Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; prior to dose on Day 2 (24 hours after Day 1 dose); and at each subsequent study visit. The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The area under the plasma concentration -time curve (AUC; measured in ng\*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma. The AUC24 of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

Time frame: Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; prior to dose on Day 2 (24 hours after Day 1 dose); and at each subsequent study visit up to Week 12

Population: Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the plasma after administration in a dosing interval. The Cmax of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

Time frame: Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

Population: Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.

Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Rapid virologic response was defined as HCV RNA levels \< the lower limit of detection (\< 15 IU/mL) at Week 4. Data are reported as percentage of participants with RVR.

Time frame: Week 4

Population: All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy and safety analyses.

Blood samples were collected at each study visit from Week 1 to Week 12. The samples were analyzed for the concentration of RBV (measured in ng/mL) using validated analytical methods and RBV concentrations in plasma were summarized at each visit. Data are reported as the median (range).

Time frame: At each study visit from Week 1 to Week 12

Population: Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. When a different number of participants at a specific time point was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.

Blood samples were collected at each study visit from Week 1 to Week 12. The samples were analyzed for the concentration of pegIFN (measured in ng/mL) using validated analytical methods and pegIFN concentrations in serum were summarized at each visit. Data are reported as the median (range).

Time frame: At each study visit from Week 1 to Week 12

Population: Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. When a different number of participants at a specific time point was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title.

Blood samples were collected immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose). The samples were analyzed for the concentration of ABT-267 using validated analytical methods. The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax. The Tmax of ABT-267 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation.

Time frame: Immediately prior to morning dose (time 0 hours); 2, 4, 6, and 8 hours after the morning dose on Day 1; and prior to dose on Day 2 (24 hours after Day 1 dose)

Population: Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters.

Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Time to suppression was defined as the time (measured in days) to HCV RNA levels \< the lower limit of quantification (\< 25 IU/mL). Data are reported as the median number of days.

Time frame: Approximately 12 weeks

Population: All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.

Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Complete EVR was defined as HCV RNA \< the lower limit of quantification (\< 25 IU/mL) at Week 12. Data are reported as the percentage of participants with cEVR.

Time frame: Week 12

Population: All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analysis.

Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Extended RVR was defined as HCV RNA levels \< the lower level of quantification (\< 25 IU/mL) at Weeks 4 through 12. Data are reported as the percentage of participants with eRVR.

Time frame: Week 4 through Week 12

Population: All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.

Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Partial EVR was defined as HCV RNA levels that decreased \> 2 log10 IU/mL at Week 12 as compared to baseline HCV RNA levels. Data are reported as the percentage of participants with pEVR.

Time frame: Baseline and Week 12

Population: All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.

Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Sustained virologic response was defined as HCV RNA levels \< the lower limit of quantification (\< 25 IU/mL) 12 weeks after the last dose of pegIFN/RBV. Data are reported as the percentage of participants with SVR12.

Time frame: 12 weeks after the last dose of pegIFN/RBV

Population: All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.

Plasma hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined for each sample using a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay. Sustained virologic response was defined as HCV RNA levels \< the lower limit of quantification (\< 25 IU/mL) 24 weeks after the last dose of pegIFN/RBV. Data are reported as the percentage of participants with SVR24.

Time frame: 24 weeks after the last dose of pegIFN/RBV

Population: All 37 participants enrolled in the study received at least 1 dose of study drug and were included in the intent-to-treat population for efficacy analyses.