Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT- 267 (ABT-450/r/ABT-267) in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection (NCT NCT02023112)

NCT ID: NCT02023112

Last Updated: 2021-07-30

Results Overview

The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

171 participants

Primary outcome timeframe

12 weeks after last dose of study drug

Results posted on

2021-07-30

Participant Flow

Participant milestones

Participant milestones
Measure	ABT-450/r/ABT-267 Plus RBV for 12 Weeks ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based ribavirin (RBV; 400 to 1,000 mg/day, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 Plus RBV for 16 Weeks ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
Overall Study STARTED	85	86
Overall Study COMPLETED	83	85
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	ABT-450/r/ABT-267 Plus RBV for 12 Weeks ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based ribavirin (RBV; 400 to 1,000 mg/day, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 Plus RBV for 16 Weeks ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT- 267 (ABT-450/r/ABT-267) in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ABT-450/r/ABT-267 Plus RBV for 12 Weeks n=85 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 Plus RBV for 16 Weeks n=86 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks	Total n=171 Participants Total of all reporting groups
Age, Customized < 65 years	56 participants n=5 Participants	62 participants n=7 Participants	118 participants n=5 Participants
Age, Customized ≥ 65 years	29 participants n=5 Participants	24 participants n=7 Participants	53 participants n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	48 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	38 Participants n=7 Participants	83 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks after last dose of study drug

Population: Primary efficacy population: all treatment-naïve, noncirrhotic participants in the intent-to-treat (ITT) population (all randomized participants who received at least 1 dose of study drug).

Outcome measures

Outcome measures
Measure	ABT-450/r/ABT-267 Plus RBV for 12 Weeks n=48 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 Plus RBV for 16 Weeks n=47 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
Percentage of Non-cirrhotic, Treatment-naive Participants in Each Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment (SVR12)	75.0 percentage of participants	91.5 percentage of participants

SECONDARY outcome

Timeframe: 12 or 16 weeks (end of treatment period)

Population: Primary efficacy population: all treatment-naïve, noncirrhotic participants in the ITT population (all randomized participants who received at least 1 dose of study drug).

On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA \< LLOQ during treatment, or confirmed increase from nadir in HCV RNA \[\> 1 log10 IU/mL above nadir\] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment).

Outcome measures

Outcome measures
Measure	ABT-450/r/ABT-267 Plus RBV for 12 Weeks n=48 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 Plus RBV for 16 Weeks n=47 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period Overall	8.3 percentage of participants	8.5 percentage of participants
Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period Rebound	8.3 percentage of participants	8.5 percentage of participants
Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period Failure to suppress	0 percentage of participants	0 percentage of participants

SECONDARY outcome

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

Population: Primary efficacy population: all treatment-naïve, noncirrhotic participants in the ITT population (all randomized participants who received at least 1 dose of study drug) with HCV RNA \< LLOQ at the final treatment visit who completed treatment.

Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA \< LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm.

Outcome measures

Outcome measures
Measure	ABT-450/r/ABT-267 Plus RBV for 12 Weeks n=41 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 Plus RBV for 16 Weeks n=47 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
Percentage of Participants With Post-treatment Relapse	12.2 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 12 weeks after last dose of study drug

Population: ITT population: all randomized participants who received at least 1 dose of study drug; n=participants in given subpopulation.

The percentage of participants with SVR12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; noncirrhotic participants who relapsed after prior IFN-based therapy (relapsers); noncirrhotic T-exp participants who were non-responders to prior IFN-based therapy; noncirrhotic T-exp participants who were intolerant to IFN-based therapy; participants with compensated cirrhosis.

