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In Brief: Abbott's ABT-538

Executive Summary

Abbott's ABT-538: Protease inhibitor preliminary data reviewed by FDA's Antiviral Drugs Advisory Committee at a closed meeting April 4. Data from a small number of patients from Phase I/II trials show that ABT-538 at a 600 mg dose b.i.d. decreases HIV viral burden by up to 80% from baseline at 32 weeks and increased CD4 counts by an average 195 cells/mL3 at 35 weeks. The same data were previewed by David Ho, MD, Aaron Diamond AIDS Research Center, at the recent National Task Force on AIDS Drug Development ("The Pink Sheet" Feb. 27, p. 3). Abbott has three Phase III trials of ABT-538 600 mg b.i.d. under way, enrolling around 2,000 patients. The company is planning an NDA filing this year but is not talking about expanded access as of yet. Abbott said it has enough ABT-538 for its clinical trials but will not have significant amounts of the drug until the beginning of 1996 because of difficulties with drug synthesis...

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