Prezista (darunavir tablet, from Tibotec Therapeutics)is available as a lower-dose 75mg formulation for the treatment of HIV infectionin pediatric patients ≥6 years of age, which received FDAapproval in December 2008.
The approval for pediatric use was based on results fromDELPHI, a 24-week, open-label, Phase 2 trial,in which antiretroviral treatment-experienced HIV-1 infected pediatric patientsreceived Prezista co-administered with ritonavir in combination with otherantiretroviral agents. At week 24, 74% of patients had a decrease from baselinein plasma HIV-1 RNA viral load. The proportion of pediatric patients reachingundetectable viral load was 50%.
Prezista is already approved for the treatment of HIVinfection in adult patients in 300mg, 400mg, and 600mg dosagestrengths.
For more information call (877) REACH-TT or visitwww.prezista.com.