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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000926-79 | EudraCT Number |
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The primary objective of this study is to evaluate the efficacy of fixed-dose combination (FDC) of bictegravir/emtricitabine/ tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + emtricitabine/tenofovir disoproxil fumarate (F/TDF) in treatment-naïve and HIV-1 and hepatitis B virus (HBV) adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blinded Phase: B/F/TAF | Experimental | Participants who are HIV-1 and HBV co-infected and treatment-naïve will receive Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination (FDC) tablet in addition to placebo to match (PTM) dolutegravir (DTG) tablet and PTM FDC emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet for 96 weeks. |
|
| Blinded Phase: DTG+F/TDF | Active Comparator | Participants who are HIV-1 and HBV co-infected and treatment-naïve will receive DTG and FDC F/TDF in addition to PTM B/F/TAF for 96 weeks. |
|
| Open-label Extension Phase: B/F/TAF from B/F/TAF | Experimental | After Week 96, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants in a country where B/F/TAF FDC is not available will be given the option to receive B/F/TAF FDC in an open-label extension phase for up to 48 weeks, or until the product becomes accessible through an access program, or until Gilead elects to discontinue the study in that country, whichever occurs first. |
|
| Open-label Extension Phase: B/F/TAF from DTG+F/TDF | Experimental | After Week 96, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants in a country where B/F/TAF FDC is not available will be given the option to receive B/F/TAF FDC in an open-label extension phase for up to 48 weeks, or until the product becomes accessible through an access program, or until Gilead elects to discontinue the study in that country, whichever occurs first. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B/F/TAF | Drug | 50/200/25 mg B/F/TAF FDC tablet administered orally once daily, without regard to food |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm (Co-primary Endpoint) | The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded-off. | Week 48 |
| Percentage of Participants With Plasma Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48 as Defined by Missing = Failure Approach (Co-primary Endpoint) | This outcome measure was analyzed using a Missing = Failure approach. In this approach, all missing data were treated as HBV DNA ≥ 29 IU/mL. Percentages were rounded-off. | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm | The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which was defined as a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded-off. |
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Key Inclusion Criteria:
Human immunodeficiency virus type 1 (HIV-1) co-infection:
HBV co-infection:
Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT)) ≤ 10 x upper limit of normal (ULN)
Total bilirubin ≤ 2.5 x ULN
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 |
|---|---|---|---|---|---|---|
| Midway Immunology & Research | Ft. Pierce | Florida | 34982 | United States | ||
| Triple O Research Institute, P.A. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Avihingsanon, A. 2022. Week 48 results of a Phase 3 randomized controlled trial of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) vs dolutegravir + emtricitabine/tenofovir Disoproxil Fumarate (DTG+F/TDF) as initial treatment in HIV/HBV-coinfected adults (ALLIANCE). AIDS, 29 July 29-2 August 2022, Montréal, Québec, Canada. | ||
| 37494942 | Background | Avihingsanon A, Lu H, Leong CL, Hung CC, Koenig E, Kiertiburanakul S, Lee MP, Supparatpinyo K, Zhang F, Rahman S, D'Antoni ML, Wang H, Hindman JT, Martin H, Baeten JM, Li T; ALLIANCE Study Team. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, emtricitabine, and tenofovir disoproxil fumarate for initial treatment of HIV-1 and hepatitis B coinfection (ALLIANCE): a double-blind, multicentre, randomised controlled, phase 3 non-inferiority trial. Lancet HIV. 2023 Oct;10(10):e640-e652. doi: 10.1016/S2352-3018(23)00151-0. Epub 2023 Jul 23. | |
| 40788226 |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
Not provided
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment
18 months after study completion
A secured external environment with username, password, and RSA code.
381 participants were screened.
