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efavirenz, emtricitabine, and tenofovir
efavirenz, emtricitabine, and tenofovir is a Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] Small molecule drug developed by University of North Carolina, Chapel Hill. It is currently FDA-approved. Also known as: Tenofovir disoproxil fumarate, Emtricitabine, FDC Emtricitabine 200 mg/ tenofovir 300 mg, Efavirenz.
At a glance
| Generic name | efavirenz, emtricitabine, and tenofovir |
|---|---|
| Also known as | Tenofovir disoproxil fumarate, Emtricitabine, FDC Emtricitabine 200 mg/ tenofovir 300 mg, Efavirenz, FDC Emtricitabine 200mg/Tenofovir 300mg DF/Efavirenz 600mg |
| Sponsor | University of North Carolina, Chapel Hill |
| Drug class | Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B virus (HBV) 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), which are components of efavirenz, emtricitabine and tenofovir disoproxil fumarate. 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 efavirenz, emtricitabine and tenofovir disoproxil fumarate. 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 HBV and HIV-1 who have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of efavirenz, emtricitabine and tenofovir disoproxil fumarate . 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 efavirenz, emtricitabine and tenofovir disoproxil fumarate . If appropriate, initiation of anti-hepatitis B therapy may be warranted. (5.1)
Common side effects
- Diarrhea
- Nausea
- Fatigue
- Headache
- Dizziness
- Depression
- Insomnia
- Abnormal dreams
- Rash
- Pain
- Impaired concentration
- Somnolence
Serious adverse events
- Pancreatitis
- Asymptomatic increases in serum amylase levels
- Psychiatric symptoms
- Nervous system symptoms
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)
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (PHASE3)
- Safety and Virologic Effect of a Human Monoclonal Antibody (VRC01) Administered Intravenously to Adults During Early Acute HIV Infection (PHASE1)
- Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (PHASE2, PHASE3)
- Research on the Psychological Status of Patients With HIV-1 Infection
- Virological and Immunological Safety of a Dose Reduction Strategy Antiretroviral Regimen With Efavirenz / Tenofovir / Emtricitabine (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:
- efavirenz, emtricitabine, and tenofovir CI brief — competitive landscape report
- efavirenz, emtricitabine, and tenofovir updates RSS · CI watch RSS
- University of North Carolina, Chapel Hill portfolio CI
Frequently asked questions about efavirenz, emtricitabine, and tenofovir
What is efavirenz, emtricitabine, and tenofovir?
efavirenz, emtricitabine, and tenofovir is a Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] drug developed by University of North Carolina, Chapel Hill.
Who makes efavirenz, emtricitabine, and tenofovir?
efavirenz, emtricitabine, and tenofovir is developed and marketed by University of North Carolina, Chapel Hill (see full University of North Carolina, Chapel Hill pipeline at /company/university-of-north-carolina-chapel-hill).
Is efavirenz, emtricitabine, and tenofovir also known as anything else?
efavirenz, emtricitabine, and tenofovir is also known as Tenofovir disoproxil fumarate, Emtricitabine, FDC Emtricitabine 200 mg/ tenofovir 300 mg, Efavirenz, FDC Emtricitabine 200mg/Tenofovir 300mg DF/Efavirenz 600mg.
What drug class is efavirenz, emtricitabine, and tenofovir in?
efavirenz, emtricitabine, and tenofovir belongs to the Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] class. See all Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] drugs at /class/human-immunodeficiency-virus-1-non-nucleoside-analog-reverse-transcriptase-inhibitor-epc.
What development phase is efavirenz, emtricitabine, and tenofovir in?
efavirenz, emtricitabine, and tenofovir is FDA-approved (marketed).
What are the side effects of efavirenz, emtricitabine, and tenofovir?
Common side effects of efavirenz, emtricitabine, and tenofovir include Diarrhea, Nausea, Fatigue, Headache, Dizziness, Depression. Serious adverse events: Pancreatitis, Asymptomatic increases in serum amylase levels, Psychiatric symptoms, Nervous system symptoms.
Related
- Drug class: All Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] drugs
- Manufacturer: University of North Carolina, Chapel Hill — full pipeline
- Also known as: Tenofovir disoproxil fumarate, Emtricitabine, FDC Emtricitabine 200 mg/ tenofovir 300 mg, Efavirenz, FDC Emtricitabine 200mg/Tenofovir 300mg DF/Efavirenz 600mg
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