Subject: Roche AIDS Drug, Bristol Rival Found Similarly Effective 
Date: Published: 1/25/93 (61 lines)
Source: Wall Street Journal. Copyright Dow Jones & Co. Inc.

    Technology:
    Roche AIDS Drug,
    Bristol Rival Found
    Similarly Effective
    ----
    By Marilyn Chase
    Staff Reporter of The Wall Street Journal

    The National Institutes of Health released a new study showing
 that the drugs DDC by Hoffmann-La Roche Inc. and DDI by
 Bristol-Myers Squibb Co. are "similarly effective" in slowing the
 progression of AIDS in patients who don't improve while taking
 Burroughs-Wellcome Co. 's AZT.  
    Results of the trial in 467 patients were released Friday by the
 National Institute of Allergy and Infectious Diseases, a unit of NIH
 in Bethesda, Md.
    The findings -- important to doctors seeking a delicate balance
 between the benefits and side effects of the three toxic, antiviral
 drugs -- could change the horse race between the Bristol and Roche
 products.
    Currently, Wellcome, a unit of Wellcome PLC, is the only one of
 the three to have won Food and Drug Administration approval as a
 first-line weapon against human immunodeficiency virus (HIV), the
 virus that causes AIDS.  
    Bristol's DDI is officially approved for people whose condition
 worsens on AZT, or for those who can't tolerate its side effects,
 such as anemia.  The Bristol drug is also approved for any patient
 who has been on prolonged AZT therapy.  Indeed, recent studies show
 that patients can benefit by switching over to DDI after as little
 as eight weeks on AZT.  
    Thus far, Roche's DDC is approved for market only in a supporting
 role, as a drug to be taken in combination with AZT.  The company's
 data last spring failed to persuade regulators the drug deserved
 approval as a stand-alone treatment.  The new study could change
 that, however.
    "Results of this study have to be looked at carefully by FDA, and
 we plan to submit it to them," said Miklos Salgo, DDC team leader
 for Roche, a Nutley, N. J., unit of Switzerland's Roche Holding Ltd.
 He said the study bolsters Roche's contention that DDC is worthy of
 market approval as a stand-alone treatment.
    NIAID director Anthony Fauci agreed the study suggests "single
 drug therapy with DDC has a role."
    However, scientists at New York-based Bristol took a different
 view.  Laurie Smaldone, Bristol's executive e/0326hdirector for
 antiviral research, said that the study's patients were so severely
 ill that "these results should not be extrapolated to a healthier
 patient population."
    San Francisco AIDS researcher Donald Abrams cautioned that when
 choosing a treatment, doctors must consider the contrasting toxic
 effects of the two drugs.  DDC's main side effect can be painful
 nerve damage to arms and legs, called peripheral neuropathy; while
 DDI may cause stomach upsets and pancreatitis.

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