Phase 2
Completed N=61
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)
Source: ClinicalTrials.gov NCT01458535 ↗Enrolled (actual)
61
Serious AEs
6.6%
Results posted
Jul 2016
Primary outcomePrimary: Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [(Extended Rapid Virologic Response (eRVR)] — 100; 90.0; 70.0; 90.0 percentage of participants — p=0.157
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [(Extended Rapid Virologic Response (eRVR)] |
100; 90.0; 70.0; 90.0; 80.0; 18.2 | 0.157 |
| SECONDARY Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment |
100; 80.0; 50.0; 60.0; 60.0; 9.1 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment |
100; 80.0; 40.0; 60.0; 60.0; 9.1 | — |
| SECONDARY Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL) |
100; 100; 100; 100; 100; 100 | — |
| SECONDARY Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 Rapid Virologic Response (RVR) |
100; 100; 90.0; 100; 90.0; 27.3 | — |
| SECONDARY Percentage of Participants With Virologic Failure During Treatment |
0; 10.0; 30.0; 10.0; 10.0; 72.7 | — |
| SECONDARY Percentage of Participants Who Experienced Virologic Relapse Through End of Post Treatment Period (up to 48 Weeks) |
0; 0; 28.6; 22.2; 22.2; 50.0 | — |
Eligibility Criteria
Inclusion Criteria
- Participants who had a body mass index 18 to 50,000 IU/mL, and FibroTest score <= 0.72 and aspartate aminotransferase (AST) to platelet ratio index <= 2, Fibroscan® result of < 9.6 kilopascal (kPa), or absence of cirrhosis based on a liver biopsy.
Exclusion Criteria
- Positive drug screen
- Previous use of anti-HCV agents
- History of cardiac disease
- History of uncontrolled diabetes or diabetes requiring insulin
- Abnormal laboratory results
- Females who were pregnant or planned to become pregnant within 6 months after their last dose of study drug/RBV or were breastfeeding; males whose partners were pregnant or would become pregnant within 6 months after their last dose of study drug/RBV
- Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus (HIV) antibody (Ab). Negative HIV status was to be confirmed at screening.
Data sourced from ClinicalTrials.gov (NCT01458535). 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.