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New Anti-HIV Agent Prevents Virus From Entering Cell

New Anti-HIV Agent Prevents Virus From Entering Cell

BARCELONA, Spain—A new anti-HIV agent from Roche and Trimeris, Inc has a
unique mode of action that suggests it will be active in HIV infections that
have developed resistance to other antiretroviral agents and can be combined
with other agents without substantially increasing toxicity.

The agent, enfuvirtide (Fuzeon, formerly known as T-20), is the first of a
new class of drugs known as fusion inhibitors. Unlike existing anti-HIV drugs
that work inside the cell to prevent viral replication, enfuvirtide is
designed to block HIV from entering T cells by preventing membrane fusion
(see Figure).

Data at 24 weeks from two large, international phase III trials presented
at the XIV International AIDS Conference showed that patients on enfuvirtide
combination regimens were twice as likely to achieve undetectable HIV levels
as those on combinations that lacked enfuvirtide. Based on these data, Roche
and Trimeris have submitted a new drug application to the FDA for approval to
market Fuzeon for use in HIV infection in combination with other
antiretroviral agents.

The sponsors have requested priority review status for Fuzeon, which, if
granted, would require the FDA to complete its review within 6 months (early
2003).

The two companies have also completed a phase I/II study of a
second-generation fusion inhibitor T-1249. The results showed that the agent
was well tolerated and exhibited antiviral activity in HIV patients.

TORO 1 and 2

Both TORO 1 (T-20 vs Optimized Regimen Only) and TORO 2 were randomized,
open-label trials that enrolled patients at 112 centers worldwide. Patients
were treatment experienced and/or had documented resistance to each of the
three classes of currently available antiretroviral agents. Patients were
required to have a plasma HIV-RNA level of more than 5,000 copies/mL.

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