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| |  Anti-HIV Combo Of Ziagen+Combivir Equivalent To Crixivan+Combivir At 24 Weeks CHICAGO, IL -- Feb. 1, 1999 -- Treatment with the anti-HIV drug combinations of Glaxo Wellcome’s Ziagen(TM) (abacavir sulfate)+Combivir(R) (lamivudine/zidovudine) and Merck’s Crixivan (indinavir)+Combivir appear to result in comparable effects between the two groups on the surrogate endpoints of viral load and CD4 cell counts, according to preliminary results of a new study presented today. Patients in the ongoing study had not previously received antiretroviral therapy and the results reported were through 24 weeks of the planned 48 week trial. The data, presented at a major scientific meeting in Chicago, showed that at 24 weeks, in a rigorous intent-to-treat analysis (including all patients who began therapy: 527/562), 66 percent (172 of 262) of patients receiving Ziagen+Combivir and 66 percent (176 of 265) of patients receiving Crixivan+Combivir had viral loads below the limit of detection of a standard assay (less than 400 copies; Roche Amplicor Monitor(TM) assay; Version 1.0). Using an as-treated data analysis, which only includes patients who are still on their assigned drug regimen, 85 percent of those (145 of 171) receiving Ziagen+Combivir and 87 percent (154 of 178) of those receiving Crixivan+Combivir had viral loads below the limit of detection. In preliminary analyses, Ziagen+Combivir can achieve viral load less than 400 copies/mL in most therapy-naive patients and may help to preserve future treatment options. Furthermore, the median increase in CD4 cell counts in both groups was the same (105 cells/mm3 above baseline). Premature discontinuations from the trial were comparable for both groups at 24 weeks, with 33 percent of patients discontinuing from the regimen containing Ziagen and 34 percent of patients discontinuing from the regimen containing Crixivan. Of those randomised to the arm containing Ziagen, 14 percent discontinued due to adverse experiences and 19 percent discontinued due to other reasons (did not start therapy, lost to follow-up, consent withdrawn and other), while 15 percent discontinued due to adverse experiences and 19 percent discontinued due to other reasons in the arm containing Crixivan. The study reported today enrolled 562 patients who had no previous history of antiretroviral drug treatment, with viral load levels greater than 10,000 copies/mL and CD4 cell counts greater than 100 cells/mm3. The study is scheduled to continue through 48 weeks.
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