New Breakthrough Drug for HIV/AIDS

Phase III studies after 24 weeks of therapy showed that patients taking the drug as part of a treatment regimen experienced greater immunologic improvements and were twice as likely to achieve undetectable plasma levels of HIV than patients receiving an individualized regimen alone. The results were posted March 13, 2003, on the website of The New England Journal of Medicine (www.nejm.org). The drug, enfuvirtide (Fuzeon), has been granted accelerated approval by the US Food and Drug Administration (FDA).

Enfuvirtide is the first in a new class of anti-HIV drugs known as infusion inhibitors. In combination with over antiretroviral agents, it is indicated for patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy. Unlike other classes of drugs that work after HIV has entered the human immune cell and begun replicating, enfuvirtide blocks the gp41 protein and disrupts the structural rearrangement necessary for the virus to fuse with the healthy immune cell, thereby inhibiting HIV infection. As a result, the drug is effective in patients with prior exposure to antiretroviral therapy who may have developed resistance to the other classes of anti-HIV drugs.

The drug is based on discoveries by researchers at Duke University Medical Center (Durham, NC, USA). In 1993, the researchers formed a biotechnology company called Trimeris, Inc. (also in Durham) to continue work on the drug. In 1999, Trimeris agreed to collaborate with Roche (Basel, Switzerland) on the final research and development of the drug.

"This new fusion inhibitor is a significant breakthrough and its approval is a milestone event in the HIV epidemic,” said Dr. Michael Saag, director, AIDS Outpatient Clinic, University of Alabama at Birmingham (USA).





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