| Primary | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. The exact 95% confidence interval (CI) for the percentage within treatment group was based on the Clopper-Pearson method. | The Full Analysis Set (FAS) included participants who were enrolled into the study and received at least 1 dose of study drug. Participants were grouped within the Full Analysis Set by genotype and treatment group to which they were enrolled. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Posttreatment Week 12 | | | | ID | Title | Description |
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| OG000 | LDV/SOF for 8 Weeks | Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks. | | OG001 | LDV/SOF for 12 Weeks | Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks. | | OG002 | LDV/SOF for 24 Weeks | Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00093.3(81.7 to 98.6)
- OG001100.0(88.8 to 100.0)
- OG00284.2(60.4 to 96.6)
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| Primary | Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event | | The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received. | Posted | | Number | | percentage of participants | | First dose date up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF for 8 Weeks | Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks. | | OG001 | LDV/SOF for 12 Weeks | Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks. | | OG002 | LDV/SOF for 24 Weeks | Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks. |
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| Secondary | Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) | SVR4 was defined as HCV RNA < LLOQ (ie, 15 IU/mL) at 4 weeks after stopping study treatment. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Posttreatment Week 4 | | | | ID | Title | Description |
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| OG000 | LDV/SOF for 8 Weeks | Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks. | | OG001 | LDV/SOF for 12 Weeks | Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks. | | OG002 | LDV/SOF for 24 Weeks | Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks. |
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| Secondary | Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) | SVR24 was defined as HCV RNA < LLOQ (ie, 15 IU/mL) at 24 weeks after stopping study treatment. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Posttreatment Week 24 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF for 8 Weeks | Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks. | | OG001 | LDV/SOF for 12 Weeks | Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks. | | OG002 | LDV/SOF for 24 Weeks | Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks. |
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| Secondary | Percentage of Participants With HCV RNA < LLOQ on Treatment | The total number of participants with HCV RNA < LLOQ was the sum of the number of participants with HCV RNA "< LLOQ detected" plus the number of participants with HCV RNA "< LLOQ target not detected (TND)". LLOQ was 15 IU/mL. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 2, 4, 6, 8, 12, 16, 20, 24 | | | | ID | Title | Description |
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| OG000 | LDV/SOF for 8 Weeks | Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks. | | OG001 | LDV/SOF for 12 Weeks | Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks. | | OG002 | LDV/SOF for 24 Weeks | Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks. |
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| Secondary | HCV RNA | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | log10 IU/mL | | Weeks 2, 4, 6, 8, 12, 16, 20, 24 | | | | ID | Title | Description |
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| OG000 | LDV/SOF for 8 Weeks | Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks. | | OG001 | LDV/SOF for 12 Weeks | Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks. | | OG002 | LDV/SOF for 24 Weeks | Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks. |
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| Secondary | Change From Baseline in HCV RNA | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | log10 IU/mL | | Weeks 2, 4, 6, 8, 12, 16, 20, 24 | | | | ID | Title | Description |
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| OG000 | LDV/SOF for 8 Weeks | Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks. | | OG001 | LDV/SOF for 12 Weeks | Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks. | | OG002 | LDV/SOF for 24 Weeks | Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks. |
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| Secondary | Percentage of Participants With Virologic Failure | Virologic failure was defined as: | Participants in the Full Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | Baseline up to Posttreatment Week 24 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF for 8 Weeks | Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks. | | OG001 | LDV/SOF for 12 Weeks | Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks. | | OG002 | LDV/SOF for 24 Weeks | Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks. |
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| Secondary | Percentage of Participants Who Developed Resistance to LDV and SOF | | The Resistance Analysis Population was defined as all participants in the Safety Analysis Set with a virologic outcome and at least 1 gene sequenced. As no participant had a relapse in this study, this outcome could not be analyzed. | Posted | | | | | | Baseline up to Posttreatment Week 24 | | | | ID | Title | Description |
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| OG000 | LDV/SOF for 8 Weeks | Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks. | | OG001 | LDV/SOF for 12 Weeks | Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks. | | OG002 | LDV/SOF for 24 Weeks | Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks. |
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| Secondary | Pharmacokinetics (PK) Parameter: AUCtau of LDV | AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval. | The PK Analysis Set included all participants who took at least 1 dose of the study drug and had at least 1 nonmissing postdose concentration value for the corresponding analyte in plasma. | Posted | | Mean | Standard Deviation | h*ng/mL | | Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2)) | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF for 8 Weeks | Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks. | | OG001 | LDV/SOF for 12 Weeks | Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks. | | OG002 | LDV/SOF for 24 Weeks | Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks. |
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| Secondary | PK Parameter: AUCtau of SOF | AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | h*ng/mL | | Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2)) | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF for 8 Weeks | Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks. | | OG001 | LDV/SOF for 12 Weeks | Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks. | | OG002 | LDV/SOF for 24 Weeks | Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks. |
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| Secondary | PK Parameter: AUCtau of GS-331007 (Metabolite of SOF) | AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval. | Participants in the PK Analysis Set were analyzed. | Posted | | Mean | Standard Deviation | h*ng/mL | | Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2)) | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF for 8 Weeks | Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks. | | OG001 | LDV/SOF for 12 Weeks | Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks. | | OG002 | LDV/SOF for 24 Weeks | Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks. |
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| Secondary | PK Parameter: Cmax of LDV | Cmax is defined as the population PK derived maximum concentration of the drug. | Participants in the PK Analysis Set were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2)) | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF for 8 Weeks | Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks. | | OG001 | LDV/SOF for 12 Weeks | Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks. | | OG002 | LDV/SOF for 24 Weeks | Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks. |
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| Secondary | PK Parameter: Cmax of SOF | Cmax is defined as the population PK derived maximum concentration of the drug. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2)) | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF for 8 Weeks | Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks. | | OG001 | LDV/SOF for 12 Weeks | Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks. | | OG002 | LDV/SOF for 24 Weeks | Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks. |
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| Secondary | PK Parameter: Cmax of GS-331007 (Metabolite of SOF) | Cmax is defined as the population PK derived maximum concentration of the drug. | Participants in the PK Analysis Set were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2)) | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF for 8 Weeks | Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks. | | OG001 | LDV/SOF for 12 Weeks | Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks. | | OG002 | LDV/SOF for 24 Weeks | Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks. |
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