Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults
NCT ID: NCT03547908
Last Updated: 2025-03-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
244 participants
INTERVENTIONAL
2018-05-30
2024-03-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Blinded Phase: B/F/TAF
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.
B/F/TAF
50/200/25 mg B/F/TAF FDC tablet administered orally once daily, without regard to food
Placebo to match DTG
Tablet administered orally once daily, without regard to food
Placebo to match F/TDF
Tablet administered orally once daily, without regard to food
Blinded Phase: DTG+F/TDF
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.
DTG
50 mg tablet administered orally once daily, without regard to food
F/TDF
200/300 mg tablet administered orally once daily, without regard to food
Placebo to match B/F/TAF
Tablet administered orally once daily, without regard to food
Open-label Extension Phase: B/F/TAF from B/F/TAF
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.
B/F/TAF
50/200/25 mg B/F/TAF FDC tablet administered orally once daily, without regard to food
Open-label Extension Phase: B/F/TAF from DTG+F/TDF
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.
B/F/TAF
50/200/25 mg B/F/TAF FDC tablet administered orally once daily, without regard to food
Interventions
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B/F/TAF
50/200/25 mg B/F/TAF FDC tablet administered orally once daily, without regard to food
Placebo to match DTG
Tablet administered orally once daily, without regard to food
Placebo to match F/TDF
Tablet administered orally once daily, without regard to food
DTG
50 mg tablet administered orally once daily, without regard to food
F/TDF
200/300 mg tablet administered orally once daily, without regard to food
Placebo to match B/F/TAF
Tablet administered orally once daily, without regard to food
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be HIV antiretroviral treatment naive with plasma HIV-1 ribonucleic acid (RNA) ≥ 500 copies/mL at screening
* ≤ 10 days of prior therapy with any antiretroviral agent, including lamivudine and entecavir, following a diagnosis of HIV-1 infection (except the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening)
Exclusion Criteria
* Must be hepatitis B virus (HBV) treatment naive (defined as \< 12 weeks of oral antiviral treatment)
* Screening HBV deoxyribonucleic acid (DNA) ≥ 2000 IU/mL
* Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT)) ≤ 10 x upper limit of normal (ULN)
* Total bilirubin ≤ 2.5 x ULN
* Hepatitis C virus (HCV) antibody positive and HCV RNA detectable
* Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) or with Child-Pugh-Turcotte (CPT) C impairment
* Current alcohol or substance use judged by the Investigator to potentially interfere with study compliance
* Active, serious infections (other than HIV-1 and HBV infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1
* Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Midway Immunology & Research
Ft. Pierce, Florida, United States
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States
Be Well Medical Center
Berkley, Michigan, United States
The Crofoot Research Center, INC (DBA: Gordon E. Crofoot MD PA)
Houston, Texas, United States
Beijing Ditan Hospital Capital Medical University
Beijing, , China
Beijing YouAn Hospital, Capital Medical University
Beijing, , China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, , China
The First Hospital of Changsha
Changsha, , China
Chengdu Public Health Clinical Center
Chengdu, , China
Guangzhou Eighth people's Hospital
Guangzhou, , China
1st Affiliated Hospital of Zhejiang University
Hangzhou, , China
The Second Hospital of Nanjing
Nanjing, , China
Shanghai Public Health Clinical Center
Shanghai, , China
Third People's Hospital Of Shenzhen
Shenzhen, , China
Instituto Dominicano de Estudios Virologicos (IDEV)
Santo Domingo, , Dominican Republic
Hôpital de la Croix Rousse
Lyon, , France
Evaggelismos General Hospital of Athens
Athens, , Greece
Korgialenio-Benakio Greek Red Cross General Hospital
Athens, , Greece
Laiko General Hospital
Athens, , Greece
AHEPA University Hospital of Thessaloniki
Thessaloniki, , 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, , Japan
University of the Ryukyus Hospital
Okinawa, , Japan
Osaka City General Hospital
Osaka, , Japan
National Hospital Organization Osaka National Hospital
Osaka, , Japan
The Jikei University Hospital
Tokyo, , Japan
Juntendo University Hospital
Tokyo, , Japan
Center Hospital of the National Center for Global Health and Medicine
Tokyo, , Japan
Yokohama City University Hospital
Yokohama, , Japan
Hospital Raja Permaisuri Bainun
Ipoh, , Malaysia
Hospital Raja Perempuan Zainab II
Kota Bharu, , Malaysia
Queen Elizabeth Hospital
Kota Kinabalu, , Malaysia
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, , Malaysia
Hospital Sultanah Nur Zahirah
Kuala Terengganu, , Malaysia
Sarawak General Hospital
Kuching, , Malaysia
Hospital Pulau Pinang
Pulau Pinang, , Malaysia
Sungai Buloh Hospital
Sungai Buloh, , Malaysia
Hope Clinical Research
San Juan, , Puerto Rico
Pusan National University Hospital
Busan, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital General Universitario Santa Lucia
Cartagena, , Spain
Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital de Canarias
Santa Cruz de Tenerife, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
CHUVI - Hospital Universitario Alvaro Cunqueiro
Vigo, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei City Hospital Linsen, Chinese Medicine and Kunming Branch
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Ministry of Health and Welfare Taoyuan General Hospital
Taoyuan, , Taiwan
Thai Red Cross AIDS Research Centre (HIV-NAT)
Bangkok, , Thailand
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Faculty of Medicine, Chiang Mai University
Chiang Mai, , Thailand
Chiang Rai Reginal Hospital
Chiang Rai, , Thailand
Srinagarind Hospital
Khon Kaen, , Thailand
Bamrasnaradura Infectious Diseases Institute
Nonthaburi, , Thailand
Istanbul University Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Marmara University Pendik Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan: Statistical Analysis Plan - Interim Analysis
Document Type: Statistical Analysis Plan: Statistical Analysis Plan - Final Analysis
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2018-000926-79
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-380-4458
Identifier Type: -
Identifier Source: org_study_id
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