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Biotech / Medical : Agouron Pharmaceuticals (AGPH)

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To: Peter Church who wrote (2606)11/3/1997 8:45:00 PM
From: Henry Niman  Read Replies (1) of 6136
 
Peter, Speaking of risky:
1/03/97- Updated 02:02 AM ET

Anti-HIV drugs to extinguish infection

For the past three weeks, several people each day have called a San
Francisco hot line in a panic: They've just had risky sex or shared dirty
drug needles and fear they've been exposed to HIV, the virus that
causes AIDS.

Once, such people would have been urged to get an HIV test and hope
for the best.

Now some are being given another option: an anti-HIV drug
combination that just might extinguish an infection before it catches fire.

Such treatment has long been available to health workers stuck with
HIV-tainted needles.And some doctors have quietly given the drugs to
occasional patients distraught over a broken or forgotten condom. But
a group of San Francisco researchers and public health officials has
gone much farther: They've announced that the treatment is available,
set up the hot line and become the first health providers in the country
to routinely offer what they call PEP - post-exposure prevention.

They hope the rest of the world won't call it a quick and easy
"morning-after pill." In fact, nervous observers all over the country say
the greatest risk of the San Francisco experiment may not be the
physical side effects of the unproven treatment, which involves taking
two to 15 pills a day for a month. Instead, they say, the greatest risk is
that news of a possible quick fix will set off a wave of risky behavior.

"Lots of people are just tired of safer sex," says Larry Siegel, an AIDS
physician at Whitman-Walker Clinic in Washington, D.C. "And lots of
young men have just not lived with the horror of losing one friend after
another to this disease. . . . I'm very concerned that we might lose
momentum on the prevention side."

There's evidence that's already happening, though for other reasons.

With AIDS deaths down 44% in 1996 and glowing reports about new
treatments constantly in the news, prevention experts say some people
are convinced the epidemic is as good as over. Recent reports suggest
that, as a result, some gay men are engaging in more anal sex without
condoms. Heterosexuals also may be getting the message that HIV is a
worry of the past: AIDS apparently was not much on the minds of
dozens of girls and young women who had sex with an upstate New
York Lothario now accused of knowingly spreading the virus.

And a mythical magic pill that could make an unprotected one-night
stand go away? That could undo much of the prevention work of the
past 16 years, experts say.

Those behind the San Francisco program are acutely aware of such
worries. "We're going into this very cautiously," says Margaret
Chesney, a researcher at the University of California, San Francisco.

In fact, the program that began in mid-October is the pilot phase of
what, in January, will become a study. And one main aim of the study is
to learn whether the program prompts an increase in risky sex or
needle-sharing, either among those who use it or the larger San
Francisco community.

One warning sign would be a considerable number of "frequent fliers" -
people who come for the treatment more than once, says Joshua
Bamberger, a physician coordinating the program at the San Francisco
Department of Public Health. "That will be a clear indication that our
counseling isn't very good," he says. Counselors try to help people
lower future risks, whether that means teaching someone how to keep a
condom intact or how to say no to unsafe sex.

The study also will look at who uses the service, whether they actually
take the drugs and what the side effects are. Expected: nausea, fatigue
and, with some regimens, diarrhea.

The program is housed in two clinics, one at San Francisco General
Hospital and one at the health department. Patients must show up
within 72 hours of sharing dirty drug needles or having high-risk sex
(generally vaginal, anal or oral sex with an injection drug user, a man
who has sex with other men or an anonymous partner). Rape victims
will be referred to a rape treatment center where the drugs also will be
offered.

The hot line has attracted some calls from people who've engaged in
what researchers don't consider very risky behavior - for example,
deep kissing. But among more than 20 callers who qualified and came
to the clinics in the first two weeks, all opted for the demanding,
unpleasant treatment, despite clear warnings that it might not work,
Bamberger says.

And the study won't settle the effectiveness question. With 500 people,
it won't be big enough, researchers say, and won't include a
comparison group of untreated people.

"Basically, we have no human data to show whether this works or not,"
says Dawn Smith, a researcher at the federal Centers for Disease
Control and Prevention, Atlanta.

The CDC does have clues that it might. A 1994 study of health
workers showed immediate drug treatment after a needle stick cut their
HIV risk by 79%.Doctors also know they can prevent two-thirds of
HIV infections in newborns by dosing their mothers with an anti-HIV
drug during pregnancy. Animal studies also are encouraging.

So the CDC is working on draft guidelines to tell doctors what is and
isn't known about the treatment and what they need to consider if they
decide to offer it.

And doctors are asking about it. Emergency rooms and health
departments now regularly call CDC to ask about giving the treatment
to rape victims, Smith says.

Doctors all over the country also are hearing questions about the
treatment from would-be patients. Siegel, the Washington physician,
says half a dozen people have asked him about it in recent months,
though none was within the 72-hour window when treatment might be
considered."I haven't yet had anyone come to me the morning after," he
says.

When that does happen, Siegel says, he may well offer the drugs,
despite reservations, if he's convinced it's a one-time thing. "I would not
want to advertise it, and I would not want to encourage it as an option
for people. I think it has a tremendous downside in terms of making
people think they can get away with things."

Howard Grossman, an AIDS doctor in New York, says he has serious
doubts the treatment will work, especially if given more than 24 hours
after someone encounters the virus. But he has prescribed it once. "It
was someone who got a little high and had unprotected sex, even
though he knew a lot better," Grossman says.

The fact that such treatment may become widespread makes New
York AIDS activist Spencer Cox extremely nervous. "When you're
talking about treating large numbers of people on the basis of absolutely
nothing, not a shred of evidence, it sets off warning bells," Cox says. He
says he's especially concerned that the drugs might be only partly
effective or that people won't take full doses, setting the stage for the
development of drug-resistant HIV strains that could endanger not only
patients but also others they might infect.

Smith, of CDC, says that's not a major concern for her: The hundreds
of thousands of patients already taking anti-HIV drugs for full-blown
infections are a much greater potential reservoir of drug-resistant
strains, she says.

The real issue, she says, is whether the treatment can reduce the
40,000 new HIV infections that still happen in this country every year.

"If it's not effective and you have even a slight increase in risky
behavior, the net effect might be negative," she says. "We might end up
doing more harm than good."

For more information call 800-367-2437 inside California or
415-863-2437 outside California.

By Kim Painter, USA TODAY
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