darunavir (Prezista)

following an abbreviated submission

darunavir (Prezista®) is accepted for restricted use within NHS Scotland.

Indication under review: once daily darunavir co-administered with low dose ritonavir in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in paediatric patients aged 3 to 12 years and ≥15kg who are 1) treatment-naive or 2) treatment-experienced with no darunavir resistance-associated mutations, plasma-HIV-1 RNA <100,000 copies/mL, and CD4+ count >100x106 cells/L.

SMC restriction: to be prescribed under the supervision of specialists in paediatric HIV.

Darunavir is listed in the British National Formulary for Children in combination with other antiretroviral drugs for HIV infection in children previously treated with antiretrovirals or not previously treated with antiretroviral therapy.  The Scottish Medicines Consortium has previously accepted darunavir in this indication in paediatric patients aged 12 to 17 years and at least 40kg body weight, and in combination with other antiretroviral medicinal products in antiretroviral (ART)-experienced paediatric patients from the age of 3 years and at least 15kg body weight.