Phase 3
Completed N=1,596
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 NCT02219490 ↗
Enrolled (actual)
1,596
Serious AEs
2.5%
Results posted
Apr 2023
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 This can indicate results are unpublished — a known publication-bias signal.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 Change From Baseline in FibroScan Score by SVR12 Status |
-2.55; -1.41; -1.81; -1.76; -1.26; -1.98 | 0.151 |
| SECONDARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
97.0 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females at least 18 years old at screening
- Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control
- Chronic hepatitis C, genotype 1 infection
- Males must be surgically sterile or agree to practice acceptable forms of birth control
- Screening laboratory result indicating HCV genotype 1 infection
Exclusion Criteria
- Use of contraindicated medications within 2 weeks of dosing
- Abnormal laboratory tests
- Current or past clinical evidence of Child-Pugh B or C classification or history of liver decompensation
- Confirmed presence of hepatocellular carcinoma
- History of solid organ transplant
Data sourced from ClinicalTrials.gov (NCT02219490). 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.