Outcome measures

Outcome measures
Measure	ABT-450/r/ABT-267 Plus RBV for 12 Weeks n=85 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 Plus RBV for 16 Weeks n=86 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations All participants; n=85, 86	72.9 percentage of participants Interval 62.7 to 81.2	81.4 percentage of participants Interval 71.9 to 88.2
Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations Noncirrhotic participants; n=80, 80	72.5 percentage of participants Interval 61.9 to 81.1	85.0 percentage of participants Interval 75.6 to 91.2
Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations Noncirrhotic T-exp; n=32, 33	68.8 percentage of participants Interval 51.4 to 82.0	75.8 percentage of participants Interval 59.0 to 87.2
Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations Noncirrhotic T-exp Relapser; n=15, 16	80.0 percentage of participants Interval 54.8 to 93.0	93.8 percentage of participants Interval 71.7 to 98.9
Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations Noncirrhotic T-exp Nonresponder; n=5, 6	40.0 percentage of participants Interval 11.8 to 76.9	50.0 percentage of participants Interval 18.8 to 81.2
Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations Noncirrhotic T-exp IFN-intolerant; n=12, 11	66.7 percentage of participants Interval 39.1 to 86.2	63.6 percentage of participants Interval 35.4 to 84.8
Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations Cirrhotic Participants; n=5, 6	80.0 percentage of participants Interval 37.6 to 96.4	33.3 percentage of participants Interval 9.7 to 70.0

SECONDARY outcome

Timeframe: 12 or 16 weeks (end of treatment period)

Population: ITT population: all randomized participants who received at least 1 dose of study drug; n=participants in given subpopulation.

The percentage of participants with on-treatment virologic failure in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis. On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA \< LLOQ during treatment, or confirmed increase from nadir in HCV RNA \[\> 1 log10 IU/mL above nadir\] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment).

Outcome measures

Outcome measures
Measure	ABT-450/r/ABT-267 Plus RBV for 12 Weeks n=85 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 Plus RBV for 16 Weeks n=86 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations All Participants: Overall; n=85, 86	15.3 percentage of participants	16.3 percentage of participants
Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations All Participants: Rebound; n=85, 86	15.3 percentage of participants	15.1 percentage of participants
Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations All Participants: Failure to Suppress; n=85, 86	4.7 percentage of participants	4.7 percentage of participants
Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations Noncirrhotic: Overall; n=80, 80	15.0 percentage of participants	13.8 percentage of participants
Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations Noncirrhotic: Rebound; n=80, 80	15.0 percentage of participants	12.5 percentage of participants
Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations Noncirrhotic: Failure to Suppress; n=80, 80	3.8 percentage of participants	3.8 percentage of participants
Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations Noncirrhotic T-exp: Overall; n=32, 33	25.0 percentage of participants	21.2 percentage of participants
Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations Noncirrhotic T-exp: Rebound; n=32, 33	25.0 percentage of participants	18.2 percentage of participants
Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations Noncirrhotic T-exp: Failure to Suppress; n=32, 33	9.4 percentage of participants	9.1 percentage of participants
Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations Cirrhotic: Overall; n=5, 6	20.0 percentage of participants	50.0 percentage of participants
Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations Cirrhotic: Rebound; n=5, 6	20.0 percentage of participants	50.0 percentage of participants
Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations Cirrhotic: Failure to Suppress; n=5, 6	20.0 percentage of participants	16.7 percentage of participants

SECONDARY outcome

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

Population: ITT population: all randomized participants who received at least 1 dose of study drug with HCV RNA \< LLOQ at the final treatment visit who completed treatment; n=participants in given subpopulation.

The percentage of participants with relapse by post-treatment Week 12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis. Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA \< LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm.

Outcome measures

Outcome measures
Measure	ABT-450/r/ABT-267 Plus RBV for 12 Weeks n=69 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 Plus RBV for 16 Weeks n=70 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
Percentage of Participants With Post-treatment Relapse Within Different Subpopulations All Participants; n=69, 70	10.1 percentage of participants	0 percentage of participants
Percentage of Participants With Post-treatment Relapse Within Different Subpopulations Noncirrhotic Participants; n=65, 68	10.8 percentage of participants	0 percentage of participants
Percentage of Participants With Post-treatment Relapse Within Different Subpopulations Noncirrhotic T-exp Participants; n=24, 25	8.3 percentage of participants	0 percentage of participants
Percentage of Participants With Post-treatment Relapse Within Different Subpopulations Cirrhotic Participants; n=4, 2	0 percentage of participants	0 percentage of participants

Adverse Events

ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Non-cirrhotic)

Serious events: 0 serious events

Other events: 52 other events

Deaths: 0 deaths

ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Non-cirrhotic)

Serious events: 3 serious events

Other events: 53 other events

Deaths: 0 deaths

ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Cirrhotic)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Cirrhotic)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Non-cirrhotic) n=80 participants at risk ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks in non-cirrhotic participants	ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Non-cirrhotic) n=80 participants at risk ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks in non-cirrhotic participants	ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Cirrhotic) n=5 participants at risk ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks in cirrhotic participants	ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Cirrhotic) n=6 participants at risk ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks in cirrhotic participants
Gastrointestinal disorders GASTRITIS ALCOHOLIC	0.00% 0/80 • Non-serious adverse events collected from initiation of study drug through 30 days post-study drug dosing (12 weeks or 16 weeks, depending on arm assignment); serious adverse events collected from signing of Informed Consent up to Post-treatment Week 48.	1.2% 1/80 • Non-serious adverse events collected from initiation of study drug through 30 days post-study drug dosing (12 weeks or 16 weeks, depending on arm assignment); serious adverse events collected from signing of Informed Consent up to Post-treatment Week 48.	0.00% 0/5 • Non-serious adverse events collected from initiation of study drug through 30 days post-study drug dosing (12 weeks or 16 weeks, depending on arm assignment); serious adverse events collected from signing of Informed Consent up to Post-treatment Week 48.	0.00% 0/6 • Non-serious adverse events collected from initiation of study drug through 30 days post-study drug dosing (12 weeks or 16 weeks, depending on arm assignment); serious adverse events collected from signing of Informed Consent up to Post-treatment Week 48.
Infections and infestations BRONCHOPNEUMONIA	0.00% 0/80 • Non-serious adverse events collected from initiation of study drug through 30 days post-study drug dosing (12 weeks or 16 weeks, depending on arm assignment); serious adverse events collected from signing of Informed Consent up to Post-treatment Week 48.	1.2% 1/80 • Non-serious adverse events collected from initiation of study drug through 30 days post-study drug dosing (12 weeks or 16 weeks, depending on arm assignment); serious adverse events collected from signing of Informed Consent up to Post-treatment Week 48.	0.00% 0/5 • Non-serious adverse events collected from initiation of study drug through 30 days post-study drug dosing (12 weeks or 16 weeks, depending on arm assignment); serious adverse events collected from signing of Informed Consent up to Post-treatment Week 48.	0.00% 0/6 • Non-serious adverse events collected from initiation of study drug through 30 days post-study drug dosing (12 weeks or 16 weeks, depending on arm assignment); serious adverse events collected from signing of Informed Consent up to Post-treatment Week 48.
Injury, poisoning and procedural complications INCISIONAL HERNIA	0.00% 0/80 • Non-serious adverse events collected from initiation of study drug through 30 days post-study drug dosing (12 weeks or 16 weeks, depending on arm assignment); serious adverse events collected from signing of Informed Consent up to Post-treatment Week 48.	1.2% 1/80 • Non-serious adverse events collected from initiation of study drug through 30 days post-study drug dosing (12 weeks or 16 weeks, depending on arm assignment); serious adverse events collected from signing of Informed Consent up to Post-treatment Week 48.	0.00% 0/5 • Non-serious adverse events collected from initiation of study drug through 30 days post-study drug dosing (12 weeks or 16 weeks, depending on arm assignment); serious adverse events collected from signing of Informed Consent up to Post-treatment Week 48.	0.00% 0/6 • Non-serious adverse events collected from initiation of study drug through 30 days post-study drug dosing (12 weeks or 16 weeks, depending on arm assignment); serious adverse events collected from signing of Informed Consent up to Post-treatment Week 48.

Other adverse events

Additional Information

Global Medical Information

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