Hepatitis C Virus
Conditions
Keywords
Genotype 1, Genotype 2, Genotype 3, Hepatitis C Virus, ABT-450/r, Ribavirin, ABT-267, Ombitasvir, Paritaprevir
Brief summary
The purpose of this study was to evaluate the efficacy, safety and pharmacokinetics of ABT-450/r when given together with ABT-267 and with and without RBV in treatment-naïve participants with genotype 1, 2 or 3 chronic HCV infection.
Detailed description
This was a 2 sequential arm, combination treatment study where each arm contained 3 cohorts: one each for HCV genotype 1, 2, and 3. The study consisted of 2 phases, a treatment phase and a post-treatment phase. The treatment phase was designed to explore the antiviral activity, safety and pharmacokinetics of ABT-450/r dosed in combination with ABT-267 with and without RBV for up to 12 weeks. The post-treatment phase was designed to monitor and evaluate Sustained Virologic Response (SVR) 12, SVR 24, and the evolution and persistence of viral resistance to ABT-267 and ABT-450 in HCV genotype 1-, 2-, and 3-infected participants who have been exposed to ABT-267 and ABT-450/r. Arms 1 and 2 were enrolled sequentially.
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participants who had a body mass index 18 to \< 35 kg/m\^2. * Females were either postmenopausal for at least 2 years, surgically sterile, or willing to use at least 2 effective forms of birth control. * Males must have been surgically sterile or agreed to use at least 2 effective forms of birth control throughout the course of the study. * Participants were in a condition of general good health, other than the HCV infection. * Participants had a chronic HCV genotype 1, 2, or 3 infection for at least 6 months, a plasma HCV RNA \> 50,000 IU/mL, and FibroTest score \<= 0.72 and aspartate aminotransferase (AST) to platelet ratio index \<= 2, Fibroscan® result of \< 9.6 kilopascal (kPa), or absence of cirrhosis based on a liver biopsy.
Exclusion criteria
* Positive drug screen * Previous use of anti-HCV agents * History of cardiac disease * History of uncontrolled diabetes or diabetes requiring insulin * Abnormal laboratory results * Females who were pregnant or planned to become pregnant within 6 months after their last dose of study drug/RBV or were breastfeeding; males whose partners were pregnant or would become pregnant within 6 months after their last dose of study drug/RBV * Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus (HIV) antibody (Ab). Negative HIV status was to be confirmed at screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [(Extended Rapid Virologic Response (eRVR)] | Week 4 through Week 12 | Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (\< 25 IU/mL). Participants with missing data were imputed as failures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment | Post-treatment Day 1 to Post-treatment Week 24 | Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; \< 25 IU/mL) 24 weeks after the last dose of study drug. Participants with missing data were imputed as failures. |
| Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL) | Week 2 | Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2. Participants with missing data were imputed as failures. |
| Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment | Post-treatment Day 1 to Post-treatment Week 12 | Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (\< LLOQ; \< 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures. |
| Percentage of Participants With Virologic Failure During Treatment | Day 1 through Week 12 | Virologic failure during treatment is defined as a participant meeting any virologic stopping criteria, including 1) rebound (defined as the first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value), or first day of 2 consecutive HCV RNA \>= LLOQ for participants who previously achieved HCV RNA \< LLOQ) during treatment, 2) participant who fails to suppress (defined as never achieving HCV RNA \< LLOQ during treatment). |
| Percentage of Participants Who Experienced Virologic Relapse Through End of Post Treatment Period (up to 48 Weeks) | Post-treatment Day 1 to Post-treatment Week 48 | Virologic relapse is defined as confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) \>= lower limit of quantitation (LLOQ) (2 consecutive measurements \>= LLOQ) at any point in the post-treatment period among participants with HCV RNA \< LLOQ at the end of treatment. Participants with missing data were imputed as failures. |
| Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 Rapid Virologic Response (RVR) | Week 4 | Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (\< 25 IU/mL). Participants with missing data were imputed as failures. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants. | 10 |
| ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants. | 10 |
| ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants. | 10 |
| ABT-450/r and ABT-267 in Genotype 1 Participants ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants. | 10 |
| ABT-450/r and ABT-267 in Genotype 2 Participants ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants. | 10 |
| ABT-450/r and ABT-267 in Genotype 3 Participants ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants. | 11 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 | 0 | 3 | 2 | 2 |
| Overall Study | Other | 0 | 0 | 0 | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 2 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants | ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants | ABT-450/r and ABT-267 in Genotype 1 Participants | ABT-450/r and ABT-267 in Genotype 2 Participants | ABT-450/r and ABT-267 in Genotype 3 Participants | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 44.3 years STANDARD_DEVIATION 12.19 | 51.1 years STANDARD_DEVIATION 8.25 | 40.3 years STANDARD_DEVIATION 13.1 | 45.9 years STANDARD_DEVIATION 7.03 | 54.9 years STANDARD_DEVIATION 10.85 | 48.7 years STANDARD_DEVIATION 8.91 | 47.6 years STANDARD_DEVIATION 10.9 |
