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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OAV Alone | Experimental | Participants will continue their prebaseline OAV regimen alone from baseline to Week 48. |
|
| OAV + GS-4774 2 YU | Experimental | Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 2 yeast units (YU) from baseline to Week 20. |
|
| OAV + GS-4774 10 YU | Experimental | Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 10 YU from baseline to Week 20. |
|
| OAV + GS-4774 40 YU | Experimental | Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 40 YU from baseline to Week 20. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-4774 | Biological | Administered as a subcutaneous injection every 4 weeks for a total of 6 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline; Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline; Week 12 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dumont-UCLA Liver Transplant Center | Los Angeles | California | 90095 | United States | ||
| Huntington Medical Research Institutes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27210427 | Derived | Lok AS, Pan CQ, Han SH, Trinh HN, Fessel WJ, Rodell T, Massetto B, Lin L, Gaggar A, Subramanian GM, McHutchison JG, Ferrari C, Lee H, Gordon SC, Gane EJ. Randomized phase II study of GS-4774 as a therapeutic vaccine in virally suppressed patients with chronic hepatitis B. J Hepatol. 2016 Sep;65(3):509-16. doi: 10.1016/j.jhep.2016.05.016. Epub 2016 May 19. |
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213 participants were screened.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | OAV Alone (Group A) | Participants continued to receive their prebaseline oral antiviral (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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| OAV Regimen | Drug | Administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination) |
|
| 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. | Baseline; Week 48 |
| 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. | Week 24 |
| 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. | Week 48 |
| 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. | Week 24 |
| 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. | Week 48 |
| 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. | Baseline; Weeks 12, 24, and 48 |
| Pasadena |
| California |
| 91105 |
| United States |
| Kaiser Permanente | Sacramento | California | 95825 | United States |
| Kaiser Permanente | San Diego | California | 92154 | United States |
| Kaiser Permanente | San Francisco | California | 94118 | United States |
| Silicon Valley Research Institute | San Jose | California | 95128 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| Digestive Disease Associates, PA | Baltimore | Maryland | 21229 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Hospital and Health System | Detroit | Michigan | 48202 | United States |
| St.Louis University | St Louis | Missouri | 63104 | United States |
| Medical Pro-care | Flushing | New York | 11355 | United States |
| North Shore LIJ Health System | Manhasset | New York | 11030 | United States |
| Bon Secours St. Mary's Hospital of Richmond | Newport News | Virginia | 23602 | United States |
| Auckland Clinical Studies | Grafton | 1141 | New Zealand |
| 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 yeast units (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. |
| FG002 | 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. |
| FG003 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set: participants who had a Group A Baseline visit or received at least 1 dose of GS-4774 for Group B, C, and D. For each participant, the average of non-missing doses were calculated and participants were assigned based on the average: Group A = 0 YU, Group B = > 0 and ≤ 6 YU, Group C = > 6 YU and ≤ 25 YU, or Group D = > 25 YU.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | 1 participant from the United States was randomized to OAV + GS-4774 2 YU but received OAV + GS-4774 10 YU. | Count of Participants | Participants | No |
| ||||||||||||||
| Hepatitis B Surface Antigen (HBsAg) (log10 IU/mL) | Mean | Standard Deviation | log10 IU/mL |
| |||||||||||||||
| HBsAg Level | Count of Participants | Participants | No |
| |||||||||||||||
| Hepatitis B Envelope Antigen (HBeAg) Status | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | log10 IU/mL | Baseline; Week 24 |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | log10 IU/mL | Baseline; Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Least Squares Mean | 95% Confidence Interval | log10 IU/mL | Baseline; Week 48 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Participants in the Full Analysis Set with HBsAg Level above 0.066 IU/mL at Baseline were analyzed. | Posted | Number | percentage of participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Participants in the Full Analysis Set with HBsAg Level above 0.066 IU/mL at Baseline were analyzed. | Posted | Number | percentage of participants | Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Participants in the Full Analysis Set with positive HBeAg at baseline were analyzed. | Posted | Number | percentage of participants | Week 24 |
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| 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. | Participants in the Full Analysis Set with positive HBeAg at baseline were analyzed. | Posted | Number | percentage of participants | Week 48 |
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| 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. | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | Baseline; Weeks 12, 24, and 48 |
|
First dose date up to Week 20 plus 28 days
The Safety Analysis Set included participants who have had a Baseline/Day 1 visit for Group A or have received at least one dose of GS-4774 for Group B, C, and D. For each participant, the average of non-missing doses of GS-4774 were calculated. The participant was assigned to Group A if the average was 0, or Group B if the average was greater than 0 and no more than 6 YU, or Group C if the average was greater than 6 YU and no more than 25 YU, or Group D if the average was greater than 25 YU.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 27 | 0 | 27 | 7 | 27 |
| EG001 | 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. | 0 | 50 | 1 | 50 | 39 | 50 |
| EG002 | 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. | 0 | 51 | 1 | 51 | 47 | 51 |
| EG003 | 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. | 0 | 50 | 0 | 50 | 46 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colonic abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| White |
|
| Other |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| American Indian or Alaska Native |
|
| United States |
|
| > 1000 IU/mL |
|
| Negative |
|
| 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. | MMRM | 0.828 | LS Mean Difference | -0.007 | 2-Sided | 95 | -0.067 | 0.053 | Superiority |
| 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. | MMRM | 0.343 | LS Mean Difference | -0.029 | 2-Sided | 95 | -0.089 | 0.031 | Superiority |
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. |
| OG003 | 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. |
|
|
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. |
| OG003 | 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. |
|
|
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. |
| OG003 | 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. |
|
|
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. |
| OG003 | 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. |
|
|
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. |
| OG003 | 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. |
|
|
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. |
| OG003 | 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. |
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| OG003 | 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. |
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