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7-day-on, 7-day-off regimen could reduce cost, toxicities of HIV therapy

A pilot study at the National Institute of Allergy and Infectious Diseases (NIAID) suggests that it may prove feasible for certain people with human immunodeficiency virus (HIV) disease to move from a continuous regimen of anti-HIV therapy to a strategy in which they discontinue and then resume anti-HIV therapy in a pre-planned, cyclic fashion.

This approach is known as "structured intermittent therapy." In the NIAID study, 10 patients received repeated "on-off" cycles of therapy: seven days of treatment with potent combinations of HIV medications, followed by seven days off the drugs. At the time of study enrollment, the patients were being successfully treated with continuous highly active antiretroviral therapy (HAART). For the study, they switched to the intermittent HAART regimen with no apparent deleterious effects on the course of their disease, and with a significant reduction in certain HAART-related side effects.

"Because it halves the total time during which patients receive anti-HIV medications, structured intermittent therapy could significantly reduce the costs and side effects of anti-HIV drugs, important issues in both resource-rich and poor countries," notes lead author Mark Dybul, M.D., NIAID assistant director for medical affairs. "It is important to stress, however, that the results of randomized, controlled clinical trials - currently under way - are needed to prove the benefits of this experimental approach before it can be recommended to patients outside the setting of a controlled clinical trial. Don't try this at home!"

The NIAID researchers, led by Dr. Dybul and NIAID Director Anthony S. Fauci, M.D., report their findings in the December 4 online early edition of the Proceedings of the National Academy of Sciences. The bulk of the research was conducted within the NIAID Laboratory of Immunoregulation, which Dr. Fauci directs and where Dr. Dybul is a staff clinician.

The authors note that HAART has
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Contact: Greg Folkers
gfolkers@nih.gov
301-496-2263
NIH/National Institute of Allergy and Infectious Diseases
3-Dec-2001


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