| Primary | Mean Change in Serum HBsAg From Baseline to Week 24 | The change from baseline to Week 24 in HBsAg was analyzed using a mixed effect model for repeated measures (MMRM). The model included treatment groups, ALT levels (> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% confidence intervals (CIs). | Participants in the Full Analysis Set (all participants who were randomized and received at least 1 dose of study drug) with available data were analyzed. | Posted | | Least Squares Mean | 95% Confidence Interval | log10 IU/mL | | Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | TDF 48 Weeks | Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG001 | TDF + GS-4774 2 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG002 | TDF + GS-4774 10 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG003 | TDF + GS-4774 40 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). |
| | Units | Counts |
|---|
| Participants | - OG00026
- OG00157
- OG00254
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-0.079(-0.192 to 0.035)
- OG001-0.096(-0.174 to -0.018)
- OG002-0.016(-0.095 to 0.064)
- 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 null hypotheses was that the mean change from baseline in serum HBsAg in each of the TDF + GS-4774 groups was equal to the mean change from baseline in serum HBsAg in the TDF only group. Each null hypothesis was tested against the 2-sided alternative hypothesis that the mean change from baseline in serum HBsAg was not equal between each of the respective GS-4774 dose groups and the TDF only group. | Mixed-Effect Model for Repeated Measures | | 0.805 | | Least Square Mean Difference | -0.017 | | | 2-Sided | 95 | -0.155 | 0.120 | | | | | Superiority | Estimated differences in treatment effects between GS-4774 treatment groups and the TDF only group at Week 24 are presented with the 95% CIs and unadjusted P-values. |
|
| Secondary | Mean Change in HBsAg From Baseline to Week 12 | The change from baseline to Week 12 in HBsAg was analyzed using a MMRM. The model included treatment groups, ALT levels (> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% CIs. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Least Squares Mean | 95% Confidence Interval | log10 IU/mL | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | TDF 48 Weeks | Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG001 | TDF + GS-4774 2 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG002 | TDF + GS-4774 10 YU | |
|
| Secondary | Mean Change in HBsAg From Baseline to Week 48 | The change from baseline to Week 48 in HBsAg was analyzed using a MMRM. The model included treatment groups, ALT levels (> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% CIs. | Participants in the Full Analysis Set with available data were analyzed. | Posted | | Least Squares Mean | 95% Confidence Interval | log10 IU/mL | | Baseline to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF 48 Weeks | Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG001 | TDF + GS-4774 2 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG002 | TDF + GS-4774 10 YU | |
|
| Secondary | Percentage of Participants With HBsAg Loss at Week 24 | HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. | Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used. | Posted | | Number | | percentage of participants | | Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | TDF 48 Weeks | Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG001 | TDF + GS-4774 2 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG002 | TDF + GS-4774 10 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). |
|
| Secondary | Percentage of Participants With HBsAg Loss at Week 48 | HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. | Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used. | Posted | | Number | | percentage of participants | | Baseline to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF 48 Weeks | Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG001 | TDF + GS-4774 2 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG002 | TDF + GS-4774 10 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). |
|
| Secondary | Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24 | HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBsAg loss and seroconversion was defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBsAg loss within the targeted time window. | Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used. | Posted | | Number | | percentage of participants | | Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | TDF 48 Weeks | Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG001 | TDF + GS-4774 2 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG002 | TDF + GS-4774 10 YU |
|
| Secondary | Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48 | HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBsAg loss and seroconversion was defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBsAg loss within the targeted time window. | Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used. | Posted | | Number | | percentage of participants | | Baseline to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF 48 Weeks | Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG001 | TDF + GS-4774 2 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG002 | TDF + GS-4774 10 YU |
|
| Secondary | Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 12 | HBsAg with a ≥ 0.5 or ≥ 1.0 log10 IU/mL decline was defined as ≥ 0.5 or ≥ 1.0 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window. | Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used. | Posted | | Number | | percentage of participants | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | TDF 48 Weeks | Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG001 | TDF + GS-4774 2 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG002 | TDF + GS-4774 10 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). |
|
| Secondary | Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 24 | HBsAg with a ≥ 0.5 or ≥ 1.0 log10 IU/mL decline was defined as ≥ 0.5 or ≥ 1.0 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window. | Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used. | Posted | | Number | | percentage of participants | | Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | TDF 48 Weeks | Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG001 | TDF + GS-4774 2 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG002 | TDF + GS-4774 10 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). |
|
