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| |  ROI CONFERENCE: Fortovase Comparable To Crixivan But Also Increases CD4 Counts CHICAGO, IL -- February 4, 1998 -- In the first-ever head-to-head trial comparing two HIV protease inhibitors, six-month data presented today show that Fortovase(TM), the newest protease inhibitor, has antiviral activity comparable to Crixivan(R) (indinavir) and an increased rate of CD4 cell recovery when either drug is taken in combination with AZT and 3TC. These data were presented at the Fifth Conference on Retroviruses and Opportunistic Infections. Six-month data from the Cheese Study show that HIV-RNA levels dropped to below the limit of detection in 93 percent of patients (400 copies/mL) in the Fortovase arm and 92 percent of patients in the Crixivan arm for whom data are available. A 16-week analysis in a larger number of patients shows that the Fortovase arm increased CD4 counts by 163 cells over baseline (301 cells/mL), while the Crixivan arm increased CD4 counts by eight cells over baseline (337 cells/mL). The Cheese Study is a Comparative trial in HIV infected patients Evaluating the Efficacy and Safety of saquinavir Enhanced oral formulation and indinavir given as part of a triple therapy. "These results demonstrate an interesting and curious phenomenon," said Jan Borleffs, M.D., Ph.D., of the University Hospital at Utrecht, The Netherlands, and lead investigator of the study. "We don't know why the CD4 cell count is increasing faster in the Fortovase arm when Fortovase and Crixivan are demonstrating an equal reduction in viral load. "We also don't yet know how effective these new cells are. We must conduct further research into immune recovery to answer these questions." The Cheese study is an open-label, randomised, parallel study designed to compare the antiviral efficacy of a triple drug regimen including AZT plus 3TC plus either Fortovase or Crixivan. Sixty-three treatment-naive patients or previous AZT users (less than 12 months) with more than 10,000 copies of HIV-RNA/mL of blood and/or CD4 counts less than 500 cells were randomised to receive AZT at 200 mg three times daily (tid), 3TC at 150 mg twice daily (bid), plus either Fortovase at 1,200 mg tid or Crixivan at 800 mg every eight hours (q8h). Patients in both groups had a mean baseline viral load of approximately 80,000 copies/mL. Patients in the Fortovase group and the Crixivan group had a mean baseline CD4 count of 301 cells and 337 cells, respectively. Fortovase and Crixivan were both generally well tolerated. Reported adverse events were mostly of mild intensity. More information on: Crixivan
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