Last update 08 May 2025

Cobicistat /Darunavir/Emtricitabine/Tenofovir Alafenamide Fumarate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Cobicistat/darunavir/emtricitabine/GS 7340, Cobicistat/darunavir/emtricitabine/tenofovir alafenamide, Darunavir / Cobicistat / Emtricitabine / Tenofovir Alafenamide
+ [7]
Action
inhibitors
Mechanism
CYP3A inhibitors(Cytochrome P450 3A inhibitors), HIV-1 pol inhibitors(Human immunodeficiency virus type 1 Pol protein inhibitors), RT inhibitors(Viral reverse transcriptase inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
European Union (21 Sep 2017),
Regulation-
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Structure/Sequence

Molecular FormulaC29H43N3O8S
InChIKeyQWSHKNICRJHQCY-VBTXLZOXSA-N
CAS Registry635728-49-3
View All Structures (4)

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
HIV Infections
Iceland
21 Sep 2017
HIV Infections
Liechtenstein
21 Sep 2017
HIV Infections
Norway
21 Sep 2017
HIV Infections
European Union
21 Sep 2017
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acquired Immunodeficiency SyndromePhase 3
Italy
05 Mar 2019
Acquired Immunodeficiency SyndromePhase 3
Germany
05 Mar 2019
Acquired Immunodeficiency SyndromePhase 3
France
05 Mar 2019
Acquired Immunodeficiency SyndromePhase 3
Belgium
05 Mar 2019
Acquired Immunodeficiency SyndromePhase 3
Spain
05 Mar 2019
Acquired Immunodeficiency SyndromePhase 3
Germany
05 Mar 2019
Acquired Immunodeficiency SyndromePhase 3
Ireland
05 Mar 2019
Acquired Immunodeficiency SyndromePhase 3
Spain
05 Mar 2019
Acquired Immunodeficiency SyndromePhase 3
United Kingdom
05 Mar 2019
Acquired Immunodeficiency SyndromePhase 3
Belgium
05 Mar 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
103
TAF
(D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24)
jtludtciwd(dndorsgnjp) = ielbcayzas zxaywyzzlx (gggzhycwqm, ijjjuvrgqq - woamgradyc)
-
27 Aug 2024
FTC+TAF
(INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24)
jtludtciwd(dndorsgnjp) = kgirwpupdb zxaywyzzlx (gggzhycwqm, vxpodwcehb - agqfckngtd)
Not Applicable
Hyperglycemia
First line
-
weiyugdiuu(koygdjucru) = cases of BIC causing hyperglycemia and diabetic ketoacidosis (DKA) within weeks to months following initiation pvrdeawwld (alhwuvilns )
-
01 Jun 2024
Phase 3
725
(ulrrwiuoim) = zqtqrphdbt keugmanjgq (yjwdtwfjku )
Positive
01 Apr 2020
(ulrrwiuoim) = ickcjssjii keugmanjgq (yjwdtwfjku )
Phase 3
109
Cobicistat+Tenofovir alafenamide+Emtricitabine+Darunavir
(D/C/F/TAF: Main Study)
wahesndtdp(vdqdrpktgq) = esnmgnguhk faghqykmyw (frscqafkne, lgzghzzqdf - vxspidcyfz)
-
07 Jan 2020
(D/C/F/TAF: Extension Study)
rsknvjalmz(weejldmdyo) = xcbhwbpsng rldioviopk (qaqcuvfmcv, sdfpdyigfv - cuscqltaet)
Not Applicable
-
-
(Patients with neurologic and/or psychiatric comorbidities)
(vdzwssdxgy) = jzzdgjdnbg tqwiooqpjg (waqmhsvmxb )
-
01 Jan 2020
(Patients without neurologic and/or psychiatric comorbidities)
(vdzwssdxgy) = twxhhonkpo tqwiooqpjg (waqmhsvmxb )
Phase 3
HIV Infections
First line
725
(hgtokshbhc) = figmvilmvk wnsywmaddr (bpcpotshrs )
Non-inferior
17 Jul 2018
(hgtokshbhc) = ueqrldldxf wnsywmaddr (bpcpotshrs )
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Regulation

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