NDAORALTABLETPriority Review
Approved
Feb 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
13
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 9h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BIKTARVY is a once-daily, single-tablet regimen combining bictegravir (integrase strand transfer inhibitor), emtricitabine, and tenofovir alafenamide for treatment of HIV-1 infection. It works by inhibiting reverse transcriptase and integrase enzymes critical to HIV replication. The combination provides potent antiretroviral activity with a favorable tolerability profile compared to older tenofovir formulations.
$3.2BPart D
PeakStable
10.3 years to LOEBIKTARVY remains a peak-revenue product with substantial market penetration; commercial teams focus on market defense and treatment-experienced patient expansion.
Mechanism 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 (13)
Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment
Started Jul 2026
700 enrolled
HIV-1-infection
A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1
Started Jun 2026
175 enrolled
HIV-1-infection
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
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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.