A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Summary
The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.
Timeline
- Start
- 2014-06-12
- Primary completion
- 2021-05-13
- Completion
- 2021-05-13
Outcome
Mixed primary results
registry Participants in Studies M14-222 and M14-423 Who Achieved SVR12: Kaplan-Meier estimate at PT Week 52: 0.1 (0.1 to 0.4) percentage of participants NCT02167945 ↗
registry analysis (superiority test); Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12 vs Participants in Studies M14-222 and M14-423 Who Achieved SVR12; p <0.001; Log-rank test NCT02167945 ↗
registry analysis (superiority test); Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12 vs Participants in Studies M14-222 and M14-423 Who Achieved SVR12; p = 0.860; Log-rank test NCT02167945 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ribavirin | Small molecule | 1000 mg | Oral |
| Subject | Ribavirin | Small molecule | 1200 mg | Oral |
| Subject | dasabuvir | Small molecule | 250 mg | Oral |
| Subject | ombitasvir | Small molecule | 12.5 mg | Oral |
| Subject | paritaprevir | Small molecule | 75 mg | Oral |
| Background | Ritonavir | Other / unclassified | 50 mg | Oral |