A Second Chance to Prevent AIDS

For years the Los Angeles man had practiced safe sex, and he was prudent again on a recent Saturday afternoon when he pulled a condom from a night-table drawer. His new partner--a casual acquaintance from the neighborhood--agreed to wear the condom but then removed it during sex.

Suddenly, this healthy 38-year-old professional was facing the possibility that he had just been exposed to AIDS. A sense of betrayal overwhelmed him.

He quickly phoned an AIDS hotline and, within two hours, was in an exam room with Dr. Ardis Moe, who is participating in a clinical study of the effectiveness of AIDS medications in preventing HIV infection after potential exposure through sex or intravenous drug use. He received his first dose in a 28-day regimen of medications and counseling.

“There are situations, apparently, where no matter how hard you try to do the right thing, something happens,” said David, who asked that his last name not be published.

The drug treatment David received has been likened to the “morning after” pill used to prevent pregnancy. Yet the treatment, called post-exposure prophylaxis, is riskier and far more controversial than the morning-after pill. Although the therapy remains largely unknown to the public, experts are debating who should receive it, who should pay for it and whether it could undermine the prevention messages at the core of the nation’s AIDS-fighting strategy.

To date, there is no sure-fire scientific proof that a short, aggressive course of drug therapy begun within 72 hours of potential exposure through sex or intravenous drug use can halt HIV transmission. But there’s reason to believe it might work. Studies of hospital and other health-care workers exposed to the virus through accidental needle sticks found that 81% remained AIDS-free after treatment.

Also, of the hundreds of people who, like David, have been treated in clinical studies after potentially risky sexual exposures, none have developed AIDS. It’s unclear, however, whether the medications worked or whether the patients would not have become sick anyway because the odds of contracting the virus through a single sexual encounter with an HIV-positive person are relatively small (one in 100 to one in 1,000).

While prophylactic treatment looks promising, gaining access to it is still difficult. And there is vigorous debate about whether to make it widely available.

Although AIDS doesn’t discriminate, society does. Americans have no qualms about offering the treatment to health-care workers exposed in the line of duty. And support has grown for providing it to victims of sexual assault.

In California, for example, the state Office of AIDS has proposed guidelines to help county-run sexual assault programs and hospitals create post-exposure treatment programs.

Elsewhere in the country, people are “much more inclined” to offer treatment to victims of sexual assaults than to others with likelier routes of infection, said Dr. Michelle Roland, the chief investigator of a post-exposure study at run by UC San Francisco at San Francisco General Hospital. That’s despite that fact that the rate of HIV among those who commit violent sexual assaults is extremely low, she noted.

More controversial is the idea of whether the treatment should be available to people potentially exposed through consensual sex--the primary means of AIDS transmission. Some Americans and policymakers oppose paying for the preventable consequences of irresponsible behavior. And some public health officials fear that growing publicity about prophylactic treatment might encourage reckless behavior among young people, a growing number of whom have become careless about safe sex.

Chuck Henry, director of L.A. County’s Office of AIDS Programs and Policies, cautioned that broader availability could create a false sense of security and lead people to “lower their guard.” He and other health officials question whether public funds should be spent on a still-unproved treatment if it means taking money away from programs that encourage disease prevention.

But others point out that, with 40,000 new AIDS diagnoses each year in the United States, any effort that might prevent one more person from getting the disease is worth it, regardless of how the person was exposed.

“For God’s sake, we offer the drugs to health-care workers,” said Debra Johnson, a nurse-practitioner at USC Medical Center’s AIDS clinic. “Is one any more deserving than another? I don’t think so.”

Dawn K. Smith, an epidemiologist with the federal Centers for Disease Control and Prevention in Atlanta, believes it is important to “get away from the concept of the innocent and the guilty. If we want to use post-exposure prophylaxis to reduce the number of new HIV infections significantly, it needs to be given in a less emotional and more rational form.”

David was aware of society’s attitudes when he turned to an AIDS hotline and not his health insurance plan for care. He feared a health plan doctor might judge him for being a gay man having recreational sex, even though he wasn’t the one who broke the safe-sex rules.

He also was fortunate enough to live in a large urban area with service organizations that can also provide psychological support and counseling.

