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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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FDA approvals. for acromegaly treatment; enfuvirtide for HIV treatment - pegvisomant Somavert - Fuzeon
From American Family Physician, 6/15/03 by Carrie Morantz

* Pegvisomant. The U.S. Food and Drug Administration (FDA) has approved pegvisomant (Somavert) for the treatment of acromegaly in patients who have had an inadequate response to existing therapies.

Pegvisomant is the first in a new class of medications called growth hormone receptor antagonists. In clinical trials, it normalized concentrations of IGF-I in more than 90 percent of patients by blocking the effects of growth hormone. The most common side effects were injection site reactions, sweating, headache, and fatigue. Patients should have tests to monitor their liver function during the first six months of therapy.

* Enfuvirtide. The FDA has approved enfuvirtide (Fuzeon) for use in combination with other anti-human immunodeficiency virus (HIV) medications to treat advanced HIV infection in adults and children ages six years and older.

Enfuvirtide is the first in a new class of medications called fusion inhibitors. It interferes with the entry of HIV into cells by inhibiting the fusion of viral and cellular membranes. This inhibition blocks the virus from infecting certain components of the immune system.

Because HIV infection must be treated with a combination of medications to be effective, enfuvirtide can be used as part of a medication regimen in patients for whom there are limited options. It should only be used in patients who have previously used other anti-HIV medications and have ongoing evidence of viral replication. It is administered as a subcutaneous injection.

Physicians should carefully monitor patients for signs and symptoms of pneumonia. Although bacterial pneumonia was uncommon in clinical study participants, more patients treated with enfuvirtide developed bacterial pneumonia than did patients who did not receive enfuvirtide. Patients are advised to seek medical evaluation immediately if they develop signs or symptoms suggestive of pneumonia, such as cough with fever, rapid breathing, and shortness of breath.

In addition, enfuvirtide can cause both serious systemic allergic reactions and local skin reactions at the site of injection. Patients taking enfuvirtide should contact their physician immediately if they develop any of the following symptoms of an allergic reaction: trouble breathing, fever, skin rash, chills, vomiting, and low blood pressure.

Local skin reactions from enfuvirtide injections are common, occur in almost all patients, and may be painful. Patients must be careful that their skin does not become infected at the injection site.

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