Biktarvy

also known as B/F/TAF · BIC/FTC/TAF · Bictegravir/Emtricitabine/Tenofovir Alafenamide · BIK

Developed for: HIV infectious disease · coinfection
Investigated by: Gilead Sciences · Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba · ANRS, Emerging Infectious Diseases · Atea Pharmaceuticals, Inc. · Boston Medical Center · Brigham and Women's Hospital
+25 more
· Centers for Disease Control and Prevention · Centre for the AIDS Programme of Research in South Africa · East Carolina University · Emory University · French National Institute of Health and Medical Research · Fundacion SEIMC-GESIDA · INSERM UMR S 1136 · Janssen Pharmaceuticals · Janssen Scientific Affairs, LLC · Johns Hopkins University · Medical Research Council, South Africa · Merck Sharp & Dohme LLC · NEAT ID Foundation · National Institute of Allergy and Infectious Diseases (NIAID) · Pierre and Marie Curie University · Radboud University Medical Center · Saskatchewan Health Authority - Regina Area · Sebastien GALLIEN/Henri Mondor University Hospital- Infectiology Department · Southampton Healthcare, Inc. · THOMAS STEHL/ HENRI MONDOR HOSPITAL-Department of Nephrology · Tufts Medical Center · University of Cape Town · University of Miami · Yale University · ZonMw: The Netherlands Organisation for Health Research and Development

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Approved	EU (EMA)	Biktarvy	—	2018-06-21	europa.eu ↗
Approved	US (FDA)	BIKTARVY	—	2018-02-07	fda.gov ↗

Trials 15 · a red edge is where a trial was stopped

today

US approved 2018

EU approved 2018

NCT06356194 · Ph 1 NCT05463783 · Ph 4 NCT05648201 · Ph 4 NCT05549180 · Ph 4 NCT04993872 · Ph 4 NCT04734652 · Ph 2 NCT04860505 · Ph 4 NCT04551573 · Ph 4 NCT04650269 · Ph 4 NCT04222283 · Ph 4 NCT04051970 · Ph 3 NCT04040075 · Ph 4 NCT03696160 · Ph 3 NCT03656783 · Ph 3 NCT03549312 · Ph 4

201820192020202120222023202420252026

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 11 trial
Phase 1	NCT06356194	Apr → May 2024	—	Atea Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 21 trial
Phase 2	NCT04734652	Feb 2022 → Jan 2024	HIV infectious disease, pulmonary tuberculosis	Centre for the AIDS Programme of Research in South Africa	Completed	No outcome recorded
Phase 33 trials
Phase 3	NCT04051970	Nov 2019 → Jun 2022	HIV infectious disease	ANRS, Emerging Infectious Diseases	Terminated	No outcome recorded
Phase 3	NCT03696160	Mar 2019 → Jun 2024	HIV infectious disease	NEAT ID Foundation	Completed	No outcome recorded
Phase 3	NCT03656783	Sep 2018 → Sep 2021	HIV infectious disease	Brigham and Women's Hospital	Completed	No outcome recorded
Phase 410 trials
Phase 4	NCT05463783	Mar 2023 → Mar 2025	HIV infectious disease, obesity disorder	East Carolina University	Unknown	No outcome recorded
Phase 4	NCT05648201	Mar 2023 → Nov 2024	HIV infectious disease	Radboud University Medical Center	Completed	No outcome recorded
Phase 4	NCT05549180	Oct 2022 → Feb 2024	HIV infectious disease	Fundacion SEIMC-GESIDA	Completed	No outcome recorded
Phase 4	NCT04993872	Sep 2022 → Jul 2023	—	Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba	Unknown	No outcome recorded
Phase 4	NCT04860505	May 2021 → May 2022	sexually transmitted disease	Emory University	Completed	No outcome recorded
Phase 4	NCT04551573	May → Oct 2021	HIV infectious disease, tuberculosis	Yale University	Withdrawn	No outcome recorded
Phase 4	NCT04650269	Mar 2021 → Dec 2023	HIV infectious disease, substance abuse	University of Miami	Completed	No outcome recorded
Phase 4	NCT04222283	Aug 2020 → Dec 2021	HIV infectious disease	Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba	Unknown	No outcome recorded
Phase 4	NCT04040075	Jul 2019 → Jun 2022	HIV infectious disease	Southampton Healthcare, Inc.	Terminated	No outcome recorded
Phase 4	NCT03549312	Feb 2018 → Jul 2020	HIV infectious disease, chronic hepatitis C virus infection, coinfection, metabolic bone disorder +1	Saskatchewan Health Authority - Regina Area	Unknown	No outcome recorded