Participants were enrolled at study sites in the North American, Asian, and European regions.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Blinded Phase: B/F/TAF | Participants who were HIV-1 and HBV co-infected and treatment-naïve received Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants also received placebo to match (PTM) dolutegravir (DTG) tablet and PTM FDC emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Blinded Phase |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 6, 2018 | Jan 11, 2023 |
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|
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| Placebo to match DTG | Drug | Tablet administered orally once daily, without regard to food |
|
| Placebo to match F/TDF | Drug | Tablet administered orally once daily, without regard to food |
|
| DTG | Drug | 50 mg tablet administered orally once daily, without regard to food |
|
| F/TDF | Drug | 200/300 mg tablet administered orally once daily, without regard to food |
|
|
| Placebo to match B/F/TAF | Drug | Tablet administered orally once daily, without regard to food |
|
| Week 96 |
| Change From Baseline in CD4 Cell Count at Week 48 | Baseline, Week 48 |
| Change From Baseline in CD4 Cell Count at Week 96 | Baseline, Week 96 |
| Change From Baseline in Percentage of CD4 Cells at Week 48 | Baseline, Week 48 |
| Change From Baseline in Percentage of CD4 Cells at Week 96 | Baseline, Week 96 |
| Percentage of Participants With Plasma HBV DNA < 29 IU/mL at Week 96 | This outcome measure was analyzed using a Missing = Failure approach. In this approach, all missing data were treated as HBV DNA ≥ 29 IU/mL. Percentages were rounded-off. | Week 96 |
| Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 by American Association for the Study of Liver Diseases (AASLD) Criteria | ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given post baseline visit. The upper limit of the normal range (ULN) for ALT using the 2018 AASLD normal range was ≤ 25 U/L for females and ≤ 35 U/L for males. The Missing = Failure approach was used for this analysis. Percentages were rounded off. | Week 48 |
| Percentage of Participants With ALT Normalization at Week 96 | ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given post baseline visit. The upper limit of the normal range (ULN) for ALT using the 2018 AASLD normal range was ≤ 25 U/L for females and ≤ 35 U/L for males. The Missing = Failure approach was used for this analysis. Percentages were rounded-off. | Week 96 |
| Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48 | HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a post baseline visit. HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative or missing at baseline to positive at a post baseline visit. The Missing = Failure approach was used for this analysis. Percentages were rounded-off. | Week 48 |
| Percentage of Participants With HBsAg Loss at Week 96 | HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a post baseline visit. HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative or missing at baseline to positive at a post baseline visit. The Missing = Failure approach was used for this analysis. Percentages were rounded-off. | Week 96 |
| West Palm Beach |
| Florida |
| 33401 |
| United States |
| Be Well Medical Center | Berkley | Michigan | 48072 | United States |
| The Crofoot Research Center, INC (DBA: Gordon E. Crofoot MD PA) | Houston | Texas | 77098 | United States |
| Beijing Ditan Hospital Capital Medical University | Beijing | 100015 | China |
| Beijing YouAn Hospital, Capital Medical University | Beijing | 100069 | China |
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | Beijing | 100730 | China |
| The First Hospital of Changsha | Changsha | 410005 | China |
| Chengdu Public Health Clinical Center | Chengdu | 610066 | China |
| Guangzhou Eighth people's Hospital | Guangzhou | 510060 | China |
| 1st Affiliated Hospital of Zhejiang University | Hangzhou | China |
| The Second Hospital of Nanjing | Nanjing | China |
| Shanghai Public Health Clinical Center | Shanghai | 201058 | China |
| Third People's Hospital Of Shenzhen | Shenzhen | 518040 | China |
| Instituto Dominicano de Estudios Virologicos (IDEV) | Santo Domingo | 10103 | Dominican Republic |
