J&J's Prezista gets expanded EU label

The European Commission has approved once-daily dosing of US health care major Johnson & Johnson's 800mg Prezista (darunavir) with low-dose  ritonavir in treatment-naive adults, broadening the protease inhibitor's  use beyond treatment-experienced HIV-1 patients.

The approval is based on 48-week analyses of plasma HIV RNA levels and  CD4+ cell counts from ARTEMIS, an open-label Phase III trial in  antiretroviral treatment-naive HIV-1-infected adults. ARTEMIS studied  the efficacy and safety of darunavir/r versus lopinavir/r in combination  with other antiretrovirals.

The data showed that darunavir was non-inferior to the comparator,  although more patients in the darunavir/r arm achieved undetectable  viral load (less than 50 copies/mL) compared to lopinavir/r (84% vs  78%). The common adverse drug reactions reported of at least moderate  intensity in the darunavir/r arm were hypertriglyceridemia,  hypercholesterolemia, headache, diarrhea, nausea and increased alanine  aminotransferase.