| HIGHLIGHTS FROM IDSA
�97 Long-term
VIRACEPT� Combination Data
Dr. Michael Saag (University of Alabama at Birmingham)
presented a poster demonstrating both the excellent safety profile of VIRACEPT�
(nelfinavir mesylate) and the durability of response in a three arm study comparing
VIRACEPT 750 mg tid + AZT+ 3TC, VIRACEPT 500 mg tid + AZT + 3TC, and AZT + 3TC. This
randomized, double-blind, placebo-controlled study enrolled 297 antiretroviral-na�ve
subjects with HIV RNA > 15,000 copies/ml; there were no CD4 level entry criteria.
Data showed that approximately 80% 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 Amplicor assay and a drop of
2.79 log10 using the ultrasensitive assay. At one year, more than 80% of
subjects on 750 mg still responded to treatment. The data demonstrate that 750 mg is
statistically superior to 500 mg and that adding VIRACEPT to an established antiretroviral
regimen does not confer as much benefit as initiating triple therapy. VIRACEPT has
demonstrated an excellent safety and efficacy profile and what few side effects were
reported seemed to subside after six months.
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