| Primary | Mean Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-333 Monotherapy Treatment | Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (reported as log10 IU/mL) were determined for each sample using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1. The maximal change during monotherapy was nadir minus the baseline log10 HCV RNA level. Nadir was defined as the lowest log10 HCV RNA level any time after the first dose of study drug on Day 1 through the last log10 HCV RNA level before the first dose of study drug on Day 3. Data are reported as the least squares mean change from nadir ± standard error. | Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA. | Posted | | Least Squares Mean | Standard Error | log10 IU/mL | | Prior to the first dose on Day 1 to before first dose on Day 3 | | | | ID | Title | Description |
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| OG000 | ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. | | OG001 | ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. | | OG002 | ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. | | OG003 | Placebo + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-1.01± 0.18
- OG001-0.78± 0.18
- OG002-0.68± 0.18
- OG003
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Eight participants per ABT-333 group and 12 participants in the placebo group provided >95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05. | ANCOVA | The treatment group was the factor and log10 baseline HCV RNA level was the covariate. | 0.012 | No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05. | | | | | 2-Sided | | | | | | | | Superiority or Other | |
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| Primary | Mean Maximal Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels Through Day 28 | Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (reported as log10 IU/mL) were determined for each sample using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1. The maximal change during treatment was nadir minus the baseline log10 HCV RNA level. Nadir was defined as the lowest log10 HCV RNA level any time after the first dose of study drug on Day 1 through the last log10 HCV RNA level on Day 28. Data are reported as the least squares mean change from nadir ± standard error. | Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA. | Posted | | Least Squares Mean | Standard Error | log10 IU/mL | | Prior to the first dose on Day 1 through Day 28 | | | | ID | Title | Description |
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| OG000 | ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. | | OG001 | ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. |
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| Primary | Maximum Plasma Concentration (Cmax) of ABT-333 | Blood samples were collected pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and pre-dose on Day 2. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation. | Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours post-dose on Day 1; and pre-dose on Day 2 | | | | ID | Title | Description |
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| OG000 | ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. | | OG001 | ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. |
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| Primary | Time to Maximum Plasma Concentration (Tmax) of ABT-333 | Blood samples were collected pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and pre-dose on Day 2. The samples were analyzed for the concentration of ABT-333 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-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation. | Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. | Posted | | Mean | Standard Deviation | Hours | | Pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours post-dose on Day 1; and pre-dose on Day 2 | | | | ID | Title | Description |
|---|
| OG000 | ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. | | OG001 | ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. |
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| Primary | Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post-dose (AUC12) of ABT-333 | Blood samples were collected pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours after the morning dose on Day 1; and pre-dose on Day 2. The samples were analyzed for the concentration of ABT-333 using validated analytical methods. The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) measures the total exposure of a drug in blood plasma. The AUC12 of ABT-333 was estimated using non-compartmental methods and data are reported as the mean ± standard deviation. | Participants received at least 1 dose of study drug and had sufficient concentrations to characterize the pharmacokinetic parameters. | Posted | | Mean | Standard Deviation | ng*hr/mL | | Pre-dose (time 0 hours); 2, 4, 8, 12, and 16 hours post-dose on Day 1; and pre-dose on Day 2 | | | | ID | Title | Description |
|---|
| OG000 | ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. | | OG001 | ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. |
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| Primary | Serum Concentrations of Pegylated Interferon (pegIFN) | Blood samples were collected prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28. The samples were analyzed for the concentration of pegIFN (measured in ng/mL) using validated analytical methods and estimated using non-compartmental methods. Data are reported as the mean ± standard deviation. | 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 timepoint was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title. | Posted | | Mean | Standard Deviation | ng/mL | | Prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28 | | | | ID | Title | Description |
|---|
| OG000 | ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. | | OG001 | ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV | |
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| Primary | Plasma Concentrations of Ribavirin (RBV) | Blood samples were collected prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28. The samples were analyzed for the concentration of RBV (measured in ng/mL) using validated analytical methods and estimated using non-compartmental methods. Data are reported as the mean ± standard deviation. | 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 timepoint was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title. | Posted | | Mean | Standard Deviation | ng/mL | | Prior to the morning dose on Day 3; 4 hours after the morning dose on Day 3; prior to the morning dose on Days 4 and 5; and single samples were collected on Days 10, 17, 24, and 28 | | | | ID | Title | Description |
|---|
| OG000 | ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. | | OG001 | ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV | |
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| Primary | Number of Participants Having Treatment-emergent Adverse Events (AEs) | An AE was any untoward medical occurrence that did not have a causal relationship with treatment. An Adverse Drug Reaction (ADR) was any noxious and undesired reaction related to the experimental drug or experiment. A serious adverse event (SAE) was an AE that resulted in death, was life-threatening, resulted in or prolonged hospitalization, resulted in congenital anomaly, was persistent or caused significant disability/incapacity, spontaneous or elective abortion, or required intervention to prevent a serious outcome. AEs were rated for severity as either:
- Mild - transient and easily tolerated;
- Moderate - caused discomfort and interrupted usual activities;
- Severe - caused considerable interference with usual activities, may be incapacitating or life-threatening.
