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Fuzeon

Enfuvirtide, with trade name Fuzeon®, is a novel antiretroviral drug used in combination therapy for the treatment of HIV-1 infection. It is currently marketed by Hoffmann-La Roche under the trade name Fuzeon. more...

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Fuzeon

Enfuvirtide is available only in injectable form since it is a peptide and would not survive digestion. The injections must be taken twice a day. This makes it inconvenient to take. With an estimated U.S. price of more than $25,000 for a year of Fuzeon, it is relatively expensive for an antiretroviral drug. Its inconvenience and price reserve it mostly for salvage therapy in patients with multi-drug resistant HIV.

The most common side effect is injection site reaction.

History

Trimeris Inc. began development on enfuvirtide in 1996 and initially designated it T-20. Trimeris partnered with Hoffmann-La Roche in 1999 to complete the drug's development. The medication has several disadvantages that resulted in its slow progress. It is difficult to manufacture, and is only available in an injectable form. The injections must be taken twice a day.

Its approval by the Food and Drug Administration (FDA) on March 13, 2003 made it the first of the new Fusion inhibitor class of antiretroviral drugs to be approved for use in the United States. It was approved on the basis of two studies (TORO 1 and TORO 2) which compared the effect of optimized regimens of antiretroviral medication with and without the addition of Fuzeon on serum viral load.

Mode of action

Enfuvirtide works by disrupting the HIV-1 molecular machinery at the final stage of fusion with the target cell, preventing uninfected cells from becoming infected. A biomimetic peptide, Enfuvirtide was rationally designed to mimic components of the HIV-1 fusion machinery and displace them, preventing normal fusion. Drugs that disrupt fusion of virus and target cell are termed entry inhibitors.

Greenberg, M. L. and N. Cammack (2004). "Resistance to enfuvirtide, the first HIV fusion inhibitor." J Antimicrob Chemother 54(2): 333-40.

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New class of medications approved for advanced HIV - Updates - Fuzeon from Roche Pharmaceuticals
From FDA Consumer, 5/1/03

People infected with the virus that causes AIDS and who no longer respond to other treatments now have another option with approval of a new class of medications. Fuzeon (enfuvirtide) was approved by the FDA in March for use in combination with other drugs that fight HIV.

Fuzeon is the first "fusion inhibitor" drug. When HIV infects a cell, it first attaches to the outside surface of the cell. Then the virus fuses its membrane with the infected cell's membrane, thereby introducing the virus into the cell. Fuzeon stops this process of fusion.

According to the Centers for Disease Control and Prevention, 850,000 to 950,000 people in the United States are currently infected with HIV. About 40,000 new infections occur each year. The new class of medications is particularly timely since a significant percentage of patients with chronic HIV have developed infection resistant to many existing medications.

A combination of medications is needed for effective HIV treatment, experts say. Fuzeon, manufactured by Roche Pharmaceuticals of Nutley, N.J., can be used as part of a medication regimen in patients for whom there are limited options. Fuzeon is administered as an injection and should be used only in adults and children ages 6 years and older who have previously used other anti-HIV medications and who have ongoing evidence of viral replication.

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