EC allows durable efficacy data for Reyataz label

US drug major Bristol-Myers Squibb says that the European Commission has approved the inclusion of 96-week data from clinical study AI424-045 towards the European labeling for its once-daily HIV drug, Reyataz (atazanavir), when administered with ritonavir. The EC decision follows a positive opinion by the Committee for Medicinal Products for Human Use.

Previously, the labeling included 48-week efficacy data from the randomized, multinational, open-label trial, in which similar antiviral efficacy was demonstrated for Reyataz and ritonavir versus a regimen of lopinavir and ritonavir. The updated labeling includes data on patients enrolled in the trial who were studied for 96 weeks, where the fomer regimen continued to demonstrate comparable efficacy to that based on the primary endpoint of time averaged difference in HIV RNA.

Margaret Johnson, clinical director of the Royal Free Hospital, London, UK, said that such long-term data are important to prescribers as they help "reinforce the durability of efficacy, safety and tolerability." Patients in the Reyataz arm of trial also demonstrated significantly lower lipid levels, as assessed by mean percent changes from baseline in total cholesterol (-7% vs 9%; p<0.0001), although the clinical impact of these differences is not known.