CDC won’t recommend non-occupational PET
CDC won’t recommend non-occupational PET
Agency to provide guidance for special situations
The Centers for Disease Control and Prevention will soon publish a statement recommending against the use of a "morning-after pill" for off-the-job HIV exposures, except for situations such as sexual assaults. Some CDC advisors, however, warn that people still are using antiretroviral therapy for high-risk sexual exposures, necessitating more guidance from the agency.
"It appears there is not enough scientific evidence to make definitive recommendations about the use of postexposure therapy [PET] in so-called non-occupational settings," says Ronald Valdiserri, MD, MPH, deputy director of the National Centers for HIV, STD, and TB Prevention. "The tone probably found in the written document is that this is essentially an issue that should be discussed between the individual and the care provider, but with the full understanding there are lot of significant gaps that we don’t know about."
Valdiserri made his comment during the December meeting of the Advisory Committee for HIV and STD Prevention. The committee gave feedback to the CDC before a U.S. Public Health Service working group publishes a statement on the issue in early 1998.
CDC: PET shouldn’t become routine’
In summing up the consensus of a CDC workshop more than 100 experts attended last summer, Rob Janssen, MD, deputy director of the CDC’s division of HIV/AIDS surveillance, told the advisory panel that "it was clear this is a complicated medical intervention, and that it shouldn’t become a prevention strategy that should become routine."
That conclusion was based on several considerations, including the following:
• Paradoxically, PET for sexual exposure could increase transmission, because it may lead people to adopt risky behaviors if they think transmission can be easily prevented.
• The therapy has serious side effects, such that up to a third of patients do not complete treatment, thereby increasing the risk of drug-resistant strains of HIV.
• Unlike in occupational exposure settings, the HIV status of a partner may not be known, and exposure may occur multiple times. For the same reason, the time between exposure and treatment also may be unknown.
• Although antiretroviral therapy appears to reduce the risk of transmission to health care workers exposed to infected blood, there are no scientific data supporting its efficacy against exposure through sex.
"When you factor all those [considerations] and you then ask the question how many people would you have to treat to prevent one infection, it is kind of worrying," said Kevin DeCock, MD, director of the CDC’s division of HIV/AIDS surveillance.
Preventive therapy being offered
But for some people worrying about possible infection after high-risk exposure to HIV, postexposure prophylaxis is worth the risk. Indeed, the AIDS director of the San Francisco Department of Health announced last fall that PET would be available for individuals who had high-risk exposures.
"We need to recognize that people are using post-exposure treatment," says Cynthia Gomez, PhD, research specialist at the Center for AIDS Prevention Studies at the University of California in San Francisco. "How far does the science have to go before there is a comfort zone for physicians in what to recommend? In the real world, nobody is waiting for these recommendations, and by the time they do come out, we may be in a different situation."
Gomez, who works with HIV-discordant couples, said she receives calls constantly for information on possible use of PET when a non-infected partner has been unintentionally exposed by an infected one.
Lawrence Gostin, JD, an expert on public health law and professor of law at Georgetown University, questioned whether certain circumstances, such as when a woman is raped by an HIV-positive man, made PET was no less warranted than for exposures to health care workers.
"I think we would be out of our minds to recommend widespread use," he told the committee, "but a lot of people are asking me this question. We can’t really have it both ways. We can’t say the evidence is good enough for health care workers but not for others."
As other members pointed out, however, the CDC’s reputation is based on science, and to move too far beyond the realm of hard data would be a mistake. Without more study, the best the CDC can do is offer physicians and their patients the possible risks and benefits of PET in any given situation, Janssen said.
In efforts to know more about the efficacy and safety of PET for non-occupational exposures, the CDC plans to institute some descriptive research of needs and utilizations of this type of intervention, and to set up a registry similar to that for exposed health care workers. Additionally, through international collaboration, the CDC may be able to develop a case-control study to better assess PET’s impact on non-occupational exposures, DeCock said.
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