| Hôpital de la Croix Rousse | Lyon | 69004 | France |
| Evaggelismos General Hospital of Athens | Athens | 10676 | Greece |
| Korgialenio-Benakio Greek Red Cross General Hospital | Athens | 11526 | Greece |
| Laiko General Hospital | Athens | 11527 | Greece |
| AHEPA University Hospital of Thessaloniki | Thessaloniki | 546 36 | Greece |
| Prince of Wales Hospital | Hong Kong | Hong Kong |
| Queen Elizabeth Hospital (QEH) | Hong Kong | Hong Kong |
| Princess Margaret Hospital | Kowloon | Hong Kong |
| National Hospital Organization Nagoya Medical Center | Aichi | 460-0001 | Japan |
| University of the Ryukyus Hospital | Okinawa | 903-0215 | Japan |
| Osaka City General Hospital | Osaka | 534-0021 | Japan |
| National Hospital Organization Osaka National Hospital | Osaka | 540-0006 | Japan |
| The Jikei University Hospital | Tokyo | 105-8471 | Japan |
| Juntendo University Hospital | Tokyo | 113-8431 | Japan |
| Center Hospital of the National Center for Global Health and Medicine | Tokyo | 162-8655 | Japan |
| Yokohama City University Hospital | Yokohama | 236-0004 | Japan |
| Hospital Raja Permaisuri Bainun | Ipoh | 31350 | Malaysia |
| Hospital Raja Perempuan Zainab II | Kota Bharu | 15580 | Malaysia |
| Queen Elizabeth Hospital | Kota Kinabalu | 88200 | Malaysia |
| University Malaya Medical Centre | Kuala Lumpur | 50603 | Malaysia |
| Hospital Kuala Lumpur | Kuala Lumpur | 53000 | Malaysia |
| Hospital Sultanah Nur Zahirah | Kuala Terengganu | 20400 | Malaysia |
| Sarawak General Hospital | Kuching | 93586 | Malaysia |
| Hospital Pulau Pinang | Pulau Pinang | 10450 | Malaysia |
| Sungai Buloh Hospital | Sungai Buloh | 47000 | Malaysia |
| Hope Clinical Research | San Juan | 00909 | Puerto Rico |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | 06591 | South Korea |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital General Universitario Santa Lucia | Cartagena | Spain |
| Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital de Canarias | Santa Cruz de Tenerife | 38320 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| CHUVI - Hospital Universitario Alvaro Cunqueiro | Vigo | 36312 | Spain |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | 80756 | Taiwan |
| Kaohsiung Veterans General Hospital | Kaohsiung City | 81362 | Taiwan |
| Far Eastern Memorial Hospital | New Taipei City | 22060 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 70403 | Taiwan |
| National Taiwan University Hospital | Taipei | 10048 | Taiwan |
| Taipei City Hospital Linsen, Chinese Medicine and Kunming Branch | Taipei | 10844 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Ministry of Health and Welfare Taoyuan General Hospital | Taoyuan City | 33004 | Taiwan |
| Thai Red Cross AIDS Research Centre (HIV-NAT) | Bangkok | 10330 | Thailand |
| Faculty of Medicine Ramathibodi Hospital, Mahidol University | Bangkok | 10400 | Thailand |
| Siriraj Hospital | Bangkok | 10700 | Thailand |
| Faculty of Medicine, Chiang Mai University | Chiang Mai | 50200 | Thailand |
| Chiang Rai Reginal Hospital | Chiang Rai | 57000 | Thailand |
| Srinagarind Hospital | Khon Kaen | 40002 | Thailand |
| Bamrasnaradura Infectious Diseases Institute | Nonthaburi | 11000 | Thailand |
| Istanbul University Cerrahpasa Medical Faculty | Istanbul | 34098 | Turkey (Türkiye) |
| Marmara University Pendik Training and Research Hospital | Istanbul | 81190 | Turkey (Türkiye) |
| Background |
| D'Antoni ML, Andreatta K, Chang S, Cox S, Hindman JT, Avihingsanon A, Martin H, VanderVeen LA, Callebaut C. Brief Report: HIV-1 Resistance Analysis of Participants With HIV-1 and Hepatitis B Initiating Therapy With Bictegravir/Emtricitabine/Tenofovir Alafenamide or Dolutegravir Plus Emtricitabine/Tenofovir Disoproxil Fumarate: A Subanalysis of ALLIANCE Data. J Acquir Immune Defic Syndr. 2024 Aug 1;96(4):380-384. doi: 10.1097/QAI.0000000000003434. Epub 2024 Jun 21. |
| Background | Avihingsanon A, Lu H, Leong CL, Hung C-C, Kiertiburanakul S, Lee M-P, Supparatpinyo K, Zhang F, Hindman JT, Wang H, Liu H and Li T. Factors Associated with HBV Response to B/F/TAF vs. DTG + F/TDF at W96 in People with HIV-1 and HBV. CROI, March 3-6, 2024. |
