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HIGHLIGHTS FROM ICAAC �97

VIRACEPT� Shows Long-Term Power

A new study presented this week has confirmed that 80 percent of study participants receiving the protease inhibitor VIRACEPT� (nelfinavir mesylate) plus AZT + 3TC still maintained reductions in HIV viral load more than one year after starting therapy. This study also confirmed the excellent safety profile of VIRACEPT.

Data showed that approximately 80 percent of subjects responded within the first 8 weeks of initiating triple drug therapy. Six-month analysis of viral load showed a mean drop of 2.0 log10 using the Roche Amplicor� assay and a drop of 2.79 log10 using the ultrasensitive assay. At one year, more than 80 percent of subjects in the 750 mg VIRACEPT arm still responded to treatment.

This randomized, double-blind, placebo-controlled study compared VIRACEPT 750 mg tid + AZT + 3TC, VIRACEPT 500 mg tid + AZT + 3TC, and AZT + 3TC alone.

The study enrolled 297 antiretroviral-na�ve subjects with HIV RNA > 15,000 copies/ml; there were no CD4 level entry criteria. The study found that participants who received the 750 mg tid dose of VIRACEPT benefited more than those in the study�s other two arms. The data also demonstrate that adding VIRACEPT to an existing antiretroviral regimen does not confer as much benefit as initiating triple therapy.

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