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)
Overview
- Phase
- Phase 3
- Intervention
- Ribavirin
- Conditions
- Chronic Hepatitis C
- Sponsor
- AbbVie
- Enrollment
- 68
- Primary Endpoint
- Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
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.
Arms & Interventions
3-DAA (Direct Acting Antivirals) with or without RBV
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
Intervention: Ribavirin
3-DAA (Direct Acting Antivirals) with or without RBV
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
Intervention: ombitasvir/paritaprevir/ritonavir
3-DAA (Direct Acting Antivirals) with or without RBV
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
Intervention: dasabuvir
Outcomes
Primary Outcomes
Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment
Time Frame: 12 weeks after the last actual dose of study drug
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.
Secondary Outcomes
- Percentage of Participants With On-treatment Virologic Failure(Up to 24 weeks)
- Percentage of Participants With Post-Treatment Relapse(Within 12 weeks after the last dose of study drug)