AEs related to direct-acting antiviral agents (DAAs) were assessed as being either probably or possibly related by the investigator. | Participants received at least 1 dose of study drug. | Posted | | Number | | participants | | AEs were collected from the time of study drug administration to 30 days after last dose of study drug (8 Weeks) | | | | ID | Title | Description |
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| OG000 | ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. | | OG001 |
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| Secondary | Change From Baseline in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels Through Day 28 or Final Visit | Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (reported as log10 IU/mL) were determined using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1 and the Day 28 or Final Visit value was the last HCV RNA measurement during the study. Data are reported as the least squares mean change from baseline ± standard error. | Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA. When a different number of participants at a specific timepoint was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title. | Posted | | Least Squares Mean | Standard Error | log10 IU/mL | | Day 28 and Final Visit | | | | ID | Title | Description |
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| OG000 | ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. | | OG001 | ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. |
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| Secondary | Percentage of Participants With at Least a 2 log10 Maximal Decrease in Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels During ABT-333 Treatment | Serum hepatitis C virus ribonucleic acid (HCV RNA) levels (measured in IU/mL) were determined using a real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay. The baseline value was the HCV RNA measurement before the first dose of ABT-333 on Day 1. Data are reported as the percentage of participants. | Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA. | Posted | | Number | | percentage of participants | | Prior to the first dose on Day 1 and Day 28 | | | | ID | Title | Description |
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| OG000 | ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. | | OG001 | ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. |
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| Secondary | Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels ≤ 25 IU/mL (the Lower Limit of Quantitation [LLOQ]) at Day 28 or Final Visit | Serum 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. The lower limit of quantification (LLOQ) was defined as HCV RNA levels ≤ 25 IU/mL. Data are reported as the percentage of participants. | Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of hepatitis C virus ribonucleic acid (HCV RNA). | Posted | | Number | | percentage of participants | | Day 28 or Final Visit | | | | ID | Title | Description |
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| OG000 | ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. | | OG001 | ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. |
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| Secondary | Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV RNA) Levels ≤ 10 IU/mL (Lower Limit of Detection [LLOD]) at Day 28 or Final Visit | Serum 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. The lower limit of detection (LLOD) was defined as a HCV RNA level equal to 10 IU/mL. Data are reported as the percentage of participants. | Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of hepatitis C virus ribonucleic acid (HCV RNA). | Posted | | Number | | percentage of participants | | Day 28 or Final Visit | | | | ID | Title | Description |
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| OG000 | ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. | | OG001 | ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. |
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| Secondary | Number of Participants With Resistance-Associated Variants in Non-structural Viral Protein 5B (NS5B) Through Day 28 | Samples from Days 1, 5, 10, 17, 24 and 28 were analyzed for the presence of resistance-associated amino acids using population sequencing and compared to the baseline non-structural viral protein 5B (NS5B) sequence to assess amino acid changes. The amino acid sequence of NS5B before the first dose of ABT-333 on Day 1 was defined as the baseline sequence. The number of participants with variants at resistance-associated amino acid positions in the post-baseline samples are presented. | Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA. When a different number of participants at a specific timepoint was used to analyze the data in the outcome measure, the n (number of participants) for each arm is denoted in the Category Title. | Posted | | Number | | participants | | Days 1, 5, 10, 17, 24 and 28 | | | | ID | Title | Description |
|---|
| OG000 | ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. | | OG001 | ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. |
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| Secondary | Number of Participants With Maximal Phenotypic Resistance to ABT-333 >10 Fold Relative to Baseline Through Day 28 | Phenotypic resistance to ABT-333 was assessed by calculating the fold difference in the half maximal effective concentration (EC50) compared with the EC50 for the corresponding baseline sample, and the maximal fold change in EC50 from baseline over the Day 5-28 period. The resistance sample drawn before the first dose of ABT-333 on Day 1 was defined as the baseline sample. The number of participants with phenotypic resistance in the post-baseline samples are presented. | Participants received at least 1 dose of study drug and had at least 1 post-baseline measurement of HCV RNA. | Posted | | Number | | participants | | Days 1 through 28 | | | | ID | Title | Description |
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| OG000 | ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. | | OG001 | ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV | Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. |
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