| Primary | Number of Patients With Drug-related Adverse Events | Number of patients with investigator defined drug-related Adverse Events | Treated Set which included all patients who were dispensed study medication and were documented to have taken at least one dose of study medication. | Posted | | Number | | participants | | From first dose of study medication until 30 days after last dose of study medication, up to 199 days | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Percentage of Participants With Virological Response at Week 4 | Percentage of participants with plasma HCV RNA (hepatitis C virus (HCV) ribonucleic acid (RNA)) level <25 IU/mL (undetected or detected) at week 4. | Full analysis set which included all patients with at least 1 on-treatment value of HCV RNA viral load | Posted | | Number | | percentage of participants | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Percentage of Participants With Virological Response at Week 8 | Percentage of participants with plasma HCV RNA (hepatitis C virus ribonucleic acid ) level <25 IU/mL (undetected or detected) at week 8. | Full analysis set which included all patients with at least 1 on-treatment value of HCV RNA viral load | Posted | | Number | | percentage of participants | | 8 weeks | | | | ID | Title | Description |
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| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Maximum Measured Concentration (Cmax) of Deleobuvir | Maximum measured concentration of BI 207127 (Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N). | Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol/L | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Time From Last Dosing to the Maximum Concentration (Tmax) of Deleobuvir | Time from last dosing to the maximum concentration of Deleobuvir (BI 207127) in plasma after the morning dose of Nth day (Tmax,N). | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Median | Full Range | hours | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Area Under the Curve (AUC) of Deleobuvir | Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ. | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Maximum Measured Concentration (Cmax) of Faldaprevir | Maximum measured concentration of Faldaprevir (BI 201335 ZW) in plasma following the morning dose of Nth day (Cmax,N). | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Time From Last Dosing to the Maximum Concentration (Tmax) of Faldaprevir | Time from last dosing to the maximum concentration of Faldaprevir (BI 201335 ZW) in plasma after the morning dose of Nth day (Tmax,N). | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Median | Full Range | hours | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Area Under the Curve (AUC) of Faldaprevir | Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ. | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Maximum Measured Concentration (Cmax) of BI 208333 | Maximum measured concentration of BI 208333 (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N). | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol/L | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Time From Last Dosing to the Maximum Concentration (Tmax) of BI 208333 | Time from last dosing to the maximum concentration of BI 208333 (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N). | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Median | Full Range | hours | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Area Under the Curve (AUC) of BI 208333 | Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ. | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Maximum Measured Concentration (Cmax) of CD 6168 | Maximum measured concentration of CD 6168 (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N). | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol/L | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Time From Last Dosing to the Maximum Concentration (Tmax) of CD 6168 | Time from last dosing to the maximum concentration of CD 6168 (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N). | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Median | Full Range | hours | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Area Under the Curve (AUC) of CD 6168 | Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ. | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Maximum Measured Concentration (Cmax) of CD 6168-AG | Maximum measured concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N). AG=acylglucuronide. | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol/L | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Time From Last Dosing to the Maximum Concentration (Tmax) of CD 6168-AG | Time from last dosing to the maximum concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N). AG=acylglucuronide. | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Median | Full Range | hours | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Area Under the Curve (AUC) of CD 6168-AG | Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ. AG=acylglucuronide. | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol*h/L | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Maximum Measured Concentration (Cmax) of RBV | Maximum measured concentration of ribavirin (RBV) in plasma following the morning dose of Nth day (Cmax,N). | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Time From Last Dosing to the Maximum Concentration (Tmax) of RBV | Time from last dosing to the maximum concentration of ribavirin (RBV) in plasma after the morning dose of Nth day (Tmax,N). | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Median | Full Range | hours | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Area Under the Curve (AUC) of RBV | Area under the concentration time curve (AUC) of ribavirin (RBV) in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ. | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Cmax Accumulation Ratio (RA,Cmax,N) of Deleobuvir | Accumulation ratio of BI 207127 (Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of Deleobuvir versus itself (RA,Cmax,Met,ss). | Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | AUC Accumulation Ratio of Deleobuvir | Accumulation ratio of BI 207127 (Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of Deleobuvir versus itself (RA,AUC,Met,ss). | Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Mean Residence Time (MRTpo,ss) of Deleobuvir | Mean residence time of BI 207127 (Deleobuvir) in the body after oral administration at steady state (MRTpo,ss). | Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. Analysis includes patients with available data for this parameter. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hours | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Apparent Clearance (CL/F,ss) of Deleobuvir | Apparent clearance of BI 207127 (Deleobuvir) in plasma following extravascular administration on the 57th day (CL/F,ss). | Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. Analysis includes patients with available data for this parameter. