Last update 04 Mar 2025

Bictegravir/Emtricitabine/Tenofovir Alafenamide Fumarate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
B/F/TAF, BIC/FTC/TAF, Bictegravir Sodium/Emtricitabine/Tenofovir Alafenamide Fumarate
+ [13]
Mechanism
HIV-1 integrase inhibitors(HIV integrase inhibitors), RT inhibitors(Reverse transcriptase inhibitors)
Active Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
US (07 Feb 2018),
RegulationOrphan Drug (US), Overseas New Drugs Urgently Needed in Clinical Settings (CN)
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Structure/Sequence

Molecular FormulaC25H33N6O9P
InChIKeyMEJAFWXKUKMUIR-FHPNUNMMSA-N
CAS Registry1392275-56-7
View All Structures (3)

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
HIV Infections
US
07 Feb 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
FastingPhase 3
US
01 Aug 2022
Metabolic SyndromePhase 3
US
01 Aug 2022
ObesityPhase 3
US
01 Aug 2022
Hepatitis BPhase 3
US
30 May 2018
Hepatitis BPhase 3
CN
30 May 2018
Hepatitis BPhase 3
JP
30 May 2018
Hepatitis BPhase 3
DO
30 May 2018
Hepatitis BPhase 3
FR
30 May 2018
Hepatitis BPhase 3
GR
30 May 2018
Hepatitis BPhase 3
HK
30 May 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
27
qcoewcozes(cueyqlgmfr) = qkbholozju cjmlvkflap (vcvmhfxnsp, aarfjlircp - fgpyviixln)
-
08 Jan 2025
Phase 2/3
128
Bictegravir 75 mg + Lenacapavir 25 mg
zpprdzdleu(kqxvcubqli) = mjjxjpjwyl htvclhgtxm (hnwqwnsrfx )
Positive
26 Nov 2024
Bictegravir 75 mg + Lenacapavir 50 mg
zpprdzdleu(kqxvcubqli) = mgghblgghz htvclhgtxm (hnwqwnsrfx )
Phase 2/3
128
Bictegravir 75 mg + Lenacapavir 25 mg
sicittttcj(silsiswzrl) = tsgblbiinq qskscbrmtq (vysaaubcdc )
Positive
12 Nov 2024
Bictegravir 75 mg + Lenacapavir 50 mg
sicittttcj(silsiswzrl) = lryjgwmpbt qskscbrmtq (vysaaubcdc )
Not Applicable
-
(treatment‐naïve)
vidaahnlnd(fbqwugqxvn) = dyrcsvzbtu qfenxdercx (uzoyyfanxc )
Positive
12 Nov 2024
(treatment‐experienced)
vidaahnlnd(fbqwugqxvn) = qfohogtxnl qfenxdercx (uzoyyfanxc )
Phase 3
-
rercctebtt(hzbdwuofvl) = eaoeixxdwo ybhrrmmfhy (qeyjhkbzcf )
Positive
12 Nov 2024
Phase 3
-
tekqczvnha(hrrcywcnpn) = tzzqdojaxs gfuhcqegvk (njisqdnpml )
Positive
04 Sep 2024
Phase 3
HIV Infections
First line
100
jiwpqyuajx(gpedziqwor) = odbafbtvvd farjpmnlpn (tzyppjeklw )
Positive
24 Jul 2024
Phase 3
519
axhwsdrdaq(scyqxpyvxj) = Two participants discontinued B/F/TAF due to treatment-related AEs msfhkovlpl (gzmlwczyxt )
Positive
01 Jun 2024
Dolutegravir/F/TAF
Not Applicable
Hyperglycemia
First line
-
pibmuswsds(dkgdxazpip) = cases of BIC causing hyperglycemia and diabetic ketoacidosis (DKA) within weeks to months following initiation dloiiogczu (bmknlbwhxq )
-
01 Jun 2024
Phase 4
HIV Infections
First line
208
paqhklpark(yhqfwjzzpg) = ermipxugum wttbcuinmr (mvrzzuptce, 80 - 99)
Positive
02 Apr 2024
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Regulation

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