Product Name and Form
Biktarvy 50 mg/200 mg/25 mg film-coated tablets.
Film-coated tablet (tablet).
Purplish-brown, capsule-shaped, film-coated tablet debossed with “GSI” on one side and “9883” on the other side of the tablet. Each tablet is approximately 15 mm × 8 mm.
Qualitative and Quantitative Composition
Each film-coated tablet contains bictegravir sodium equivalent to 50 mg of bictegravir, 200 mg of emtricitabine, and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
For the full list of excipients, see section 6.1.
Bictegravir is a type of antiviral agent called an ‘integrase inhibitor’. It blocks an enzyme called integrase that is needed by the HIV virus to make new copies of itself in the body.
Emtricitabine is a synthetic nucleoside analogue of cytidine with activity that is specific to human immunodeficiency virus (HIV-1 and HIV-2) and hepatitis B virus (HBV).
Tenofovir alafenamide is a phosphonamidate prodrug of tenofovir. The pharmacologically active metabolite tenofovir diphosphate inhibits HBV replication through incorporation into viral DNA by the HBV reverse transcriptase, which results in DNA chain termination. Tenofovir has activity that is specific to hepatitis B virus and human immunodeficiency virus (HIV-1 and HIV-2).
Titanium dioxide (E171)
Iron oxide red (E172)
Iron oxide black (E172)
Pack sizes and Marketing
White, high density polyethylene (HDPE) bottle with a polypropylene continuous-thread, child-resistant cap, lined with an induction activated aluminium foil liner containing 30 film-coated tablets. Each bottle contains silica gel desiccant and polyester coil.
The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets.
Not all pack sizes may be marketed.
Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Date of first authorisation: 21 June 2018