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Litres per hour | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Predose Measured Concentration of Deleobuvir | Predose measured concentration of BI 207127 (Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss). | Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol/L | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Cmax Accumulation Ratio (RA,Cmax,N) of Faldaprevir | Accumulation ratio of Faldaprevir (BI 201335 ZW) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N). | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | AUC Accumulation Ratio of Faldaprevir | Accumulation ratio of Faldaprevir (BI 201335 ZW) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N). | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Mean Residence Time (MRTpo,ss) of Faldaprevir | Mean residence time of Faldaprevir (BI 201335 ZW) in the body after oral administration at steady state (MRTpo,ss). This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups. | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | | | | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Apparent Clearance (CL/F,ss) of Faldaprevir | Apparent clearance of Faldaprevir (BI 201335 ZW) in plasma following extravascular administration on the 57th day (CL/F,ss). | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. Analysis includes patients with available data for this parameter. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mL/min | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Predose Measured Concentration of Faldaprevir | Predose measured concentration of Faldaprevir (BI 201335 ZW) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss). | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Cmax Accumulation Ratio of BI 208333 | Accumulation ratio of BI 208333 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of BI 208333 versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss). | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | AUC Accumulation Ratio of BI 208333 | Accumulation ratio of BI 208333 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of BI 208333 versus AUC,ss of Deleobuvir (RA,AUC,Met,ss). | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Mean Residence Time (MRTpo,ss) of BI 208333 | Mean residence time of BI 208333 (a metabolite of Deleobuvir) in the body after oral administration at steady state (MRTpo,ss). This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups. | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | | | | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Predose Measured Concentration of BI 208333 | Predose measured concentration of BI 208333 (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss). | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol/L | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Cmax Accumulation Ratio of CD 6168 | Accumulation ratio of CD 6168 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of CD 6168 versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss). | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
|
| Secondary | AUC Accumulation Ratio of CD 6168 | Accumulation ratio of CD 6168 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of CD 6168 versus AUC,ss of Deleobuvir (RA,AUC,Met,ss). | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Mean Residence Time (MRTpo,ss) of CD 6168 | Mean residence time of CD 6168 (a metabolite of Deleobuvir) in the body after oral administration at steady state (MRTpo,ss). This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups. | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | | | | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on day 57 | | | | ID | Title | Description |
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| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Predose Measured Concentration of CD 6168 | Predose measured concentration of CD 6168 (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss). | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol/L | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 11 and 57 | | | | ID | Title | Description |
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| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Cmax Accumulation Ratio of CD 6168-AG | Accumulation ratio of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of CD 6168-AG versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss). AG=acylglucuronide. | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57 | | | | ID | Title | Description |
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| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | AUC Accumulation Ratio of CD 6168-AG | Accumulation ratio of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of CD 6168-AG versus AUC,ss of Deleobuvir (RA,AUC,Met,ss). AG=acylglucuronide. | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57 | | | | ID | Title | Description |
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| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Mean Residence Time (MRTpo,ss) of CD 6168-AG | Mean residence time of CD 6168-AG (a metabolite of Deleobuvir) in the body after oral administration at steady state (MRTpo,ss). AG=acylglucuronide. This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups. | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | | | | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on day 57 | | | | ID | Title | Description |
|---|
| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Predose Measured Concentration of CD 6168-AG | Predose measured concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss). AG=acylglucuronide. | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nmol/L | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 11 and 57 | | | | ID | Title | Description |
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| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | AUC Accumulation Ratio of RBV | Accumulation ratio of ribavirin (RBV) in plasma after the administration of the 57th day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the 57th day and after the first dose (RA,AUC,57). | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. Analysis includes patients with available data for this parameter. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57 | | | | ID | Title | Description |
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| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Cmax Accumulation Ratio (RA,Cmax,57) of RBV | Accumulation ratio of ribavirin (RBV) in plasma after the administration of the 57th day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the 57th day and after the first dose (RA,Cmax,57). | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. Analysis includes patients with available data for this parameter. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57 | | | | ID | Title | Description |
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| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Mean Residence Time (MRTpo,ss) of RBV | Mean residence time of ribavirin (RBV) in the body after oral administration at steady state (MRTpo,ss). This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups. | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | | | | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on day 57 | | | | ID | Title | Description |
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| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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| Secondary | Predose Measured Concentration of RBV | Predose measured concentration of ribavirin (RBV) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss). | PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 11 and 57 | | | | ID | Title | Description |
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| OG000 | 600mg Deleobuvir and 80mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). | | OG001 | 600mg Deleobuvir and 120mg Faldaprevir | Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). |
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