BIKTARVY Gilead Sciences Pty Ltd
Product name
BIKTARVY
Sponsor
Accepted date
Jun-2026
Active ingredients
bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate
Summary of proposed indication
BIKTARVY (bictegravir, emtricitabine and tenofovir alafenamide) is proposed to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults and children who weigh at least 25 kg. BIKTARVY is intended for people whose HIV has no known genetic changes that would make bictegravir or tenofovir ineffective against the virus.
Application type
C (new indication)
Publication date
Jun-2026