Chronic Hepatitis C Infection, Chronic Hepatitis C
Conditions
Keywords
HCV Genotype 1, Hepatitis Genotype 1, Interferon Free, methadone, HCV, Buprenorphine, Hepatitis C, Viekira Pak, paritaprevir, Viekira, ombitasvir, dasabuvir
Brief summary
The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults taking methadone or buprenorphine ± naloxone.
Detailed description
This study consisted of 2 periods: a 12-week treatment period and a 48-week post-treatment period (for all participants who received study drugs). All participants who received at least 1 dose of study drug were to be followed for 48 weeks post-treatment to monitor for safety, HCV RNA, the emergence and/or persistence of resistant viral variants, and assessment of patient-reported outcome (PRO) instruments.
Interventions
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Females must be practicing specific forms of birth control on study treatment, or be postmenopausal for more than 2 years or surgically sterile. * Chronic HCV infection prior to study enrollment. * Screening laboratory result indicating HCV genotype 1-infection. * Subject must be treatment naive or previous pegylated interferon/ribavirin treatment experienced. * Subjects must be on a stable opioid replacement therapy of methadone or buprenorphine ± naloxone for at least 6 months prior to screening.
Exclusion criteria
* Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab) at screening. * Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir and boceprevir. * Females who are pregnant or plan to become pregnant, or breastfeeding, or males whose partners are pregnant or planning to become pregnant within 7 months (or per local RBV label) after their last dose of study drug. * Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis, e.g., a Metavir Score of \>3 or Ishak score of \> 4.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment | 12 weeks after the last actual 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 quantification \[\< LLOQ\]) 12 weeks after the last dose of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Virologic Relapse Post-treatment | From the end of treatment through 12 weeks after the last actual dose of study drug | Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA \< LLOQ at the end of treatment. Completion of treatment was defined as a study drug duration ≥ 77 days. |
| Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose | Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and were analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Area under the plasma concentration-time curve from time 0 to 24 hours (AUC24 in ng\*hr/mL)\] was estimated using noncompartmental analyses. For ABT-450, ritonavir, and ABT-267, the AUC from time 0 to the last measureable concentration (AUCt in ng\*hr/mL) was calculated instead of AUC24 due to time deviations at 24 hours. The AUCt values are approximately equivalent to AUC24. For ABT-333, ABT-333 M1, and RBV, the AUC from time 0 to 12 hours (AUC12 in ng\*hr/mL) after the morning dose was calculated using the 24-hour concentration as the 12-hour concentration as dosing was twice a day and a 12-hour sample was not collected in this study. |
| Percentage of Participants With Virologic Failure During Treatment | Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12 | Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation \[≥ LLOQ\] after HCV RNA \< LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA \[2 consecutive HCV RNA measurements \> 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline\] at any time point during treatment) or fail to suppress (HCV RNA ≥ LLOQ) persistently during treatment with at least 6 weeks \[≥ 36 days\] of treatment. |
| Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose | Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. The time to maximum plasma concentration (Tmax; measured in hours) was directly determined from the concentration-time data. |
| Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose | Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Minimum plasma concentration (C trough; measured in ng/mL) was directly determined from the concentration-time data. |
| Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose | Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and were analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Maximum plasma concentration (Cmax; measured in ng/mL) was directly determined from the concentration-time data. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks | 38 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Other (not specified) | 3 |
Baseline characteristics
| Characteristic | ABT-450/r/ABT-267 and ABT-333, Plus RBV |
|---|---|
| Age, Continuous | 48.2 years STANDARD_DEVIATION 11 |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 35 / 38 |
| serious Total, serious adverse events | 2 / 38 |
Outcome results
Primary
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment
The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantification \[\< LLOQ\]) 12 weeks after the last dose of study drug.
Time frame: 12 weeks after the last actual dose of study drug
Population: All enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment | 97.4 Percentage of participants |
Secondary
Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin
Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and were analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Area under the plasma concentration-time curve from time 0 to 24 hours (AUC24 in ng\*hr/mL)\] was estimated using noncompartmental analyses. For ABT-450, ritonavir, and ABT-267, the AUC from time 0 to the last measureable concentration (AUCt in ng\*hr/mL) was calculated instead of AUC24 due to time deviations at 24 hours. The AUCt values are approximately equivalent to AUC24. For ABT-333, ABT-333 M1, and RBV, the AUC from time 0 to 12 hours (AUC12 in ng\*hr/mL) after the morning dose was calculated using the 24-hour concentration as the 12-hour concentration as dosing was twice a day and a 12-hour sample was not collected in this study.
Time frame: Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose
Population: Participants who consented for intensive pharmacokinetic blood sampling
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-267 | 1523.48 ng*hr/mL | Standard Deviation 4444.58 |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-333 M1 metabolite | 3086.73 ng*hr/mL | Standard Deviation 1807.51 |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | Ritonavir | 14303.27 ng*hr/mL | Standard Deviation 8367.86 |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | Ribavirin | 33362.24 ng*hr/mL | Standard Deviation 10340.16 |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-333 | 5666.15 ng*hr/mL | Standard Deviation 2550.86 |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-450 | 27438.94 ng*hr/mL | Standard Deviation 34380.77 |
| Methadone | Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-450 | 37174.89 ng*hr/mL | Standard Deviation 49655.37 |
| Methadone | Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | Ritonavir | 11375.38 ng*hr/mL | Standard Deviation 5586.62 |
| Methadone | Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-267 | 1486.72 ng*hr/mL | Standard Deviation 519.84 |
| Methadone | Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-333 | 5021.41 ng*hr/mL | Standard Deviation 2353.06 |
| Methadone | Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-333 M1 metabolite | 2950.36 ng*hr/mL | Standard Deviation 2094.61 |
| Methadone | Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | Ribavirin | 33499.39 ng*hr/mL | Standard Deviation 10697.75 |
Secondary
Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin
Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and were analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Maximum plasma concentration (Cmax; measured in ng/mL) was directly determined from the concentration-time data.
