8 MONTROSE VOICE/JANUARY 16, 1987
Ribaviran Testing to
Continue in Houston
By Sheri Cohen Darbonne
Testing ofthe experimental drug ribaviran. also called virazole, will continue
on Houston patients previously enrolled
in a six-month study of the drug. Dr.
Peter Mansell, medical director of the
Institute for Immunological Disorders,
announced Monday. Results of the
study, conducted at research centers
across the country, were released Friday, Jan. 9, in Washington, D.C.
Ribavirin, which interferes with the
replication of HIV virus that causes
AIDS, appears to at least slow the progression to full-blown AIDS in patients
with Lymphadenopathy syndrome, or
LAS. Of 163 patients with LAS in the
national study, 52 were given a daily
dose of 800 milligrams of the drug; 55
were given a lower dose of 600 milligrams and 56 were given a placebo. Ten
patients in the placebo group and six in
the group receiving 600 milligrams
developed AIDS, while none who
received the higher dose progressed to
AIDS as defined by the National Centers for Disease Control, Mansell said.
In Houston, 47 patients at M.D. Anderson Hospital and (after its opening
Sept. 2, 1986) the Institute for Immunological Disorders were involved in the
study. Of these, six in a placebo group
developed AIDS. One patient who
received 600 milligrams of ribavirin
daily went on to develop the disease.
Mansell acknowledged "some possible objections" to the statistics in the
placebo group. Three of the patients
who got AIDS developed the disease
early on in the study, indicating they
may have already had it; two actually
did not develop full-blown AIDS until
after the technical conclusion date of
the trial. However, he pointed out that
in terms of "significant events," such as
opportunistic infections, the results of
the test were even more favorable for the
drug. In the placebo group, 17 significant events were recorded and 10
appeared in the low-dose group, while
none of the patients taking 800 milligrams daily developed significant infections.
Another advantage of ribavirin,
according to Mansell, is its low toxicity.
Only mild side effects, including insomnia and gastrointestinal discomfort,
were reported in the group taking the
higher dose. Other side effects of the
orally-administered drug could be
noticed in trials of ribavirin on "sicker"
patients, or at higher doses, Mansell
The drug's manufacturer, Viratek,
Inc., a division of ICN Pharmaceuti
cals, has not yet applied for Investigative New Drug status because the FDA
has only had data on the tests for a few
days, Mansell said.
"It's important not to rush these federal agencies," he commented. The FDA
is in the process of reviewing and analyzing the test results, he said. When.
and how widely, ribavirin is made available depends on how the FDA chooses
to respond to the drug company, he said.
There are three directions the agency
could take in its decision, Mansell
explained. He said he favored a "treatment IND," which would make the drug
available for use on I_AS patients only.
The FDA could also approve the drug
for general access and use for a variety
of indications, or it could decide not to
approve the drug at all.
A separate trial of the drug's effects
on patients with AIDS-related complex
(ARC) will be completed in mid-
February, but the results will probably
not be available until April, Mansell
said. Testing of the drug on AIDS
patients was begun in Boston.
The drug does not appear to do anything to restore a damaged immune system, hut may slow immune decline
although the latter has not been proved.
The researchers still do not know what,
if any, effect ribavirin has on the HIV
virus, Mansell said.
Mansell dismissed as "nonsense"
accusations that the pharmaceutical
company and research team released
the test results too early. The results had
to be released for three reasons, he said.
"The investigators involved in the
study had to tell their patients what
they were getting. It was no longer ethical to keep this information from them,"
Mansell said. Also, the FDA requires
pharmaceutical companies to disclose
such information, and the Securities
and Exchange Commission requires
companies to make available any information that could affect their stock rating, he added.
All patients involved in the local
study were offered the opportunity to go
on the 800-milligram dose of the drug.
About 40 patients at the institute are
now on ribavirin, Mansell said.
Besides Mansell, the researchers
involved in the national ribavirin trial
were Dr. Richard Roberts, New York
Hospital, Cornell University Medical
Center; Dr. Gordon Dickinson, University of Miami: Dr. Peter Heseltine and
Dr.John I_eedom, Los Angeles County/
University of Southern California Medical Center, Los Angeles.
SATURDAY, JANUARY 24
Celebrate Mayan culture with Fidelia
Mendoza, a Tzutuhil Indian from
Guatemala as she weaves her magic
in our store.
January 24 -
Put an exotic flavor in your life
with crafts from Central
America & the Philippines.
Get great deals on handwoven
tablecloths, palm hats, baskets
& bags, exquisite weavings,
hammocks, kid's goods and
Pueblo to People * 523-1197
1616 Montrose (at W Cray)
Mon-Sat 10 am - 6 pm
Mention this ad and get a FREE
$20,000 OF NEW
I Bring us your present gym con-
Itract from any other gym and we|
I will honor the balance of the prepaid time with the purchase ofl
[equal time from Parkway Athletic|
(Offer expires January 30)
• Kucquciball Handball Civ
• Nautilus & Tree Weights
• Aerobics Studio
Basketball / Volleyball
• Barber Shop
• Tanning Solarium*
• I'ull Linen Service
\ • Pro Shop
• locker Room, Steam Room.
Saunas & Whirlpool Spa
I. • Massage Room
\ • Rental Lockers
• Nutrition Classes
• Juice Bar
• Meeting / Conference Room
starting at $35°°
No Start-Up Fee
30 minutes for $4.50
800 Rosine St. • Houston • 528-5467