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 New Mexico AIDS InfoNet

Fact Sheet Number 451

ENFUVIRTIDE (Fuzeon)


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WHAT IS ENFUVIRTIDE?

Enfuvirtide, also called Fuzeon® or T-20, is a drug used for

antiviral therapy. It is manufactured by Roche and Trimeris. Enfuvirtide

has not been approved by the FDA for use against HIV. It is available

through an expanded access program.

Enfuvirtide is the first “fusion inhibitor” drug.

When HIV infects a cell, it attaches to the outside of the cell.

Then it “fuses” or joins itself with the cell. Enfuvirtide

stops this process of fusion. This means that HIV cannot infect

that cell.


WHO SHOULD TAKE

IT?

There are no absolute rules about when to start antiviral drugs.

You and your doctor should consider your T-cell

count, your viral load,

any symptoms you are having, and your attitude about taking HIV

medications. Fact Sheet 411

has more information about guidelines

for the use of antiviral medications.

Enfuvirtide is injected twice a day. It will most likely be

used by people who have run out of choices to use antiviral medications

in pill form.

If you take enfuvirtide with other antiviral drugs, you can

reduce your viral load and increase your T-cell counts. This should

mean staying healthier longer.


WHAT ABOUT DRUG

RESISTANCE?

The HIV virus is sloppy when it makes copies of its genetic code

(RNA). Many new copies of HIV are mutations: they are slightly

different from the original virus. Some mutations can continue

to multiply even when you are taking an antiviral drug. When this

happens, the drug will stop working. This is called “developing

resistance” to the drug. See Fact

Sheet 414 for more information on resistance.

Resistance to enfuvirtide can develop quickly if it is taken

by itself. With combination therapy (taking more than one antiviral

drug at the same time), HIV mutates much more slowly. Resistance

takes longer to develop. It is very important to take antiviral

medications according to instructions, on schedule, and not to

skip or reduce doses.

Sometimes, if you develop resistance to one drug, you will

also have resistance to other antiviral drugs. This is called

“cross-resistance”. Enfuvirtide does not have cross

resistance with any other antiviral drugs.


HOW IS ENFUVIRTIDE

TAKEN?

If enfuvirtide is swallowed, it is destroyed by stomach acids.

This means that it cannot be taken in pill form. Enfuvirtide is

injected just under the skin. This is called a “subcutaneous”

injection.

The adult dosage of enfuvirtide is 90 mg per injection, twice

a day. The dosage for children is based on their body weight.

If your doctor prescribes enfuvirtide, you will shown how to

prepare each injection, and how and where to inject it.

Enfuvirtide is a new class of antiviral drug. This means that

it is active against HIV that has developed resistance to any

other antiviral drug. However, it cannot be used by itself. It

must be combined with other antiviral drugs.


WHAT ARE THE SIDE EFFECTS?

The most common side effects of enfuvirtide are skin reactions

where the drug is injected. Almost everybody who uses enfuvirtide

gets these reactions. They can be very mild, such as slight redness.

They can include itching, swelling, pain, hardened skin, or hard

lumps. Each reaction might last up to a week. With two injections

each day, people using enfuvirtide might have reactions at several

spots on their body at the same time. Very few patients have stopped

using it because of skin reactions.

The most common other side effects of enfuvirtide are headache,

pain and numbness in feet or legs, dizziness, and loss of sleep.


HOW DOES IT REACT

WITH OTHER DRUGS?

Enfuvirtide has been studied to see if it interacts with other

drugs. There are no known interactions with other anti-HIV medications.

However, it has not been studied with all medicines, over-the-counter

drugs or vitamin or herbal supplements. Be sure your doctor knows

about all medications and supplements that you are taking.


THE BOTTOM LINE

Enfuvirtide is the first drug in a new class. It stops HIV

from “fusing” with a cell it has attached to. This prevents

HIV from infecting the cell. Enfuvirtide has not yet been approved

by the Food and Drug Administration, but it is available through

an expanded access program. Enfuvirtide helps control HIV, even

when it is resistant to other medications.

Enfuvirtide has to be injected under the skin twice daily.

Almost everyone who uses it gets skin reactions where it is injected.

Most of these are not serious.


Revised November 24, 2002

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