BIKTARVY (bictegravir sodium)
BIKTARVY is a three-drug combination of bictegravir (BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF) indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg. It is approved for use in patients with no prior antiretroviral treatment history or to replace a current stable antiretroviral regimen in patients who are virologically suppressed (HIV-1 RNA < 50 copies/mL). For patients switching regimens, there must be no known or suspected substitutions associated with resistance to bictegravir or tenofovir.
How BIKTARVY Works
BIKTARVY combines three antiretroviral agents to inhibit HIV-1 replication through two distinct mechanisms: * **Bictegravir:** An integrase strand transfer inhibitor (INSTI) that binds to the integrase active site and blocks the strand transfer step of retroviral DNA integration, which is essential for the HIV replication cycle. * **Emtricitabine and Tenofovir Alafenamide:** Both are nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs). After intracellular phosphorylation, they compete with natural substrates for incorporation into viral DNA, acting as chain terminators to inhibit the activity of HIV-1 reverse transcriptase.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-02-07
- Patent Cliff
- 2036
- Revenue
- $4.0B (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
BIKTARVY Approval History
What BIKTARVY Treats
1 indicationsBIKTARVY is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Human Immunodeficiency Virus
BIKTARVY Boxed Warning
POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If ap...
WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1) ] . WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B See full prescribing information for complete boxed warning. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function in these patients. If appropriate, anti-hepatitis B therapy may be warranted. ( 5.1 )
BIKTARVY Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to BIKTARVY
3 of 10FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03696160 LAPTOP results posted | NEAT44 | Ph 3 | completed | The Late Presenter Treatment Optimisation Study |
| NCT03986697 HART CT | UoL001362 2017-005033-22 | Ph 4 | withdrawn | How Does Antiretroviral Therapy Affect Coronary Atherosclerosis: a Serial CT Study |
| NCT04653194 BIC-T&T | CRF002 2019-003208-11 | Ph 3 | completed | Efficacy of BIC/F/TAF Versus Standard of Care in the Treatment of New HIV Infection Diagnoses in the Context of 'Test and Treat' |
| NCT04416906 Test&Treat | Biktarvy Test&Treat 2019-004837-17 | Ph 3 | completed | A Test and Treat Strategy in New HIV Diagnosis. |
| NCT04860505 results posted | STUDY00002242 0000058968 | Ph 4 | completed | Combo-PEP: Multipurpose Prevention of Post-Exposure Prophylaxis Regimens |
| NCT03656783 BETTER results posted | 2018P001579 | Ph 3 | completed | Effects of Biktarvy on CFR in Stable HIV Patients |
| NCT04039217 results posted | IRB00111410 | Ph 4 | completed | Antiretroviral Therapy (ART) Persistence in Different Body Compartments in HIV Negative MSM |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BIKTARVY FDA Label Details
Indications & Usage
FDA Label (PDF)BIKTARVY is indicated for the treatment of Human Immunodeficiency Virus.
WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discon...
BIKTARVY Patents & Exclusivity
Patents (11 active)
Exclusivity
Pro Intelligence Preview
Deep insights for BIKTARVY
Revenue Insights
- • Q4-2025: $4.0B
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 40 active patents
Trial Analysis
- • 7 total trials
- • Stage: Mature
Competitive Landscape
- • 10 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment