Bristol-Myers Squibb Receives FDA Approval To Update Labeling For Reyataz Capsules

Bristol-Myers Squibb has reported that FDA has approved a labeling update for Reyataz to include long-term data from the Castle study. The Castle study assessed a once-daily Reyataz/ritonavir (Reyataz/r)-based regimen versus a twice-daily lopinavir/ritonavir (LPV/r)-based regimen in previously untreated adult patients infected with HIV-1.

In the Castle study, a majority of patients on the Reyataz/r regimen achieved undetectable viral load defined as HIV-1 RNA <50 copies/ml confirming efficacy through 96 weeks. 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.

The primary endpoint for the study was the proportion of patients with viral load less than 50 copies/ml at 48weeks with an intent-to-treat (ITT) analysis according to confirmed virologic response.

In a pre-specified analysis, 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 vs. 67% of 222 patients in the twice-daily LPV/r arm.

In addition, the 96-week data confirmed the effect of Reyataz on lipids. There were lower mean increases from baseline in total cholesterol, LDL cholesterol and triglycerides with Reyataz/r compared to LPV/r.