Product
B/F/TAF
Aliases
B/F/TAF (Adult Strength), B/F/TAF (Low Dose), B/F/TAF (TOS), Biktarvy ® (2 other aliases)
Name
Biktarvy
INN Name
bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate
FDA Approved
Yes
14 clinical trials
2 organizations
6 indications
1 document
Indication
HIV-1 InfectionIndication
HIV-1/HBV Co-InfectionIndication
HIV-1 infectionIndication
HIV InfectionsIndication
Hepatitis BIndication
OsteoporosisClinical trial
A Phase 2 Randomized, Open-Label, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIVStatus: Active (not recruiting), Estimated PCD: 2023-12-19
Clinical trial
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naïve, HIV-1 and Hepatitis B Co-Infected AdultsStatus: Completed, Estimated PCD: 2022-02-25
Clinical trial
A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and ChildrenStatus: Recruiting, Estimated PCD: 2024-06-01
Clinical trial
A Phase 4 Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral B/F/TAF After Discontinuing Injectable CAB + RPVStatus: Recruiting, Estimated PCD: 2024-11-01
Clinical trial
Phase 3 Double-blind Multicenter Randomized Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Biktarvy® (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1Status: Recruiting, Estimated PCD: 2025-12-01
Clinical trial
A Phase 1b, Open-label Study to Evaluate the PK, Safety and Efficacy of B/F/TAF in HIV-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third TrimestersStatus: Completed, Estimated PCD: 2022-07-20
Clinical trial
A Phase 2 Randomized, Open Label, Active Controlled Study Evaluating the Safety and Efficacy of Long-acting Capsid Inhibitor GS-6207 in Combination With Other Antiretroviral Agents in People Living With HIVStatus: Completed, Estimated PCD: 2021-09-30
Clinical trial
Switching From Tenofovir Disoproxil Fumarate-based Antiretroviral Therapy Regimens to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virally Suppressed Adults With HIV-1 InfectionStatus: Active (not recruiting), Estimated PCD: 2024-02-28
Clinical trial
Antiretroviral Speed Access Program Switch Study (The ASAP Switch Study) - A Pilot Study to Switch ART-experienced and Newly-referred Migrant People With HIV to B/F/TAFStatus: Not yet recruiting, Estimated PCD: 2026-06-01
Clinical trial
Efficacy, Safety, and Tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Adults With HIV-HBV CoinfectionStatus: Completed, Estimated PCD: 2022-11-22
Clinical trial
Multi-center, Canadian, Non-interventional, Cohort Study of the Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adult Patients Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF)Status: Active (not recruiting), Estimated PCD: 2024-05-01
Clinical trial
An Umbrella Phase 1b, Open-label, Multi-Cohort Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Novel Antiretrovirals in Participants With HIV-1Status: Active (not recruiting), Estimated PCD: 2027-03-01
Clinical trial
A Phase IV Open-Label Trial to Assess Bone Mineral Density in a Cohort of African Women on Depo-provera and Tenofovir Disoproxil Fumurate Switched to Tenofovir Alafenamide Fumarate Based Anti-Retroviral TherapyStatus: Recruiting, Estimated PCD: 2024-03-31
Clinical trial
The Efficacy and Safety of Biktarvy in Treatment-Naïve Late Presenters With HIV-1 InfectionStatus: Active (not recruiting), Estimated PCD: 2022-12-13
Organization
Gilead Sciences, Inc.Document
DailyMed Label: BiktarvyOrganization
A-S Medication Solutions