B/F/TAF

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

ImmunodeficiencyHepatitis BHIV-1 Infection

296 competitors in Immunodeficiency

#DrugCompanyPhaseTrials

1

Cabenuva

GSK

Phase 3

62

Farxiga

AstraZeneca

Phase 3

13

Isentress

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Phase 3

84

B/F/TAF

Gilead

Approved

75

Prevnar 13

Merck & Co.

Phase 3

26

Atripla

Gilead

Phase 3

37

V114

Merck & Co.

Phase 3

28

Immunoglobulin G

CSL Behring

Phase 3

19

Nrtis

Gilead

Phase 3

110

PCV15

Merck & Co.

Phase 3

1Show 32 more competitors

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

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Immunodeficiency7 trials

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

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

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

Show 4 more 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

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 of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1

Active, not recruiting·Gilead·Phase 2/3·NCT02881320·177 enrolled

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

Safety and Efficacy5 trials

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

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

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

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 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

HIV-1 infection4 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

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

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

Show 1 more trial

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

Tenofovir3 trials

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV

Recruiting·Gilead·Phase 1·NCT07055451·16 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

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

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

12 more indications

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

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

First-line1 trial

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

Recruiting·—··NCT06619288·630 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

Adolescent1 trial

A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments

Recruiting·Gilead·Phase 4·NCT06337032·350 enrolled

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

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

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

Itching1 trial

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

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

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

Details

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