ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-Administered With Ribavirin (RBV) in Treatment Naïve and Treatment Experienced Asian Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Compensated Cirrhosis
CompletedPhase 3Results postedLast updated 9 October 2018
What this trial tests
Phase 3 trial testing ABT-450/r/ABT-267 in Chronic Hepatitis C Virus (HCV) in 104 participants. Completed in 16 March 2017.
Adults 18 to 70, any sex, with Chronic Hepatitis C Virus (HCV). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12)Primary· 12 weeks after last dose of study drug
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) at 12 weeks following therapy. 95% confidence interval (CI) is calculated using Wilson's score method. The lower bound of the 95% CI for the percentage of participants with SVR12 must exceed 67% to achieve superiority.
Group
Value
95% CI
ABT-450/r/ABT-267 + ABT-333 + Ribavirin
100
96.4 – 100.0
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)Primary· 24 weeks after last dose of study drug
SVR24 is defined as HCV RNA less than the LLOQ at 24 weeks following therapy. 95% CI is calculated using Wilson's score method. The lower bound of the 95% CI for the percentage of participants with SVR12 must exceed 67% to achieve superiority. SVR24 is primary outcome measure only for China.
Group
Value
95% CI
ABT-450/r/ABT-267 + ABT-333 + Ribavirin
100
96.4 – 100.0
Percentage of Participants With On Treatment Virologic FailureSecondary· Within 12 weeks after first dose of study drug
On treatment virologic failure is defined as confirmed HCV RNA greater than or equal to the LLOQ at any point during treatment after HCV RNA less than LLOQ, confirmed increase from the lowest value post-baseline in HCV RNA (two consecutive HCV RNA measurements greater than 1 log10 IU/mL above the lowest value post-baseline) at any time point during treatment, or HCV RNA greater than or equal to LLOQ persistently during treatment with at least 6 weeks (greater than or equal to 36 days) of treatment. 95% CI is calculated using Wilson's score method.
Group
Value
95% CI
ABT-450/r/ABT-267 + ABT-333 + Ribavirin
0
0.0 – 3.6
Percentage of Participants With Virologic RelapseSecondary· Within 12 weeks after the last dose of study drug
Virologic relapse is defined as confirmed HCV RNA greater than or equal to LLOQ between end of treatment and 12 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA less than LLOQ at the end of treatment. Completion of treatment is defined as a study drug duration greater than or equal to 77 days. 95% CI is calculated using Wilson's score method.
Group
Value
95% CI
ABT-450/r/ABT-267 + ABT-333 + Ribavirin
0
0.0 – 3.6
Percentage of Participants With Virologic Relapse by Post-Treatment Week 24Secondary· Within 24 weeks after the last dose of study drug
Virologic relapse is defined as confirmed HCV RNA greater than or equal to LLOQ between end of treatment and 24 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA less than LLOQ at the end of treatment. Completion of treatment is defined as a study drug duration greater than or equal to 77 days. 95% CI is calculated using Wilson's score method.
Group
Value
95% CI
ABT-450/r/ABT-267 + ABT-333 + Ribavirin
0
0.0 – 3.6
Adverse events — posted to ClinicalTrials.gov
Time frame: Serious adverse events (AEs) collected from Screening through Post-Treatment Week 48 (or discontinuation); AEs collected from Screening through 30 days post-dosing..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a Phase 3, open-label, multicenter study evaluating the efficacy and safety of ABT-450/r/ ABT-267 and ABT-333 coadministered with RBV for 12 weeks in HCV genotype 1b, treatment naïve and Interferon (IFN) (alpha, beta or pegIFN) plus RBV treatment-experienced Asian adults with compensated cirrhosis.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02219490 — A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-33
· Phase 3
· completed
NCT02167945 — A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-33
· Phase 3
· completed
NCT01939197 — A Multipart, Open-label Study to Evaluate the Safety and Efficacy of ABT-450/r/ABT-267 With and Without ABT-333 Coadmini
· Phase 2, PHASE3
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 9 October 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02517528.