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Date of Report: 03/18/2003
Author: Susa Coffey, MD, Associate Medical Editor, AETC NRC
Source: National Resource Center
Description: News brief
The Food and Drug Administration has approved enfuvirtide (T-20, Fuzeon) for the treatment of advanced HIV infection in adults and children. Enfuvirtide is administered twice daily by subcutaneous injection and is to be used in combination with other antiretroviral medications.
Enfuvirtide belongs to the class of fusion inhibitors, and is the first of these agents to gain FDA approval. It is a 36-amino acid peptide that binds to a specific region of the HIV envelope glycoprotein gp41, thereby blocking a conformational change required for fusion of the HIV virus with the host cell membrane. Like other fusion inhibitors, enfuvirtide prevents HIV from entering the host cell.
In Phase III trials, enfuvirtide was studied in subjects with advanced HIV infection and extensive prior treatment with the three previously approved classes of antiretroviral agents. When combined with other antiretroviral agents in salvage regimens, enfuvirtide offered significant improvement in HIV viral load reduction and CD4 cell increase as compared with regimens that did not include enfuvirtide. No clinical endpoints have been reported. The primary adverse effects of enfuvirtide therapy are local reactions at injection sites.
The FDA has emphasized that enfuvirtide is to be used "only in patients who have previously used other anti-HIV medications and have evidence of ongoing viral replication."
Because of the complexity of manufacturing enfuvirtide, drug supply may initially be limited. The price of enfuvirtide is in excess of $20,000 per year; it is not yet clear whether third-party payers will offer coverage for this medication.
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