“If you’re in San Francisco, swell,” said the CDC’s Smith. “If you’re in Omaha, Neb., where’s the doctor going to send you for behavioral risk reduction?”

Hotlines in California steer patients to free clinical trials at UCSF-San Francisco General, at USC and a program at Friends Research Institute in Los Angeles. Some people locate treatment through advertisements in gay men’s magazines; others consult Internet sites and self-medicate with AIDS drugs obtained from infected sexual partners and friends.

However, advocates are heartened by preliminary findings that people who complete post-exposure treatment and counseling become more circumspect, said Steve Shoptaw, lead investigator for the Friends Research Institute study.

The drug regimens are far more complicated than morning-after pills used after unprotected sex. Taken for weeks on a strict schedule, they can produce nausea, headache and fatigue, sometimes liver damage and anemia.

“It’s not just this simple morning-after option,” cautioned Roland, who noted that studies in health-care workers found large numbers never finished their prescriptions.

A 38-year-old Los Angeles psychotherapist attested to how grueling the treatment was. Three years ago, a condom broke while he was having sex with his HIV-positive boyfriend. “I ended up calling my doctor, and he basically prescribed a three-drug cocktail immediately.”

The man, a counselor for HIV-positive men, suffered diarrhea, fatigue and lost interest in sex. Yet, he was better able to empathize with men in similar straits. What he found difficult was not knowing if the drugs were working. Fortunately, he emerged HIV-negative.

In the absence of prescribing guidelines, doctors rely on the drugs used to battle established AIDS infections.

They frequently give 28 days of Combivir, a pill combining AZT and 3TC; others add a protease inhibitor such as Crixivan or Viracept. USC is experimenting with seven days of a three-drug cocktail.

With a sobering increase in the transmission of drug-resistant HIV, it’s important that experienced doctors tailor treatment to avoid further spreading resistance, said Dr. Gary Cohan, an internist with Pacific Oaks Medical Group in Beverly Hills, the nation’s largest HIV practice.

The medical community is waiting for the CDC to issue guidelines for post-exposure treatment for non-health-care workers. The agency is considering whether to remain neutral or tell doctors that “there may be some situations where it is probably reasonable to suggest” preventive treatment, the CDC’s Smith said.

Three sets of studies, including those of health-care workers, are driving the reassessment. Recent animal studies have shown early treatment can abort HIV infections, and several studies show medications given soon after birth can dramatically reduce chances that newborns with infected mothers will develop AIDS.

As more evidence has become available, some government agencies and health insurers have joined doctors in moving ahead with prophylactic treatment. In Massachusetts, doctors and hospitals helped push for a state program to train doctors and hospitals and to cover the cost of treating the uninsured. There have been other scattered efforts to improve access to the treatment, which runs about $800 to $1,000, for women and minorities.

While many patients pay out of pocket, some health insurers, including Blue Cross of California and Kaiser Permanente of Southern California, say they cover HIV prophylactic treatment.

Blue Cross honors any HIV prophylaxis prescription written by one of its physicians, said Dr. Jeff Kamil, vice president of medical policy and quality.

Dr. Mark Katz, Kaiser’s regional HIV-AIDS coordinator, said the HMO has been educating its doctors “so that if a patient comes into Kaiser and says they’ve just had unprotected sex with someone who is HIV-positive, the provider doesn’t just say, ‘Oh, don’t worry about it.’ For them ... to then become HIV-infected would be a tremendous emotional, if not legal, burden on the system. We don’t want to be the first to go through that.”

Kaiser established a system in which infectious-disease specialists are on call at its Southern California medical centers to advise ER doctors who may lack expertise in post-exposure treatment. With perhaps a few dozen Kaiser patients in the region receiving treatment in a year, he said “$30,000 to $40,000 is worth it to avoid any bad press or litigation.”

However, those requesting prophylaxis represent a fraction of those who might benefit.

Said Katz: “For every person who comes into an ER or doctor’s office within three days of an unprotected act of sex, my guess is there are dozens ... who don’t know to come in.”

David knew enough to find medication and counseling, which changed--and may have saved--his life.

“All of a sudden, you realize, ‘Oh, my God, I’m taking AZT and 3TC and the only other people taking these are HIV-positive.’ It’s very sobering,” he said. “My days of recreational sex are over.”