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The purpose of this study is to evaluate the safety and antiviral effect of multiple doses of ABT-493 and ABT-530 in adults with genotype 1 HCV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 Non-cirrhotic | Experimental | ABT-493 Dose A (100 mg once daily [QD]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
|
| Arm 2 Non-cirrhotic | Experimental | ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
|
| Arm 3 Non-cirrhotic | Experimental | ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
|
| Arm 4 Non-cirrhotic | Experimental | ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-493 | Drug | Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Decrease From Baseline in log10 HCV RNA Levels During ABT-493 or ABT-530 Monotherapy Treatment | Maximal decrease from baseline in log10 HCV RNA levels during ABT-493 or ABT-530 monotherapy treatment. The baseline value was the last measurement before the first dose of monotherapy on Day 1. | Day 1 through prior to first dose of the combination regimen on Study Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [](streamdown:incomplete-link) | 12 weeks after last actual dose of combination study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26183611 | Background | Lawitz E, Freilich B, Link J, German P, Mo H, Han L, Brainard DM, McNally J, Marbury T, Rodriguez-Torres M. A phase 1, randomized, dose-ranging study of GS-5816, a once-daily NS5A inhibitor, in patients with genotype 1-4 hepatitis C virus. J Viral Hepat. 2015 Dec;22(12):1011-9. doi: 10.1111/jvh.12435. Epub 2015 Jul 16. | |
| 26711747 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 Non-cirrhotic | ABT-493 Dose A (100 mg once daily [QD]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| FG001 | Arm 2 Non-cirrhotic |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Arm 5 Compensated cirrhotic | Experimental | ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
|
| Arm 6 Non-cirrhotic | Experimental | ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
|
| Arm 7 Non-cirrhotic | Experimental | ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
|
| Arm 8 Non-cirrhotic | Experimental | ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
|
| Arm 9 Non-cirrhotic | Experimental | ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
|
| Arm 10 Compensated cirrhotic | Experimental | ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
|
| Arm 11 Non-cirrhotic | Experimental | ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
|
| Arm 12 Non-cirrhotic | Experimental | ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
|
|
| ABT-530 | Drug | Tablet |
|
|
| ABT-450/r/ABT-267, ABT-333 | Drug | Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet |
|
|
| Ribavirin (RBV) | Drug | Tablet |
|
| Percentage of Participants With On-treatment Virologic Failure | On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during combination treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during combination treatment; or HCV RNA ≥ LLOQ at end of combination treatment with at least 6 weeks of combination treatment. | Up to 87 days |
| Percentage of Participants With Post-treatment Relapse | Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants completing combination treatment with HCV RNA levels < LLOQ at the end of treatment. | From the end of treatment through 12 weeks after the last dose of combination study drug |
| Lawitz EJ, O'Riordan WD, Asatryan A, Freilich BL, Box TD, Overcash JS, Lovell S, Ng TI, Liu W, Campbell A, Lin CW, Yao B, Kort J. Potent Antiviral Activities of the Direct-Acting Antivirals ABT-493 and ABT-530 with Three-Day Monotherapy for Hepatitis C Virus Genotype 1 Infection. Antimicrob Agents Chemother. 2015 Dec 28;60(3):1546-55. doi: 10.1128/AAC.02264-15. |
ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| FG002 | Arm 3 Non-cirrhotic | ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| FG003 | Arm 4 Non-cirrhotic | ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| FG004 | Arm 5 Compensated Cirrhotic | ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| FG005 | Arm 6 Non-cirrhotic | ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| FG006 | Arm 7 Non-cirrhotic | ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| FG007 | Arm 8 Non-cirrhotic | ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| FG008 | Arm 9 Non-cirrhotic | ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| FG009 | Arm 10 Compensated Cirrhotic | ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| FG010 | Arm 11 Non-cirrhotic | ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| FG011 | Arm 12 Non-cirrhotic | ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
|
| COMPLETED |
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| NOT COMPLETED |
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|
The safety population: all participants who received at least 1 dose of any study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 Non-cirrhotic | ABT-493 Dose A (100 mg once daily [QD]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| BG001 | Arm 2 Non-cirrhotic | ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| BG002 | Arm 3 Non-cirrhotic | ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| BG003 | Arm 4 Non-cirrhotic | ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| BG004 | Arm 5 Compensated Cirrhotic | ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| BG005 | Arm 6 Non-cirrhotic | ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| BG006 | Arm 7 Non-cirrhotic | ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| BG007 | Arm 8 Non-cirrhotic | ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| BG008 | Arm 9 Non-cirrhotic | ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| BG009 | Arm 10 Compensated Cirrhotic | ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| BG010 | Arm 11 Non-cirrhotic | ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| BG011 | Arm 12 Non-cirrhotic | ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| BG012 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Maximal Decrease From Baseline in log10 HCV RNA Levels During ABT-493 or ABT-530 Monotherapy Treatment | Maximal decrease from baseline in log10 HCV RNA levels during ABT-493 or ABT-530 monotherapy treatment. The baseline value was the last measurement before the first dose of monotherapy on Day 1. | Monotherapy Analysis Sets for Substudy 1 (Arms 1-5, 11) and SubStudy 2 (Arms 6-10, 12) are defined as all participants who received at least 1 dose of monotherapy and have a baseline and at least 1 postbaseline measurement of HCV RNA during monotherapy. Data for subjects who received the same treatment (Arms 4+5; Arms 7+10) were analyzed together. | Posted | Mean | Standard Deviation | Log10 IU/mL | Day 1 through prior to first dose of the combination regimen on Study Day 4 |
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| Secondary | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [](streamdown:incomplete-link) | Combination Treatment Analysis Set: all participants who receive at least 1 dose of the combination regimen of ABT-450/r/ABT-267 + ABT-333 + RBV; participants with missing data after backwards imputation were counted as nonresponders. | Posted | Number | percentage of participants | 12 weeks after last actual dose of combination study drug |
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| Secondary | Percentage of Participants With On-treatment Virologic Failure | On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during combination treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during combination treatment; or HCV RNA ≥ LLOQ at end of combination treatment with at least 6 weeks of combination treatment. | Combination Treatment Analysis Set: all participants who receive at least 1 dose of the combination regimen of ABT-450/r/ABT-267 + ABT-333 + RBV. | Posted | Number | 95% Confidence Interval | participants | Up to 87 days |
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| Secondary | Percentage of Participants With Post-treatment Relapse | Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants completing combination treatment with HCV RNA levels < LLOQ at the end of treatment. | Combination Treatment Analysis Set: all participants who receive at least 1 dose of the combination regimen of ABT-450/r/ABT-267 + ABT-333 + RBV, completed treatment, and had HCV RNA \ | Posted | Number | 95% Confidence Interval | percentage of participants | From the end of treatment through 12 weeks after the last dose of combination study drug |
|
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16.5 weeks).
TEAEs and TESAEs are defined as any AE or SAE with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 Non-cirrhotic | ABT-493 Dose A (100 mg once daily [QD]) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks | 1 | 8 | 8 | 8 | ||
| EG001 | Arm 2 Non-cirrhotic | ABT-493 Dose B (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks | 0 | 8 | 7 | 8 | ||
| EG002 | Arm 3 Non-cirrhotic | ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks | 0 | 9 | 7 | 9 | ||
| EG003 | Arm 4 Non-cirrhotic | ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks | 0 | 8 | 8 | 8 | ||
| EG004 | Arm 5 Compensated Cirrhotic | ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks | 1 | 8 | 7 | 8 | ||
| EG005 | Arm 6 Non-cirrhotic | ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks | 0 | 8 | 7 | 8 | ||
| EG006 | Arm 7 Non-cirrhotic | ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks | 0 | 8 | 8 | 8 | ||
| EG007 | Arm 8 Non-cirrhotic | ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks | 1 | 8 | 4 | 8 | ||
| EG008 | Arm 9 Non-cirrhotic | ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks | 1 | 8 | 5 | 8 | ||
| EG009 | Arm 10 Compensated Cirrhotic | ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks | 0 | 8 | 7 | 8 | ||
| EG010 | Arm 11 Non-cirrhotic | ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks | 0 | 8 | 7 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| MANIA | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
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| RENAL FAILURE | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| ANAEMIA MACROCYTIC | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
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| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
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| PALPITATIONS | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
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| EAR PAIN | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
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| TINNITUS | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
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| DRY EYE | Eye disorders | MedDRA 18.0 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA 18.0 | Systematic Assessment |
| |
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| CHEILITIS | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| DENTAL CARIES | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| DRY MOUTH | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| DYSPEPSIA | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| FAECAL VOLUME INCREASED | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| FAECES DISCOLOURED | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| FLATULENCE | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| GINGIVAL PAIN | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| GINGIVAL RECESSION | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| HAEMATEMESIS | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| STOMATITIS | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| TOOTHACHE | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| ASTHENIA | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| CHEST DISCOMFORT | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| DISCOMFORT | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| DRUG WITHDRAWAL SYNDROME | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| FEELING ABNORMAL | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| PERIPHERAL SWELLING | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| SECRETION DISCHARGE | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| THIRST | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| SEASONAL ALLERGY | Immune system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| BURSITIS INFECTIVE | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| LIP INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| PYURIA | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| TINEA CRURIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| TOOTH INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| ANIMAL BITE | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| CLAVICLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| LACERATION | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| PROCEDURAL ANXIETY | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| BLOOD BILIRUBIN UNCONJUGATED INCREASED | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| BLOOD URIC ACID INCREASED | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| BLOOD URINE PRESENT | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| HAEMOGLOBIN DECREASED | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| HEART RATE INCREASED | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| LYMPHOCYTE COUNT DECREASED | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| HYPERURICAEMIA | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| INCREASED APPETITE | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| JOINT SWELLING | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL DISCOMFORT | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL STIFFNESS | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| BURNING SENSATION | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| DYSARTHRIA | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| HEAD DISCOMFORT | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| MIGRAINE | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| NERVE COMPRESSION | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| AGGRESSION | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| AGITATION | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| ANGER | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| BIPOLAR DISORDER | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| EMOTIONAL DISORDER | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| IRRITABILITY | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| LIBIDO DECREASED | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| LIBIDO INCREASED | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| MOOD SWINGS | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| RESTLESSNESS | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| NOCTURIA | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| VAGINAL DISCHARGE | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| NASAL DISCOMFORT | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| ECCHYMOSIS | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| HAIR GROWTH ABNORMAL | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| PHOTOSENSITIVITY REACTION | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| PRURITUS GENERALISED | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| RASH MACULAR | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| SKIN EXFOLIATION | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| SWELLING FACE | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| TOOTH EXTRACTION | Surgical and medical procedures | MedDRA 18.0 | Systematic Assessment |
| |
| FLUSHING | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
| |
| HOT FLUSH | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000612853 | glecaprevir |
| C000622691 | pibrentasvir |
| C588260 | dasabuvir |
| C586094 | ombitasvir |
| C585405 | paritaprevir |
| C000607373 | Viekira Pak |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Male |
|
| OG003 | Arm 4 Non-cirrhotic | ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| OG004 | Arm 5 Compensated Cirrhotic | ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| OG005 | Arm 6 Non-cirrhotic | ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| OG006 | Arm 7 Non-cirrhotic | ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| OG007 | Arm 8 Non-cirrhotic | ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| OG008 | Arm 9 Non-cirrhotic | ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| OG009 | Arm 10 Compensated Cirrhotic | ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| OG010 | Arm 11 Non-cirrhotic | ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| OG011 | Arm 12 Non-cirrhotic | ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
|
|
ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
| OG003 | Arm 4 Non-cirrhotic | ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| OG004 | Arm 5 Compensated Cirrhotic | ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| OG005 | Arm 6 Non-cirrhotic | ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| OG006 | Arm 7 Non-cirrhotic | ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| OG007 | Arm 8 Non-cirrhotic | ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| OG008 | Arm 9 Non-cirrhotic | ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| OG009 | Arm 10 Compensated Cirrhotic | ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| OG010 | Arm 11 Non-cirrhotic | ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| OG011 | Arm 12 Non-cirrhotic | ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
|
|
ABT-493 Dose C (700 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
| OG003 | Arm 4 Non-cirrhotic | ABT-493 Dose D (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| OG004 | Arm 5 Compensated Cirrhotic | ABT-493 Dose E (200 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| OG005 | Arm 6 Non-cirrhotic | ABT-530 Dose A (15 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| OG006 | Arm 7 Non-cirrhotic | ABT-530 Dose B (120 mg QD) for 3 days,followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| OG007 | Arm 8 Non-cirrhotic | ABT-530 Dose C (400 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| OG008 | Arm 9 Non-cirrhotic | ABT-530 Dose D (40 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| OG009 | Arm 10 Compensated Cirrhotic | ABT-530 Dose E (120 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| OG010 | Arm 11 Non-cirrhotic | ABT-493 Dose F (300 mg QD) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| OG011 | Arm 12 Non-cirrhotic | ABT-530 Dose F (≤ 400 mg) for 3 days, followed by ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
|
|