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Prezista (also called darunavir, or TMC-114), a new protease inhibitor active against many of the viruses resistant to other protease inhibitors, was approved by the FDA on June 23 "for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor. At this time, the addition of darunavir or tipranavir to the GS 9137 study arms was permitted, following the availability of data demonstrating a lack of drug interactions between both protease inhibitors and GS 9137. They recommend for the first time that the goal of therapy in heavily treatment-experienced patients should be to achieve undetectable levels of HIV (less than 50 copies/mL), and highlight the results from several pivotal studies with newer anti-HIV treatments, such as darunavir and tipranavir, in which concomitant use of FUZEON was associated with a significantly greater likelihood of achieving this result. |
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