Hepatitis C Virus
Conditions
Keywords
Japanese, Hepatitis C, Treatment naive, Treatment experienced, Genotype 2, Ombitasvir, Paritaprevir, Ritonavir, Ribavirin, VIEKIRAX Combination Tablets
Brief summary
This is a Phase 3, randomized, open-label, multicenter study, enrolling non-cirrhotic and cirrhotic subjects. The purpose of this study is to evaluate the efficacy and safety of ABT-450/r/ABT-267 co-administered with weight-based RBV for 12 or 16 weeks in adult chronic HCV genotype 2-infected treatment-naïve and interferon (IFN) treatment-experienced subjects with and without compensated cirrhosis.
Interventions
Tablet; ABT-450 coformulated with ritonavir and ABT-267
DRUGRibavirin
Capsule
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Chronic HCV-infection prior to study enrollment * Screening laboratory result indicating HCV genotype 2 infection * Subject has plasma HCV ribonucleic acid (RNA) level greater than 10,000 IU/mL at Screening * Voluntarily sign an informed consent
Exclusion criteria
* Co-infection of Hepatitis B Virus (HBV), human immunodeficiency virus (HIV) and any HCV genotype other than genotype 2 * Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir, simeprevir and boceprevir * Any cause of liver disease other than chronic HCV-infection, including but not limited to the following: hemochromatosis; alpha-1 antitrypsin deficiency; Wilson's disease; autoimmune hepatitis; alcoholic liver disease; drug-related liver disease * Clinically significant laboratory abnormalities * Uncontrolled clinically significant disease, disorder or medical illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Non-cirrhotic, Treatment-naive Participants in Each Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 12 weeks after last dose of study drug | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period | 12 or 16 weeks (end of treatment period) | 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). |
| Percentage of Participants With Post-treatment Relapse | within 12 weeks after the last dose of study drug | 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. |
| Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations | 12 weeks after last dose of study drug | 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. |
| Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations | 12 or 16 weeks (end of treatment period) | 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). |
| Percentage of Participants With Post-treatment Relapse Within Different Subpopulations | within 12 weeks after the last dose of study drug | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ABT-450/r/ABT-267 Plus RBV for 12 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 12 weeks | 85 |
| 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 | 86 |
| Total | 171 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | ABT-450/r/ABT-267 Plus RBV for 12 Weeks | ABT-450/r/ABT-267 Plus RBV for 16 Weeks | Total |
|---|---|---|---|
| Age, Customized < 65 years | 56 participants | 62 participants | 118 participants |
| Age, Customized ≥ 65 years | 29 participants | 24 participants | 53 participants |
| Sex: Female, Male Female | 40 Participants | 48 Participants | 88 Participants |
| Sex: Female, Male Male | 45 Participants | 38 Participants | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 52 / 80 | 53 / 80 | 3 / 5 | 4 / 6 |
| serious Total, serious adverse events | 0 / 80 | 3 / 80 | 0 / 5 | 0 / 6 |
Outcome results
Primary
Percentage of Non-cirrhotic, Treatment-naive Participants in Each Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
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.
Time frame: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABT-450/r/ABT-267 Plus RBV for 12 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 |
| ABT-450/r/ABT-267 Plus RBV for 16 Weeks | Percentage of Non-cirrhotic, Treatment-naive Participants in Each Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 91.5 percentage of participants |
Comparison: Among non-cirrhotic treatment-naïve participants, superiority of the 16-week treatment arm to a clinically relevant threshold.~Lower bound of 95% confidence interval (LCB) must have exceeded 67% to achieve superiority. Threshold indicates value the LCB had to exceed to demonstrate superiority for the treatment arm and was based on the SVR rates with pegylated-interferon (IFN) alfa-2a or 2b/RBV in treatment-naïve, noncirrhotic HCV genotype 2-infected participants.95% CI: [80.1, 96.6]
Comparison: Among non-cirrhotic treatment-naïve participants, superiority of the 12-week treatment arm to a clinically relevant threshold.~LCB must have exceeded 67% to achieve superiority. Threshold indicates value the LCB had to exceed to demonstrate superiority for the treatment arm and was based on the SVR rates with pegylated-IFN alfa-2a or 2b/RBV in treatment-naïve, noncirrhotic HCV genotype 2-infected participants.95% CI: [61.2, 85.1]
Secondary
Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period
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).
