B/F/TAF

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Safety and EfficacyHIV-1 InfectionTenofovirHIV-1

130 competitors in Safety and Efficacy

#DrugCompanyPhaseTrials

1

Avastin

Roche

Phase 3

32

Actemra

Roche

Phase 3

13

Humira

RRanbaxy Laboratories Limited

Phase 3

34

Rayos

RRoxane Laboratories

Phase 3

35

Empaveli

Apellis Pharmaceuticals

Phase 3

26

CAB LA

GSK

Phase 3

17

Nuzyra

PParatek Pharmaceuticals Inc

Phase 3

18

Bomedemstat

Merck & Co.

Phase 3

19

Xylocaine

MMEDRx USA, Inc.

Phase 2

510

Fabhalta

AstraZeneca

Phase 3

1Show 36 more competitors

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

HIV-1 infection9 trials

Switching From TDF-based Antiretroviral Therapy Regimens to B/F/TAF in Virally Suppressed Adults With HIV-1 Infection

Unknown status·SShanghai Public Health Clinical Center·Phase 4·NCT05122754·150 enrolled

Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)

Completed·Gilead·Phase 4·NCT06104306·33 enrolled

Biktarvy in Treatment-Naïve Late Presenters With HIV-1 Infection

Unknown status·PPeking Union Medical College Hospital·Phase 4·NCT04296695·250 enrolled

Show 6 more trials

A Platform, Active-Controlled Study Evaluating the Safety and Efficacy of Long-Acting Oral Regimens in People With HIV-1; Substudy-01: Phase 2, Open-Label, Weekly, Long-Acting, Oral Regimens in Virologically Suppressed People With HIV-1

Recruiting·Gilead·Phase 2·NCT07841990·125 enrolled

An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments

Recruiting·Gilead·Approved·NCT06337032·350 enrolled

A Phase 2 Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1

Recruiting·Gilead·Phase 2·NCT07645287·175 enrolled

An Operationally Seamless Phase 2/3 Randomized, Open-label, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Treatment-Naive People With HIV-1

Recruiting·Gilead·Preclinical·NCT07708727·700 enrolled

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 Children

Active, not recruiting·Gilead·Preclinical·NCT02881320·177 enrolled

A Phase 1b Study to Evaluate the Safety and Pharmacokinetics of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Neonates Exposed to HIV-1

Active, not recruiting·Gilead·Phase 1·NCT07055451·16 enrolled

Immunodeficiency6 trials

Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

Completed·Gilead·Phase 3·NCT02607930·631 enrolled

Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed

Completed·Gilead·Phase 3·NCT03110380·567 enrolled

Study to Evaluate the Pharmacokinetics (PK), Safety, and Efficacy of B/F/TAF in Human Immunodeficiency Virus (HIV)-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters

Completed·Gilead·Phase 1·NCT03960645·62 enrolled

Show 3 more trials

Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

Completed·Gilead·Phase 3·NCT02607956·657 enrolled

Study to Evaluate Switching From an E/C/F/TAF Fixed-Dose Combination (FDC) Regimen or a TDF Containing Regimen to B/F/TAF FDC in Human Immunodeficiency Virus-1 (HIV-1) Infected Participants Aged ≥ 65 Years

Completed·Gilead·Phase 3·NCT03405935·86 enrolled

Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults

Completed·Gilead·Phase 1·NCT03739866·53 enrolled

Safety and Efficacy5 trials

Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With Other Antiretroviral Agents in People Living With HIV

Completed·Gilead·Phase 2·NCT04143594·183 enrolled

Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV

Active, not recruiting·Gilead·Phase 2·NCT05052996·142 enrolled

Safety and Efficacy of Switching to a FDC of B/F/TAF From E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF in Virologically Suppressed HIV-1 Infected Women

Completed·Gilead·Phase 3·NCT02652624·472 enrolled

Show 2 more trials

Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed

Completed·Gilead·Phase 3·NCT02603120·567 enrolled

Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults

Completed·Gilead·Phase 3·NCT02603107·578 enrolled

HIV-12 trials

Study of Novel Antiretrovirals in Participants With HIV-1

Completed·Gilead·Phase 1·NCT05585307·49 enrolled

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy

Active, not recruiting·Gilead·Phase 3·NCT06333808·577 enrolled

Tenofovir2 trials

Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants

Completed·Gilead·Phase 3·NCT03631732·496 enrolled

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1

Active, not recruiting·Gilead·Phase 3·NCT06630286·609 enrolled

11 more indications

ESS1 trial

The Antiretroviral Speed Access Program Switch (ASAP-Switch) Study

Not yet recruiting·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·Phase 4·NCT06375304·50 enrolled

Treatment1 trial

Study to Assess Switching to B/F/TAF in Treatment Experienced People With HIV Who Are at Least 65 Years of Age

Unknown status·—·Phase 4·NCT05147740·50 enrolled

Antiretroviral Treatment1 trial

Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Completed·Gilead·Phase 2·NCT02397694·98 enrolled

Double-blind1 trial

B/F/TAF vs Atripla Double-Blind Switch Study in HIV-1 Infected Adults

Terminated·UUniversity of Alberta·Phase 4·NCT03532425·28 enrolled

Hepatitis B1 trial

Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults

Completed·Gilead·Phase 3·NCT03547908·244 enrolled

First-line1 trial

Good-first: B/F/TAF As First-line ART

Recruiting·—··NCT06619288·630 enrolled

Hemodialysis1 trial

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Adults on Chronic Hemodialysis

Completed·Gilead·Phase 3·NCT02600819·55 enrolled

Itching1 trial

BONE: STAR (Switching to TAF Based Anti-Retroviral Therapy) Study

Unknown status·MMU-JHU CARE·Phase 4·NCT03916328·330 enrolled

Quality of Life1 trial

Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adults Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide

Completed·Gilead··NCT03580668·201 enrolled

Second-line Therapy1 trial

Continuation of Protease-Inhibitor Based Second-Line Therapy vs. Switch to B/F/TAF in Virologically Suppressed Adults

Unknown status·HHaitian Group for the Study of Kaposi's Sarcoma and Opportunistic·Phase 4·NCT04311957·386 enrolled

HBV Coinfection1 trial

B/F/TAF Switch Study for HIV-HBV Coinfection

Completed·UUniversity of Maryland, Baltimore·Phase 4·NCT03797014·28 enrolled

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