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Darunavir-Cobicistat-Tenofovir alafenamide-Emtricitabine (Symtuza)
Other Names: DRV-COBI-TAF-FTCAll Clinical Trials
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Official Title A Phase 3, Randomized, Active-controlled, Double-blind Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed Dose Combination Regimen Versus a Regimen Consisting of Darunavir/Cobicistat Fixed Dose Combination Coadministered With Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 Infected Subjects
Phase Phase III
ClinicalTrials.gov NCT02431247
Treatments
Tenofovir alafenamide-Emtricitabine
, Tenofovir alafenamide-Emtricitabine
Tradename:DescovyOther Names:TAF-FTCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Darunavir-Cobicistat-Tenofovir alafenamide-Emtricitabine
Darunavir-Cobicistat-Tenofovir alafenamide-Emtricitabine
Tradename:SymtuzaOther Names:DRV-COBI-TAF-FTCClass:Single-Tablet RegimensCategories Treatment-Naive
Funding
IndustryJanssen
References
- Eron JJ, Orkin C, Gallant J, et al. A week-48 randomized phase-3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients. AIDS. 2018;32:1431-1442.
Official Title A Phase 3, Randomized, Active-controlled, Open-label Study to Evaluate the Efficacy, Safety and Tolerability of Switching to a Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) Once-daily Single-tablet Regimen Versus Continuing the Current Regimen Consisting of a Boosted Protease Inhibitor (bPI) Combined With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) in Virologically-suppressed, Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects
Phase Phase III
ClinicalTrials.gov NCT02269917
Treatments
Tenofovir alafenamide-Emtricitabine
, Tenofovir alafenamide-Emtricitabine
Tradename:DescovyOther Names:TAF-FTCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Darunavir-Cobicistat-Tenofovir alafenamide-Emtricitabine
Darunavir-Cobicistat-Tenofovir alafenamide-Emtricitabine
Tradename:SymtuzaOther Names:DRV-COBI-TAF-FTCClass:Single-Tablet RegimensCategories Treatment-ExperiencedSwitch/Simplification
Funding
IndustryJanssen R & D Ireland
References
- Orkin C, Molina JM, Negredo E, et al. Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppressed HIV-1 (EMERALD): a phase 3, randomised, non-inferiority trial. Lancet HIV. 2018;5:e23-e34.
Common TitleGS-299-0102 Industry
Official Title A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide (GS-7340) Single Tablet Regimen Versus Cobicistat-boosted Darunavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in HIV-1 Infected, Antiretroviral Treatment Naive Adults
Phase Phase II
ClinicalTrials.gov NCT01565850
Treatments
Darunavir-Cobicistat
, Darunavir-Cobicistat
Tradename:PrezcobixOther Names:DRV-COBIClass:Protease Inhibitors (PI)Darunavir-Cobicistat-Tenofovir alafenamide-Emtricitabine
Darunavir-Cobicistat-Tenofovir alafenamide-Emtricitabine
Tradename:SymtuzaOther Names:DRV-COBI-TAF-FTCClass:Single-Tablet RegimensCategories PharmacologyTreatment-NaiveAdverse Effects
Funding
IndustryGilead Sciences
References
- Mills A, Crofoot G Jr, McDonald C, et al. Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate in the First Protease Inhibitor-Based Single-Tablet Regimen for Initial HIV-1 Therapy: A Randomized Phase 2 Study. J Acquir Immune Defic Syndr. 2015;69:439-45.
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December 19, 2022
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AMBER - December 18, 2022
EMERALD - December 18, 2022