| Primary | Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) | SVR24 was defined as HCV RNA < the limit of detection (LOD; < 15 IU/mL) 24 weeks after the last dose of study drug. | Participants in the Safety Analysis Set (participants who were randomized and received at least 1 dose of study drug) with genotype 1 and who had available data were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Post-treatment Week 24 | | | | ID | Title | Description |
|---|
| OG000 | SOF+PEG+RBV 12 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks. | | OG001 | SOF+PEG+RBV 24 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks. | | OG002 | SOF+PEG+RBV 12 Week/Rerandomization Group | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks. | | OG003 | SOF Rerandomization Group | This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks. | | OG004 | SOF+RBV Rerandomization Group | This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks. |
| | Units | Counts |
|---|
| Participants | - OG00052
- OG001109
- OG002155
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00090.4(79.0 to 96.8)
- OG00192.7(86.0 to 96.8)
- OG00291.0(85.3 to 95.0)
- 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 |
|---|
| The analyses was stratified by IL28B (CC versus any T allele) and plasma HCV RNA (< 800,000 IU/mL versus ≥ 800,000 IU/mL). Only participants with genotype 1 were included in the comparison due to the fact that participants with genotype 4 and 6 were only enrolled in the SOF+PEG+RBV 24 weeks group. | Cochran-Mantel-Haenszel | | 0.77 | The p-value is based on the Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factors. | Difference in proportions | -1.4 | | | 2-Sided | 95 | -12.2 | 9.4 | | | The difference in proportions and its 95% confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel (MH) proportions. | No |
|
| Primary | Percentage of Participants Who Experienced Adverse Events | Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event. | | Posted | | Number | | percentage of participants | | Baseline (Day 1) to post-treatment Day 30 | | | | ID | Title | Description |
|---|
| OG000 | SOF+PEG+RBV 12 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks. | | OG001 | SOF+PEG+RBV 24 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks. | | OG002 | SOF+PEG+RBV 12 Week/Rerandomization Group | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks. | | OG003 | SOF Rerandomization Group | This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks. |
|
| Secondary | Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12) | SVR12 was defined as HCV RNA < LOD 12 weeks after the last dose of study drug. | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Post-treatment Week 12 | | | | ID | Title | Description |
|---|
| OG000 | SOF+PEG+RBV 12 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks. | | OG001 | SOF+PEG+RBV 24 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks. | | OG002 | SOF+PEG+RBV 12 Week/Rerandomization Group | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks. | | OG003 | SOF Rerandomization Group | This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks. |
|
| Secondary | Change in HCV RNA at Week 2 | | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | log10 IU/mL | | Baseline (Day 1) to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | SOF+PEG+RBV 12 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks. | | OG001 | SOF+PEG+RBV 24 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks. | | OG002 | SOF+PEG+RBV 12 Week/Rerandomization Group | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks. |
| |
| Secondary | Change in HCV RNA at Week 4 | | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | log10 IU/mL | | Baseline (Day 1) to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | SOF+PEG+RBV 12 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks. | | OG001 | SOF+PEG+RBV 24 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks. | | OG002 | SOF+PEG+RBV 12 Week/Rerandomization Group | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks. |
| |
| Secondary | Change in HCV RNA at Week 8 | | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | log10 IU/mL | | Baseline (Day 1) to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | SOF+PEG+RBV 12 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks. | | OG001 | SOF+PEG+RBV 24 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks. | | OG002 | SOF+PEG+RBV 12 Week/Rerandomization Group | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks. |
| |
| Secondary | Change in HCV RNA at Week 12 | | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | log10 IU/mL | | Baseline (Day 1) to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | SOF+PEG+RBV 12 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks. | | OG001 | SOF+PEG+RBV 24 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks. | | OG002 | SOF+PEG+RBV 12 Week/Rerandomization Group | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks. |
| |
| Secondary | Percentage of Participants With HCV RNA < LOD at Week 2 | | Participants in the Safety Analysis Set with Available data were analyzed. | Posted | | Number | | percentage of participants | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | SOF+PEG+RBV 12 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks. | | OG001 | SOF+PEG+RBV 24 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks. | | OG002 | SOF+PEG+RBV 12 Week/Rerandomization Group | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks. |
| |
| Secondary | Percentage of Participants With HCV RNA Below < LOD at Week 4 | | Participants in the Safety Analysis Set with Available data were analyzed. | Posted | | Number | | percentage of participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | SOF+PEG+RBV 12 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks. | | OG001 | SOF+PEG+RBV 24 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks. | | OG002 | SOF+PEG+RBV 12 Week/Rerandomization Group | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks. |
