| Primary | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. | Full Analysis Set: participants who were enrolled and took at least 1 dose of study drug. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Posttreatment Week 12 | | | | ID | Title | Description |
|---|
| OG000 | SOF 200 mg + RBV 200 mg (Cohort 1) | SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG001 | SOF 400 mg + RBV 200 mg (Cohort 2) | SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG002 | LDV/SOF (Cohort 3) | LDV/SOF 90/400 mg FDC tablet for 12 weeks |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00040.0(12.2 to 73.8)
- OG00160.0(26.2 to 87.8)
- OG002100.0(81.5 to 100.0)
|
|
| |
| Primary | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | | | Posted | | Number | | percentage of participants | | Up to 24 weeks plus 30 days | | | | ID | Title | Description |
|---|
| OG000 | SOF 200 mg + RBV 200 mg (Cohort 1) | SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG001 | SOF 400 mg + RBV 200 mg (Cohort 2) | SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG002 | LDV/SOF (Cohort 3) | LDV/SOF 90/400 mg FDC tablet for 12 weeks |
| |
| Primary | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Treatment-emergent laboratory abnormalities were defined as values that increased by at least 1 toxicity grade from baseline at any time postbaseline up to the date of last dose of study drug plus 30 days. | | Posted | | Number | | percentage of participants | | Up to 24 weeks plus 30 days | | | | ID | Title | Description |
|---|
| OG000 | SOF 200 mg + RBV 200 mg (Cohort 1) | SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG001 | SOF 400 mg + RBV 200 mg (Cohort 2) | SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG002 | LDV/SOF (Cohort 3) | LDV/SOF 90/400 mg FDC tablet for 12 weeks |
| |
| Primary | Percentage of Participants Experiencing Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities | | | Posted | | Number | | percentage of participants | | Up to 24 weeks plus 30 days | | | | ID | Title | Description |
|---|
| OG000 | SOF 200 mg + RBV 200 mg (Cohort 1) | SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG001 | SOF 400 mg + RBV 200 mg (Cohort 2) | SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG002 | LDV/SOF (Cohort 3) | LDV/SOF 90/400 mg FDC tablet for 12 weeks |
| |
| Primary | Percentage of Participants Experiencing Treatment-Emergent Adverse Events Associated With Vital Sign Abnormalities | | | Posted | | Number | | percentage of participants | | Up to 24 weeks plus 30 days | | | | ID | Title | Description |
|---|
| OG000 | SOF 200 mg + RBV 200 mg (Cohort 1) | SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG001 | SOF 400 mg + RBV 200 mg (Cohort 2) | SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG002 | LDV/SOF (Cohort 3) | LDV/SOF 90/400 mg FDC tablet for 12 weeks |
| |
| Primary | Pharmacokinetic (PK) Parameter: AUCtau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2) | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). | Participants in the PK Analysis Set (all enrolled participants who took at least 1 dose of study drug and have at least 1 nonmissing postdose PK concentration value) from Cohorts 1 and 2 with available data were analyzed. | Posted | | Mean | Standard Deviation | h*ng/mL | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 | | | | ID | Title | Description |
|---|
| OG000 | SOF 200 mg + RBV 200 mg (Cohort 1) | SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG001 | SOF 400 mg + RBV 200 mg (Cohort 2) | SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks |
| |
| Primary | PK Parameter: AUCtau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2) | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). | Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed. | Posted | | Mean | Standard Deviation | h*ng/mL | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12 | | | | ID | Title | Description |
|---|
| OG000 | SOF 200 mg + RBV 200 mg (Cohort 1) | SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG001 | SOF 400 mg + RBV 200 mg (Cohort 2) | SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks |
| |
| Primary | PK Parameter: AUCtau of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3) | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). | Participants in the PK Analysis Set from Cohort 3 with available data were analyzed. | Posted | | Mean | Standard Deviation | h*ng/mL | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 3) | LDV/SOF 90/400 mg FDC tablet for 12 weeks |
| |
| Primary | PK Parameter: Cmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2) | Cmax is defined as the maximum concentration of drug. | Participants in the PK Analysis Set from Cohorts 1 and 2 were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 | | | | ID | Title | Description |
|---|
| OG000 | SOF 200 mg + RBV 200 mg (Cohort 1) | SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG001 | SOF 400 mg + RBV 200 mg (Cohort 2) | SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks |
| |
| Primary | PK Parameter: Cmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2) | Cmax is defined as the maximum concentration of drug. | Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12 | | | | ID | Title | Description |
|---|
| OG000 | SOF 200 mg + RBV 200 mg (Cohort 1) | SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG001 | SOF 400 mg + RBV 200 mg (Cohort 2) | SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks |
| |
| Primary | PK Parameter: Cmax of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3) | Cmax is defined as the maximum concentration of drug. | Participants in the PK Analysis Set from Cohort 3 with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 3) | LDV/SOF 90/400 mg FDC tablet for 12 weeks |
| | |
