Chronic HBV Infection
Conditions
Keywords
Hepatitis B (HBV), Oral antiviral (OAV), GS-4774
Brief summary
The primary objectives of this study are to evaluate the safety and efficacy of GS-4774 in adults with chronic hepatitis B (CHB) viral infection who have been virally suppressed with an oral antiviral (OAV) medication.
Interventions
BIOLOGICALGS-4774
Administered as a subcutaneous injection every 4 weeks for a total of 6 doses
DRUGOAV Regimen
Administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures * Currently taking an approved HBV oral antiviral medication * Documented evidence of chronic HBV infection (eg, HBsAg positive for more than 6 months) * Virally-suppressed (HBV DNA below the lower limit of quantification (LLOQ) for ≥ 1 year) Key
Exclusion criteria
* Cirrhosis * Inadequate liver function * Co-infection with hepatitic C virus (HCV), HIV or hepatitic D virus (HDV) * Evidence of hepatocellular carcinoma * Significant cardiovascular, pulmonary, or neurological disease * Females who are pregnant or may wish to become pregnant during the study * Received solid organ or bone marrow transplant * Use of another investigational agents within 3 months of screening * Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance * History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease ulcerative colitis, autoimmune disease * Known hypersensitivity to study drug, metabolites or formulation excipients * Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc). Participants under evaluation for possible malignancy are not eligible. Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in HBsAg at Week 24 | Baseline; 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 included treatment, HBsAg baseline level (≤ 1000 IU/mL or \> 1000 IU/mL), HBeAg baseline status (positive or negative), visit, and treatment-by-visit interaction as fixed effects and visit as a repeated measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in HBsAg at Week 48 | Baseline; Week 48 | The change from baseline to Week 48 in HBsAg was analyzed using a MMRM. The model included included treatment, HBsAg baseline level (≤ 1000 IU/mL or \> 1000 IU/mL), HBeAg baseline status (positive or negative), visit, and treatment-by-visit interaction as fixed effects and visit as a repeated measure. |
| Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24 | Week 24 | HBsAg loss was defined as HBsAg level decreasing from \>0.066 IU/mL at baseline to ≤ 0.066 IU/mL at any postbaseline visit. HBsAb seroconversion was defined as HBsAb level increasing from \< 12 mIU/mL at baseline to ≥ 12 mIU/mL at any postbaseline visit. |
| Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48 | Week 48 | HBsAg loss was defined as HBsAg level decreasing from \>0.066 IU/mL at baseline to ≤ 0.066 IU/mL at any postbaseline visit. HBsAb seroconversion was defined as HBsAb level increasing from \< 12 mIU/mL at baseline to ≥ 12 mIU/mL at any postbaseline visit. |
| Change From Baseline in HBsAg at Week 12 | Baseline; Week 12 | The change from baseline to Week 12 in HBsAg was analyzed using a MMRM. The model included included treatment, HBsAg baseline level (≤ 1000 IU/mL or \> 1000 IU/mL), HBeAg baseline status (positive or negative), visit, and treatment-by-visit interaction as fixed effects and visit as a repeated measure. |
| Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 48 | Week 48 | HBeAg loss was defined as a qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit. HBeAb seroconversion was defined as a qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit. |
| Percentage of Participants With a 1-log Decline in HBsAg by Weeks 12, 24, and 48 | Baseline; Weeks 12, 24, and 48 | HBsAg 1-log decline was defined as ≥ 1 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window. |
| Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 24 | Week 24 | HBeAg loss was defined as a qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit. HBeAb seroconversion was defined as a qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit. |
Countries
New Zealand, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in United States and New Zealand. The first participant was screened on 13 September 2013. The last study visit occurred on 03 March 2015.