Also used as a comparator or background therapy in 1 trial

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 3	NCT05592613 Background	Feb 2023 → Jul 2024	HIV infectious disease	Brigham and Women's Hospital	Completed	No outcome recorded

Press releases naming this drug 31 releases

Date	Issuer	Release
2024-04-26	Gilead Sciences	FDA Approves Biktarvy® Label Update With Data for Pregnant Adults With HIV gilead.com ↗
2024-03-06	Gilead Sciences	Biktarvy® Demonstrates High Rates of Viral Suppression in People With HIV and Comorbidities gilead.com ↗
2024-02-26	Gilead Sciences	U.S. FDA Approves Expanded Indication for Gilead’s Biktarvy® to Treat People with HIV with Suppressed Viral Loads, Pre-existing Resistance gilead.com ↗
2023-10-19	Gilead Sciences	Real-World Evidence Reinforces Biktarvy® as a Long-Term Treatment Option With a High Barrier to Resistance for People With HIV and a Range of Comorbidities gilead.com ↗
2023-07-23	Gilead Sciences	New Biktarvy® Data Presented at IAS 2023 Further Demonstrate Safety and Efficacy Profile in a Broad Range of People and Communities Affected by the Global HIV Epidemic gilead.com ↗
2022-11-29	Gilead Sciences	European Commission Grants Expanded Marketing Authorization for Gilead’s Biktarvy® for the Treatment of HIV in Pediatric Populations gilead.com ↗
2022-10-24	Gilead Sciences	Gilead Presents Real-World Evidence Reinforcing the Use of Biktarvy® for the Treatment of People Living With HIV With a Range of Comorbidities gilead.com ↗
2022-07-28	Gilead Sciences	Biktarvy® Demonstrates High Efficacy for a Broad Range of People Initiating Treatment for HIV, Including Those With HBV Coinfection gilead.com ↗
2022-02-11	Gilead Sciences	Biktarvy® Demonstrates High Efficacy and Durable Viral Suppression at Five Years, in Treatment-Naïve Adults gilead.com ↗
2021-10-29	Gilead Sciences	Clinical and Patient-Reported Outcomes in People Living With HIV on Biktarvy® in Observational BICSTaR Study Demonstrate Consistent Efficacy Profile in Real-World Setting gilead.com ↗
2021-10-21	Gilead Sciences	Gilead Presents Long-Term Switch Data Reinforcing Biktarvy® as a Treatment Option for a Broad Range of People Living With HIV gilead.com ↗
2021-10-18	Gilead Sciences	U.S. Food and Drug Administration Approves Expanded Indication of Gilead’s Biktarvy® for Treatment of HIV-1 in Pediatric Populations gilead.com ↗
2021-07-17	Gilead Sciences	Four-Year Biktarvy® Data Presented at IAS 2021 Demonstrate High Efficacy and Durable Viral Suppression in Treatment-Naïve Adults gilead.com ↗
2021-03-06	Gilead Sciences	Biktarvy® Demonstrates High Efficacy and Durable Viral Suppression in Treatment-Naïve Adults in Four-Year Data Presented at CROI gilead.com ↗
2020-10-21	Gilead Sciences	Gilead Announces New Data on Biktarvy® for the Treatment of HIV in Black Americans gilead.com ↗
2020-10-05	Gilead Sciences	Gilead Presents Biktarvy® Findings From Switch Studies & Analysis of Real-World BICSTaR Study At HIV Glasgow 2020 gilead.com ↗
2020-07-04	Gilead Sciences	New Findings on Gilead’s Biktarvy® Presented at AIDS 2020: Virtual Include Positive Switch Data in Older Adults gilead.com ↗
2020-03-09	Gilead Sciences	New Data on Gilead’s Biktarvy® Presented at CROI 2020, Including Data in Black Americans and Older Adults gilead.com ↗
2019-11-06	Gilead Sciences	Gilead’s Biktarvy Maintained High Efficacy With No Cases of Treatment-Emergent Resistance Through Three Years in Phase 3 HIV Clinical Trials gilead.com ↗
2019-08-09	Gilead Sciences	China National Medical Products Administration Approves Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection gilead.com ↗
2019-07-22	Gilead Sciences	Gilead Presents New Data on Biktarvy® for the Treatment of HIV in Women and in Virologically Suppressed Patients With Known Resistance gilead.com ↗
2019-03-26	Gilead Sciences	Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection gilead.com ↗
2019-03-06	Gilead Sciences	Gilead Presents New Data on Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) and TAF-Based Regimens for the Treatment of HIV-1 in Children, Older Adults and Women gilead.com ↗
2019-03-06	Gilead Sciences	Gilead Presents Data on Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) in Virologically Suppressed Adults, Including Those With Pre-Existing NRTI Resistance gilead.com ↗
2018-10-30	Gilead Sciences	Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 in Adults New to HIV Therapy gilead.com ↗
2018-10-03	Gilead Sciences	Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 in Adults New to HIV Therapy gilead.com ↗
2018-06-25	Gilead Sciences	European Commission Grants Marketing Authorization for Gilead’s Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection gilead.com ↗
2018-04-27	Gilead Sciences	European CHMP Adopts Positive Opinion for Gilead’s Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) gilead.com ↗
2018-03-05	Gilead Sciences	Gilead Presents Results from Phase 3 Study Evaluating Patients Who Switched to Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) from Regimen Containing Abacavir, Dolutegravir and Lamivudine gilead.com ↗
2018-03-05	Gilead Sciences	Gilead Presents Data From Phase 3 Study Evaluating Women Who Switched to Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) From a Boosted Protease Inhibitor-Based Regimen or Boosted Elvitegravir-Containing Regimen gilead.com ↗
2018-02-07	Gilead Sciences	U.S. Food and Drug Administration Approves Gilead’s Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV-1 Infection gilead.com ↗

