A Study to Evaluate Paritaprevir With Ritonavir (ABT-450/r) When Given Together With Ombitasvir and With and Without Ribavirin (RBV) in Treatment-Naïve Participants With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)
Summary
The purpose of this study was to evaluate the efficacy, safety and pharmacokinetics of ABT-450/r when given together with ABT-267 and with and without RBV in treatment-naïve participants with genotype 1, 2 or 3 chronic HCV infection.
Timeline
- Start
- 2011-09
- Primary completion
- 2013-05
- Completion
- 2013-05
Outcome
Mixed primary results
registry analysis (superiority or other test); ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants vs ABT-450/r and ABT-267 in Genotype 3 Participants; p = 0.045; Cochran-Mantel-Haenszel NCT01458535 ↗
registry NUMBER ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants: 70.0 percentage of participants NCT01458535 ↗
registry NUMBER ABT-450/r and ABT-267 in Genotype 3 Participants: 18.2 percentage of participants NCT01458535 ↗
registry analysis (superiority or other test); ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants vs ABT-450/r and ABT-267 in Genotype 1 Participants; p = 0.157; Cochran-Mantel-Haenszel NCT01458535 ↗
registry analysis (superiority or other test); ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants vs ABT-450/r and ABT-267 in Genotype 2 Participants; p = 0.999; Cochran-Mantel-Haenszel NCT01458535 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ribavirin | Small molecule | — | — |
| Subject | ombitasvir | Small molecule | 25 mg | — |
| Subject | paritaprevir | Small molecule | 200 mg | — |
| Background | Ritonavir | Other / unclassified | 100 mg | — |