Biktarvy

(Bictegravir)

ApprovedSmall 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.[2] Biktarvy is currently approved and in use across 7 indications[4].[1]

Biktarvy is one of 208 small molecule programs targeting Metabolic Syndrome. It is currently in Approved.

Indications

Total Trials

Active Trials

207

Competitors

Pipeline

Status by Indication[4][1]

Indication

Metabolic SyndromeActive, not recruiting

HIV InfectionUnknown

HIV-1 InfectionActive, not recruiting

ImmunodeficiencyActive, not recruiting

HIVActive, not recruiting

TuberculosisActive, not recruiting

HIV InfectionsCompleted

Metabolic SyndromePreclinical

Active, not recruiting

HIV InfectionPreclinical

Unknown

HIV-1 InfectionPhase 3

Active, not recruiting

ImmunodeficiencyPhase 1

Active, not recruiting

HIVPhase 3

Active, not recruiting

TuberculosisPreclinical

Active, not recruiting

HIV InfectionsApproved

Completed

Competition

Competitive Landscape

326 competitors in HIV Infection

#DrugCompanyPhaseTrials

Biktarvy

Gilead

Approved

1 2

Leukine

Sanofi

Phase 3

2 3

Intron a

Merck & Co.

Phase 3

1 4

Sunlenca

Gilead

Phase 3

1 5

Hivid

CConrado Roberto Hoffmann Filho

Phase 3

9 6

Praluent

Regeneron

Phase 3

1 7

Betaseron

PEG-Intron

Isentress

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

Phase 3

3 10

Proleukin

IIovance Biotherapeutics, Inc.

Phase 3

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

Timeline

Expected Milestones

Q3 2026

Phase 1Active, not recruiting

Study completion

NCT07532304

Q4 2026

Post-ApprovalRecruiting

CAR

NCT06374758

Q1 2027

Phase 3Active, not recruiting

HIV

NCT05979311

Q2 2027

ApprovedRecruiting

HIV-1 Infection

NCT07476339

Clinical

Trials by Indication[1]

HIV-14 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

Show 1 more trial

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

Active, not recruiting· Gilead logo

Gilead·Phase 2/3·NCT05502341·689 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

Impaired Renal Function1 trial

Pharmacokinetics of Bictegravir in Adults With Normal and Impaired Renal Function

Completed· Gilead logo

Gilead·Phase 1·NCT02400307·19 enrolled

21 more indications

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

CAR1 trial

Accelerated ART Initiation for PWHIV Who Are Out of Care

Recruiting·UUniversity of Missouri-Columbia·Phase 4·NCT06374758·120 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

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

Advanced1 trial

Advanced HIV: Outcomes for Rapid ART

Unknown status·VValley AIDS Council··NCT05526118·50 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

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

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

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

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

HIV-1 infection1 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

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·NCT05979311·307 enrolled

HIV Infections1 trial

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

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

Active, not recruiting· Merck & Co. logo

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

Sources

References

[1]
ClinicalTrials.gov — 33 trial records for Bictegravir. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Biktarvy drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Bictegravir compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Bictegravir. EMBL-EBI & Wellcome Sanger Institute.
[5]
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[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Gilead

Biktarvy

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

HIV-14 trials

Itching2 trials

ART2 trials

Tenofovir2 trials

Impaired Renal Function1 trial

Prophylaxis1 trial

Substance Use1 trial

Treatment1 trial

Efficacy1 trial

Antiretroviral Treatment1 trial

Elderly1 trial

CAR1 trial

HIV infection1 trial

Maintenance Therapy1 trial

BIC/FTC/TAF1 trial

Advanced1 trial

Drug Interactions1 trial

Effectiveness1 trial

Metabolic Syndrome1 trial

Gut Microbiota1 trial

Immunodeficiency1 trial

Tuberculosis1 trial

HIV-1 infection1 trial

HIV1 trial

HIV Infections1 trial

Unspecified2 trials

References

Drug Info

Quick Facts

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