F/TAF

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

TenofovirPre-Exposure Prophylaxis of HIV Infection

9 competitors in Tenofovir

#DrugCompanyPhaseTrials

1

Tybost

Gilead

Phase 3

62

B/F/TAF

Gilead

Phase 3

23

ISL/LEN

Gilead

Phase 3

14

Cobicistat TOS

Gilead

Phase 3

15

PTM SEMA

Gilead

Phase 3

16

Third Agent

Gilead

Phase 3

27

Lpv/r

Gilead

Phase 3

18

F/TAF

Gilead

Phase 3

19

Truvada

Gilead

Preclinical

3

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

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Immunodeficiency3 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 Emtricitabine/Tenofovir Alafenamide (F/TAF) in Human Immunodeficiency Virus 1 (HIV-1) Infected Children and Adolescents Virologically Suppressed on a 2-Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (2-NRTI)-Containing Regimen

Completed·Gilead·Phase 2/3·NCT02285114·41 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

HIV-12 trials

Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF

Completed·Gilead·Phase 3·NCT02121795·668 enrolled

Switch Study to Evaluate F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed on Regimens Containing ABC/3TC

Completed·Gilead·Phase 3·NCT02469246·567 enrolled

Tenofovir1 trial

Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV

Active, not recruiting·Gilead·Phase 2/3·NCT02016924·133 enrolled

Interaction1 trial

Relative Bioavailability Study to Investigate a Potential Interaction Between DTG DT and F/TAF TOS.

Completed·RRadboud University Medical Center·Phase 1·NCT05489406·16 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

6 more indications

Safety and Efficacy1 trial

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

Insulin Sensitivity1 trial

Changes in Insulin Sensitivity in Healthy Volunteers Taking Tenofovir Alafenamide (TAF)-Containing Antiretroviral Medication

Completed·TTechnical University of Munich·Phase 1·NCT03092206·30 enrolled

HIV-1 infection1 trial

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

Pre-Exposure Prophylaxis of HIV-1 Infection1 trial

A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection

Terminated·Gilead·Phase 3·NCT02842086·5,399 enrolled

Pre-Exposure Prophylaxis of HIV Infection1 trial

A Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long-Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection

Active, not recruiting·Gilead·Phase 3·NCT04994509·5,368 enrolled

HIV1 trial

PURPOSE-1: Lenacapavir PrEP for HIV Prevention

Completed·Gilead·Phase 3·NCT04925752·5,338 enrolled

Details

Drug Info

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