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Elvitegravir-Cobicistat-Tenofovir alafenamide-Emtricitabine (Genvoya)
Other Names: EVG-COBI-TAF-FTCAll Clinical Trials
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Official Title A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults
Phase Phase III
ClinicalTrials.gov NCT01797445
Treatments
Tenofovir alafenamide-Emtricitabine
, Tenofovir alafenamide-Emtricitabine
Tradename:DescovyOther Names:TAF-FTCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Elvitegravir-Cobicistat-Tenofovir DF-Emtricitabine
, Elvitegravir-Cobicistat-Tenofovir DF-Emtricitabine
Tradename:StribildOther Names:EVG-COBI-TDF-FTCClass:Single-Tablet RegimensElvitegravir-Cobicistat-Tenofovir alafenamide-Emtricitabine
Elvitegravir-Cobicistat-Tenofovir alafenamide-Emtricitabine
Tradename:GenvoyaOther Names:EVG-COBI-TAF-FTCClass:Single-Tablet RegimensCategories Resistance/Virological FailureTreatment-Naive
Funding
IndustryGilead Sciences
References
- Margot NA, Kitrinos KM, Fordyce M, McCallister S, Miller MD, Callebaut C. Rare emergence of drug resistance in HIV-1 treatment-naïve patients after 48 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. HIV Clin Trials. 2016;17:78-87.
- Sax PE, Wohl D, Yin MT, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. Lancet. 2015;385:2606-15.
Official Title A Phase 3, Open-Label Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-Suppressed, HIV-1 Positive Subjects
Phase Phase III
ClinicalTrials.gov NCT01815736
Treatments
Tenofovir alafenamide-Emtricitabine
, Tenofovir alafenamide-Emtricitabine
Tradename:DescovyOther Names:TAF-FTCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Elvitegravir-Cobicistat-Tenofovir alafenamide-Emtricitabine
Elvitegravir-Cobicistat-Tenofovir alafenamide-Emtricitabine
Tradename:GenvoyaOther Names:EVG-COBI-TAF-FTCClass:Single-Tablet RegimensCategories PharmacologyTreatment-ExperiencedSwitch/SimplificationAdverse Effects
Funding
IndustryGilead Sciences
References
- Mills A, Arribas JR, Andrade-Villanueva J, et al. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study. Lancet Infect Dis. 2016;16:43-52.
Official Title A Phase 3 Open-label Safety Study of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1 Positive Patients With Mild to Moderate Renal Impairment
Phase Phase III
ClinicalTrials.gov NCT01818596
Treatments
Tenofovir alafenamide-Emtricitabine
, Tenofovir alafenamide-Emtricitabine
Tradename:DescovyOther Names:TAF-FTCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Elvitegravir-Cobicistat-Tenofovir alafenamide-Emtricitabine
Elvitegravir-Cobicistat-Tenofovir alafenamide-Emtricitabine
Tradename:GenvoyaOther Names:EVG-COBI-TAF-FTCClass:Single-Tablet RegimensCategories PharmacologyTreatment-ExperiencedSwitch/SimplificationAdverse Effects
Funding
IndustryGilead Sciences
References
- Post FA, Tebas P, Clarke A, et al. Brief Report: Switching to Tenofovir Alafenamide, Coformulated With Elvitegravir, Cobicistat, and Emtricitabine, in HIV-Infected Adults With Renal Impairment: 96-Week Results From a Single-Arm, Multicenter, Open-Label Phase 3 Study. J Acquir Immune Defic Syndr. 2017;74:180-184.
- Pozniak A, Arribas JR, Gathe J, et al. Switching to Tenofovir Alafenamide, Coformulated With Elvitegravir, Cobicistat, and Emtricitabine, in HIV-Infected Patients With Renal Impairment: 48-Week Results From a Single-Arm, Multicenter, Open-Label Phase 3 Study. J Acquir Immune Defic Syndr. 2016;71:530-7.
Official Title A Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults
Phase Phase III
ClinicalTrials.gov NCT01968551
Treatments
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Tenofovir alafenamide-Emtricitabine
, Tenofovir alafenamide-Emtricitabine
Tradename:DescovyOther Names:TAF-FTCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Elvitegravir-Cobicistat-Tenofovir alafenamide-Emtricitabine
Elvitegravir-Cobicistat-Tenofovir alafenamide-Emtricitabine
Tradename:GenvoyaOther Names:EVG-COBI-TAF-FTCClass:Single-Tablet RegimensCategories Treatment-ExperiencedSwitch/Simplification
Funding
IndustryGilead Sciences
References
- Huhn GD, Tebas P, Gallant J, et al. A Randomized, Open-Label Trial to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Darunavir in Treatment-Experienced HIV-1-Infected Adults. J Acquir Immune Defic Syndr. 2017;74:193-200.
Official Title A Phase 3b Open-label Study of the Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1/Hepatitis B Co-infected Adults
Phase Phase IIIB
ClinicalTrials.gov NCT02071082
Treatments
Tenofovir alafenamide-Emtricitabine
, Tenofovir alafenamide-Emtricitabine
Tradename:DescovyOther Names:TAF-FTCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Elvitegravir-Cobicistat-Tenofovir alafenamide-Emtricitabine
Elvitegravir-Cobicistat-Tenofovir alafenamide-Emtricitabine
Tradename:GenvoyaOther Names:EVG-COBI-TAF-FTCClass:Single-Tablet RegimensCategories PharmacologyTreatment-ExperiencedSwitch/SimplificationAdverse Effects
Funding
IndustryGilead Sciences
References
- Gallant J, Brunetta J, Crofoot G, et al. Brief Report: Efficacy and Safety of Switching to a Single-Tablet Regimen of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1/Hepatitis B-Coinfected Adults. J Acquir Immune Defic Syndr. 2016;73:294-8.
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