Time frame: Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose
Population: Participants who consented for intensive pharmacokinetic blood sampling
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-450 | 3269.50 ng/mL | Standard Deviation 4388.48 |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | Ritonavir | 1261.92 ng/mL | Standard Deviation 657.35 |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-267 | 102.00 ng/mL | Standard Deviation 27.21 |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-333 | 805.08 ng/mL | Standard Deviation 354.04 |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-333 M1 metabolite | 469.92 ng/mL | Standard Deviation 271.13 |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | Ribavirin | 3389.17 ng/mL | Standard Deviation 1064.98 |
| Methadone | Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-333 M1 metabolite | 439.64 ng/mL | Standard Deviation 272.91 |
| Methadone | Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-450 | 2973.30 ng/mL | Standard Deviation 3371.83 |
| Methadone | Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-333 | 671.90 ng/mL | Standard Deviation 302.08 |
| Methadone | Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | Ritonavir | 888.70 ng/mL | Standard Deviation 409.56 |
| Methadone | Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | Ribavirin | 3232.00 ng/mL | Standard Deviation 948.39 |
| Methadone | Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-267 | 95.98 ng/mL | Standard Deviation 35.56 |
Secondary
Percentage of Participants With Virologic Failure During Treatment
Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation \[≥ LLOQ\] after HCV RNA \< LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA \[2 consecutive HCV RNA measurements \> 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline\] at any time point during treatment) or fail to suppress (HCV RNA ≥ LLOQ) persistently during treatment with at least 6 weeks \[≥ 36 days\] of treatment.
Time frame: Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12
Population: All enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | Percentage of Participants With Virologic Failure During Treatment | 0 Percentage of participants |
Secondary
Percentage of Participants With Virologic Relapse Post-treatment
Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA \< LLOQ at the end of treatment. Completion of treatment was defined as a study drug duration ≥ 77 days.
Time frame: From the end of treatment through 12 weeks after the last actual dose of study drug
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 and ABT-333, Plus RBV | Percentage of Participants With Virologic Relapse Post-treatment | 0 Percentage of participants |
Secondary
Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin
Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Minimum plasma concentration (C trough; measured in ng/mL) was directly determined from the concentration-time data.
Time frame: Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose
Population: Participants who consented for intensive pharmacokinetic blood sampling
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-450 | 170.01 ng/mL | Standard Deviation 368.36 |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | Ritonavir | 167.35 ng/mL | Standard Deviation 406.5 |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-267 | 33.75 ng/mL | Standard Deviation 17.28 |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-333 | 223.76 ng/mL | Standard Deviation 246.63 |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-333 M1 metabolite | 86.98 ng/mL | Standard Deviation 110.35 |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | Ribavirin | 2555.83 ng/mL | Standard Deviation 1115.82 |
| Methadone | Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-333 M1 metabolite | 71.10 ng/mL | Standard Deviation 83.23 |
| Methadone | Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-450 | 458.53 ng/mL | Standard Deviation 988.11 |
| Methadone | Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-333 | 147.95 ng/mL | Standard Deviation 115.2 |
| Methadone | Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | Ritonavir | 136.87 ng/mL | Standard Deviation 273.44 |
| Methadone | Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | Ribavirin | 2632.00 ng/mL | Standard Deviation 1039.54 |
| Methadone | Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-267 | 32.78 ng/mL | Standard Deviation 14.11 |
Secondary
Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin
Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. The time to maximum plasma concentration (Tmax; measured in hours) was directly determined from the concentration-time data.
Time frame: Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose
Population: Participants who consented for intensive pharmacokinetic blood sampling
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-450 | 4.38 hours | Standard Deviation 1.45 |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | Ritonavir | 4.18 hours | Standard Deviation 1.33 |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-267 | 4.69 hours | Standard Deviation 1 |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-333 | 4.25 hours | Standard Deviation 2.74 |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-333 M1 metabolite | 4.40 hours | Standard Deviation 0.84 |
| ABT-450/r/ABT-267 and ABT-333, Plus RBV | Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | Ribavirin | 3.72 hours | Standard Deviation 2.95 |
| Methadone | Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-333 M1 metabolite | 4.65 hours | Standard Deviation 1.11 |
| Methadone | Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-450 | 6.81 hours | Standard Deviation 6.04 |
| Methadone | Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-333 | 4.05 hours | Standard Deviation 1.4 |
| Methadone | Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | Ritonavir | 7.01 hours | Standard Deviation 5.97 |
| Methadone | Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | Ribavirin | 5.83 hours | Standard Deviation 4.34 |
| Methadone | Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin | ABT-267 | 5.26 hours | Standard Deviation 0.98 |