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Darunavir was initially approved for treatment-experienced patients at a dose of 600 mg, with 100 mg of ritonavir, twice daily. However, data from the POWER 1 and 2 trials suggested that the once-daily dose approved for use in treatment-naive patients — 800 mg, with 100 mg of ritonavir — might also be effective in treatment-experienced patients with no baseline darunavir resistance. The ODIN trial, a phase III, open-label, manufacturer-funded study, was designed to evaluate this possibility.
A total of 590 patients who were on a failing regimen and had no darunavir resistance–associated mutations were randomized to receive ritonavir-boosted darunavir either once daily (800 mg, with 100 mg of ritonavir) or twice daily (600 mg, with 100 mg of …