A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 (or ABT-493/ABT-530) With and Without Ribavirin in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Failed a Prior Direct-Acting Antiviral Agent (DAA)-Containing Therapy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 141
- Primary Endpoint
- Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Study Overview
Brief Summary
The purpose of this study is to assess the efficacy and safety of ABT-493 and ABT-530 with or without ribavirin (RBV) in participants with chronic hepatitis C virus, (HCV)-infection who previously failed treatment with a direct acting antiviral (DAA)-containing regimen.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients from 18 to 70 years in Arms A, B, and C; patients 18 years of age or older in Arms D and E.
- •Previous treatment with DAA-containing regimen for chronic hepatitis C virus (HCV) infection resulting in either on-treatment virologic failure or post-treatment relapse
- •Chronic HCV genotype (GT) 1, 4, 5, or 6-infection (GT4-6 in Arms D and E)
Exclusion Criteria
- •History of severe, life-threatening or other significant sensitivity to any drug
- •Female who is pregnant, planning to become pregnant during the study or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study
- •Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol
- •Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
- •Co-infection with more than one HCV genotype
Arms & Interventions
Arm A
ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
Intervention: ABT-493, ABT-530 (Drug)
Arm B
ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus ribavirin (RBV) for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
Intervention: ABT-493, ABT-530 (Drug)
Arm B
ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus ribavirin (RBV) for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
Intervention: ribavirin (RBV) (Drug)
Arm C
ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
Intervention: ABT-493, ABT-530 (Drug)
Arm D
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks in HCV genotypes 1- or 4-6- infected participants with or without cirrhosis.
Intervention: ABT-493/ABT-530 (Drug)
Arm E
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 16 weeks in HCV genotype 1- or 4-6- infected participants with or without cirrhosis.
Intervention: ABT-493/ABT-530 (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
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(Day 3, Treatment Weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment for 12-week treatment arms), and 16 (end of treatment for 16-week treatment arm) or premature discontinuation from treatment)
- Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4)(4 weeks after the last actual dose of study drug)
- Percentage of Participants With Post-treatment Relapse(From the end of treatment through 12 weeks after the last dose of study drug)