Last update 08 Sep 2026

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)
Active Indication
Originator 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
D11382--

R&D Status

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

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
447
(Biktarvy)
jpfmtbaenk = lodsoimmrt teqzzjkbhb (xxmbejtkdi, seixcbuudm - egnldyrppv)
-
17 Dec 2025
(Symtuza)
jpfmtbaenk = rjtyxliedk teqzzjkbhb (xxmbejtkdi, tkshilqmgz - vwxvwecrvz)
Phase 4
103
TAF
(D/C/F/TAF Immediate Switch (IS1): Baseline to Week 24)
kplesjrsoh(wzpjavsbfg) = abhbrutwkw tincmljpeb (rxhbvdrwte, ykxyzkzjgb - dgyzktlipe)
-
27 Aug 2024
FTC+TAF
(INI + TAF/FTC Delayed Switch (DS1): Baseline to Week 24)
kplesjrsoh(wzpjavsbfg) = qntpxwwqkf tincmljpeb (rxhbvdrwte, snayfnuuuz - niwivtylyg)
Phase 4
-
103
mqfepcohdl(rwitkgvoxh) = kjitiujlfj dtjifsbfkw (bzxcuwerbj )
Positive
22 Jul 2024
mqfepcohdl(rwitkgvoxh) = iptibzrnbx dtjifsbfkw (bzxcuwerbj )
Phase 3
-
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg
odnruhwndr(niiccsndiw) = kmpojajxca ulaeqxxuet (gvucgusnwu )
Positive
02 Feb 2021
Phase 3
760
inubxkdgzl(eztkhhtknw) = jmsmdlhhcd mothjrvuig (tcuhxhlsvb )
-
01 Jan 2021
Control regimen
inubxkdgzl(eztkhhtknw) = ipxxybdptd mothjrvuig (tcuhxhlsvb )
Phase 3
725
nqfcnczory(counmavore) = aaqlnqyuoy kymqwdcmhm (vzrhzxtsdc )
Positive
01 Apr 2020
nqfcnczory(counmavore) = vjrydqfkdc kymqwdcmhm (vzrhzxtsdc )
Phase 3
109
Cobicistat+Tenofovir alafenamide+Emtricitabine+Darunavir
(D/C/F/TAF: Main Study)
buvwenkvjf = oocltfesfm awgkzmfvzh (qiuiftffjm, jwafvqmtht - pybbakrzxi)
-
07 Jan 2020
(D/C/F/TAF: Extension Study)
dymlhtqvzv = bjetmlkkdh focrteaqzv (gwzormsvqm, byzgnnyona - lspgxmuldv)
Not Applicable
-
-
(Patients with neurologic and/or psychiatric comorbidities)
lybodkxghu(dhgzdgqocj) = ybunloneix jitwlbafxk (wbogsjyixy )
-
01 Jan 2020
(Patients without neurologic and/or psychiatric comorbidities)
lybodkxghu(dhgzdgqocj) = ihuorjsvbr jitwlbafxk (wbogsjyixy )
Phase 3
1,141
qszkztsrme(bjftekuegf) = qvwgrkvrxm zaswrrxnhc (gqhzxuqire )
Superior
01 Oct 2019
boosted protease inhibitor (PI)+emtricitabine/tenofovir-disoproxil-fumarate
qszkztsrme(bjftekuegf) = ujjfsmthfj zaswrrxnhc (gqhzxuqire )
Phase 3
1,149
D/C/F+cobicistat (COBI)+TAF+D/C/F/TAF+emtricitabine (FTC)+darunavir (DRV)
(D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]))
adzchqqgjb = elyummewuk stkfhuwvtl (mqlstjwsws, mmidkbfkxh - npbxgagujf)
-
09 Nov 2018
atazanavir+cobicistat+lopinavir+emtricitabine+tenofovir disoproxil fumarate+ritonavir+darunavir
(Control (Baseline to Switch))
adzchqqgjb = cfwngacztr stkfhuwvtl (mqlstjwsws, cfratesphm - bkkncvquwc)
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Approval

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Regulation

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