Study compares efficacy and adherence to triple nucleoside therapy Ziagen + Combivir with protease inhibitor plus Combivir regimens in thera...( Toronto - Sept. 18 2000 - An interi...),Health

Toronto - Sept. 18, 2000 - An interim analysis of an ongoing study comparing efficacy, safety, and patient adherence to the triple nucleoside regimen of Ziagen® (abacavir sulfate) plus Combivir® (lamivudine/zidovudine) with a triple-drug regimen containing a protease inhibitor (PI) as first-line antiretroviral therapy (ART) was presented here today at the 40th annual meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).

Preliminary 24-week data from the open-label randomized trial reported on patient adherence to Ziagen/Combivir compared to the PI-containing regimen. Adherence was assessed by a patient self-reported questionnaire. Preliminary adherence data at week 24 found that 74 percent (108/145) of subjects on Ziagen/Combivir and 45 percent (66/146) on indinavir/Combivir reported they took all antiretroviral doses over the previous four weeks or missed less than one dose per week. Further, 38 percent (55/145) of patients on indinavir/Combivir said their triple regimen was difficult to take, compared to 6 percent (9/146) on Ziagen/Combivir.

The regimen of Ziagen/Combivir consisted of taking one Ziagen® tablet and one Combivir tablet twice a day without dietary restriction. Patients on Combivir plus PI regimen took indinavir tablets every eight hours and one Combivir tablet twice a day. The patients taking indinavir were required to take the tablets 1 hour before or 2 hours after a meal and drink one-and-a-half quarts of water a day in accordance with the approved prescribing information for each product.

"We are pleased to have these additional, preliminary data that assess efficacy, safety and patient adherence to the Ziagen® plus Combivir regimen of two tablets twice a day," said Lynn Smiley, M.D., vice president, HIV and Opportunistic Infections Clinical Development at Glaxo Wellcome.

In this open-label multi-center study (CNAB3014) of 342 antiretroviral therapy-naive patients, pati
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Contact: Bob Szafranski
bszafranski@pcipr.com
312-558-1770
Public Communications Inc.
17-Sep-2000