Prezista darunavir regulatory update

FDA approved an updated label for Johnson & Johnson's Prezista darunavir to include 192-week data from the open-label, international Phase III ARTEMIS trial to treat HIV-1 infection in 689 treatment-naive patients. Data from ARTEMIS showed that 800 mg once-daily Prezista plus 100 mg Norvir ritonavir was non-inferior to Kaletra lopinavir/ritonavir at week 192. Specifically, 70% of patients receiving Prezista/Norvir reached an undetectable viral load (<50 copies/mL) vs. 61% of patients receiving Kaletra (95% CI: 1.9; 16.1). The trial previously met the primary endpoint of non-inferiority to Kaletra at week 48 and the secondary endpoint of non-inferiority to Kaletra at week 96 (see BioCentury, Nov. 3, 2008). ...