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 (Alliance)
HIV-1/HBV Co-Infection
About this trial
This is an interventional treatment trial for HIV-1/HBV Co-Infection
Eligibility Criteria
Key Inclusion Criteria:
HIV-1 co-infection:
- Must be HIV antiretroviral treatment naive with plasma HIV-1 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)
- Screening genotype report must show sensitivity to emtricitabine (FTC) and tenofovir (TFV). This report will be provided by Gilead Sciences. Alternatively, if genotype results from a local laboratory obtained ≤ 90 days prior to screening visit date show sensitivity to these drugs, this genotype will be acceptable to fulfill this inclusion criterion in the event that the genotype obtained at screening is not yet available and all other inclusion/exclusion criteria have been confirmed
HBV co-infection:
- Must be HBV treatment naive (defined as < 12 weeks of oral antiviral treatment)
- Screening HBV DNA ≥ 2000 IU/mL
- Hepatic transaminases (aspartate aminotransferase (AST) and ALT) ≤ 10 x upper limit of normal (ULN)
- Total bilirubin ≤ 2.5 x ULN
Key Exclusion Criteria:
- 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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Midway Immunology & Research
- Triple O Research Institute, P.A.
- Be Well Medical Center
- The Crofoot Research Center, INC (DBA: Gordon E. Crofoot MD PA)
- Beijing Ditan Hospital Capital Medical University
- Beijing YouAn Hospital, Capital Medical University
- Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
- The First Hospital of Changsha
- Chengdu Public Health Clinical Center
- Guangzhou Eighth people's Hospital
- 1st Affiliated Hospital of Zhejiang University
- The Second Hospital of Nanjing
- Shanghai Public Health Clinical Center
- Third People's Hospital Of Shenzhen
- Instituto Dominicano de Estudios Virologicos (IDEV)
- Hôpital de la Croix Rousse
- Evaggelismos General Hospital of Athens
- Korgialenio-Benakio Greek Red Cross General Hospital
- Laiko General Hospital
- AHEPA University Hospital of Thessaloniki
- Prince of Wales Hospital
- Queen Elizabeth Hospital (QEH)
- Princess Margaret Hospital
- National Hospital Organization Nagoya Medical Center
- University of the Ryukyus Hospital
- Osaka City General Hospital
- National Hospital Organization Osaka National Hospital
- The Jikei University Hospital
- Juntendo University Hospital
- Center Hospital of the National Center for Global Health and Medicine
- Yokohama City University Hospital
- Pusan National University Hospital
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Hospital Raja Permaisuri Bainun
- Hospital Raja Perempuan Zainab II
- Queen Elizabeth Hospital
- University Malaya Medical Centre
- Hospital Kuala Lumpur
- Hospital Sultanah Nur Zahirah
- Sarawak General Hospital
- Hospital Pulau Pinang
- Sungai Buloh Hospital
- Hope Clinical Research
- Hospital Clinic de Barcelona
- Hospital General Universitario Santa Lucia
- Fundacion Jimenez Diaz
- Hospital Universitario 12 de Octubre
- Hospital Universitario La Paz
- Hospital de Canarias
- Hospital General Universitario de Valencia
- CHUVI - Hospital Universitario Alvaro Cunqueiro
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Kaohsiung Veterans General Hospital
- Far Eastern Memorial Hospital
- Taichung Veterans General Hospital
- National Cheng Kung University Hospital
- Taipei Veterans General Hospital
- National Taiwan University Hospital
- Taipei City Hospital Linsen, Chinese Medicine and Kunming Branch
- Ministry of Health and Welfare Taoyuan General Hospital
- Thai Red Cross AIDS Research Centre (HIV-NAT)
- Faculty of Medicine Ramathibodi Hospital, Mahidol University
- Siriraj Hospital
- Faculty of Medicine, Chiang Mai University
- Chiang Rai Reginal Hospital
- Srinagarind Hospital
- Bamrasnaradura Infectious Diseases Institute
- Istanbul University Cerrahpasa Medical Faculty
- Marmara University Pendik Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Experimental
B/F/TAF
DTG+F/TDF
Open-label Extension Phase: B/F/TAF
B/F/TAF + placebo to match DTG + placebo to match F/TDF for 96 weeks.
DTG + F/TDF + placebo to match B/F/TAF for 96 weeks.
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.