Tibotec release lower dose of Prezista

The USA's Tibotec Therapeutics, a division of US drug major Johnson & Johnson, has released a lower-dose (75mg) formulation of Prezista  (darunavir) for the treatment of HIV infection in pediatric patients six  years of age and older.

The pediatric indication for Prezista is based on 24-week analyses of  pharmacokinetics, safety, tolerability and antiviral activity from the  open-label Phase II DELPHI trial, of Prezista in combination with other  antiretrovirals in 80 treatment-experienced HIV-1-infected pediatric  subjects six to 18 years of age and weighing at least 44 lbs.

At week 24, 74% of subjects had at least 1 log10 HIV-1 RNA decrease from  baseline. The proportion of pediatric subjects reaching undetectable  viral load (<50 HIV-1 RNA copies/mL) was 50%, and the proportion of  patients with <400 HIV-1 RNA copies/mL was 64%.