Darunavir / cobicistat / emtricitabine / tenofovir alafenamide Medicine 03 June 2025 Extended indication Darunavir/cobicistat/emtricitabine/tenofovir alafenamide monotherapy for treatment of HIV-1 infection in children over 6 years of age with body weight at least 25kg. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Darunavir / cobicistat / emtricitabine / tenofovir alafenamide Domain Infectious diseases Reason of inclusion Indication extension IND Main indication HIV Extended indication Darunavir/cobicistat/emtricitabine/tenofovir alafenamide monotherapy for treatment of HIV-1 infection in children over 6 years of age with body weight at least 25kg. Current proprietary name Already available biosimilars / generics Proprietary name Symtuza Manufacturer Janssen Portfolio holder Mechanism of action Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date February 2025 Expected Registration December 2025 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Een combinatie van twee NRTI’s + een INSTI Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Voor deze groep is darunavir / cobicistat / emtricitabine / tenofovir alafenamide niet het eerste keus medicament. Dit is mogelijk wel een goede single tablet regimen indien er HIV-resistentie is (met name tegen INSTI) of bij bijwerkingen tegen andere middelen. Duration of treatment Frequency of administration Dosage per administration References NCT02016924 (GS-US-216-0128) Additional remarks Expected patient volume per year Patient volume 5 - 10 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie Additional remarks In Nederland zijn er tussen de vijf en tien patiënten tussen de zes en twaalf jaar oud met HIV/AIDS. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks