NDAORALTABLETPriority Review
Approved
Feb 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
12
Data completeness
8/8 — Comprehensive
Priority Review
BIKTARVY (bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate) by Gilead Sciences is nucleoside reverse transcriptase inhibitors [moa]. Approved for human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor [epc]. First approved in 2018.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BIKTARVY is a once-daily, single-tablet regimen combining bictegravir (an integrase strand transfer inhibitor), emtricitabine, and tenofovir alafenamide for the treatment of human immunodeficiency virus (HIV) infection. The product works through multiple mechanisms of action targeting reverse transcriptase and integrase enzymes essential for HIV replication. Approved in February 2018, BIKTARVY represents a modern, well-tolerated option in the HIV treatment landscape, offering improved renal and bone safety compared to older tenofovir formulations.
$3.2BPart D
10.5 years to LOEMechanism of Action
Nucleoside Reverse Transcriptase Inhibitors
Pharmacologic Class:
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (12)
Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated
Started Oct 2024
73 enrolled
HIV-1-infection
Study of Oral Weekly Lepetegravir (Formerly GS-1720) and Lenacapavir Pacfosacil (Formerly GS-4182) Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed
Started Aug 2024
675 enrolled
HIV-1-Infection
Drug-drug Interaction Study of Biktarvy and Bemnifosbuvir/Ruzasvir
Started Apr 2024
28 enrolled
Healthy Volunteer Study
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
Started Mar 2024
577 enrolled
HIV-1-infection
Effect of Biktarvy & Symtuza on microRNAs in HIV and Correlation With Weight Gain
Started Mar 2023
30 enrolled
HIV InfectionsObesity
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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.