| Secondary | Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 48 | HBsAg with a ≥ 0.5 or ≥ 1.0 log10 IU/mL decline was defined as ≥ 0.5 or ≥ 1.0 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window. | Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used. | Posted | | Number | | percentage of participants | | Baseline to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF 48 Weeks | Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG001 | TDF + GS-4774 2 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG002 | TDF + GS-4774 10 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). |
|
| Secondary | Percentage of Participants With HBeAg Loss at Week 24 | HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. | Participants in the Full Analysis Set with HBeAg positive at baseline were analyzed. The missing equals failure approach was used. | Posted | | Number | | percentage of participants | | Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | TDF 48 Weeks | Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG001 | TDF + GS-4774 2 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG002 | TDF + GS-4774 10 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). |
|
| Secondary | Percentage of Participants With HBeAg Loss at Week 48 | HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. | Participants in the Full Analysis Set with HBeAg positive at baseline were analyzed. The missing equals failure approach was used. | Posted | | Number | | percentage of participants | | Baseline to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF 48 Weeks | Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG001 | TDF + GS-4774 2 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG002 | TDF + GS-4774 10 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). |
|
| Secondary | Composite Endpoint Measuring the Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 24 | HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBeAg loss and seroconversion was defined as qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBeAg loss within the targeted time window. | Participants in the Full Analysis Set with HBeAg positive at baseline were analyzed. The missing equals failure approach was used. | Posted | | Number | | percentage of participants | | Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | TDF 48 Weeks | Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG001 | TDF + GS-4774 2 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG002 | TDF + GS-4774 10 YU |
|
| Secondary | Composite Endpoint Measuring the Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 48 | HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBeAg loss and seroconversion was defined as qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBeAg loss within the targeted time window. | Participants in the Full Analysis Set with HBeAg positive at baseline were analyzed. The missing equals failure approach was used. | Posted | | Number | | percentage of participants | | Baseline to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF 48 Weeks | Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG001 | TDF + GS-4774 2 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG002 | TDF + GS-4774 10 YU |
|
| Secondary | Percentage of Participants With HBV DNA < Lower Limit of Quantification (LLOQ) at Week 24 | The LLOQ was defined as 20 IU/mL. | Participants in the Full Analysis Set with available data were analyzed. The missing equals excluded approach was used. | Posted | | Number | | percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | TDF 48 Weeks | Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG001 | TDF + GS-4774 2 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG002 | TDF + GS-4774 10 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). |
|
| Secondary | Percentage of Participants With HBV DNA < LLOQ at Week 48 | The LLOQ was defined as 20 IU/mL. | Participants in the Full Analysis Set with available data were analyzed. The missing equals excluded approach was used. | Posted | | Number | | percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF 48 Weeks | Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG001 | TDF + GS-4774 2 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG002 | TDF + GS-4774 10 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). |
|
| Secondary | Percentage of Participants Experiencing Virologic Breakthrough at Week 24 | Virologic breakthrough was defined as HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL, or having had ≥ 1.0 log10 increase in HBV DNA from nadir. Two consecutive visits that met the definition were required for a participant to be classified as having had virologic breakthrough. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | TDF 48 Weeks | Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG001 | TDF + GS-4774 2 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG002 | TDF + GS-4774 10 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). |
|
| Secondary | Percentage of Participants Experiencing Virologic Breakthrough at Week 48 | Virologic breakthrough was defined as HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL, or a ≥ 1.0 log10 increase in HBV DNA from nadir. Two consecutive visits that met the definition were required for a participant to be classified as having had virologic breakthrough. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | Baseline to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF 48 Weeks | Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG001 | TDF + GS-4774 2 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG002 | TDF + GS-4774 10 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). |
|
| Secondary | Number of Participants With Drug-Resistance Mutations at Week 48 or at the Last Visit Available | Resistance surveillance analysis was conducted at Week 48 or Early Discontinuation (with at least 24 weeks of exposure to TDF) for any participants who met inclusion criteria (HBV DNA ≥ 69 IU/mL). Drug-resistant mutation status was assessed using HBV polymerase/ reverse transcriptase (pol/RT) population sequencing. | Participants with at least 24 weeks of exposure to TDF and with HBV DNA ≥ 69 IU/mL at Week 48 or Early Discontinuation were analyzed. | Posted | | Count of Participants | | Participants | No | Baseline to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | TDF 48 Weeks | Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG001 | TDF + GS-4774 2 YU | Participants received TDF 300 mg tablet orally once daily for 48 weeks + GS-4774 2 yeast units (YU) administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP). | | OG002 | TDF + GS-4774 10 YU | |
|