| Background | Avihingsanon A, Lu H, Leong C, Hung C, Koenig E, Kiertiburanakul S, et al. Week-96 results of ALLIANCE, a Phase 3, randomized, double-blind study comparing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus dolutegravir + emtricitabine/tenofovir disoproxil fumarate (DTG+F/TDF) in treatment-naive people with both HIV-1 and hepatitis B. 12th International AIDS Society Conference on HIV Science 2023, 23-26 July. |
| Background | D'Antoni M, Andreatta K, Cox S, Chang S, Hindman J, Martin H, et al. HIV-1 resistance analysis of treatment-naive participants with HIV-1 and hepatitis B coinfection receiving bictegravir/emtricitabine/tenofovir alafenamide or dolutegravir + emtricitabine/tenofovir disoproxil fumarate. European Meeting on HIV and Hepatitis 2023, 7-9 June, Rome, Italy. |
| Background | Avihingsanon A, Leong C, Hung C, Koenig E, Lee M, Supparatpinyo K, et al. Predictors of hepatitis B treatment response in people with HIV-1/HBV coinfection. Conference on Retroviruses and Opportunistic Infections (CROI) 2023, 19-22 February; Seattle, Washington. |
| Background | Avihingsanon A, Lu H, Leong C, Hung C, Koenig E, Kiertiburanakul S, et al. Week 48 results of a Phase 3 randomized controlled trial of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) vs dolutegravir + emtricitabine/tenofovir disoproxil fumarate (DTG+F/TDF) as initial treatment in HIV/HBV coinfected adults (ALLIANCE). AIDS (Conference) 2022, 29 July 2 August; Montréal, Québec, Canada. |
| 40857111 | Derived | D'Antoni ML, Boopathy AV, Andreatta K, Chang S, Hindman JT, Avihingsanon A, VanderVeen LA, Callebaut C. Brief Report: HIV-1 Resistance Analysis of Participants With HIV-1 and Hepatitis B Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide or Dolutegravir Plus Emtricitabine/Tenofovir Disoproxil Fumarate Through the Open-Label Extension of the ALLIANCE Study. J Acquir Immune Defic Syndr. 2025 Dec 1;100(4):342-346. doi: 10.1097/QAI.0000000000003749. |
| FG001 | Blinded Phase: DTG + F/TDF | Participants who were HIV-1 and HBV co-infected and treatment-naïve received DTG (50 mg) tablet + F/TDF (200/300 mg) FDC tablet, orally, once daily without regard to food for 96 weeks. Participants also received PTM FDC B/F/TAF tablet, orally, once daily without regard to food for 96 weeks. |
| FG002 | Open-Label Extension Phase: B/F/TAF From B/F/TAF | After Week 96, participants continued their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF FDC was demonstrated for the HIV-1 and HBV coinfected participants, in a country where B/F/TAF FDC was not available, participants were given the option to receive 48 weeks of open-label B/F/TAF until the product became accessible through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first. |
| FG003 | Open-Label Extension Phase: B/F/TAF From DTG+F/TDF | After Week 96, participants continued their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF FDC was demonstrated for the HIV-1 and HBV coinfected participants, in a country where B/F/TAF FDC was not available, participants were given the option to receive 48 weeks of open-label B/F/TAF until the product became accessible through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open-label Extension Phase |
|
|
The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Blinded Phase: B/F/TAF | Participants who were HIV-1 and HBV coinfected and treatment-naïve received Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants also received placebo to match (PTM) dolutegravir (DTG) tablet and PTM FDC emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks. |
| BG001 | Blinded Phase: DTG + F/TDF | Participants who were HIV-1 and HBV coinfected and treatment-naïve received DTG (50 mg) tablet + F/TDF (200/300 mg) FDC tablet, orally, once daily without regard to food for 96 weeks. Participants also received PTM FDC B/F/TAF tablet, orally, once daily without regard to food for 96 weeks. |
| BG002 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| CD4 Cell Count | Mean | Standard Deviation | cells/µL |
| |||||||||||||||||
| CD4 Percentage | Mean | Standard Deviation | percentage of CD4 cells |
|
| 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 | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm (Co-primary Endpoint) | The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded-off. | The Full Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, and had at least 1 postbaseline HIV-1 RNA or HBV DNA result while on study drug. | Posted | Number | percentage of participants | Week 48 |