Pre-assignment details
213 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| OAV Alone (Group A) Participants continued to receive their prebaseline OAV regimen alone from baseline to Week 48. Prebaseline OAV regimen may have included the following: tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination. | 27 |
| OAV + GS-4774 2 YU (Group B) Participants continued to receive their prebaseline OAV regimen from baseline to Week 48 and received GS-4774 2 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Prebaseline OAV regimen may have included the following: tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination. | 50 |
| OAV + GS-4774 10 YU (Group C) Participants continued to receive their prebaseline OAV regimen from baseline to Week 48 and received GS-4774 10 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Prebaseline OAV regimen may have included the following: tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination. | 51 |
| OAV + GS-4774 40 YU (Group D) Participants continued to receive their prebaseline OAV regimen from baseline to Week 48 and received GS-4774 40 YU administered via subcutaneous injection every 4 weeks for 20 weeks (total of 6 doses). Prebaseline OAV regimen may have included the following: tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination. | 50 |
| Total | 178 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | OAV Alone (Group A) | OAV + GS-4774 2 YU (Group B) | OAV + GS-4774 10 YU (Group C) | OAV + GS-4774 40 YU (Group D) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 10.9 | 50 years STANDARD_DEVIATION 9 | 47 years STANDARD_DEVIATION 10 | 47 years STANDARD_DEVIATION 11.1 | 47 years STANDARD_DEVIATION 10.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 48 Participants | 50 Participants | 49 Participants | 174 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| HBsAg Level ≤ 1000 IU/mL | 13 Participants | 18 Participants | 21 Participants | 21 Participants | 73 Participants |
| HBsAg Level > 1000 IU/mL | 14 Participants | 32 Participants | 30 Participants | 29 Participants | 105 Participants |
| Hepatitis B Envelope Antigen (HBeAg) Status Negative | 20 Participants | 37 Participants | 39 Participants | 38 Participants | 134 Participants |
| Hepatitis B Envelope Antigen (HBeAg) Status Positive | 7 Participants | 13 Participants | 12 Participants | 12 Participants | 44 Participants |
| Hepatitis B Surface Antigen (HBsAg) (log10 IU/mL) | 2.5 log10 IU/mL STANDARD_DEVIATION 1.46 | 3.1 log10 IU/mL STANDARD_DEVIATION 0.72 | 3.0 log10 IU/mL STANDARD_DEVIATION 1.02 | 3.0 log10 IU/mL STANDARD_DEVIATION 0.86 | 2.9 log10 IU/mL STANDARD_DEVIATION 0.99 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 21 Participants | 40 Participants | 41 Participants | 34 Participants | 136 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 1 Participants | 2 Participants | 5 Participants | 8 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 3 Participants | 4 Participants | 2 Participants | 10 Participants |
| Race/Ethnicity, Customized White | 5 Participants | 6 Participants | 3 Participants | 7 Participants | 21 Participants |
| Region of Enrollment New Zealand | 4 Participants | 6 Participants | 2 Participants | 7 Participants | 19 Participants |
| Region of Enrollment United States | 23 Participants | 44 Participants | 49 Participants | 43 Participants | 159 Participants |
| Sex: Female, Male Female | 7 Participants | 16 Participants | 14 Participants | 19 Participants | 56 Participants |
| Sex: Female, Male Male | 20 Participants | 34 Participants | 37 Participants | 31 Participants | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 50 | 0 / 51 | 0 / 50 |
| other Total, other adverse events | 7 / 27 | 39 / 50 | 47 / 51 | 46 / 50 |
| serious Total, serious adverse events | 0 / 27 | 1 / 50 | 1 / 51 | 0 / 50 |
Outcome results
Primary
Change From Baseline in HBsAg at 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 included treatment, HBsAg baseline level (≤ 1000 IU/mL or \> 1000 IU/mL), HBeAg baseline status (positive or negative), visit, and treatment-by-visit interaction as fixed effects and visit as a repeated measure.
