New regimen may reduce cost, toxicity of HIV therapy

February 1, 2002

Pharmaceutical Representative

A pilot study suggests that certain people with HIV may benefit from moving from a continuous regimen of anti-HIV therapy to a strategy known as "structured intermittent therapy."

A pilot study conducted at the National Institute of Allergy and Infectious Diseases suggests that certain people with human immunodeficiency virus disease may benefit from moving 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 - an approach 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. 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.

Said lead author Mark Dybul, assistant director for medical affairs, "It is important to stress, however, that the results of randomized, controlled clinical trials - currently underway - 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!"

Limited applications

The authors note that HAART has 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. Also, high 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, to reduced costs and, potentially, to improved adherence," said NIAID Director Anthony S. Fauci. "Ultimately, structured intermittent therapy might be adapted for use in developing nations, where more than 95% of the world's HIV-infected people live, but where very few have access to HAART because of the cost of antiretroviral agents." PR

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