Subject: Regimen Alternating 2 AIDS Drugs Found to Limit Negative Side Effects
Date: Published: 1/15/88 75 lines
Source:  WALL STREET JOURNAL. Copyright Dow Jones & Co. Inc. 

   Regimen Alternating 2 AIDS Drugs
   Found to Limit Negative Side Effects
    ---
   By Marilyn Chase
   Staff Reporter of The Wall Street Journal

   Treating AIDS patients with a one-two punch, teaming up
two potent but toxic anti-viral drugs given on alternating
weeks, apparently avoids the side effects of both products,
government and industry scientists said.
   Scientists at the National Institutes of Health reported
the finding in a preliminary study of dideoxycytidine, or
DDC, a drug developed at NIH and licensed to Hoffmann-La
Roche Inc., Nutley, N. J., the U. S. unit of F. Hoffmann-La
Roche & Co. of Switzerland.  The report is scheduled for
publication today in the British journal The Lancet.
DDC, when administered alone, gave half of 20 patients in
the study a peripheral neuropathy -- tingling, numbness and
pain -- principally in the feet.  At its worst, the nerve
damage brought treatment to a halt, and sometimes took months
to disappear.
   Like its sister compound, AZT, which is manufactured by
Burroughs-Wellcome Co., DDC slips false building blocks into
the genetic material of the acquired immune deficiency
syndrome virus, halting its reproduction.  AZT prolongs
survival of AIDS patients, but is toxic to the bone marrow,
and causes anemia requiring blood transfusions in roughly
half of those who receive it.
   However, in a study of six patients given a regimen of DDC
for one week followed by AZT for one week, patients escaped
both the neuropathy and the anemia, scientists said.  Patients
also experienced a drop in the level of virus in their blood
and increased production of T4 cells, white blood cells which
are part of the body's immune response.
   The results were cheered by scientists at Hoffmann-La
Roche, who were discouraged when DDC's toxicity began to show
up last summer.  "The neuropathy was a disappointing
surprise," said L. Patrick Gage, vice president for
exploratory research.  He added he is excited about the Lancet
report for showing "there is a way out."
   Despite such encouraging signs, scientists emphasized that
the test, a phase one study, is preliminary and doesn't prove
clinical effectiveness.  Phase one studies are designed to
assess safety and toxicity.  Phases two and three essentially
determine effectiveness.  Further studies are needed to find
out whether the drug lengthens or improves the quality of
life for AIDS patients.
   "We don't know if the drug has clinical efficacy, as
defined by FDA. We don't know if it's better than AZT. But we
do know we can get around the toxicity," said Samuel Broder,
chief of clinical oncology at the National Cancer Institute
and a co-author of the study with another NCI scientist,
Robert Yarchoan.
   Scientists also said that they are uncertain whether the
combination is superior to either drug given alone with a
rest period in between doses.  Such potent anti-virals might
best be administered in low-dose regimens, with pauses built
in to rest the body and rebuild nerves and bone marrow, Dr. 
Broder said.
   Whaijen Soo, a Hoffmann-La Roche scientist, said the
company plans to enlarge its DDC studies, testing the drug at
lower doses with rest periods.  Dr. Soo added that the drug
also will continue to be tested in alternation with other
drugs by the National Institute for Allergy and Infectious
Diseases, a unit of NIH. 

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