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Efavirenz, lamivudine, and tenofovir
Efavirenz, lamivudine, and tenofovir is a marketed antiretroviral combination therapy developed by the University of Maryland, Baltimore. The key composition patent expires in 2028, providing a strong barrier to generic competition until then. The primary risk is the lack of recent key trial results to support ongoing efficacy and safety, which may impact market confidence.
At a glance
| Generic name | Efavirenz, lamivudine, and tenofovir |
|---|---|
| Also known as | Atripla, Epivir and Viread |
| Sponsor | University of Maryland, Baltimore |
| Drug class | Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: POST TREATMENT ACUTE EXACERBATIONS OF HEPATITIS B Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine or tenofovir disoproxil fumarate, two components of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment [see Warnings and Precautions (5.1) ]. WARNING: POST TREATMENT ACUTE EXACERBATIONS OF HEPATITIS B See full prescribing information for complete boxed warning. • Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with HBV and human immunodeficiency virus (HIV-1) and have discontinued lamivudine and tenofovir disoproxil fumarate. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment. ( 5.1 )
Common side effects
- Rash event
- Headache
- Pain
- Diarrhea
- Depression
- Back pain
- Nausea
- Fever
- Abdominal pain
- Asthenia
- Anxiety
- Vomiting
Serious adverse events
- Pancreatitis (fatal in some cases)
- Fasting Cholesterol elevation (Grade 3-4)
- Creatine Kinase elevation (Grade 3-4)
- Serum Amylase elevation (Grade 3-4)
- Hematuria (Grade 3-4)
- AST elevation (Grade 3-4)
- ALT elevation (Grade 3-4)
- Neutrophils decrease (Grade 3-4)
- Bone mineral density loss
- Clinically relevant fractures
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)
- Safety and Virologic Effect of a Human Monoclonal Antibody (VRC01) Administered Intravenously to Adults During Early Acute HIV Infection (PHASE1)
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (PHASE2, PHASE3)
- Safety and Pharmacokinetics of Dolutegravir in Pregnant HIV Mothers and Their Neonates: A Pilot Study (PHASE2, PHASE3)
- Research on the Psychological Status of Patients With HIV-1 Infection
- Effects of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppressed Participants (MK-1439A-028) (PHASE2)
- Study Evaluating the Safety, in Terms of HBV Virological Control At 96 Weeks, of 2 Antiviral Treatment Relief Strategies, in Patients Co-infected with the HIV-1 and HBV Viruses (PHASE2)
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
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