Time frame: Baseline; Week 24
Population: Participants in the Full Analysis Set (participants who were randomized and had a Baseline/Day 1 visit for Treatment Group A or have received at least 1 dose of GS-4774 for Treatment Group B, C, and D) with available data were analyzed. Participants were analyzed according to the randomized treatment assignment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| OAV Alone (Group A) | Change From Baseline in HBsAg at Week 24 | -0.019 log10 IU/mL |
| OAV + GS-4774 2 YU (Group B) | Change From Baseline in HBsAg at Week 24 | -0.020 log10 IU/mL |
| OAV + GS-4774 10 YU (Group C) | Change From Baseline in HBsAg at Week 24 | -0.026 log10 IU/mL |
| OAV + GS-4774 40 YU (Group D) | Change From Baseline in HBsAg at Week 24 | -0.048 log10 IU/mL |
Comparison: Each null hypothesis was tested against the 2-sided alternative that the mean change from baseline in serum HBsAg (log10 IU/mL) titers in the respective GS-4774 group was not equal to that of the OAV group. Estimated least squares means (LSM) of treatment effects and estimated differences in treatment effects between GS-4774 treatment groups and the OAV group at Week 24 were calculated with 95% confidence intervals (CIs) and unadjusted p-values.p-value: 0.34395% CI: [-0.089, 0.031]MMRM
Comparison: Each null hypothesis was tested against the 2-sided alternative that the mean change from baseline in serum HBsAg (log10 IU/mL) titers in the respective GS-4774 group was not equal to that of the OAV group. Estimated least squares means (LSM) of treatment effects and estimated differences in treatment effects between GS-4774 treatment groups and the OAV group at Week 24 were calculated with 95% confidence intervals (CIs) and unadjusted p-values.p-value: 0.97695% CI: [-0.061, 0.059]MMRM
Comparison: Each null hypothesis was tested against the 2-sided alternative that the mean change from baseline in serum HBsAg (log10 IU/mL) titers in the respective GS-4774 group was not equal to that of the OAV group. Estimated least squares means (LSM) of treatment effects and estimated differences in treatment effects between GS-4774 treatment groups and the OAV group at Week 24 were calculated with 95% confidence intervals (CIs) and unadjusted p-values.p-value: 0.82895% CI: [-0.067, 0.053]MMRM
Secondary
Change From Baseline in HBsAg at Week 12
The change from baseline to Week 12 in HBsAg was analyzed using a MMRM. The model included included treatment, HBsAg baseline level (≤ 1000 IU/mL or \> 1000 IU/mL), HBeAg baseline status (positive or negative), visit, and treatment-by-visit interaction as fixed effects and visit as a repeated measure.
Time frame: Baseline; Week 12
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| OAV Alone (Group A) | Change From Baseline in HBsAg at Week 12 | -0.004 log10 IU/mL |
| OAV + GS-4774 2 YU (Group B) | Change From Baseline in HBsAg at Week 12 | -0.016 log10 IU/mL |
| OAV + GS-4774 10 YU (Group C) | Change From Baseline in HBsAg at Week 12 | -0.017 log10 IU/mL |
| OAV + GS-4774 40 YU (Group D) | Change From Baseline in HBsAg at Week 12 | -0.028 log10 IU/mL |
Secondary
Change From Baseline in HBsAg at Week 48
The change from baseline to Week 48 in HBsAg was analyzed using a MMRM. The model included included treatment, HBsAg baseline level (≤ 1000 IU/mL or \> 1000 IU/mL), HBeAg baseline status (positive or negative), visit, and treatment-by-visit interaction as fixed effects and visit as a repeated measure.
Time frame: Baseline; Week 48
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| OAV Alone (Group A) | Change From Baseline in HBsAg at Week 48 | -0.043 log10 IU/mL |
| OAV + GS-4774 2 YU (Group B) | Change From Baseline in HBsAg at Week 48 | -0.055 log10 IU/mL |
| OAV + GS-4774 10 YU (Group C) | Change From Baseline in HBsAg at Week 48 | -0.051 log10 IU/mL |
| OAV + GS-4774 40 YU (Group D) | Change From Baseline in HBsAg at Week 48 | -0.166 log10 IU/mL |
Secondary
Percentage of Participants With a 1-log Decline in HBsAg by Weeks 12, 24, and 48
HBsAg 1-log decline was defined as ≥ 1 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window.
