BIKTARVY (Gilead Sciences Pty Ltd)
Product name
BIKTARVY
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
195 working days (255)
Active ingredients
bictegravir (as sodium); tenofovir alafenamide (as fumarate); emtricitabine
Registration type
NCE/NBE
Indication
BIKTARVY fixed dose combination (tablets) is indicated for the treatment of HIV-1 infection in adults who are antiretroviral therapy (ART)-naive or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA < 50 copies per mL) on a stable antiretroviral regimen at the start of therapy with no history of treatment failure, and no known substitutions associated with resistance to the individual components of BIKTARVY.