NDAORALTABLETPriority Review
Approved
Jul 2006
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
15
Data completeness
5/8 — Partial
Priority Review
ATRIPLA (efavirenz; emtricitabine; tenofovir disoproxil fumarate) by Gilead Sciences is fixed-dose combination of antiviral drugs efavirenz, emtricitabine and tenofovir disoproxil fumarate. First approved in 2006.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ATRIPLA is a fixed-dose combination oral tablet containing efavirenz, emtricitabine, and tenofovir disoproxil fumarate, three antiretroviral agents that work synergistically to inhibit HIV replication. It is indicated for treatment of HIV-1 infection in antiretroviral-naive and experienced patients. The combination targets reverse transcriptase and integrase pathways to suppress viral load.
$0.085BPart D
LOE ApproachingDeclining
3.0 years to LOEAs a mature product approaching loss of exclusivity in 2029, the brand team is likely in optimization and transition mode with reduced headcount and focus on loyalty and managed care.
Mechanism of Action
fixed-dose combination of antiviral drugs efavirenz, emtricitabine and tenofovir disoproxil fumarate. [See ].
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (15)
B/F/TAF vs Atripla Double-Blind Switch Study in HIV-1 Infected Adults
Started Oct 2018
28 enrolled
HIV-1-infection
Effects of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppressed Participants (MK-1439A-028)
Started Mar 2016
86 enrolled
HIV-1Central Nervous System
SSAT058: Atripla to Eviplera Switch in Patients Without Central Nervous System Symptoms
Started Nov 2015
40 enrolled
HIV
Evolution of Plasma Lipid Profile in Patients With HIV1 Who Change Atripla to Eviplera Compared to Continue With Atripla
Started Sep 2015
30 enrolled
HIV-1
Switching From Efavirenz/Atripla to Rilpivirine Among Patients With Neurocognitive or Neuropsychological Side Effects
Started Jul 2015
74 enrolled
Impaired CognitionDepression/AnxietyPoor Quality Sleep+2 more
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.