Doravirine / islatravir Medicine 04 December 2025 Extended indication Doravirine/islatravir combination therapy for treatment of HIV-1 infection in adults who are treatment naive or virologically suppressed on antiretroviral therapy. Therapeutic value Total cost € 1,100,000.00 Registration phase Clinical trials Product Active substance Doravirine / islatravir Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication HIV Extended indication Doravirine/islatravir combination therapy for treatment of HIV-1 infection in adults who are treatment naive or virologically suppressed on antiretroviral therapy. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer MSD Portfolio holder MSD Mechanism of action HIV inhibitor 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 June 2026 Expected Registration July 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Een combinatie van twee of drie antivirale middelen uit verschillende groepen met verschillende werkingsmechanismen en niet-overlappende resistentieprofielen. Therapeutic value Substantiation Doravirine plus islatravir toonde in recente fase-3 programma’s dat het bij onderhoud van virologische suppressie niet-inferieur is aan comparatorregimes (week-48 topline/peer-review resultaten / persmededelingen). Merck rapporteerde positieve topline-uitkomsten. Dit middel lijkt geen effect te hebben op gewichtstoename, wat een groot voordeel kan zijn. Nog niet alle resultaten zijn echter beschikbaar. Duration of treatment Frequency of administration 1 times a day Dosage per administration References NCT05631093 (MK-8591A-051); NCT05705349 (MK-8519A-053); Expertopinie Additional remarks Expected patient volume per year Patient volume < 100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie Additional remarks Er zijn 22.000 HIV/Aids patiënten in Nederland. De verwachting is dat 100 patiënten per jaar in aanmerking gaan komen voor dit middel. Expected cost per patient per year Cost € 11,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References Additional remarks Kosten op basis van IHSI-inschatting, afgeleid van de mediane kosten van dezelfde ATC-klasse (J05AR - antivirale middelen voor de behandeling van HIV‑infecties, combinaties) geneesmiddelen in Nederland. Potential total cost per year Total cost € 1,100,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks