Darunavir / cobicistat Medicine 04 December 2025 Extended indication Darunavir/cobicistat monotherapy for add-on treatment of HIV-1 infection in children over 3 years of age weighing at least 15kg. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Darunavir / cobicistat Domain Infectious diseases Reason of inclusion Indication extension IND Main indication HIV Extended indication Darunavir/cobicistat monotherapy for add-on treatment of HIV-1 infection in children over 3 years of age weighing at least 15kg. Current proprietary name Already available biosimilars / generics Proprietary name Rezolsta Manufacturer Janssen Portfolio holder Janssen Mechanism of action Virus inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Darunavir is een proteaseremmer. Cobicistat versterkt de werking van darunavir doordat het de tijd dat darunavir in het lichaam werkzaam is verlengt. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date May 2025 Expected Registration June 2026 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 niet het eerste keus medicament. De verwachting is dat het gebruik bij kinderen 3 - 6 jaar klein zal zijn. Het middel heeft echter mogelijk wel meerwaarde bij HIV-resistentie, bijvoorbeeld bij INSTI resistentie. Duration of treatment Frequency of administration Dosage per administration References NCT02016924 (GS-US-216-0128); Expertopinie 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 drie en zes 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