Biktarvy

(Bictegravir)

Phase 3Small molecule

Bictegravir is used to treat HIV infection by helping to stop the virus from multiplying in the body. It is typically used as part of a combination treatment with other HIV medications.[1] Biktarvy is currently being investigated across 5 indications[3], with its most advanced program in Phase 3.[1]

Biktarvy is one of 147 small molecule programs targeting Metabolic Syndrome. It is currently in Phase 3.

Indications

Total Trials

Active Trials

146

Competitors

Pipeline

Status by Indication[3][1]

Indication

Metabolic SyndromeActive, not recruiting

HIV-1 InfectionRecruiting

TuberculosisActive, not recruiting

HIV InfectionsCompleted

HIV-1Active, not recruiting

Metabolic SyndromePreclinical

Active, not recruiting

HIV-1 InfectionPhase 3

Recruiting

TuberculosisPreclinical

Active, not recruiting

HIV InfectionsPhase 3

Completed

HIV-1Phase 3

Active, not recruiting

Competition

Competitive Landscape

82 competitors in Tuberculosis

#DrugCompanyPhaseTrials

Rifadin

Sanofi

Phase 3

17 2

Avelox

Bayer

Phase 3

12 3

Zyvox

Pfizer

Phase 3

10 4

Tebrazid

AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Phase 3

25 5

Lamprene

Novartis

Phase 3

5 6

Sirturo

WWim Janssens

Phase 3

9 7

Levaquin

WWim Janssens

Phase 3

8 8

TB Alliance

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Phase 3

2 9

Biktarvy

Gilead

Phase 3

1 10

Rayos

RRoxane Laboratories

Phase 3

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

Timeline

Expected Milestones

Q1 2027

Phase 3Active, not recruiting

HIV

NCT05979311

Q2 2027

ApprovedRecruiting

HIV-1 Infection

NCT07476339

Q3 2027

ApprovedActive, not recruiting

HIV Infections

NCT06374758

Q1 2028

Not yet recruiting

HIV-1 Infection

NCT07859904

Clinical

Trials by Indication[1]

HIV-1 infection4 trials

An Operationally Seamless Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens

Active, not recruiting· Gilead logo

Gilead·Preclinical·NCT05502341·689 enrolled

Ambispective Observational Study on Retention in Care and on Clinical Chracteristics of HIV-infected Women Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIKWO).

Not yet recruiting·EEnte Ospedaliero Ospedali Galliera··NCT07859904·100 enrolled

A Phase 2/3, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1

Active, not recruiting· Gilead logo

Gilead·Preclinical·NCT06532656·75 enrolled

Show 1 more trial

A Multi-Center, Single-Arm, Open-Label, Prospective, Phase 4 Study to Investigate the Safety and Efficacy of Rapidly Restarting Oral Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) in Viremic and Virologically-Suppressed Male and Female HIV-Positive Patients Aged ≥18 Years Who Are Treatment-Experienced and Returning to Care After Experiencing a Treatment Interruption of ≥12 Weeks

Recruiting·CCAN Community Health·Approved·NCT07476339·200 enrolled

HIV-13 trials

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

Active, not recruiting· Gilead logo

Gilead·Phase 3·NCT06333808·577 enrolled

Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated

Active, not recruiting· Gilead logo

Gilead·Phase 2/3·NCT06613685·675 enrolled

Study of Oral Weekly GS-1720 and GS-4182 Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed

Active, not recruiting· Gilead logo

Gilead·Phase 2/3·NCT06544733·675 enrolled

Itching2 trials

Evaluating Inflammatory and Immunological Changes of HIV-positive Patients Switching to DTG Dual Regimen Compared to Those Switching to a Triple Drugs Regimen (B/F/TAF)

Unknown status·CCristina Mussini·Phase 4·NCT04054089·66 enrolled

Neurological Monitoring in Patients Switching From Dolutegravir Based Regimen to Bictegravir Based Regimen

Unknown status·AAzienda Ospedaliera Universitaria Senese·Phase 3·NCT04155554·100 enrolled

ART2 trials

A Study of JNJ-56136379 in Healthy Participants

Withdrawn· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04853524

Rapid Start vs. Standard Start Antiretroviral Therapy (ART) in HIV

Terminated·UUniversity of Colorado, Denver·Phase 4·NCT04249037·10 enrolled

Tenofovir2 trials

Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Marginalized Populations Who Are Virologically Suppressed

Unknown status·VVancouver Infectious Diseases Centre·Phase 4·NCT04132674·40 enrolled

Bictegravir/Emtricitabine/Tenofovir Alafenide Plus Doravirine

Completed·QQuest Clinical Research·Phase 4·NCT04538040·20 enrolled

20 more indications

HIV Infections2 trials

ACCELERATE a Multisite Prospective Hybrid (Effectiveness-implementation) Type 2 Design, Single-arm, Mixed-methods Study of a Simplified Accelerated ART Initiation Protocol for People With HIV Who Are Out of Care.

Active, not recruiting·UUniversity of Missouri-Columbia·Approved·NCT06374758·120 enrolled

Simplified Model of Linkage and Retention to Healthcare System, Using a Mobil Unit and a Same-day Test and Treat Approach Among Excluded Population.

Completed·FFundacion SEIMC-GESIDA·Approved·NCT05405751·101 enrolled

Drug Interactions1 trial

The Incidence and Severity of Drug Interactions Before and After Switching Antiretroviral Therapy to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Treatment Experienced Patients

Completed·TThomas Jefferson University··NCT03789968·411 enrolled

Metabolic Syndrome1 trial

Incidence of Metabolic Syndrome in People Living With HIV Without ExperienCe to ART Who Start DoLutegravir Based-Regimen Compared With BictegrAvir Based-RegimeN

Completed·IInstituto Mexicano del Seguro Social·N/A·NCT06629480·378 enrolled

Gut Microbiota1 trial

Gut Microbiota, PGx and INSTIs Response

Completed·CCliniques universitaires Saint-Luc- Université Catholique de Louvain··NCT04805944·180 enrolled

Impaired Renal Function1 trial

Pharmacokinetics of Bictegravir in Adults With Normal and Impaired Renal Function

Completed· Gilead logo

Gilead·Phase 1·NCT02400307·19 enrolled

Tuberculosis1 trial

Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT04518228·205 enrolled

Immunodeficiency1 trial

Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Bictegravir (GS-9883) in Human Immunodeficiency Virus (HIV)-1 Infected Participants

Completed· Gilead logo

Gilead·Phase 1·NCT02275065·23 enrolled

Prophylaxis1 trial

Biktarvy for Non-Occupational Post-Exposure Prophylaxis (nPEP)

Completed·FFenway Community Health·Phase 4·NCT03499483·52 enrolled

Substance Use1 trial

Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Patients With Active Illicit Substance usE

Completed·UUniversity of Nebraska·Phase 4·NCT03998176·43 enrolled

Treatment1 trial

Empiric Treatment for Acute HIV in the ED

Unknown status·UUniversity of Southern California·Phase 4·NCT03711253·40 enrolled

Efficacy1 trial

Efficacy of Switching to DTG/3TC in Virologically-suppressed Adults Currently on B/F/TAF

Completed·—·Phase 4·NCT04585737·222 enrolled

Antiretroviral Treatment1 trial

Rapid Antiretroviral Treatment Initiation With BIC/FTC/TAF in HIV-infected People Who Inject Drugs (PWID)

Completed·HHellenic Scientific Society for the Study of AIDS, Sexually Transmitted and Emerging Diseases··NCT07004933·37 enrolled

Elderly1 trial

Bictegravir in the Elderly Living With HIV (BICEP)

Active, not recruiting·SState University of New York at Buffalo··NCT05064020·162 enrolled

HIV infection1 trial

Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection

Unknown status·AAnna Cruceta·Phase 2·NCT04483674·66 enrolled

Maintenance Therapy1 trial

DTG/3TC vs. BIC/FTC/TAF Maintenance Therapy in People Living With HIV:

Completed·FFundacion SEIMC-GESIDA·Phase 4·NCT04884139·554 enrolled

Advanced1 trial

Advanced HIV: Outcomes for Rapid ART

Unknown status·VValley AIDS Council··NCT05526118·50 enrolled

Effectiveness1 trial

Safety, Tolerability and Effectiveness of DTG/3TC vs BIC/TAF/FTC in PWH Without Antiretroviral Experience

Recruiting·IInstituto Mexicano del Seguro Social·Phase 4·NCT07031063·124 enrolled

BIC/FTC/TAF1 trial

Efficacy, Safety & Tolerability of Switching EFV/TDF/FTC to BIC/FTC/TAF in Virologically Suppressed Adults With HIV-1

Completed·MMidland Research Group, Inc.·Phase 4·NCT03502005·100 enrolled

HIV1 trial

A Phase 3b, Multi-center, Randomized, Parallel-group, Open-label, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Oral Dolutegravir/Lamivudine Once-daily as a First-line Regimen Compared to Oral Bictegravir/Emtricitabine/Tenofovir Alafenamide Once Daily for Virologic Suppression and Maintenance in Antiretroviral Therapy Naive Adults Living With HIV

Active, not recruiting· GSK logo

GSK·Phase 3·NCT05979311·463 enrolled

Unspecified2 trials

Same-day Antiretroviral Therapy With BIC/F/TAF

Unknown status·NNational Taiwan University Hospital·N/A·NCT04712058·200 enrolled

A Drug-Drug Interaction Study of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT07532304·16 enrolled

Sources

References

[1]
ClinicalTrials.gov — 35 trial records for Bictegravir. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Bictegravir compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Bictegravir. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Gilead company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Human Immunodeficiency Virus Type 1 Integrase Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Gilead

Biktarvy

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q3 2027

Q1 2028

Trials by Indication[1]

HIV-1 infection4 trials

HIV-13 trials

Itching2 trials

ART2 trials

Tenofovir2 trials

HIV Infections2 trials

Drug Interactions1 trial

Metabolic Syndrome1 trial

Gut Microbiota1 trial

Impaired Renal Function1 trial

Tuberculosis1 trial

Immunodeficiency1 trial

Prophylaxis1 trial

Substance Use1 trial

Treatment1 trial

Efficacy1 trial

Antiretroviral Treatment1 trial

Elderly1 trial

HIV infection1 trial

Maintenance Therapy1 trial

Advanced1 trial

Effectiveness1 trial

BIC/FTC/TAF1 trial

HIV1 trial

Unspecified2 trials

References

Drug Info

Quick Facts

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