to compare atc phiii 24 wk results to recent accelerated approval hiv drugs
Isentress In October 2007, the U.S. Food and Drug Administration (FDA) granted ISENTRESS accelerated approval for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients with evidence of viral replication with HIV-1 strains resistant to multiple antiretroviral agents. The approval was based on analyses of viral load reductions and CD4 cell count increases from baseline through 24 weeks in two Phase III studies of ISENTRESS, which are ongoing. comparator= non-active placebo +obt
24 wk cd4 improvement = 84 c/ml
Prezista The approval of darunavir was granted after the drug?s manufacturer, Tibotec Inc., presented data from two randomised studies to the FDA. These studies, called TMC114-C213 (POWER 1) and TMC114-C202 (POWER 2), looked at the risks and benefits of the drug in patients with substantial treatment experience, finding that patients taking ritonavir-boosted darunavir had larger reductions in their viral loads than patients taking other ritonavir-boosted protease inhibitors. comparator= other PI +obt
24 wk cd4 improvement = 92 c/ml
ATC significant improvement in clinical measures in ATC arm compared to active control
24 wk cd4 improvement = 98 c/ml
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