Trial Outcomes & Findings for 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 (NCT NCT02517528)

Last Updated: 2018-10-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

104 participants

Primary outcome timeframe

12 weeks after last dose of study drug

Results posted on

2018-10-09

Participant Flow

Participant milestones

Participant milestones
Measure	ABT-450/r/ABT-267 + ABT-333 + Ribavirin ABT-450/r/ABT-267 once daily + ABT-333 twice daily + weight-based ribavirin (RBV) divided twice daily for 12 weeks
Overall Study STARTED	104
Overall Study COMPLETED	103
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	ABT-450/r/ABT-267 + ABT-333 + Ribavirin ABT-450/r/ABT-267 once daily + ABT-333 twice daily + weight-based ribavirin (RBV) divided twice daily for 12 weeks
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ABT-450/r/ABT-267 + ABT-333 + Ribavirin n=104 Participants ABT-450/r/ABT-267 once daily + ABT-333 twice daily + weight-based RBV divided twice daily for 12 weeks
Age, Continuous	56.43 years STANDARD_DEVIATION 8.11 • n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants
Region of Enrollment China	63 participants n=5 Participants
Region of Enrollment South Korea	21 participants n=5 Participants
Region of Enrollment Taiwan	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks after last dose of study drug

Population: Intent-to-Treat Population: all enrolled participants who received at least one dose of study drug. Participants with missing data were imputed as failures.

Outcome measures

Outcome measures
Measure	ABT-450/r/ABT-267 + ABT-333 + Ribavirin n=104 Participants ABT-450/r/ABT-267 once daily + ABT-333 twice daily + weight-based RBV divided twice daily for 12 weeks
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12)	100 percentage of participants Interval 96.4 to 100.0

PRIMARY outcome

Timeframe: 24 weeks after last dose of study drug

Population: Intent-to-Treat Population: all enrolled participants who received at least one dose of study drug. Participants with missing data were imputed as failures.

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.

Outcome measures

Outcome measures
Measure	ABT-450/r/ABT-267 + ABT-333 + Ribavirin n=104 Participants ABT-450/r/ABT-267 once daily + ABT-333 twice daily + weight-based RBV divided twice daily for 12 weeks
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)	100 percentage of participants Interval 96.4 to 100.0

SECONDARY outcome

Timeframe: Within 12 weeks after first dose of study drug

Population: Intent-to-Treat Population: all enrolled participants who received at least one 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.

Outcome measures

Outcome measures
Measure	ABT-450/r/ABT-267 + ABT-333 + Ribavirin n=104 Participants ABT-450/r/ABT-267 once daily + ABT-333 twice daily + weight-based RBV divided twice daily for 12 weeks
Percentage of Participants With On Treatment Virologic Failure	0 percentage of participants Interval 0.0 to 3.6

SECONDARY outcome

Timeframe: Within 12 weeks after the last dose of study drug

Population: Intent-to-Treat Population: all enrolled participants who received at least one dose of study drug. Only completers (ie, participants who were dosed with study drug at least 77 days) were included.

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.

Outcome measures

Outcome measures
Measure	ABT-450/r/ABT-267 + ABT-333 + Ribavirin n=103 Participants ABT-450/r/ABT-267 once daily + ABT-333 twice daily + weight-based RBV divided twice daily for 12 weeks
Percentage of Participants With Virologic Relapse	0 percentage of participants Interval 0.0 to 3.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	ABT-450/r/ABT-267 + ABT-333 + Ribavirin n=103 Participants ABT-450/r/ABT-267 once daily + ABT-333 twice daily + weight-based RBV divided twice daily for 12 weeks
Percentage of Participants With Virologic Relapse by Post-Treatment Week 24	0 percentage of participants Interval 0.0 to 3.6

Adverse Events

ABT-450/r/ABT-267 + ABT-333 + Ribavirin

Serious events: 4 serious events

Other events: 71 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ABT-450/r/ABT-267 + ABT-333 + Ribavirin n=104 participants at risk ABT-450/r/ABT-267 once daily + ABT-333 twice daily + weight-based RBV divided twice daily for 12 weeks
Cardiac disorders VENTRICULAR EXTRASYSTOLES	0.96% 1/104 • Number of events 1 • Serious adverse events (AEs) collected from Screening through Post-Treatment Week 48 (or discontinuation); AEs collected from Screening through 30 days post-dosing.
Gastrointestinal disorders FOOD POISONING	0.96% 1/104 • Number of events 1 • Serious adverse events (AEs) collected from Screening through Post-Treatment Week 48 (or discontinuation); AEs collected from Screening through 30 days post-dosing.
Injury, poisoning and procedural complications CONCUSSION	0.96% 1/104 • Number of events 1 • Serious adverse events (AEs) collected from Screening through Post-Treatment Week 48 (or discontinuation); AEs collected from Screening through 30 days post-dosing.
Injury, poisoning and procedural complications CONTUSION	0.96% 1/104 • Number of events 1 • Serious adverse events (AEs) collected from Screening through Post-Treatment Week 48 (or discontinuation); AEs collected from Screening through 30 days post-dosing.
Injury, poisoning and procedural complications LIGAMENT SPRAIN	0.96% 1/104 • Number of events 1 • Serious adverse events (AEs) collected from Screening through Post-Treatment Week 48 (or discontinuation); AEs collected from Screening through 30 days post-dosing.
Injury, poisoning and procedural complications SPINAL COLUMN INJURY	0.96% 1/104 • Number of events 1 • Serious adverse events (AEs) collected from Screening through Post-Treatment Week 48 (or discontinuation); AEs collected from Screening through 30 days post-dosing.
Metabolism and nutrition disorders TYPE 2 DIABETES MELLITUS	0.96% 1/104 • Number of events 1 • Serious adverse events (AEs) collected from Screening through Post-Treatment Week 48 (or discontinuation); AEs collected from Screening through 30 days post-dosing.