| |
| Secondary | Percentage of Participants With HCV RNA Below < LOD at Week 8 | | Participants in the Safety Analysis Set with Available data were analyzed. | Posted | | Number | | percentage of participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | SOF+PEG+RBV 12 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks. | | OG001 | SOF+PEG+RBV 24 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks. | | OG002 | SOF+PEG+RBV 12 Week/Rerandomization Group | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks. |
| |
| Secondary | Percentage of Participants With HCV RNA Below < LOD at Week 12 | | Participants in the Safety Analysis Set with Available data were analyzed. | Posted | | Number | | percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | SOF+PEG+RBV 12 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks. | | OG001 | SOF+PEG+RBV 24 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks. | | OG002 | SOF+PEG+RBV 12 Week/Rerandomization Group | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks. |
| |
| Secondary | Percentage of Participants With HCV RNA Below < LOD at Week 24 | | Participants in the Safety Analysis Set with Available data were analyzed. No participants in the SOF+PEG+RBV 12 weeks group were analyzed because they received only 12 weeks of treatment. | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | SOF+PEG+RBV 12 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks. | | OG001 | SOF+PEG+RBV 24 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks. | | OG002 | SOF Rerandomization Group | This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks. | | OG003 | SOF+RBV Rerandomization Group | This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks. |
|
| Secondary | Percentage of Participants With ALT Normalization at Week 12 | ALT normalization was defined as ALT > ULN at baseline and ALT ≤ ULN at Week 12. | Participants in the Safety Analysis Set with ALT > ULN at baseline and with available data were analyzed. | Posted | | Number | | percentage of participants | | Baseline (Day 1) to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | SOF+PEG+RBV 12 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks. | | OG001 | SOF+PEG+RBV 24 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks. | | OG002 | SOF+PEG+RBV 12 Week/Rerandomization Group | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks. |
| |
| Secondary | Percentage of Participants With ALT Normalization at Week 24 | ALT normalization was defined as ALT > ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Week 24. | Participants in the Safety Analysis Set with ALT > ULN at baseline and with available data were analyzed. No participants in the SOF+PEG+RBV 12 weeks group were analyzed because they received only 12 weeks of treatment. | Posted | | Number | | percentage of participants | | Baseline (Day 1) to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | SOF+PEG+RBV 12 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks. | | OG001 | SOF+PEG+RBV 24 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks. | | OG002 | SOF Rerandomization Group | This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks. | | OG003 | SOF+RBV Rerandomization Group | |
|
| Secondary | Percentage of Participants With ALT Normalization at Post-treatment Week 4 | ALT normalization was defined as ALT > ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Post-treatment Week 4. | Participants in the Safety Analysis Set with ALT > ULN at baseline and with available data were analyzed. | Posted | | Number | | percentage of participants | | Baseline (Day 1) to Post-treatment Week 4 | | | | ID | Title | Description |
|---|
| OG000 | SOF+PEG+RBV 12 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks. | | OG001 | SOF+PEG+RBV 24 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks. | | OG002 | SOF+PEG+RBV 12 Week/Rerandomization Group | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks. | | OG003 | SOF Rerandomization Group | This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks. |
|
| Secondary | Percentage of Participants With Virologic Failure During Treatment | Virologic failure was defined as either
- HCV RNA ≥ 15 IU/mL after having previously had HCV RNA < 15 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement (ie, breakthrough);
- > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement (ie, rebound);or
- HCV RNA persistently ≥ 15 IU/mL through 8 weeks of treatment (ie, nonresponse)
Baseline was Day 1 for all groups. | | Posted | | Number | | percentage of participants | | Baseline (Day 1) to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | SOF+PEG+RBV 12 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks. | | OG001 | SOF+PEG+RBV 24 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks. | | OG002 | SOF+PEG+RBV 12 Week/Rerandomization Group | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks. |
|
| Secondary | Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse). | Viral relapse was defined as HCV RNA < 15 IU/mL at end of treatment, confirmed with 2 consecutive values or last available measurement. | Participants in the Safety Analysis Set with available data were analyzed. | Posted | | Number | | percentage of participants | | End of treatment to Post-treatment Week 24 | | | | ID | Title | Description |
|---|
| OG000 | SOF+PEG+RBV 12 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks. | | OG001 | SOF+PEG+RBV 24 Weeks | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks. | | OG002 | SOF+PEG+RBV 12 Week/Rerandomization Group | Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks. | | OG003 | SOF Rerandomization Group | This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks. |
|