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."
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By Kim Painter, USA TODAY |