Phase 3
Completed N=68
Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease
Source: ClinicalTrials.gov NCT02207088 ↗Enrolled (actual)
68
Serious AEs
25.0%
Results posted
Nov 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment — 94.1 percentage of participants
◆ Published Evidence
Highly cited
278citations · ~28 / year
Efficacy of Direct-Acting Antiviral Combination for Patients With Hepatitis C Virus Genotype 1 Infection and Severe Renal Impairment or End-Stage Renal Disease.
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.
Linked Publications (2)
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Efficacy of Direct-Acting Antiviral Combination for Patients With Hepatitis C Virus Genotype 1 Infection and Severe Renal Impairment or End-Stage Renal Disease.
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Effects of chronic kidney disease stage 4, end-stage renal disease, or dialysis on the plasma concentrations of ombitasvir, paritaprevir, ritonavir, and dasabuvir in patients with chronic HCV infection: pharmacokinetic analysis of the phase 3 RUBY-I and RUBY-II trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment |
94.1 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Failure |
— | — |
| SECONDARY Percentage of Participants With Post-Treatment Relapse |
1.5 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02207088) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.