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European Union Approves Darunavir for Treatment-Experienced Patients NEW YORK -- December 3, 2008 -- The European Commission has broadened the indication for darunavir (Prezista) in combination with ritonavir and other antiretroviral drugs for the treatment of HIV-1 infection in all treatment-experienced adult patients. The extended indication was based on the 48-week analysis of the phase 3 TMC4/R in Treatment-Experienced Patients Naive to Lopinavir (TITAN) trial. Results showed that 77% of patients in the darunavir/r arm (n=298) versus 67% of patients in the lopinavir/r arm (n=297) reached less than 400 copies/mL (P<.0001). Darunavir was generally well tolerated. The majority of the adverse reactions reported in patients who initiated therapy with darunavir 600 mg co-administered with 100 mg ritonavir twice daily were mild to moderate in severity. SOURCE: Johnson&Johnson E-mail this page to a friend or colleague! To print, use this version