In a small study conducted at the U.S. National Institutes of Health (NIH), researchers have shown that it may be feasible to treat HIV-infected patients with a simple, once-daily regimen of anti-HIV drugs given in pre-planned, 7-day-on, 7-day-off cycles. This approach is known formally as "short-cycle structured intermittent antiretroviral therapy" (SIT) or colloquially as the "7-7" approach.

"Our data suggest that the 7-7 approach, used with well-chosen drug regimens in settings where patient adherence is high, could be a powerful and cost-effective tool in treating HIV-infected individuals," says study author Mark Dybul, M.D., of the National Institute of Allergy and Infectious Diseases (NIAID), a component of NIH. "By using half as much antiretroviral medication, drug costs are reduced and drug-related toxicities may be less in the long run." He adds, "The 7-7 approach may have particular relevance to resource-poor countries around the world."

Dr. Dybul, NIAID Director Anthony S. Fauci, M.D., and their colleagues report their findings in the June 1, 2004 issue of the Journal of Infectious Diseases.

In their study, the NIH investigators enrolled eight HIV-infected people who had been successfully treated with a combination of three or more antiretroviral drugs for at least 6 months. Upon enrollment, the patients began following a treatment regimen of 7 days without antiretroviral therapy, followed by once-daily treatment with the drugs didanosine (ddI), lamivudine (3TC) and efavirenz for 7 days, followed by 7 days off the antiretroviral drugs, repeating the off-on cycle for more than a year. One patient withdrew from the study for personal reasons at week 24; the other seven patients receiving the 7-7 regimen maintained undetectable levels of HIV in their bloodstream [<50 HIV RNA copies per milliliter] for 60 to 84 weeks. During this period, the study volunteers had no significant changes in their CD4+ T-cell counts, and no evidenc
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Contact: Greg Folkers
gfolkers@niaid.nih.gov
301-496-2263
NIH/National Institute of Allergy and Infectious Diseases
20-May-2004

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