San Francisco Chronicle - The Voice of the West, 901 Mission Street, San Francisco, CA 94119 - 4 March 1997
Sabin Russell, Chronicle Staff Writer

Sometime this spring, researchers at San Francisco General Hospital hope to begin a study that may shed some light on that question, and could -- to the concern of AIDS prevention experts -- change the perception of just how risky unsafe sex can be.

Participants in the study would be uninfected people who believe they were exposed to the AIDS virus during an isolated incident of unsafe sex or because of a broken condom. They would be offered a 30-day supply of some of the same anti-viral drugs taken by people already battling the disease.

The idea is to snuff out an early viral infection before it can take hold.

San Francisco's proposed experiment is inspired by the results of studies of similar prophylactic therapy given to health care workers who are accidently stuck by needles contaminated with HIV, the human immunodeficiency virus that causes AIDS. A Centers for Disease Control and Prevention study of needle- stick injuries in several countries concluded that a 30-day course of the anti-viral drug AZT reduced the participants' risk of infection by about two-thirds. Other studies show a protection rate as high as 79 percent -- comparable to protections offered by vaccines to some other diseases. "If there is a way we can prevent somebody from getting infected, we should," said Tom Coates, director of the AIDS Research Institute at the University of California at San Francisco.

But with the potential of significantly reducing transmission of the virus comes the risk that the treatment will undermine AIDS prevention efforts that emphasize the importance of using condoms in every sexual encounter.

"The fear is that someone will hear about it and feel they can have unsafe sex and still be protected," said Mitch Katz, director of the San Francisco AIDS Office.

On balance, Katz said, the possibility that medical intervention could save a person from infection with the deadly virus outweighs the concern that the therapy could be abused.

UNNERVING IMPLICATIONS

One 29-year-old San Francisco man, who asked that his name not be used, wishes such a drug had been available six months ago, when a condom he was using broke. The implications of that night are unnerving. The man is infected with the AIDS virus, and his sexual partner was not.

"Reality," he said, "can sometimes slap you in the face."

Chances are that the man did not infect his friend. One study estimates that the odds of infection during a single act of unprotected anal sex with an HIV-positive partner is somewhere between 1 in 30 and 1 in 125. But when the consequences of infection are as catastrophic as AIDS, those are uncomfortable odds, indeed.

The man and his friend have not discussed the accident since it happened, and he still does not know if he passed on the virus. "A morning-after pill," he said, "would have relieved a lot of anxiety."

Within two months, the San Francisco health department hopes to win clearances and federal grant money to conduct a trial of the therapy. Subjects who seek care within 72 hours of exposure will be offered a combination of the anti-viral drugs AZT and 3TC. The highly effective protease inhibitors, which came into widespread usage in the past year, will not be included in the study at first.

The health of the study's participants, and their record at maintaining safe sex practices, will be monitored long afterward.

PREVENTION EXPERTS AMBIVALENT

AIDS prevention experts in San Francisco admit to ambivalent feelings about the idea of pre-emptive anti-viral treatment. "We would love nothing more than to have an effective morning-after pill, but we have to recognize that there is a whole lot about the pills and treatments that we just don't understand," said Dan Wohlfeiler of San Francisco's Stop AIDS Project.

Most anti-viral drugs have been on the market only a few years, and scientists do not know what the long-term health risks are. Researchers are also concerned that repeated use of anti-viral drugs in an on-and-off fashion could speed the evolution of viral strains resistant to current combination therapies.

But the overriding concern is that the gay community will perceive the availability of a prophylactic AIDS drug as a signal people can lower their guard and engage in unprotected sex.

"There is a lot of wishful thinking out there," said Wohlfeiler. "I'm worried that enough guys will interpret this information in such a way that we'll lose some ground we've gained in the past 17 years."

`LIFELONG COMMITMENT'

San Francisco AIDS Office director Katz said he, too, is worried how the experiment will be perceived. "Please don't call it a morning-after pill," he said, while acknowledging that this is how doctors and patients alike have been describing it. "There is nothing someone can take the next morning that can always prevent HIV infection. What's needed is a lifelong commitment to safe sex."

The San Francisco study itself will be too small to determine if the treatment works. Thousands of patients would have to be enrolled in such an experiment for the effects to be statistically significant. But the early research will provide important data on how often such isolated exposures take place, how quickly patients would attempt to get treatment and how many -- once the options are explained to them -- would actually agree to the 30-day pill regimen and complete it.

As a practical matter, it will mean the city will be able to offer "morning-after" therapy at its clinics, something only private doctors can do today.

Prophylactic anti-viral therapy will not be cheap. The wholesale cost of a month's supply of AZT and 3TC is $300, and if protease drugs are added, the price will rise about $400 more. If large numbers of uninfected people seek out the therapy from public clinics, it could tax the ability to pay the enormous cost of providing drugs to people already battling AIDS.

Katz said that the price of the drugs is insignificant if the therapy leads to a reduction in overall AIDS cases. "Three hundred dollars is not a lot of money to prevent a disease that costs $100,000 over a lifetime," he said.

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