Lenacapavir

Extended indication	Lenacapavir monotherapy for prophylactic treatment of HIV infection in adolescents over 16 years of age, adults and elderly
Therapeutic value	No estimate possible yet
Registration phase	Clinical trials

Product

Active substance	Lenacapavir
Domain	Infectious diseases
Reason of inclusion	Indication extension
Main indication	HIV
Extended indication	Lenacapavir monotherapy for prophylactic treatment of HIV infection in adolescents over 16 years of age, adults and elderly
Proprietary name	Sunlenca
Manufacturer	Gilead
Mechanism of action	Virus inhibitor
Budgetting framework	Extramural (GVS)
Additional remarks	Long acting, capsid protein inhibitor. Als tablet voor orale toediening en als injectie voor subcutane toediening.

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	December 2024
Expected Registration	October 2025
Orphan drug	No
Registration phase	Clinical trials
Additional remarks	Indieningsdatum gebaseerd op de primary completion datum van PURPOSE-1 fase 3-trial (september 2024). De verwachte registratie is ingeschat op basis van een gemiddelde doorlooptijd van 10 maanden voor een indicatieuitbreiding.

Current treatment options	Andere HIV PrEP
Therapeutic value	No estimate possible yet
Duration of treatment	continuous
Frequency of administration	1 times every 6 months
References	NCT04994509 (PURPOSE-1); NCT04925752 (PURPOSE-2)
Additional remarks	600mg oral loading dose on days 1 and 2 with 927mg subcutaneous dose on day 1. Then subcutaneous dose every 6 months.

There is currently nothing known about the expected patient volume.

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.