| 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 received at least 1 dose of study drug. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Posttreatment Week 12 | | | | ID | Title | Description |
|---|
| OG000 | SOF/VEL+RBV 12 Weeks (GT1) | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 (GT1) HCV infection | | OG001 | SOF/VEL+RBV 12 Weeks (GT2) | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 2 (GT2) HCV infection | | OG002 | SOF/VEL+RBV 24 Weeks (GT1) | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 (GT1) HCV infection | | OG003 | SOF/VEL+RBV 24 Weeks (GT2) | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 2 (GT2) HCV infection |
| | Units | Counts |
|---|
| Participants | - OG00047
- OG00110
- OG00248
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00085.1(71.7 to 93.8)
- OG00170.0(34.8 to 93.3)
- OG00297.9(88.9 to 99.9)
- OG003
|
|
| | 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 |
|---|
| | Binomial test | P-value is obtained from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL+RBV 12 Weeks (GT1) over the performance goal of 50%. | <0.001 | | | | | | | | | | | | | | Superiority | | | | | Binomial test | |
|
| Primary | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | | | Posted | | Number | | percentage of participants | | Up to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | SOF/VEL+RBV 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or 2 HCV infection | | OG001 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or 2 HCV infection |
| |
| 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/VEL+RBV 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection | | OG001 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| |
| 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 | SOF/VEL+RBV 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection | | OG001 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| |
| 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 | SOF/VEL+RBV 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection | | OG001 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| |
| 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 | SOF/VEL+RBV 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection | | OG001 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| |
| 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 | SOF/VEL+RBV 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection | | OG001 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| |
| 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 | SOF/VEL+RBV 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection | | OG001 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| |
| 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 | SOF/VEL+RBV 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection | | OG001 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| |
| 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 | SOF/VEL+RBV 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection | | OG001 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| |
| 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 | SOF/VEL+RBV 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection | | OG001 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| |
| 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 | SOF/VEL+RBV 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection | | OG001 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| |
| 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 | SOF/VEL+RBV 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection | | OG001 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| |
| Secondary | Percentage of Participants With HCV RNA < LLOQ at Week 16 | | Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| | |
| Secondary | Percentage of Participants With HCV RNA < LLOQ at Week 20 | | Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 20 | | | | ID | Title | Description |
|---|
| OG000 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| | |
| Secondary | Percentage of Participants With HCV RNA < LLOQ at Week 24 | | Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| | |
| 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 | SOF/VEL+RBV 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection | | OG001 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| |
| 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 | SOF/VEL+RBV 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection | | OG001 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| |
| 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 | SOF/VEL+RBV 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection | | OG001 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| |
| 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 | SOF/VEL+RBV 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection | | OG001 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| |
| 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 | SOF/VEL+RBV 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection | | OG001 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| |
| 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 | SOF/VEL+RBV 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection | | OG001 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| |
| 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 | SOF/VEL+RBV 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection | | OG001 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| |
| 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 | SOF/VEL+RBV 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection | | OG001 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| |
| 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 | SOF/VEL+RBV 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection | | OG001 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| |
| Secondary | Change From Baseline in HCV RNA at Week 16 | | Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed. | Posted | | Mean | Standard Deviation | log10 IU/mL | | Baseline; Week 16 | | | | ID | Title | Description |
|---|
| OG000 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| | |
| Secondary | Change From Baseline in HCV RNA at Week 20 | | Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed. | Posted | | Mean | Standard Deviation | log10 IU/mL | | Baseline; Week 20 | | | | ID | Title | Description |
|---|
| OG000 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| | |
| Secondary | Change From Baseline in HCV RNA at Week 24 | | Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed. | Posted | | Mean | Standard Deviation | log10 IU/mL | | Baseline; Week 24 | | | | ID | Title | Description |
|---|
| OG000 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| | |
| 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/VEL+RBV 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 12 weeks in participants with genotype 1 or genotype 2 HCV infection | | OG001 | SOF/VEL+RBV 24 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily + RBV capsule (600, 800, or 1000 mg daily based on weight) for 24 weeks in participants with genotype 1 or genotype 2 HCV infection |
| |