Other adverse events

Other adverse events
Measure	ABT-450/r/ABT-267 + ABT-333 + Ribavirin n=104 participants at risk ABT-450/r/ABT-267 once daily + ABT-333 twice daily + weight-based RBV divided twice daily for 12 weeks
Blood and lymphatic system disorders ANAEMIA	14.4% 15/104 • Number of events 15 • Serious adverse events (AEs) collected from Screening through Post-Treatment Week 48 (or discontinuation); AEs collected from Screening through 30 days post-dosing.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	5.8% 6/104 • Number of events 7 • Serious adverse events (AEs) collected from Screening through Post-Treatment Week 48 (or discontinuation); AEs collected from Screening through 30 days post-dosing.
General disorders ASTHENIA	11.5% 12/104 • Number of events 13 • Serious adverse events (AEs) collected from Screening through Post-Treatment Week 48 (or discontinuation); AEs collected from Screening through 30 days post-dosing.
General disorders FATIGUE	10.6% 11/104 • Number of events 11 • Serious adverse events (AEs) collected from Screening through Post-Treatment Week 48 (or discontinuation); AEs collected from Screening through 30 days post-dosing.
Investigations BILIRUBIN CONJUGATED INCREASED	11.5% 12/104 • Number of events 12 • Serious adverse events (AEs) collected from Screening through Post-Treatment Week 48 (or discontinuation); AEs collected from Screening through 30 days post-dosing.
Investigations BLOOD BILIRUBIN INCREASED	25.0% 26/104 • Number of events 27 • Serious adverse events (AEs) collected from Screening through Post-Treatment Week 48 (or discontinuation); AEs collected from Screening through 30 days post-dosing.
Investigations BLOOD BILIRUBIN UNCONJUGATED INCREASED	11.5% 12/104 • Number of events 14 • Serious adverse events (AEs) collected from Screening through Post-Treatment Week 48 (or discontinuation); AEs collected from Screening through 30 days post-dosing.
Investigations HAEMOGLOBIN DECREASED	6.7% 7/104 • Number of events 10 • Serious adverse events (AEs) collected from Screening through Post-Treatment Week 48 (or discontinuation); AEs collected from Screening through 30 days post-dosing.
Investigations RETICULOCYTE COUNT INCREASED	5.8% 6/104 • Number of events 7 • Serious adverse events (AEs) collected from Screening through Post-Treatment Week 48 (or discontinuation); AEs collected from Screening through 30 days post-dosing.
Metabolism and nutrition disorders DECREASED APPETITE	7.7% 8/104 • Number of events 8 • Serious adverse events (AEs) collected from Screening through Post-Treatment Week 48 (or discontinuation); AEs collected from Screening through 30 days post-dosing.
Nervous system disorders DIZZINESS	10.6% 11/104 • Number of events 15 • Serious adverse events (AEs) collected from Screening through Post-Treatment Week 48 (or discontinuation); AEs collected from Screening through 30 days post-dosing.
Nervous system disorders HEADACHE	6.7% 7/104 • Number of events 12 • Serious adverse events (AEs) collected from Screening through Post-Treatment Week 48 (or discontinuation); AEs collected from Screening through 30 days post-dosing.
Psychiatric disorders INSOMNIA	5.8% 6/104 • Number of events 6 • Serious adverse events (AEs) collected from Screening through Post-Treatment Week 48 (or discontinuation); AEs collected from Screening through 30 days post-dosing.
Respiratory, thoracic and mediastinal disorders COUGH	9.6% 10/104 • Number of events 14 • Serious adverse events (AEs) collected from Screening through Post-Treatment Week 48 (or discontinuation); AEs collected from Screening through 30 days post-dosing.
Skin and subcutaneous tissue disorders PRURITUS	15.4% 16/104 • Number of events 18 • Serious adverse events (AEs) collected from Screening through Post-Treatment Week 48 (or discontinuation); AEs collected from Screening through 30 days post-dosing.
Skin and subcutaneous tissue disorders RASH	6.7% 7/104 • Number of events 7 • Serious adverse events (AEs) collected from Screening through Post-Treatment Week 48 (or discontinuation); AEs collected from Screening through 30 days post-dosing.

Additional Information

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Phone: 800-633-9110

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Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
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