|
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| Primary | Percentage of Participants With Plasma Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48 as Defined by Missing = Failure Approach (Co-primary Endpoint) | This outcome measure was analyzed using a Missing = Failure approach. In this approach, all missing data were treated as HBV DNA ≥ 29 IU/mL. Percentages were rounded-off. | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | Week 48 |
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| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm | The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which was defined as a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded-off. | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | Week 96 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CD4 Cell Count at Week 48 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | cells/µL | Baseline, Week 48 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CD4 Cell Count at Week 96 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | cells/uL | Baseline, Week 96 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Percentage of CD4 Cells at Week 48 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | percentage of CD4 cells | Baseline, Week 48 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Percentage of CD4 Cells at Week 96 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | percentage of CD4 cells | Baseline, Week 96 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Plasma HBV DNA < 29 IU/mL at Week 96 | This outcome measure was analyzed using a Missing = Failure approach. In this approach, all missing data were treated as HBV DNA ≥ 29 IU/mL. Percentages were rounded-off. | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | Week 96 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 by American Association for the Study of Liver Diseases (AASLD) Criteria | ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given post baseline visit. The upper limit of the normal range (ULN) for ALT using the 2018 AASLD normal range was ≤ 25 U/L for females and ≤ 35 U/L for males. The Missing = Failure approach was used for this analysis. Percentages were rounded off. | Participants in the Full Analysis Set with Baseline ALT > ULN were analyzed. | Posted | Number | percentage of participants | Week 48 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With ALT Normalization at Week 96 | ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given post baseline visit. The upper limit of the normal range (ULN) for ALT using the 2018 AASLD normal range was ≤ 25 U/L for females and ≤ 35 U/L for males. The Missing = Failure approach was used for this analysis. Percentages were rounded-off. | Participants in the Full Analysis Set with Baseline ALT > ULN were analyzed. | Posted | Number | percentage of participants | Week 96 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48 | HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a post baseline visit. HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative or missing at baseline to positive at a post baseline visit. The Missing = Failure approach was used for this analysis. Percentages were rounded-off. | The Serologically Evaluable Full Analysis Set for HBsAg loss/seroconversion included all participants who were in the Full Analysis Set and with HBsAg positive and HBsAb negative or missing at baseline. | Posted | Number | percentage of participants | Week 48 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HBsAg Loss at Week 96 | HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a post baseline visit. HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative or missing at baseline to positive at a post baseline visit. The Missing = Failure approach was used for this analysis. Percentages were rounded-off. | Participants in the Serologically Evaluable Full Analysis Set were analyzed. | Posted | Number | percentage of participants | Week 96 |
|
Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study.
Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blinded Phase: B/F/TAF | Participants who were HIV-1 and HBV coinfected and treatment-naïve received Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants also received placebo to match (PTM) dolutegravir (DTG) tablet and PTM emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks. | 2 | 122 | 17 | 121 | 102 | 121 |
| EG001 | Blinded Phase: DTG + F/TDF | Participants who were HIV-1 and HBV coinfected and treatment-naïve received DTG (50 mg) tablet + F/TDF (200/300 mg) FDC tablet, orally, once daily without regard to food for 96 weeks. Participants also received PTM B/F/TAF tablet, orally, once daily without regard to food for 96 weeks. | 1 | 122 | 16 | 122 | 98 | 122 |
| EG002 | Open-Label Extension Phase: B/F/TAF From B/F/TAF | After Week 96, participants continued their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF FDC was demonstrated for the HIV-1 and HBV coinfected participants, in a country where B/F/TAF FDC was not available, participants were given the option to receive open-label B/F/TAF until the product became accessible through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first. | 1 | 95 | 4 | 95 | 42 | 95 |
| EG003 | Open-Label Extension Phase: B/F/TAF From DTG+F/TDF | After Week 96, participants continued their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF FDC was demonstrated for the HIV-1 and HBV coinfected participants, in a country where B/F/TAF FDC was not available, participants were given the option to receive open-label B/F/TAF until the product became accessible through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first. | 0 | 89 | 2 | 89 | 40 | 89 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedRA 26.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedRA 26.1 | Systematic Assessment |
| |
| Rhegmatogenous retinal detachment | Eye disorders | MedRA 26.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedRA 26.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedRA 26.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedRA 26.1 | Systematic Assessment |
| |
| Haemorrhoids thrombosed | Gastrointestinal disorders | MedRA 26.1 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedRA 26.1 | Systematic Assessment |
| |
| Lumbar hernia | Gastrointestinal disorders | MedRA 26.1 | Systematic Assessment |
| |
| Death, not otherwise specified | General disorders | MedRA 26.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedRA 26.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedRA 26.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedRA 26.1 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedRA 26.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedRA 26.1 | Systematic Assessment |
| |
| Cytomegalovirus chorioretinitis | Infections and infestations | MedRA 26.1 | Systematic Assessment |
| |
| Dengue haemorrhagic fever | Infections and infestations | MedRA 26.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedRA 26.1 | Systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedRA 26.1 | Systematic Assessment |
| |
| Hepatic amoebiasis | Infections and infestations | MedRA 26.1 | Systematic Assessment |
| |
| Meningitis cryptococcal | Infections and infestations | MedRA 26.1 | Systematic Assessment |
| |
| Mycotoxicosis | Infections and infestations | MedRA 26.1 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedRA 26.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedRA 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedRA 26.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedRA 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedRA 26.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedRA 26.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedRA 26.1 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRA 26.1 | Systematic Assessment |
| |
| Glottis carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRA 26.1 | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRA 26.1 | Systematic Assessment |
| |
| Laryngeal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRA 26.1 | Systematic Assessment |
| |
| Sinonasal papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRA 26.1 | Systematic Assessment |
| |
| Alcoholic seizure | Nervous system disorders | MedRA 26.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedRA 26.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedRA 26.1 | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedRA 26.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedRA 26.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedRA 26.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedRA 26.1 | Systematic Assessment |
| |
| Acute hepatitis C | Infections and infestations | MedRA 26.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedRA 26.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedRA 26.1 | Systematic Assessment |
| |
| Latent syphilis | Infections and infestations | MedRA 26.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedRA 26.1 | Systematic Assessment |
| |
| Secondary syphilis | Infections and infestations | MedRA 26.1 | Systematic Assessment |
| |
| Syphilis | Infections and infestations | MedRA 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedRA 26.1 | Systematic Assessment |
| |
| Vaccination complication | Injury, poisoning and procedural complications | MedRA 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedRA 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedRA 26.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedRA 26.1 | Systematic Assessment |
| |
| Abnormal weight gain | Metabolism and nutrition disorders | MedRA 26.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedRA 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedRA 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedRA 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedRA 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedRA 26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedRA 26.1 | 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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Statistical Analysis Plan - Interim Analysis | Mar 31, 2022 | Jan 11, 2023 | SAP_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Statistical Analysis Plan - Final Analysis | Apr 9, 2024 | Jan 10, 2025 | SAP_002.pdf |
| ID | Term |
|---|---|
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Death |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| White |
|
| Black |
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| Other |
|
| China |
|
| Malaysia |
|
| Taiwan |
|
| Dominican Republic |
|
| Turkey |
|
| Japan |
|
| Spain |
|
| Hong Kong |
|
| United States |
|
| South Korea |
|
| Puerto Rico |
|
| Cochran-Mantel-Haenszel | The p-value was calculated from Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL). | 0.2113 | Superiority |
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