DESCOVY (Gilead Sciences Pty Ltd)
Product name
DESCOVY
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
191 (255 working days)
Active ingredients
emtricitabine; tenofovir alafenamide fumarate
Registration type
EOI
Indication
Treatment of HIV-1 Infection
DESCOVY (tablet) is now also indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and paediatric patients weighing at least 25kg. The patients must not have a history of treatment failure or known mutations associated with resistance to the individual components of DESCOVY (see section 5.1 Pharmacodynamic properties).
HIV-1 Pre-Exposure Prophylaxis
DESCOVY is now also indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35 kg, excluding individuals at risk from receptive vaginal sex.