BIKTARVY
PeakNDAORALTABLETPriority Review
Approved
Feb 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
13
Data completeness
6/8 — Strong
Priority Review
BIKTARVY by Gilead Sciences is (bic), emtricitabine (ftc), and tenofovir alafenamide (taf) [see ] . First approved in 2018.
Drug data last refreshed 2h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BIKTARVY is a once-daily, single-tablet oral antiretroviral combining bictegravir (BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF) for HIV-1 treatment. It works through three complementary mechanisms: integrase strand transfer inhibition, nucleoside reverse transcriptase inhibition, and nucleotide reverse transcriptase inhibition. The fixed-dose combination simplifies HIV management with improved tolerability compared to earlier regimens.
$3.2BPart D
PeakStable
10.0 years to LOEThe product is at peak commercial performance with >750k annual Part D claims, indicating a mature, well-established revenue stream supporting large brand and commercial teams.
Mechanism of Action
(BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF) [see ] .
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.