Last reviewed · How we verify
Emtricitabine/rilpivirine/tenofovir disoproxil fumarate
Emtricitabine/rilpivirine/tenofovir disoproxil fumarate is a Antiretroviral combination therapy (NRTI/NtRTI + NNRTI) Small molecule drug developed by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. It is currently FDA-approved for HIV-1 infection in treatment-naïve adults, HIV-1 infection in virologically suppressed patients as maintenance therapy. Also known as: FTC/RPV/TDF, Complera.
This combination drug inhibits HIV reverse transcriptase and integrase through three complementary antiretroviral agents, preventing viral replication and reducing viral load.
This combination drug inhibits HIV reverse transcriptase and integrase through three complementary antiretroviral agents, preventing viral replication and reducing viral load. Used for HIV-1 infection in treatment-naïve adults, HIV-1 infection in virologically suppressed patients as maintenance therapy.
At a glance
| Generic name | Emtricitabine/rilpivirine/tenofovir disoproxil fumarate |
|---|---|
| Also known as | FTC/RPV/TDF, Complera |
| Sponsor | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections |
| Drug class | Antiretroviral combination therapy (NRTI/NtRTI + NNRTI) |
| Target | HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
Emtricitabine and tenofovir disoproxil fumarate are nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs/NtRTIs) that block the enzyme HIV uses to convert its RNA genome into DNA. Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that binds directly to reverse transcriptase and inhibits its activity. Together, these three agents provide potent suppression of HIV replication through complementary mechanisms.
Approved indications
- HIV-1 infection in treatment-naïve adults
- HIV-1 infection in virologically suppressed patients as maintenance therapy
Common side effects
- Nausea
- Diarrhea
- Headache
- Rash
- Elevated liver enzymes
- Renal impairment (tenofovir-related)
Key clinical trials
- Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2, PHASE3)
- Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (PHASE3)
- Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
- Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 (PHASE3)
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (PHASE2, PHASE3)
- Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive (PHASE4)
- Research on the Psychological Status of Patients With HIV-1 Infection
- Study to Evaluate the Efficacy and Safety of a Rilpivarine-based Antiretroviral Tratment Regimen in HIV- Infected Patients With Liver Metabolic Disease Who Maintain Udetectable HIV Viral Load (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Emtricitabine/rilpivirine/tenofovir disoproxil fumarate CI brief — competitive landscape report
- Emtricitabine/rilpivirine/tenofovir disoproxil fumarate updates RSS · CI watch RSS
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections portfolio CI
Frequently asked questions about Emtricitabine/rilpivirine/tenofovir disoproxil fumarate
What is Emtricitabine/rilpivirine/tenofovir disoproxil fumarate?
How does Emtricitabine/rilpivirine/tenofovir disoproxil fumarate work?
What is Emtricitabine/rilpivirine/tenofovir disoproxil fumarate used for?
Who makes Emtricitabine/rilpivirine/tenofovir disoproxil fumarate?
Is Emtricitabine/rilpivirine/tenofovir disoproxil fumarate also known as anything else?
What drug class is Emtricitabine/rilpivirine/tenofovir disoproxil fumarate in?
What development phase is Emtricitabine/rilpivirine/tenofovir disoproxil fumarate in?
What are the side effects of Emtricitabine/rilpivirine/tenofovir disoproxil fumarate?
What does Emtricitabine/rilpivirine/tenofovir disoproxil fumarate target?
Related
- Drug class: All Antiretroviral combination therapy (NRTI/NtRTI + NNRTI) drugs
- Target: All drugs targeting HIV reverse transcriptase
- Manufacturer: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Virology
- Indication: Drugs for HIV-1 infection in treatment-naïve adults
- Indication: Drugs for HIV-1 infection in virologically suppressed patients as maintenance therapy
- Also known as: FTC/RPV/TDF, Complera
- Compare: Emtricitabine/rilpivirine/tenofovir disoproxil fumarate vs similar drugs
- Pricing: Emtricitabine/rilpivirine/tenofovir disoproxil fumarate cost, discount & access