| HCV Genotype/ Subtype 1A | 8 participants | 0 participants | 0 participants | 8 participants | 0 participants | 0 participants | 16 participants |
| HCV Genotype/ Subtype 1B | 2 participants | 0 participants | 0 participants | 2 participants | 0 participants | 0 participants | 4 participants |
| HCV Genotype/ Subtype 2A | 0 participants | 2 participants | 0 participants | 0 participants | 2 participants | 0 participants | 4 participants |
| HCV Genotype/ Subtype 2B | 0 participants | 8 participants | 0 participants | 0 participants | 8 participants | 0 participants | 16 participants |
| HCV Genotype/ Subtype 3A | 0 participants | 0 participants | 10 participants | 0 participants | 0 participants | 11 participants | 21 participants |
| HCV Genotype/ Subtype 3B | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Interleukin 28B (IL28B) CC | 1 participants | 2 participants | 2 participants | 4 participants | 4 participants | 3 participants | 16 participants |
| Interleukin 28B (IL28B) CT | 7 participants | 4 participants | 7 participants | 4 participants | 5 participants | 7 participants | 34 participants |
| Interleukin 28B (IL28B) Missing | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Interleukin 28B (IL28B) TT | 2 participants | 4 participants | 1 participants | 2 participants | 1 participants | 1 participants | 11 participants |
| Sex: Female, Male Female | 8 Participants | 2 Participants | 3 Participants | 7 Participants | 3 Participants | 4 Participants | 27 Participants |
| Sex: Female, Male Male | 2 Participants | 8 Participants | 7 Participants | 3 Participants | 7 Participants | 7 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 10 | 9 / 10 | 8 / 10 | 9 / 10 | 9 / 10 | 10 / 11 |
| serious Total, serious adverse events | 1 / 10 | 0 / 10 | 0 / 10 | 1 / 10 | 1 / 10 | 1 / 11 |
Outcome results
Primary
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [(Extended Rapid Virologic Response (eRVR)]
Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (\< 25 IU/mL). Participants with missing data were imputed as failures.
Time frame: Week 4 through Week 12
Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants | Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [(Extended Rapid Virologic Response (eRVR)] | 100 percentage of participants |
| ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants | Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [(Extended Rapid Virologic Response (eRVR)] | 90.0 percentage of participants |
| ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants | Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [(Extended Rapid Virologic Response (eRVR)] | 70.0 percentage of participants |
| ABT-450/r and ABT-267 in Genotype 1 Participants | Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [(Extended Rapid Virologic Response (eRVR)] | 90.0 percentage of participants |
| ABT-450/r and ABT-267 in Genotype 2 Participants | Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [(Extended Rapid Virologic Response (eRVR)] | 80.0 percentage of participants |
| ABT-450/r and ABT-267 in Genotype 3 Participants | Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [(Extended Rapid Virologic Response (eRVR)] | 18.2 percentage of participants |
p-value: 0.157Cochran-Mantel-Haenszel
p-value: 0.999Cochran-Mantel-Haenszel
p-value: 0.045Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Experienced Virologic Relapse Through End of Post Treatment Period (up to 48 Weeks)
Virologic relapse is defined as confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) \>= lower limit of quantitation (LLOQ) (2 consecutive measurements \>= LLOQ) at any point in the post-treatment period among participants with HCV RNA \< LLOQ at the end of treatment. Participants with missing data were imputed as failures.
Time frame: Post-treatment Day 1 to Post-treatment Week 48
Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT) with hepatitis C virus (HCV) ribonucleic acid (RNA) \< lower limit of quantitation (LLOQ) at the final treatment visit who completed treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants | Percentage of Participants Who Experienced Virologic Relapse Through End of Post Treatment Period (up to 48 Weeks) | 0 percentage of participants |
| ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants | Percentage of Participants Who Experienced Virologic Relapse Through End of Post Treatment Period (up to 48 Weeks) | 0 percentage of participants |
| ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants | Percentage of Participants Who Experienced Virologic Relapse Through End of Post Treatment Period (up to 48 Weeks) | 28.6 percentage of participants |
| ABT-450/r and ABT-267 in Genotype 1 Participants | Percentage of Participants Who Experienced Virologic Relapse Through End of Post Treatment Period (up to 48 Weeks) | 22.2 percentage of participants |
| ABT-450/r and ABT-267 in Genotype 2 Participants | Percentage of Participants Who Experienced Virologic Relapse Through End of Post Treatment Period (up to 48 Weeks) | 22.2 percentage of participants |
| ABT-450/r and ABT-267 in Genotype 3 Participants | Percentage of Participants Who Experienced Virologic Relapse Through End of Post Treatment Period (up to 48 Weeks) | 50.0 percentage of participants |
Secondary
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)
Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2. Participants with missing data were imputed as failures.