Time frame: Baseline; Weeks 12, 24, and 48
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OAV Alone (Group A) | Percentage of Participants With a 1-log Decline in HBsAg by Weeks 12, 24, and 48 | ≥ 1 log10 IU/mL Decline at Week 12 | 0 percentage of participants |
| OAV Alone (Group A) | Percentage of Participants With a 1-log Decline in HBsAg by Weeks 12, 24, and 48 | ≥ 1 log10 IU/mL Decline at Week 48 | 0 percentage of participants |
| OAV Alone (Group A) | Percentage of Participants With a 1-log Decline in HBsAg by Weeks 12, 24, and 48 | ≥ 1 log10 IU/mL Decline at Week 24 | 0 percentage of participants |
| OAV + GS-4774 2 YU (Group B) | Percentage of Participants With a 1-log Decline in HBsAg by Weeks 12, 24, and 48 | ≥ 1 log10 IU/mL Decline at Week 12 | 0 percentage of participants |
| OAV + GS-4774 2 YU (Group B) | Percentage of Participants With a 1-log Decline in HBsAg by Weeks 12, 24, and 48 | ≥ 1 log10 IU/mL Decline at Week 48 | 0 percentage of participants |
| OAV + GS-4774 2 YU (Group B) | Percentage of Participants With a 1-log Decline in HBsAg by Weeks 12, 24, and 48 | ≥ 1 log10 IU/mL Decline at Week 24 | 0 percentage of participants |
| OAV + GS-4774 10 YU (Group C) | Percentage of Participants With a 1-log Decline in HBsAg by Weeks 12, 24, and 48 | ≥ 1 log10 IU/mL Decline at Week 24 | 0 percentage of participants |
| OAV + GS-4774 10 YU (Group C) | Percentage of Participants With a 1-log Decline in HBsAg by Weeks 12, 24, and 48 | ≥ 1 log10 IU/mL Decline at Week 12 | 0 percentage of participants |
| OAV + GS-4774 10 YU (Group C) | Percentage of Participants With a 1-log Decline in HBsAg by Weeks 12, 24, and 48 | ≥ 1 log10 IU/mL Decline at Week 48 | 0 percentage of participants |
| OAV + GS-4774 40 YU (Group D) | Percentage of Participants With a 1-log Decline in HBsAg by Weeks 12, 24, and 48 | ≥ 1 log10 IU/mL Decline at Week 12 | 0 percentage of participants |
| OAV + GS-4774 40 YU (Group D) | Percentage of Participants With a 1-log Decline in HBsAg by Weeks 12, 24, and 48 | ≥ 1 log10 IU/mL Decline at Week 48 | 2.0 percentage of participants |
| OAV + GS-4774 40 YU (Group D) | Percentage of Participants With a 1-log Decline in HBsAg by Weeks 12, 24, and 48 | ≥ 1 log10 IU/mL Decline at Week 24 | 0 percentage of participants |
Secondary
Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 24
HBeAg loss was defined as a qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit. HBeAb seroconversion was defined as a qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit.
Time frame: Week 24
Population: Participants in the Full Analysis Set with positive HBeAg at baseline were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OAV Alone (Group A) | Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 24 | HBeAg Loss | 0 percentage of participants |
| OAV Alone (Group A) | Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 24 | HBeAg Loss and Seroconversion | 0 percentage of participants |
| OAV + GS-4774 2 YU (Group B) | Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 24 | HBeAg Loss and Seroconversion | 0 percentage of participants |
| OAV + GS-4774 2 YU (Group B) | Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 24 | HBeAg Loss | 0 percentage of participants |
| OAV + GS-4774 10 YU (Group C) | Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 24 | HBeAg Loss | 25.0 percentage of participants |
| OAV + GS-4774 10 YU (Group C) | Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 24 | HBeAg Loss and Seroconversion | 25.0 percentage of participants |
| OAV + GS-4774 40 YU (Group D) | Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 24 | HBeAg Loss | 0 percentage of participants |
| OAV + GS-4774 40 YU (Group D) | Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 24 | HBeAg Loss and Seroconversion | 0 percentage of participants |
Secondary
Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 48
HBeAg loss was defined as a qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit. HBeAb seroconversion was defined as a qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit.
