| 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 randomized and took at least 1 dose of study drug. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Posttreatment Week 12 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 1) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks | | OG001 | SOF+RBV (Cohort 1) | SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks | | OG002 | LDV/SOF (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00096.2(90.6 to 99.0)
- OG00195.4(89.5 to 98.5)
- OG00296.0(79.6 to 99.9)
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | | | | | Difference in proportions | 0.9 | | | 2-Sided | 95 | -5.3 | 7.1 | | | Difference in proportions between treatment groups and associated 95% confidence intervals (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions. | | Non-Inferiority | A sample size of 100 participants per treatment group would provide over 90% power to establish non-inferiority in the SVR12 rates between the LDV/SOF group and SOF+RBV group. Sample size was based on the assumptions that the clinically meaningful non-inferiority margin is 10%, both groups have a SVR12 rate of 96%, and the significance level is 0.025 one-sided. |
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| Primary | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | | | Posted | | Number | | percentage of participants | | Up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 1) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks | | OG001 | SOF+RBV (Cohort 1) | SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks | | OG002 | LDV/SOF (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy |
| |
| 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 | LDV/SOF (Cohort 1) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks | | OG001 | SOF+RBV (Cohort 1) | SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks | | OG002 | LDV/SOF (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy |
| |
| Secondary | Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) | SVR 24 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 | LDV/SOF (Cohort 1) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks | | OG001 | SOF+RBV (Cohort 1) | SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks | | OG002 | LDV/SOF (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy |
| |
| Secondary | Percentage of Participants With HCV RNA < LLOQ at Week 1 | | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 1) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks | | OG001 | SOF+RBV (Cohort 1) | SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks | | OG002 | LDV/SOF (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy |
| |
| Secondary | Percentage of Participants With HCV RNA < LLOQ at Week 2 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 1) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks | | OG001 | SOF+RBV (Cohort 1) | SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks | | OG002 | LDV/SOF (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy |
| |
| Secondary | Percentage of Participants With HCV RNA < LLOQ at Week 3 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 3 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 1) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks | | OG001 | SOF+RBV (Cohort 1) | SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks | | OG002 | LDV/SOF (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy |
| |
| Secondary | Percentage of Participants With HCV RNA < LLOQ at Week 4 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 1) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks | | OG001 | SOF+RBV (Cohort 1) | SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks | | OG002 | LDV/SOF (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy |
| |
| Secondary | Percentage of Participants With HCV RNA < LLOQ at Week 5 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 5 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 1) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks | | OG001 | SOF+RBV (Cohort 1) | SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks | | OG002 | LDV/SOF (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy |
| |
| Secondary | Percentage of Participants With HCV RNA < LLOQ at Week 6 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 1) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks | | OG001 | SOF+RBV (Cohort 1) | SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks | | OG002 | LDV/SOF (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy |
| |
| Secondary | Percentage of Participants With HCV RNA < LLOQ at Week 8 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 1) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks | | OG001 | SOF+RBV (Cohort 1) | SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks | | OG002 | LDV/SOF (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy |
| |
| Secondary | Percentage of Participants With HCV RNA < LLOQ at Week 10 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 10 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 1) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks | | OG001 | SOF+RBV (Cohort 1) | SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks | | OG002 | LDV/SOF (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy |
| |
| Secondary | Percentage of Participants With HCV RNA < LLOQ at Week 12 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 1) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks | | OG001 | SOF+RBV (Cohort 1) | SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks | | OG002 | LDV/SOF (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy |
| |
| Secondary | Change From Baseline in HCV RNA at Week 1 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | log10 IU/mL | | Baseline; Week 1 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 1) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks | | OG001 | SOF+RBV (Cohort 1) | SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks | | OG002 | LDV/SOF (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy |
| |
| Secondary | Change From Baseline in HCV RNA at Week 2 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | log10 IU/mL | | Baseline; Week 2 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 1) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks | | OG001 | SOF+RBV (Cohort 1) | SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks | | OG002 | LDV/SOF (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy |
| |
| Secondary | Change From Baseline in HCV RNA at Week 3 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | log10 IU/mL | | Baseline; Week 3 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 1) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks | | OG001 | SOF+RBV (Cohort 1) | SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks | | OG002 | LDV/SOF (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy |
| |
| Secondary | Change From Baseline in HCV RNA at Week 4 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | log10 IU/mL | | Baseline; Week 4 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 1) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks | | OG001 | SOF+RBV (Cohort 1) | SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks | | OG002 | LDV/SOF (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy |
| |
| Secondary | Change From Baseline in HCV RNA at Week 5 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | log10 IU/mL | | Baseline; Week 5 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 1) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks | | OG001 | SOF+RBV (Cohort 1) | SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks | | OG002 | LDV/SOF (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy |
| |
| Secondary | Change From Baseline in HCV RNA at Week 6 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | log10 IU/mL | | Baseline; Week 6 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 1) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks | | OG001 | SOF+RBV (Cohort 1) | SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks | | OG002 | LDV/SOF (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy |
| |
| Secondary | Change From Baseline in HCV RNA at Week 8 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | log10 IU/mL | | Baseline; Week 8 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 1) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks | | OG001 | SOF+RBV (Cohort 1) | SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks | | OG002 | LDV/SOF (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy |
| |
| Secondary | Change From Baseline in HCV RNA at Week 10 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | log10 IU/mL | | Baseline; Week 10 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 1) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks | | OG001 | SOF+RBV (Cohort 1) | SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks | | OG002 | LDV/SOF (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy |
| |
| Secondary | Change From Baseline in HCV RNA at Week 12 | | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | log10 IU/mL | | Baseline; Week 12 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF (Cohort 1) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks | | OG001 | SOF+RBV (Cohort 1) | SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks | | OG002 | LDV/SOF (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy |
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| 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 | LDV/SOF (Cohort 1) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks | | OG001 | SOF+RBV (Cohort 1) | SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks | | OG002 | LDV/SOF (Cohort 2) | LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy |
| |