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Biktarvy

(bictegravir/emtricitabine/tenofovir alafenamide)

Biktarvy is a single-tablet, once-daily HIV regimen combining bictegravir with emtricitabine and tenofovir alafenamide. It is the most prescribed HIV treatment globally, preferred for high efficacy, high barrier to resistance, and favorable safety.

Infectious Diseases$11.0B RevenueGrowth blockbuster — HIV market leader
HIV Market Share
~40%
Resistance Cases
0 (trials)
Once-Daily Single Tablet
Yes
Patients Treated
5M+

Drug Overview

Generic Name
bictegravir/emtricitabine/tenofovir alafenamide
Company
Gilead Sciences
Mechanism
INSTI + 2 NRTIs (single-tablet regimen)
Drug Class
Single-tablet antiretroviral regimen
Route
Oral tablet (once daily)
Approval Year
2018
Peak Sales Estimate
$13B+ by 2026
Patent Expiry
2033+ (relatively late)

How It Works

Bictegravir inhibits HIV integrase, preventing viral DNA integration. Emtricitabine and tenofovir alafenamide are NRTIs blocking viral RNA-to-DNA conversion. Three-drug combo provides synergistic HIV suppression.

Revenue History ($B)

Annual revenue trajectory

Competitor Revenue Comparison ($B)

Revenue of competing drugs in the same class

Approved Indications

1 indications

Key Indications

All approved therapeutic uses

HIV-1 infection (treatment-naive and experienced)

Market Position

Biktarvy is the #1 prescribed HIV regimen globally with ~40% market share. Dominance driven by high barrier to resistance, single-tablet convenience, and no HLA-B*5701 testing needed.

Future Outlook

Projected to reach $13B+ by 2026. Long-acting injectable competition from ViiV’s Cabenuva is primary threat. Gilead developing lenacapavir (twice-yearly injection) to extend HIV franchise.

Competitive Landscape

DrugCompanyRevenue
Triumeq (dolutegravir/ABC/3TC)ViiV (GSK)$2.5B
Dovato (dolutegravir/3TC)ViiV (GSK)$2.0B
Cabenuva (cabotegravir/rilpivirine)ViiV (GSK)$1.5B
Symtuza (darunavir/c/FTC/TAF)J&J$0.5B

Approval Timeline

Feb 2018
HIV-1 (treatment-naive/experienced)
FDASingle-tablet regimen
Aug 2019
Pediatric HIV (≥25kg)
FDAPediatric formulation
Oct 2021
Pediatric HIV (≥14kg)
FDAExpanded pediatric

Key Clinical Trials

NCT05536341Completed
Switch studies
Phase 32,000 patients
Non-inferior, high switch rate
NCT04975955Ongoing
Long-acting formulation
Phase 3800 patients
Exploring long-acting BIC
Data Sources

Revenue figures from company annual reports (FY2023). Clinical trial data from ClinicalTrials.gov. Competitive intelligence from Evaluate Pharma World Preview 2024 and IQVIA MIDAS. Market analysis by Medifirm Intelledge Global.