Phase 3
Completed N=615
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
Chronic Hepatitis C Virus (HCV) Infection Genotype 1
Source: ClinicalTrials.gov NCT02167945 ↗
Enrolled (actual)
615
Serious AEs
4.1%
Results posted
Apr 2022
Primary outcomePrimary: All-Cause Death: Time to Event — 8.3; 0.1; 8.3; 0.7 percentage of participants — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-Cause Death: Time to Event |
8.3; 0.1; 8.3; 0.7; 8.3; 1.2 | <0.001 sig |
| PRIMARY Liver-Related Death: Time to Event |
1.4; 0; 1.4; 0; 1.4; 0.1 | <0.001 sig |
| PRIMARY Liver Decompensation: Time to Event |
4.5; 0.2; 4.5; 0.2; 4.5; 0.3 | <0.001 sig |
| PRIMARY Liver Transplantation: Time to Event |
0; 0; 0; 0; 0; 0.1 | 0.860 |
| PRIMARY Hepatocellular Carcinoma: Time to Event |
0; 0.2; 0; 0.4; 0; 0.5 | 0.608 |
| PRIMARY All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event |
11.4; 0.5; 11.4; 1.2; 11.4; 1.9 | <0.001 sig |
| SECONDARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
95.3 | — |
| SECONDARY Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Physical Component Summary (PCS) Score at Post-Treatment Week 12 and Post-Treatment Week 24 |
1.2; 0.0; 1.8; 1.4; 1.1; 0.5 | 0.026 sig |
| SECONDARY Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Mental Component Summary (MCS) Score at Post-Treatment Week 12 and Post-Treatment Week 24 |
2.7; 1.0; 0.9; 0.3; 3.2; 1.9 | 0.216 |
| SECONDARY Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score at Post-Treatment Week 12 and Post-Treatment Week 24 |
3.9; 2.0; 2.0; 3.0; 3.9; 3.1 | 0.035 sig |
| SECONDARY Treatment Compliance: Percentage of Tablets Taken Relative to the Total Tablets |
100.22; 99.86 | — |
Eligibility Criteria
Inclusion Criteria
- Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control
- Chronic hepatitis C, genotype 1-infection (HCV RNA level greater than 1,000 IU/mL at screening)
- HCV genotype 1 infection per screening laboratory result
Exclusion Criteria
- Use of contraindicated medications within 2 weeks of dosing
- Abnormal laboratory tests
- Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus Antibody
- History of solid organ transplant, clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation
- Presence of hepatocellular carcinoma at screening
Data sourced from ClinicalTrials.gov (NCT02167945). 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.