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Official Title Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults
Phase Phase III
ClinicalTrials.gov NCT02607930
Treatments
Tenofovir alafenamide-Emtricitabine
, Tenofovir alafenamide-Emtricitabine
Tradename:DescovyOther Names:TAF-FTCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Dolutegravir-Abacavir-Lamivudine
, Dolutegravir-Abacavir-Lamivudine
Tradename:TriumeqOther Names:DTG-ABC-3TCClass:Single-Tablet RegimensBictegravir-Tenofovir alafenamide-Emtricitabine
Bictegravir-Tenofovir alafenamide-Emtricitabine
Tradename:BiktarvyOther Names:BIC-TAF-FTCClass:Single-Tablet RegimensCategories Treatment-Naive
Funding
IndustryGilead Sciences
References
- Gallant J, Lazzarin A, Mills A, et al. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Lancet. 2017;390:2063-72.
- Wohl DA, Yazdanpanah Y, Baumgarten A, et al. Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019;6:e355-e363.
Official Title A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults
Phase Phase III
ClinicalTrials.gov NCT02607956
Treatments
Dolutegravir
, Dolutegravir
Tradename:TivicayOther Names:DTGClass:Integrase Inhibitors (INSTI)Tenofovir alafenamide-Emtricitabine
, Tenofovir alafenamide-Emtricitabine
Tradename:DescovyOther Names:TAF-FTCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Bictegravir-Tenofovir alafenamide-Emtricitabine
Bictegravir-Tenofovir alafenamide-Emtricitabine
Tradename:BiktarvyOther Names:BIC-TAF-FTCClass:Single-Tablet RegimensCategories Treatment-Naive
Funding
IndustryGilead Sciences
References
- Sax PE, Pozniak A, Montes ML, et al. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet. 2017;390:2073-82.
Official Title A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of Bictegravir (GS-9883)/F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed
Phase Phase III
ClinicalTrials.gov NCT02603120
Treatments
Tenofovir alafenamide-Emtricitabine
, Tenofovir alafenamide-Emtricitabine
Tradename:DescovyOther Names:TAF-FTCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Bictegravir-Tenofovir alafenamide-Emtricitabine
Bictegravir-Tenofovir alafenamide-Emtricitabine
Tradename:BiktarvyOther Names:BIC-TAF-FTCClass:Single-Tablet RegimensCategories Treatment-ExperiencedSwitch/Simplification
Funding
IndustryGilead Sciences
References
- Molina JM, Ward D, Brar I, et al. Switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir plus abacavir and lamivudine in virologically suppressed adults with HIV-1: 48 week results of a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. Lancet HIV. 2018;5:e357-e365.
Official Title A Phase 3, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to Bictegravir (GS-9883)/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults
Phase Phase III
ClinicalTrials.gov NCT02603107
Treatments
Tenofovir alafenamide-Emtricitabine
, Tenofovir alafenamide-Emtricitabine
Tradename:DescovyOther Names:TAF-FTCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Bictegravir-Tenofovir alafenamide-Emtricitabine
Bictegravir-Tenofovir alafenamide-Emtricitabine
Tradename:BiktarvyOther Names:BIC-TAF-FTCClass:Single-Tablet RegimensCategories Treatment-ExperiencedSwitch/Simplification
Funding
IndustryGilead Sciences
References
- Daar ES, DeJesus E, Ruane P, et al. Efficacy and safety of switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from boosted protease inhibitor-based regimens in virologically suppressed adults with HIV-1: 48 week results of a randomised, open-label, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2018;5:e347-e356.
Official Title A Phase 3, Randomized, Open Label Study to Evaluate the Safety and Efficacy of Switching to a Fixed Dose Combination (FDC) of Bictegravir (GS-9883)/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) From Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF), Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate (E/C/F/TDF) or Atazanavir + Ritonavir + Emtricitabine/Tenofovir Disoproxil Fumarate (ATV+RTV+FTC/TDF) in Virologically Suppressed HIV-1 Infected Women
Phase Phase III
ClinicalTrials.gov NCT02652624
Treatments
Bictegravir-Tenofovir alafenamide-Emtricitabine
Bictegravir-Tenofovir alafenamide-Emtricitabine
Tradename:BiktarvyOther Names:BIC-TAF-FTCClass:Single-Tablet RegimensCategories Pregnancy/WomenSwitch/Simplification
Funding
IndustryGilead Sciences
References
- Kityo C, Hagins D, Koenig E, et al. Switching to Fixed-Dose Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) in Virologically Suppressed HIV-1 Infected Women: A Randomized, Open-Label, Multicenter, Active-Controlled, Phase 3, Noninferiority Trial. J Acquir Immune Defic Syndr. 2019;82:321-8.
Official Title A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects Who Are Virologically Suppressed
Phase Phase III
ClinicalTrials.gov NCT03110380
Treatments
Bictegravir-Tenofovir alafenamide-Emtricitabine
Bictegravir-Tenofovir alafenamide-Emtricitabine
Tradename:BiktarvyOther Names:BIC-TAF-FTCClass:Single-Tablet RegimensCategories Treatment-ExperiencedSwitch/Simplification
Funding
IndustryGilead Sciences
References
- Sax PE, Rockstroh JK, Luetkemeyer AF, et al. Switching to Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Virologically Suppressed Adults With Human Immunodeficiency Virus. Clin Infect Dis. 2021;73:e485-e493.
Official Title A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants
Phase Phase IIIB
ClinicalTrials.gov NCT03631732
Treatments
Bictegravir-Tenofovir alafenamide-Emtricitabine
Bictegravir-Tenofovir alafenamide-Emtricitabine
Tradename:BiktarvyOther Names:BIC-TAF-FTCClass:Single-Tablet RegimensCategories Treatment-ExperiencedSwitch/Simplification
Funding
IndustryGilead Sciences
References
- Hagins D, Kumar P, Saag M, et al. Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Black Americans With HIV-1: A Randomized Phase 3b, Multicenter, Open-Label Study. J Acquir Immune Defic Syndr. 2021;88:86-95.