibody) and HCV RNA >1,000 IU/mL at Screening. Screening laboratory result indicating HCV genotype 1 infection. 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). 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: Women who are pregnant or breastfeeding. Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency Virus (HIV Ab). 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3-DAA (Direct Acting Antivirals) with or without RBV<br>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 | Drug: ombitasvir/paritaprevir/ritonavir<br>* tablet<br>* Other names: dasabuvir also known as ABT-333;Drug: dasabuvir<br>* tablet<br>* Other names: ABT-333;Drug: Ribavirin<br>* tablet<br>* Other names: RBV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of study drug. | 12 weeks after the last actual dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With On-treatment Virologic Failure | On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after < LLOQ during treatment, confirmed increase of > 1 log (subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment. | Up to 24 weeks | 
| Percentage of Participants With Post-Treatment Relapse | Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA < LLOQ at the end of treatment. | Within 12 weeks after the last dose of study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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