Time frame: Week 48
Population: Participants in the Full Analysis Set with positive HBeAg at baseline were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OAV Alone (Group A) | Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 48 | HBeAg Loss | 0 percentage of participants |
| OAV Alone (Group A) | Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 48 | HBeAg Loss and Seroconversion | 0 percentage of participants |
| OAV + GS-4774 2 YU (Group B) | Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 48 | HBeAg Loss and Seroconversion | 7.7 percentage of participants |
| OAV + GS-4774 2 YU (Group B) | Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 48 | HBeAg Loss | 7.7 percentage of participants |
| OAV + GS-4774 10 YU (Group C) | Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 48 | HBeAg Loss | 33.3 percentage of participants |
| OAV + GS-4774 10 YU (Group C) | Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 48 | HBeAg Loss and Seroconversion | 25.0 percentage of participants |
| OAV + GS-4774 40 YU (Group D) | Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 48 | HBeAg Loss | 0 percentage of participants |
| OAV + GS-4774 40 YU (Group D) | Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 48 | HBeAg Loss and Seroconversion | 0 percentage of participants |
Secondary
Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24
HBsAg loss was defined as HBsAg level decreasing from \>0.066 IU/mL at baseline to ≤ 0.066 IU/mL at any postbaseline visit. HBsAb seroconversion was defined as HBsAb level increasing from \< 12 mIU/mL at baseline to ≥ 12 mIU/mL at any postbaseline visit.
Time frame: Week 24
Population: Participants in the Full Analysis Set with HBsAg Level above 0.066 IU/mL at Baseline were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OAV Alone (Group A) | Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24 | HBsAg Loss | 0 percentage of participants |
| OAV Alone (Group A) | Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24 | HBsAg Loss and Seroconversion | 0 percentage of participants |
| OAV + GS-4774 2 YU (Group B) | Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24 | HBsAg Loss and Seroconversion | 0 percentage of participants |
| OAV + GS-4774 2 YU (Group B) | Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24 | HBsAg Loss | 0 percentage of participants |
| OAV + GS-4774 10 YU (Group C) | Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24 | HBsAg Loss | 0 percentage of participants |
| OAV + GS-4774 10 YU (Group C) | Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24 | HBsAg Loss and Seroconversion | 0 percentage of participants |
| OAV + GS-4774 40 YU (Group D) | Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24 | HBsAg Loss | 0 percentage of participants |
| OAV + GS-4774 40 YU (Group D) | Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24 | HBsAg Loss and Seroconversion | 0 percentage of participants |
Secondary
Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48
HBsAg loss was defined as HBsAg level decreasing from \>0.066 IU/mL at baseline to ≤ 0.066 IU/mL at any postbaseline visit. HBsAb seroconversion was defined as HBsAb level increasing from \< 12 mIU/mL at baseline to ≥ 12 mIU/mL at any postbaseline visit.
Time frame: Week 48
Population: Participants in the Full Analysis Set with HBsAg Level above 0.066 IU/mL at Baseline were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OAV Alone (Group A) | Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48 | HBsAg Loss and Seroconversion | 0 percentage of participants |
| OAV Alone (Group A) | Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48 | HBsAg Loss | 0 percentage of participants |
| OAV + GS-4774 2 YU (Group B) | Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48 | HBsAg Loss | 0 percentage of participants |
| OAV + GS-4774 2 YU (Group B) | Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48 | HBsAg Loss and Seroconversion | 0 percentage of participants |
| OAV + GS-4774 10 YU (Group C) | Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48 | HBsAg Loss | 0 percentage of participants |
| OAV + GS-4774 10 YU (Group C) | Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48 | HBsAg Loss and Seroconversion | 0 percentage of participants |
| OAV + GS-4774 40 YU (Group D) | Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48 | HBsAg Loss and Seroconversion | 0 percentage of participants |
| OAV + GS-4774 40 YU (Group D) | Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48 | HBsAg Loss | 0 percentage of participants |