Reyataz labeling updated to include long-term data in treatment-naive adults with HIV

Bristol-Myers Squibb announced that the FDA has approved updated labeling for Reyataz (atazanavir sulfate capsules), a protease inhibitor indicated for the treatment of HIV-1 infection, to include long-term (96-week) data from the CASTLE study. The CASTLE study was an international, multicenter, open-label, non-inferiority study which assessed a once-daily Reyataz/ritonavir (Reyataz/r)-based regimen versus a twice-daily lopinavir/ritonavir (LPV/r)-based regimen in 883 treatment-naive adults infected with HIV-1.

Patients were randomized to receive the Reyataz/r regimen or LPV/r regimen in combination with a once-daily, fixed-dose combination of tenofovir disoproxil fumarate/emtricitabine.  At 96 weeks, 75% of patients treated Reyataz/r regimen achieved an undetectable viral load (HIV-1 RNA <50 copies/mL) versus 68% of patients who received LPV/r. Low rates of drug resistance were observed at 96 weeks in patients who failed the Reyataz/r regimen, with one patient developing genotypic/phenotypic resistance to Reyataz and five patients developing genotypic/phenotypic resistance to emtricitabine. Efficacy in patients with high baseline viral load (≥100,000 copies/mL) was demonstrated: 74% of 223 patients in the once-daily Reyataz/r arm achieved undetectable viral load at 96 weeks versus 67% of 222 patients in the twice-daily LPV/r arm.

Additionally, the effects of Reyataz on lipid levels were assessed. At 96 weeks there were lower mean increases from baseline in total cholesterol, LDL-C and triglycerides with Reyataz/r compared to LPV/r, respectively: total cholesterol (13% vs. 25%), LDL-C (14% vs. 17%), HDL-C (21% vs. 29%), and triglycerides (13% vs. 50%).

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