EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE (emtricitabine)
Biktarvy is a complete daily regimen used for adults and children weighing at least 14 kg who are living with HIV-1. It helps patients who are either starting HIV therapy for the first time or those who are already stable on another treatment and want to switch. This combination therapy is used to maintain viral suppression in patients who do not have a history of resistance to its specific ingredients
Development Insights
Details
- Status
- Prescription
- First Approved
- 2026-01-30
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE Approval History
What EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE Treats
1 indicationsEMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE is approved for 1 conditions since its original approval in 2026. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Human Immunodeficiency Virus
EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE 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 )
EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE Competitive Set
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Indication competitors
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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 EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE
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Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05979311 VOGUE | 219816 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy |
| NCT01400412 results posted | ACTG A5303 1U01AI068636 | Ph 2 | completed | Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen |
| NCT00799864 results posted | CR002677 TMC278-TiDP38-C213, 2008-001696-30 | Ph 2 | completed | A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years |
| NCT02475915 | SEARCH 019 | Ph 1, Ph 2 | completed | Efficacy of VHM After Treatment Interruption in Subjects Initiating ART During Acute HIV Infection |
| NCT01505114 results posted | HPTN 069/A5305 (NEXT Prep) 11789, HPTN 069/A5305 | Ph 2 | completed | Evaluating the Safety and Tolerability of Antiretroviral Drug Regimens Used as Pre-Exposure Prophylaxis to Prevent HIV Infection in At-Risk Men Who Have Sex With Men and in At-Risk Women |
| NCT01709084 SALIF results posted | CR100875 TMC278IFD3002 | Ph 3 | completed | A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment |
| NCT04477096 | HS-10234-108 | Ph 1 | completed | Evaluation of Drug Interaction Between HS-10234 and Emtriccitabine |
| NCT01803074 results posted | 206739 2012-004124-38, AI468-002 | Ph 2 | completed | Study to Evaluate a HIV Drug for the Treatment of HIV Infection |
| NCT01335620 results posted | RTG_60 2010-022907-23 | Ph 4 | completed | The Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age |
| NCT02116660 RANIA results posted | 0518-284 2013-001637-40, MK-0518-284 | Ph 2 | terminated | Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) |
| NCT02904369 | A15-137 | Ph 1 | completed | PK and PD Study of Oral F/TAF for HIV Prevention |
| NCT00869960 results posted | F080428014 1K23AI074390-01A2 | Ph 4 | completed | Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in Healthy Women |
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.
EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE FDA Label Details
Indications & Usage
EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE 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...
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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