It is accepted for use in patients who are treatment-naive or treatment-experienced with no darunavir resistance-associated mutations, plasma-HIV-1 RNA <100,000 copies/mL, and CD4+ count >100x106 cells/L, and is restricted to prescription under the supervision of specialists in paediatric HIV.
The SMC 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 antiretrovirals in antiretroviral (ART)-experienced paediatric patients from the age of 3 years and at least 15kg body weight