Time frame: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABT-450/r/ABT-267 Plus RBV for 12 Weeks | Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period | Overall | 8.3 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV for 12 Weeks | Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period | Rebound | 8.3 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV for 12 Weeks | Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period | Failure to suppress | 0 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV for 16 Weeks | Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period | Overall | 8.5 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV for 16 Weeks | Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period | Rebound | 8.5 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV for 16 Weeks | Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period | Failure to suppress | 0 percentage of participants |
Secondary
Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABT-450/r/ABT-267 Plus RBV for 12 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 |
| ABT-450/r/ABT-267 Plus RBV for 12 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: Rebound; n=85, 86 | 15.3 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV for 12 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: Failure to Suppress; n=85, 86 | 4.7 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV for 12 Weeks | 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 |
| ABT-450/r/ABT-267 Plus RBV for 12 Weeks | 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 |
| ABT-450/r/ABT-267 Plus RBV for 12 Weeks | 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 |
| ABT-450/r/ABT-267 Plus RBV for 12 Weeks | 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 |
| ABT-450/r/ABT-267 Plus RBV for 12 Weeks | 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 |
| ABT-450/r/ABT-267 Plus RBV for 12 Weeks | 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 |
| ABT-450/r/ABT-267 Plus RBV for 12 Weeks | 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 |
| ABT-450/r/ABT-267 Plus RBV for 12 Weeks | 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 |
| ABT-450/r/ABT-267 Plus RBV for 12 Weeks | 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 |
| ABT-450/r/ABT-267 Plus RBV 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 | Cirrhotic: Rebound; n=5, 6 | 50.0 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV 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 | 16.3 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV 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 | Noncirrhotic T-exp: Overall; n=32, 33 | 21.2 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV 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: Rebound; n=85, 86 | 15.1 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV 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 | Cirrhotic: Overall; n=5, 6 | 50.0 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV 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: Failure to Suppress; n=85, 86 | 4.7 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV 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 | Noncirrhotic T-exp: Rebound; n=32, 33 | 18.2 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV 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 | Noncirrhotic: Overall; n=80, 80 | 13.8 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV 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 | Cirrhotic: Failure to Suppress; n=5, 6 | 16.7 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV 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 | Noncirrhotic: Rebound; n=80, 80 | 12.5 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV 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 | Noncirrhotic T-exp: Failure to Suppress; n=32, 33 | 9.1 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV 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 | Noncirrhotic: Failure to Suppress; n=80, 80 | 3.8 percentage of participants |
Secondary
Percentage of Participants With Post-treatment Relapse
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABT-450/r/ABT-267 Plus RBV for 12 Weeks | Percentage of Participants With Post-treatment Relapse | 12.2 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV for 16 Weeks | Percentage of Participants With Post-treatment Relapse | 0 percentage of participants |
Secondary
Percentage of Participants With Post-treatment Relapse Within Different Subpopulations
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABT-450/r/ABT-267 Plus RBV for 12 Weeks | Percentage of Participants With Post-treatment Relapse Within Different Subpopulations | All Participants; n=69, 70 | 10.1 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV for 12 Weeks | Percentage of Participants With Post-treatment Relapse Within Different Subpopulations | Noncirrhotic Participants; n=65, 68 | 10.8 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV for 12 Weeks | Percentage of Participants With Post-treatment Relapse Within Different Subpopulations | Noncirrhotic T-exp Participants; n=24, 25 | 8.3 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV for 12 Weeks | Percentage of Participants With Post-treatment Relapse Within Different Subpopulations | Cirrhotic Participants; n=4, 2 | 0 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV for 16 Weeks | Percentage of Participants With Post-treatment Relapse Within Different Subpopulations | Cirrhotic Participants; n=4, 2 | 0 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV for 16 Weeks | Percentage of Participants With Post-treatment Relapse Within Different Subpopulations | All Participants; n=69, 70 | 0 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV for 16 Weeks | Percentage of Participants With Post-treatment Relapse Within Different Subpopulations | Noncirrhotic T-exp Participants; n=24, 25 | 0 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV for 16 Weeks | Percentage of Participants With Post-treatment Relapse Within Different Subpopulations | Noncirrhotic Participants; n=65, 68 | 0 percentage of participants |
Secondary
Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABT-450/r/ABT-267 Plus RBV for 12 Weeks | 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 |
| ABT-450/r/ABT-267 Plus RBV for 12 Weeks | 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 |
| ABT-450/r/ABT-267 Plus RBV for 12 Weeks | 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 |
| ABT-450/r/ABT-267 Plus RBV for 12 Weeks | 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 |
| ABT-450/r/ABT-267 Plus RBV for 12 Weeks | 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 |
| ABT-450/r/ABT-267 Plus RBV for 12 Weeks | 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 |
| ABT-450/r/ABT-267 Plus RBV for 12 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 |
| ABT-450/r/ABT-267 Plus RBV for 16 Weeks | Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations | Cirrhotic Participants; n=5, 6 | 33.3 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV for 16 Weeks | Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations | All participants; n=85, 86 | 81.4 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV for 16 Weeks | Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations | Noncirrhotic participants; n=80, 80 | 85.0 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV for 16 Weeks | Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations | Noncirrhotic T-exp; n=32, 33 | 75.8 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV for 16 Weeks | Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations | Noncirrhotic T-exp Relapser; n=15, 16 | 93.8 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV for 16 Weeks | Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations | Noncirrhotic T-exp Nonresponder; n=5, 6 | 50.0 percentage of participants |
| ABT-450/r/ABT-267 Plus RBV for 16 Weeks | Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations | Noncirrhotic T-exp IFN-intolerant; n=12, 11 | 63.6 percentage of participants |