darunavir (Prezista)

Following an abbreviated submission:

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

Indication under review: co-administered with low dose ritonavir in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients as well as antiretroviral therapy (ART)-experienced paediatric patients from the age of 3 years and at least 15 kg body weight.

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

Darunavir is listed in the British National Formulary for Children for the treatment of HIV resistant to other protease inhibitors. 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.