EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE (emtricitabine)
This combination tablet treats HIV-1 infection in adults and children weighing at least 35 kg. It serves as a complete daily regimen for patients who have never taken antiretroviral therapy before, provided their viral load is 100,000 copies/mL or less at the start of treatment. It is also used to replace current medications in patients who have
Details
- Status
- Prescription
- First Approved
- 2025-05-20
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE Approval History
What EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE Treats
1 indicationsEMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Human Immunodeficiency Virus
EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE Boxed Warning
POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B virus (HBV) have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), two of the components of emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets . Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are co...
WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B virus (HBV) have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), two of the components of emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets . 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 emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1) ] . WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B See full prescribing information for complete boxed warning. Severe acute exacerbations of hepatitis B virus (HBV) have been reported in patients coinfected with HIV-1 and HBV who have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), two of the components of emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets. 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 emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets. If appropriate, initiation of anti-hepatitis B therapy may be warranted. ( 5.1 )
EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE 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 EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE
3 of 10FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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 DISOPROXIL FUMARATE FDA Label Details
Indications & Usage
EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE is indicated for the treatment of Human Immunodeficiency Virus.
WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B virus (HBV) have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), two of the com...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.