Wednesday, September 19, 2007

New Phase 3 Study In Treatment-Naive Adults With HIV Evaluates Efficacy And Safety Of Once-Daily PREZISTA(TM)/ritonavir Vs. KALETRA(R)

Results from a new ongoing, randomized, controlled, open-label Phase 3 study showed that 84 percent of treatment-naive HIV-1 infected adults taking an investigational dose of PREZISTA(TM) (darunavir) 800 mg (two 400 mg tablets) with 100 mg ritonavir once daily with TRUVADA(R)(1) (emtricitabine and tenofovir disoproxil fumarate) reached an undetectable viral load (<50 copies/mL) at week 48, compared with 78 percent of patients taking KALETRA(R)(2) (lopinavir/ritonavir) 800 mg/200 mg once daily (or 400 mg/100 mg twice daily) with TRUVADA. The mean difference in response between the treatment groups was 5.3 percent (95 percent confidence interval -0.5; 11.2). read more

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