| Primary | PK Parameter: Ctau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2) | Ctau is defined as the observed drug concentration at the end of the dosing interval. | Participants in the PK Analysis Set from Cohorts 1 and 2 were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 | | | | ID | Title | Description |
|---|
| OG000 | SOF 200 mg + RBV 200 mg (Cohort 1) | SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG001 | SOF 400 mg + RBV 200 mg (Cohort 2) | SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks |
| |
| Primary | PK Parameter: Ctau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2) | Ctau is defined as the observed drug concentration at the end of the dosing interval. | Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12 | | | | ID | Title | Description |
|---|
| OG000 | SOF 200 mg + RBV 200 mg (Cohort 1) | SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG001 | SOF 400 mg + RBV 200 mg (Cohort 2) | SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks |
| |
| Primary | PK Parameter: Ctau of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3) | Ctau is defined as the observed drug concentration at the end of the dosing interval. | Participants in the PK Analysis Set from Cohort 3 with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 3) | LDV/SOF 90/400 mg FDC tablet for 12 weeks |
| | |
| Secondary | Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) | SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Posttreatment Week 4 | | | | ID | Title | Description |
|---|
| OG000 | SOF 200 mg + RBV 200 mg (Cohort 1) | SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG001 | SOF 400 mg + RBV 200 mg (Cohort 2) | SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG002 | LDV/SOF (Cohort 3) | LDV/SOF 90/400 mg FDC tablet for 12 weeks |
| |
| Secondary | Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) | SVR4 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Posttreatment Week 24 | | | | ID | Title | Description |
|---|
| OG000 | SOF 200 mg + RBV 200 mg (Cohort 1) | SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG001 | SOF 400 mg + RBV 200 mg (Cohort 2) | SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG002 | LDV/SOF (Cohort 3) | LDV/SOF 90/400 mg FDC tablet for 12 weeks |
| |
| Secondary | Percentage of Participants With Overall Virologic Failure | Virologic failure was defined as: | | Posted | | Number | | percentage of participants | | Up to Posttreatment Week 24 | | | | ID | Title | Description |
|---|
| OG000 | SOF 200 mg + RBV 200 mg (Cohort 1) | SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG001 | SOF 400 mg + RBV 200 mg (Cohort 2) | SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG002 | LDV/SOF (Cohort 3) | LDV/SOF 90/400 mg FDC tablet for 12 weeks |
| |
| Secondary | PK Parameter: AUClast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2) | AUClast is defined as the concentration of drug from time zero to the last observable concentration. | Participants in the PK Analysis Set from Cohorts 1 and 2 were analyzed. | Posted | | Mean | Standard Deviation | h*ng/mL | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 | | | | ID | Title | Description |
|---|
| OG000 | SOF 200 mg + RBV 200 mg (Cohort 1) | SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG001 | SOF 400 mg + RBV 200 mg (Cohort 2) | SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks |
| |
| Secondary | PK Parameter: AUClast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2) | AUClast is defined as the concentration of drug from time zero to the last observable concentration. | Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed. | Posted | | Mean | Standard Deviation | h*ng/mL | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12 | | | | ID | Title | Description |
|---|
| OG000 | SOF 200 mg + RBV 200 mg (Cohort 1) | SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG001 | SOF 400 mg + RBV 200 mg (Cohort 2) | SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks |
| |
| Secondary | PK Parameter: AUClast of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3) | AUClast is defined as the concentration of drug from time zero to the last observable concentration. | Participants in the PK Analysis Set from Cohort 3 with available data were analyzed. | Posted | | Mean | Standard Deviation | h*ng/mL | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 3) | LDV/SOF 90/400 mg FDC tablet for 12 weeks |
| |
| Secondary | PK Parameter: Clast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2) | Clast is defined as the last observable concentration of drug. | Participants in the PK Analysis Set from Cohorts 1 and 2 were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 | | | | ID | Title | Description |
|---|
| OG000 | SOF 200 mg + RBV 200 mg (Cohort 1) | SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG001 | SOF 400 mg + RBV 200 mg (Cohort 2) | SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks |
| |
| Secondary | PK Parameter: Clast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2) | Clast is defined as the last observable concentration of drug. | Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12 | | | | ID | Title | Description |
|---|
| OG000 | SOF 200 mg + RBV 200 mg (Cohort 1) | SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG001 | SOF 400 mg + RBV 200 mg (Cohort 2) | SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks |
| |
| Secondary | PK Parameter: Clast of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3) | Clast is defined as the last observable concentration of drug. | Participants in the PK Analysis Set from Cohort 3 with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 3) | LDV/SOF 90/400 mg FDC tablet for 12 weeks |
| | |
| Secondary | PK Parameter: Tmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2) | Tmax is defined as the time (observed time point) of Cmax. | Participants in the PK Analysis Set from Cohorts 1 and 2 were analyzed. | Posted | | Median | Inter-Quartile Range | hours | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 | | | | ID | Title | Description |
|---|
| OG000 | SOF 200 mg + RBV 200 mg (Cohort 1) | SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG001 | SOF 400 mg + RBV 200 mg (Cohort 2) | SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks |
| |
| Secondary | PK Parameter: Tmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2) | Tmax is defined as the time (observed time point) of Cmax. | Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed. | Posted | | Median | Inter-Quartile Range | hours | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12 | | | | ID | Title | Description |
|---|
| OG000 | SOF 200 mg + RBV 200 mg (Cohort 1) | SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG001 | SOF 400 mg + RBV 200 mg (Cohort 2) | SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks |
| |
| Secondary | PK Parameter: Tmax of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3) | Tmax is defined as the time (observed time point) of Cmax. | Participants in the PK Analysis Set from Cohort 3 with available data were analyzed. | Posted | | Median | Inter-Quartile Range | hours | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 3) | LDV/SOF 90/400 mg FDC tablet for 12 weeks |
| | |
| Secondary | PK Parameter: Tlast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2) | Tlast is defined as the time (observed time point) of Clast. | Participants in the PK Analysis Set from Cohorts 1 and 2 were analyzed. | Posted | | Median | Inter-Quartile Range | hours | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 | | | | ID | Title | Description |
|---|
| OG000 | SOF 200 mg + RBV 200 mg (Cohort 1) | SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG001 | SOF 400 mg + RBV 200 mg (Cohort 2) | SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks |
| |
| Secondary | PK Parameter: Tlast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2) | Tlast is defined as the time (observed time point) of Clast. | Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed. | Posted | | Median | Inter-Quartile Range | hours | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12 | | | | ID | Title | Description |
|---|
| OG000 | SOF 200 mg + RBV 200 mg (Cohort 1) | SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG001 | SOF 400 mg + RBV 200 mg (Cohort 2) | SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks |
| |
| Secondary | PK Parameter: Tlast of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3) | Tlast is defined as the time (observed time point) of Clast. | Participants in the PK Analysis Set from Cohort 3 with available data were analyzed. | Posted | | Median | Inter-Quartile Range | hours | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 3) | LDV/SOF 90/400 mg FDC tablet for 12 weeks |
| | |
| Secondary | PK Parameter: λz of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2) | λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug. | Participants in the PK Analysis Set from Cohorts 1 and 2 were analyzed. | Posted | | Mean | Standard Deviation | 1/hour | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 | | | | ID | Title | Description |
|---|
| OG000 | SOF 200 mg + RBV 200 mg (Cohort 1) | SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG001 | SOF 400 mg + RBV 200 mg (Cohort 2) | SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks |
| |
| Secondary | PK Parameter: λz of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2) | λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug. | Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed. | Posted | | Mean | Standard Deviation | 1/hour | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12 | | | | ID | Title | Description |
|---|
| OG000 | SOF 200 mg + RBV 200 mg (Cohort 1) | SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG001 | SOF 400 mg + RBV 200 mg (Cohort 2) | SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks |
| |
| Secondary | PK Parameter: λz of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3) | λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug. | Participants in the PK Analysis Set from Cohort 3 with available data were analyzed. | Posted | | Mean | Standard Deviation | 1/hour | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 3) | LDV/SOF 90/400 mg FDC tablet for 12 weeks |
| |
| Secondary | PK Parameter: t1/2 of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2) | t1/2 is defined as the estimate of the terminal elimination half-life of the drug. | Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed. | Posted | | Median | Inter-Quartile Range | hours | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 | | | | ID | Title | Description |
|---|
| OG000 | SOF 200 mg + RBV 200 mg (Cohort 1) | SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG001 | SOF 400 mg + RBV 200 mg (Cohort 2) | SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks |
| |
| Secondary | PK Parameter: t1/2 of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2) | t1/2 is defined as the estimate of the terminal elimination half-life of the drug. | Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed. | Posted | | Median | Inter-Quartile Range | hours | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12 | | | | ID | Title | Description |
|---|
| OG000 | SOF 200 mg + RBV 200 mg (Cohort 1) | SOF 200 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks | | OG001 | SOF 400 mg + RBV 200 mg (Cohort 2) | SOF 400 mg tablet once daily + RBV 200 mg tablet once daily for 24 weeks |
| |
| Secondary | PK Parameter: t1/2 of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3) | t1/2 is defined as the estimate of the terminal elimination half-life of the drug. | Participants in the PK Analysis Set from Cohort 3 with available data were analyzed. | Posted | | Median | Inter-Quartile Range | hours | | Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 3) | LDV/SOF 90/400 mg FDC tablet for 12 weeks |
| | |