Complete trial results of the Anglo-French Concorde study ofWellcome's PLC's HIV treatment Retrovir, or AZT, show the drug byitself is not effective in slowing the disease's progress.The study, published Saturday in the British journal Lancet, showed nostatistically significant difference in clinical outcomes between thoseasymptomatic patients who received early treatment of AZT and thosewho received treatment after developing symptoms. The survival rateamong the 1,749 asymptomatic patients was 92 percent in the earlytreatment group and 94 percent in the group that received AZT later.Three-year progression rates to AIDS or death were 18 percent in bothgroups, and to AIDS-related complex (ARC), AIDS or death were 29percent in the early treatment group and 32 percent in the group startedon placebo.Wellcome, based in London, said the Concorde study, preliminaryresults of which were published last year, should be looked at incontext with other studies that have reviewed AZT in HIV patients."Several other studies of therapy with asymptomatic patients havedemonstrated benefits in terms of delay of the progression of thedisease," Doug Stokke, a spokesman for Burroughs Wellcome Co. ofResearch Triangle Park, N.C., told BioWorld. "AZT is still the bestweapon that is currently available to slow the spread of the virus."The study didn't question the efficacy of AZT in treating late-stageAIDS and HIV. It's an effective drug. The question at this point iswhen to initiate therapy and ...we believe early therapy is a validstrategy."The investigators concluded differently: "The results of Concorde donot encourage the early use of (AZT) in symptom-free HIV-infectedadults," they wrote in Lancet. "They also call into question theuncritical use of CD4 cell counts as a surrogate endpoint for assessmentof benefit from long-term antiretroviral therapy."Stokke said the company believes that the most promising long-termtherapies rest in a combination of antiretrovirals.The final results of the Concorde study did not significantly affect thecompany's stock after they appeared in The Wall Street Journal onFriday. Those results affirmed what was presented last year. Shareswere already trading near a 12-month low of $8. Wellcome (NYSE:WEL) stock fell 13 cents to close at $8.13 per share in trading of465,000 shares.Michael Walsh, an analyst with Robertson, Stephens & Co. of SanFrancisco, said the bigger loss is in sales of the product, which fell 25percent in the U.S. in the past year and now could fall even further. Theearly stage patients are the largest market for AZT."The Concorde study doesn't mean the drug will go away," Walsh toldBioWorld. "It means it will be limited to a smaller patient population.It's still the best therapy out there. Unfortunately, it just shows thatnone of these therapies works very well."The bad news for Wellcome, Walsh said, is good news for VertexPharmaceuticals Inc. of Cambridge, Mass., which licensed toWellcome in December its protease inhibitor (VX-478). Walsh saidWellcome, wanting to keep its share of the market, will be motivated tospeed up development of the drug.

-- Jim Shrine

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