| Primary | Percentage of Participants With ≥ 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1-3 and 5) | | The Full Analysis Set included all participants who were randomized to Groups 1 or 2, or enrolled in Group 3 and 5, and who took at least 1 dose of any study drug. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Inarigivir Soproxil 50 mg + TAF | Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | | OG001 | Group 2: TAF | Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks. | | OG002 | Group 3: Inarigivir Soproxil 200 mg + TAF | Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | | OG003 | Group 5: Inarigivir Soproxil 400 mg + TAF | Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks. |
| | Units | Counts |
|---|
| Participants | - OG00030
- OG00112
- OG00230
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00023.3(9.9 to 42.3)
- OG00125.0(5.5 to 57.2)
- OG0020(0.0 to 11.6)
- 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 |
|---|
| | | | | | Percentage Difference | -2.0 | | | 2-Sided | 95 | -30.4 | 26.4 | | | The percentage difference (Group 1 - Group 2) & corresponding 2-sided 95% confidence interval (CI) were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline hepatitis B e antigen (HBeAg) status (positive,negative). | | Other | | | |
|
| Primary | Percentage of Participants With ≥ 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Group 4) | | The Full Analysis Set (Group 4) included all participants who were enrolled in Group 4, and who took at least 1 dose of any study drug. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s) | Virally suppressed participants who were receiving commercially available NUC(s) were administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants continued commercially available NUC(s) for 48 weeks. |
| |
| Secondary | Percentage of Participants With ≥ 1 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1 Through 3 and 5) | | Participants in the Full Analysis Set (Group 1-3 and 5) were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Inarigivir Soproxil 50 mg + TAF | Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | | OG001 | Group 2: TAF | Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks. | | OG002 | Group 3: Inarigivir Soproxil 200 mg + TAF | Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | | OG003 | Group 5: Inarigivir Soproxil 400 mg + TAF |
|
| Secondary | Percentage of Participants With ≥ 1 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Group 4) | | Participants in the Full Analysis Set (Group 4) were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s) | Virally suppressed participants who were receiving commercially available NUC(s) were administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants continued commercially available NUC(s) for 48 weeks. |
| |
| Secondary | Percentage of HBeAg-positive Participants Who Achieved HBeAg Loss and Seroconversion at Weeks 12, 24, 36, and 48 (Groups 1 Through 3 and 5) | HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit. HBeAg seroconversion was defined as HBeAb changing from negative or missing at baseline to positive at any postbaseline visit. Participants who had missing information were assumed to have no HBeAg loss and no HBeAg seroconversion. | Participants in the Full Analysis Set (Group 1-3 and 5) with HBeAg-positive status at baseline were analyzed. | Posted | | Number | | percentage of participants | | Baseline, Weeks 12, 24, 36, and 48 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Inarigivir Soproxil 50 mg + TAF | Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | | OG001 | Group 2: TAF | Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks. | | OG002 | Group 3: Inarigivir Soproxil 200 mg + TAF | |
|
| Secondary | Percentage of HBeAg-positive Participants Who Achieved HBeAg Loss and Seroconversion at Weeks 12, 24, 36, and 48 (Group 4) | HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit. HBeAg seroconversion was defined as HBeAb changing from negative or missing at baseline to positive at any postbaseline visit. Participants who had missing information were assumed to have no HBeAg loss and no HBeAg seroconversion. | Participants in the Full Analysis Set (Group 4) with HBeAg-positive status at baseline were analyzed. | Posted | | Number | | percentage of participants | | Baseline, Weeks 12, 24, 36, and 48 | | | | ID | Title | Description |
|---|
| OG000 | Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s) | Virally suppressed participants who were receiving commercially available NUC(s) were administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants continued commercially available NUC(s) for 48 weeks. |
| |
| Secondary | Percentage of Participants Who Achieved HBsAg Loss at Weeks 12, 24, 36, and 48 (Groups 1 Through 3 and 5) | HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit. Participants who had missing information were assumed to have no HBeAg loss. | Participants in the Full Analysis Set (Groups 1 through 3 and 5) were analyzed. | Posted | | Number | | percentage of participants | | Baseline, Weeks 12, 24, 36, and 48 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Inarigivir Soproxil 50 mg + TAF | Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | | OG001 | Group 2: TAF | Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks. | | OG002 | Group 3: Inarigivir Soproxil 200 mg + TAF | Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. |
|
| Secondary | Percentage of Participants Who Achieved HBsAg Loss at Weeks 12, 24, 36, and 48 (Group 4) | HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit. | Participants in the Full Analysis Set (Group 4) were analyzed. | Posted | | Number | | percentage of participants | | Baseline, Weeks 12, 24, 36, and 48 | | | | ID | Title | Description |
|---|
| OG000 | Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s) | Virally suppressed participants who were receiving commercially available NUC(s) were administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants continued commercially available NUC(s) for 48 weeks. |
| |
| Secondary | Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Had HBV DNA ≥ 69 IU/mL (Groups 1 Through 3 and 5) | | Participants with at least 12 weeks and 48 weeks of exposure to inarigivir soproxil and TAF, respectively, and with HBV DNA ≥ 69 IU/mL at Week 48 or Early Discontinuation were analyzed. | Posted | | Count of Participants | | Participants | No | Baseline, Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Inarigivir Soproxil 50 mg + TAF | Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | | OG001 | Group 2: TAF | Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks. | | OG002 | Group 3: Inarigivir Soproxil 200 mg + TAF | Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. |
|
| Secondary | Percentage of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough During 12 Weeks of Inarigivir Soproxil Treatment (Group 4) | Virologic breakthrough was defined as HBV deoxyribonucleic acid (DNA) ≥69 IU/mL for 2 consecutive visits | Participants in the Full Analysis Set (Group 4) were analyzed. | Posted | | Number | | percentage of participants | | Baseline up to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s) | Virally suppressed participants who were receiving commercially available NUC(s) were administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants continued commercially available NUC(s) for 48 weeks. |
| |
| Secondary | Change From Baseline in HBV DNA at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5) | | Participants in the Full Analysis Set (Groups 1-3 and 5) with available data were analyzed. | Posted | | Mean | Standard Deviation | log10 IU/mL | | Baseline, Weeks 12, 16, 24, 36, and 48 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Inarigivir Soproxil 50 mg + TAF | Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | | OG001 | Group 2: TAF | Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks. | | OG002 | Group 3: Inarigivir Soproxil 200 mg + TAF | Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | | OG003 | Group 5: Inarigivir Soproxil 400 mg + TAF |
|
| Secondary | Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5) | | Participants in the Full Analysis Set (Groups 1-3 and 5) with available data were analyzed. | Posted | | Mean | Standard Deviation | log10 IU/mL | | Baseline, Weeks 12, 16, 24, 36, and 48 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Inarigivir Soproxil 50 mg + TAF | Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | | OG001 | Group 2: TAF | Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks. | | OG002 | Group 3: Inarigivir Soproxil 200 mg + TAF | Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | | OG003 | Group 5: Inarigivir Soproxil 400 mg + TAF |
|
| Secondary | Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Group 4) | | Participants in the Full Analysis Set (Group 4) were analyzed. | Posted | | Mean | Standard Deviation | log10 IU/mL | | Baseline, Weeks 12, 16, 24, 36, and 48 | | | | ID | Title | Description |
|---|
| OG000 | Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s) | Virally suppressed participants who were receiving commercially available NUC(s) were administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants continued commercially available NUC(s) for 48 weeks. |
| |