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September 2006 Cover
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The FDA has granted approval for TMC114 (darunavir, Prezista), a protease inhibitor indicated for the treatment of multidrug-resistant, HIV-infected patients. The twice-daily drug, which must be co-administered
with ritonavir (Norvir), is the first HIV antiretroviral to receive US approval since tipranavir (Aptivus) was approved in June 2005.
Twenty-four-week data from the POWER studies showed that 70 percent of treatment-experienced patients receiving an optimized HAART regimen that included the FDA-approved dose of 600mg TMC114 plus
100mg ritonavir twice-daily experienced a viral load reduction of at least one log or greater, compared to 21 percent of control patients. The approval of TMC114 makes it the 26th antiretroviral medication or
fixed-dose combination approved by the FDA
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HIV Digest!
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