Time frame: Week 2
Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants | Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL) | 100 percentage of participants |
| ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants | Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL) | 100 percentage of participants |
| ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants | Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL) | 100 percentage of participants |
| ABT-450/r and ABT-267 in Genotype 1 Participants | Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL) | 100 percentage of participants |
| ABT-450/r and ABT-267 in Genotype 2 Participants | Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL) | 100 percentage of participants |
| ABT-450/r and ABT-267 in Genotype 3 Participants | Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL) | 100 percentage of participants |
Secondary
Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 Rapid Virologic Response (RVR)
Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (\< 25 IU/mL). Participants with missing data were imputed as failures.
Time frame: Week 4
Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants | Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 Rapid Virologic Response (RVR) | 100 percentage of participants |
| ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants | Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 Rapid Virologic Response (RVR) | 100 percentage of participants |
| ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants | Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 Rapid Virologic Response (RVR) | 90.0 percentage of participants |
| ABT-450/r and ABT-267 in Genotype 1 Participants | Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 Rapid Virologic Response (RVR) | 100 percentage of participants |
| ABT-450/r and ABT-267 in Genotype 2 Participants | Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 Rapid Virologic Response (RVR) | 90.0 percentage of participants |
| ABT-450/r and ABT-267 in Genotype 3 Participants | Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 Rapid Virologic Response (RVR) | 27.3 percentage of participants |
Secondary
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (\< LLOQ; \< 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures.
Time frame: Post-treatment Day 1 to Post-treatment Week 12
Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants | Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment | 100 percentage of participants |
| ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants | Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment | 80.0 percentage of participants |
| ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants | Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment | 50.0 percentage of participants |
| ABT-450/r and ABT-267 in Genotype 1 Participants | Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment | 60.0 percentage of participants |
| ABT-450/r and ABT-267 in Genotype 2 Participants | Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment | 60.0 percentage of participants |
| ABT-450/r and ABT-267 in Genotype 3 Participants | Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment | 9.1 percentage of participants |
Secondary
Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment
Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; \< 25 IU/mL) 24 weeks after the last dose of study drug. Participants with missing data were imputed as failures.
Time frame: Post-treatment Day 1 to Post-treatment Week 24
Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants | Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment | 100 percentage of participants |
| ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants | Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment | 80.0 percentage of participants |
| ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants | Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment | 40.0 percentage of participants |
| ABT-450/r and ABT-267 in Genotype 1 Participants | Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment | 60.0 percentage of participants |
| ABT-450/r and ABT-267 in Genotype 2 Participants | Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment | 60.0 percentage of participants |
| ABT-450/r and ABT-267 in Genotype 3 Participants | Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment | 9.1 percentage of participants |
Secondary
Percentage of Participants With Virologic Failure During Treatment
Virologic failure during treatment is defined as a participant meeting any virologic stopping criteria, including 1) rebound (defined as the first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value), or first day of 2 consecutive HCV RNA \>= LLOQ for participants who previously achieved HCV RNA \< LLOQ) during treatment, 2) participant who fails to suppress (defined as never achieving HCV RNA \< LLOQ during treatment).
Time frame: Day 1 through Week 12
Population: Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants | Percentage of Participants With Virologic Failure During Treatment | Participant Rebounds | 0 percentage of participants |
| ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants | Percentage of Participants With Virologic Failure During Treatment | Participants who fail to Suppress | 0 percentage of participants |
| ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants | Percentage of Participants With Virologic Failure During Treatment | Participant Rebounds | 10.0 percentage of participants |
| ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants | Percentage of Participants With Virologic Failure During Treatment | Participants who fail to Suppress | 0 percentage of participants |
| ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants | Percentage of Participants With Virologic Failure During Treatment | Participant Rebounds | 30.0 percentage of participants |
| ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants | Percentage of Participants With Virologic Failure During Treatment | Participants who fail to Suppress | 0 percentage of participants |
| ABT-450/r and ABT-267 in Genotype 1 Participants | Percentage of Participants With Virologic Failure During Treatment | Participant Rebounds | 10.0 percentage of participants |
| ABT-450/r and ABT-267 in Genotype 1 Participants | Percentage of Participants With Virologic Failure During Treatment | Participants who fail to Suppress | 0 percentage of participants |
| ABT-450/r and ABT-267 in Genotype 2 Participants | Percentage of Participants With Virologic Failure During Treatment | Participant Rebounds | 10.0 percentage of participants |
| ABT-450/r and ABT-267 in Genotype 2 Participants | Percentage of Participants With Virologic Failure During Treatment | Participants who fail to Suppress | 0 percentage of participants |
| ABT-450/r and ABT-267 in Genotype 3 Participants | Percentage of Participants With Virologic Failure During Treatment | Participant Rebounds | 72.7 percentage of participants |
| ABT-450/r and ABT-267 in Genotype 3 Participants | Percentage of Participants With Virologic Failure During Treatment | Participants who fail to Suppress | 0 percentage of participants |