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

provided extraordinary benefits to many people infected with HIV, substantially reducing HIV-related morbidity and mortality. Unfortunately, the utility of HAART is limited by significant short- and long-term toxicities, complicated dosing regimens and associated problems with adherence, and the development of drug resistance. In addition, high monetary costs have precluded the widespread use of HAART in resource-limited countries.

"With further research, we would hope that the approach of structured intermittent therapy for HIV disease will lead to decreased HAART-related toxicities, reduced costs, and, potentially, to improved adherence," says Dr. Fauci. "Ultimately, structured intermittent therapy might be adapted for use in developing nations, where more than 95 percent of the world's HIV-infected people live, but where very few have access to HAART because of the cost of antiretroviral agents."

STUDY DETAILS

Upon study entry, patients were receiving HAART daily, in regimens that included combinations of three or four anti-HIV drugs. This therapy had kept patients' HIV levels below 500 copies per milliliter (mL) of plasma for more than six months, and below 50 copies/mL at the time of enrollment. All patients entering the study had CD4+ T-cell counts of at least 300 cells per cubic millimeter (mm3) of blood. CD4+ T cells are crucial immune cells typically depleted during HIV disease.

After enrollment in the NIAID study, the patients received a four-drug regimen comprising stavudine, lamivudine, indinavir and ritonavir, administered twice per day in the intermittent schedule of seven days on therapy followed by seven days off therapy. This on-off cycle was repeated 16 to 34 times - that is, for 32 to 68 weeks.

While receiving seven-day-on, seven-day-off cycles of intermittent HAART, study participants had no significant increases in the amount of HIV in their bodies, as determined by tests that measured HIV
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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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