darunavir (Prezista)

following an abbreviated submission

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

Indication under review: 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 12 to 17 years of age and at least 40kg body weight who are: antiretroviral therapy (ART) naïve; or, ART-experienced with no darunavir resistance associated mutations and who have plasma HIV-1 RNA <100,000 copies/mL and CD4+ cell count ≥100 cells/mm3.

SMC restriction: in patients <18 years, to be prescribed under the supervision of specialists in paediatric HIV.

The Scottish Medicines Consortium has previously accepted darunavir for use in this indication in adults and in highly pre-treated children and adolescents, from the age of 6 years and at least 20kg body weight, who have failed on more than one regimen containing a protease inhibitor. Darunavir is listed in the British National Formulary for Children in combination with other antiretroviral drugs, for HIV infection resistant to other protease inhibitors in children previously treated with antiretrovirals.