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Last summer, based on the results of the three POWER studies, the FDA approved the PI darunavir for use in treatment-experienced patients. Now, results from the POWER 1 study have finally been published.
Patients were eligible for the study if they had evidence of virologic failure (>1000 copies/mL), prior exposure to all three major drug classes, and at least one major PI resistance mutation. Enrolled patients were randomized to receive an optimized background regimen plus either ritonavir-boosted darunavir (at 1 of 4 doses) or an investigator-selected comparator PI. The 318 patients treated (mean viral load, 4.5 log copies/mL; median CD4 count, 179 cells/mm3) were highly treatment-experienced, and approximately 60% had virus resistant to a…