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BIKTARVY (Gilead Sciences Pty Ltd)
Product name
BIKTARVY
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
183 (255 working days)
Active ingredients
bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate
Registration type
EOI
Indication
BIKTARVY is indicated for the treatment of HIV-1 infection in adults and paediatric patients weighing at least 25 kg who are antiretroviral therapy (ART)-naïve or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA < 50 copies/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 bictegravir or tenofovir.