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 16 sources stand behind the page.

Field	Value	Cited text
Known as	Biktarvy	“Subjects will receive once-daily Biktarvy for 4 weeks to ensure all moieties of interest reach steady-state prior to the baseline PK assessment.” NCT04551573 ↗ 15 “a once daily integrase inhibitor (Stribild® or Genvoya® or Biktarvy®)” NCT04051970 ↗ NCT05648201 ↗ NCT04040075 ↗ NCT05592613 ↗ NCT04222283 ↗ NCT04860505 ↗ NCT03696160 ↗ NCT04734652 ↗ NCT03656783 ↗ NCT04650269 ↗ NCT03549312 ↗ NCT04993872 ↗ NCT05549180 ↗ NCT05463783 ↗ NCT06356194 ↗
Known as	B/F/TAF	“Biktarvy is a combination of bictegravir, emtricitabine, and tenofovir (B/F/TAF).” NCT03696160 ↗
Known as	BIC/FTC/TAF	“containing Bictegravir 50mg Emtricitabine 200mg and tenofovir alafenamide 25mg (BIC/FTC/TAF; Biktarvy®)” NCT04734652 ↗
Known as	Bictegravir/Emtricitabine/Tenofovir Alafenamide	“Between Bemnifosbuvir/Ruzasvir and Bictegravir/Emtricitabine/Tenofovir Alafenamide (Biktarvy®) in Healthy Adult Subjects” NCT06356194 ↗
Known as	BIK	“A co-administered dose of Bemnifosbuvir (BEM)/Ruzasvir (RZR) as separate formulations and Biktarvy (BIK)” NCT06356194 ↗
Action	Inhibit	“Bictegravir, co-formulated with emtricitabine (FTC) and tenofovir alafenamide (TAF) (BIKTARVY) a new generation integrase inhibitor” NCT04222283 ↗
Modality	Other / unclassified	“Biktarvy® is a fixed dose combination” NCT04734652 ↗
Route	Oral	“Oral Biktarvy 50/200/25 mg.” NCT03549312 ↗