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The FDA granted accelerated approval for the PI darunavir (Prezista) on June 23, 2006. Darunavir has in vitro activity against many PI-resistant viruses and must be coadministered with ritonavir to achieve therapeutic drug levels.
Darunavir is indicated for the treatment of HIV infection in treatment-experienced adults, such as those with strains resistant to more than one PI. Its approval was based on favorable 24-week results from the POWER studies, which have been presented at several meetings over the past 2 years (ACC Mar 21 2005, Sep 14 2005 and Feb 1 2006). In these studies, triple-class–experienced patients with viral loads >1000 copies/mL and at least one major PI-associated mutation were randomized to receive…