CDC issues new drug guidance on HIV infection
■ The agency addresses sexual and needlestick exposures outside the work setting.
By Victoria Stagg Elliott — Posted Feb. 14, 2005
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A patient presenting to a physician within 72 hours of a sexual assault, condom breakage or needlestick injury that poses a high risk of contracting HIV should be prescribed 28 days of highly active anti-retroviral therapy to reduce the chance of infection, say guidelines published by the Centers for Disease Control and Prevention in the Jan. 21 Morbidity and Mortality Weekly Report.
"Using anti-retroviral drugs after exposure is an important safety net to prevent HIV infection in certain cases," said Ronald O. Valdiserri, MD, MPH, deputy director of the CDC's National Center for HIV, STD and TB Prevention.
The guidelines, developed by the CDC in conjunction with the Food and Drug Administration, the National Institutes of Health and the Health Resources and Services Administration, recommend the use of post-exposure prophylaxis -- PEP -- in cases where the source of the possible exposure is known to be HIV-positive. When the HIV status of the source is unknown, physicians should evaluate the risks and benefits, including a patient's ability to adhere to an expensive drug regimen with a high rate of side effects, on a case-by-case basis.
PEP is not recommended for people who have frequent exposures to HIV or as a replacement to more traditional forms of prevention. Rather, it is to be used as a last resort when primary prevention fails or is not possible, such as in the case of rape.
"The drugs are not a substitute for abstinence, mutual monogamy or consistent and correct condom use and should not be viewed as a quick fix," Dr. Valdiserri said.
Creating a national standard
These guidelines are the latest move by the agency to further reduce the rates of new HIV infections, which have remained steady for several years. The agency previously issued guidelines in 1998 covering occupational exposures. Until now, only a handful of states and one medical society, the American Academy of Pediatrics, had guidelines for non-occupational exposures. Physicians praised the CDC action for providing a national standard for these situations.
"I'm impressed that they came out with them, and, in general, they're very balanced," said James M. Sosman, MD, associate director of the HIV program at the University of Wisconsin in Madison and chair of the Society of General Internal Medicine's AIDS task force.
Experts say insurers might be more likely to cover it, and state programs that pay for crime victims' medical care also might be more willing to pay for this as part of recovery from assault. It also makes easier some decisions a patient has to make, particularly after traumatic sex.
"When someone is already barely able to tell you their name, it really helps when a physician is able to say, 'This is what you should take and this is what you'll need,' rather than saying, 'This may or may not help,' and introducing a level of doubt," said Charles John Gonzalez, MD, PhD, assistant professor of medicine at New York University School of Medicine and a member of the board that wrote the New York state guidelines.
Experts also hope that the CDC announcement will increase awareness of the availability of PEP and lead to more people presenting for care within the 72-hour window.
"This level of publicity is incredibly helpful," Dr. Gonzalez said.
But many note that, despite the expanded recommendations, it is still unlikely to have broad appeal or impact the rate of new infections significantly. A vaccine is much more likely to do so, and to that end, the Global HIV/AIDS Vaccine Enterprise published a scientific strategic plan for HIV vaccine development in the February issue of Public Library of Science Medicine.
The international alliance of groups conducting or supporting HIV vaccine research identified the questions that need to be answered before a successful vaccine can be developed and set standards for laboratory assays used to validate effectiveness to let the various vaccine trials be compared head to head.
"A preventive vaccine is the world's best long-term hope for bringing the HIV/AIDS epidemic under control," said Helene Gayle, MD, MPH, one of the authors and director of the Gates Foundation's HIV, TB and Reproductive Health Program.