[procaare] Re: First drug in a new class - Fuzeon (2)

["Janmohd & ProCAARE" <procaare@healthnet.org>]

Subject: Re: First drug in a new class - Fuzeon (2)
- Janmohd & ProCAARE Moderation Team
****************************

Forum member, Mubarak Janmohd <mjanmohd@hotmail.com> asked the ProCAARE moderators:
<<Excuse me for my ignorance...but can somebody enlighten me on the mechanism of action of
Fuzeon as an anti-HIV preparation>>

Perhaps there are others who would like this information as well. Pasted below is a
fact-sheet and further resources we found on the web

ProCAARE Moderation Team
E-mail: procaare@healthdev.net
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Fuzeon (T-20): a complete guide from AIDSmeds.com
Source: www.aidsmeds.com/drugs/T-20.htm

Fuzeon(tm) brand enfuvirtide (T-20)
(Pronunciation: FUSE ee on)

Fuzeon belongs to a class of anti-HIV drugs called Entry Inhibitors (including Fusion
Inhibitors). Fuzeon is being developed by Trimeris and Hoffmann-La Roche.

What is the most important information I should know about Fuzeon?

? Fuzeon is a fusion inhibitor being manufactured by Trimeris and Hoffmann-La Roche. It
was approved by the U.S. Food and Drug Administration (FDA) in March, 2003. Fuzeon is
approved for HIV-positive people who have tried other anti-HIV drugs in the past and are
unable to keep their viral loads undetectable using drugs that are currently available. It
has not yet been approved for HIV-positive people who are starting anti-HIV drug treatment
for the first time.
? Fuzeon must be used in combination with other anti-HIV drugs.
? Fuzeon will be available by the end of March 2003. Because Fuzeon is a difficult drug to
make, the manufacturers will not be able to provide Fuzeon to everyone who needs it when
it first becomes available (enough drug for 8,000 to 10,000 people will be available, in
the United States, by the end of 2003). In turn, Trimeris and Hoffmann-La Roche have
developed a "progressive distribution plan" to help HIV-positive people with the greatest
need in obtaining the drug. Prescriptions for Fuzeon will need to be called in, mailed, or
faxed to Hoffmann-La Roche and will be processed on a first-come, first-served basis.
Prescriptions will be filled and shipped to patients (or their health-care providers) by a
single pharmacy: Chronimed/StatScript. Your health-care provider can learn more about the
process for filing prescriptions by calling the following toll-free number:
1-866-694-6670.

What is Fuzeon?

? Fuzeon is an anti-HIV medication. It is in a category of HIV medicines called fusion
inhibitors, or more broadly, entry inhibitors.
? Fuzeon binds to a protein on HIV's surface called gp41. Once it does this, HIV cannot
successfully bind with the surface of T-cells, thus preventing the virus from infecting
healthy cells.
 ?  Fuzeon will most likely need to be used in combination with other anti-HIV drugs.

What is already known about Fuzeon?

? Because of its fragile structure (it is a peptide), Fuzeon cannot be taken by mouth. It
is currently given in an injectable form and requires two shots a day: one in the morning
and one 12 hours later at night. Each shot contains 90 mg of Fuzeon. Small hypodermic
needles, similar to those used by diabetics to inject insulin, are used.

Injecting Fuzeon is actually a multi-step process. A month's supply of Fuzeon comes in
boxes containing 120 little vials. 60 vials contain Fuzeon powder and 60 vials contain
sterile water (one Fuzeon vial and one sterile water vial, twice a day). Before Fuzeon can
be injected, you will need to use the hypodermic needle to remove sterile water from one
vial and inject it into a vial containing Fuzeon powder. Once you have mixed a single
dose - a process called "reconstitution" - the liquid is injected directly under the skin
using the hypodermic needle. The mixing and injecting of Fuzeon can be a difficult and
time-consuming process and must be done correctly to ensure that the drug is effective. Be
sure that your doctor or nurse carefully explains how Fuzeon needs to be mixed and
injected correctly.

? Fuzeon might interact with other medications, including those used to treat HIV. It is
important that your personal physician and/or the research nurse or study investigator be
aware of all drugs you are taking, including those you buy without a prescription.
? Fuzeon holds promise for HIV-positive patients who have taken (and failed) numerous
anti-HIV drugs in the past. Because Fuzeon targets HIV differently than currently
available drugs, chances are that most people living with the virus - regardless of the
medications they have taken in the past - will likely benefit from using Fuzeon.
? It is also expected that Fuzeon, when combined with other anti-HIV drugs, will have
strong activity against HIV in people who have never taken anti-HIV medications in the
past. According to early results from one study, Fuzeon taken alone reduced viral load
from anywhere between 30% to more than 90% in patients who had not taken any other
anti-HIV drugs in the past. Fuzeon is not yet approved by the FDA for HIV-positive people
who are new to anti-HIV treatment. What's more, Fuzeon is only available in limited
quantitities - whatever quantities of Fuzeon that are available are being reserved for
HIV-positive people who cannot benefit from other anti-HIV drugs that are currently
available.

What has been learned from clinical trials?

? A number of clinical trials of Fuzeon have been conducted. The most important clinical
trials are two phase III studies: TORO 1 and TORO 2.
? TORO 1 enrolled 491 HIV-positive people living in North America and Brazil. On average,
these study volunteers had taken 12 anti-HIV drugs in the past. When they entered the
study, they had approximately 80 T-cells and a viral load above 100,000. Everyone in this
study took a combination of three to five approved anti-HIV drugs, which were chosen by
each of the patients' doctors. One group of patients took the approved anti-HIV drugs
alone and a second group took the approved anti-HIV drugs in combination with Fuzeon.
After six months of treatment, 37% of the patients who added Fuzeon to their drug
combination had undetectable viral loads (less than 400), compared to only 16% of patients
who only took a combination of approved anti-HIV treatments. Approximately 20% of those
who took Fuzeon had levels of HIV below 50, compared to 7% of those who only took approved
anti-HIV drugs. As for T-cells, those who took Fuzeon saw their counts jump by
approximately 76 cells after six months of treatment, compared to an increase of 32
T-cells among those who did not take Fuzeon.
? TORO 2 was the second Phase III clinical trial. This study was very similar to TORO 1.
It enrolled 504 patients living in Europe and Australia. These individuals had tried and
failed several anti-HIV drugs in the past and entered the study with an average T-cell
count of 98. After six months of treatment, 28% of the patients who took a new regimen of
approved drugs in combination with Fuzeon had undetectable viral loads (less than 400)
after six months, compared to 14% of those who did not add Fuzeon to their drug regimens.
T-cells increased by 65 cells in those who took Fuzeon for six months, compared to an
increase of 38 cells among those who did not take Fuzeon.

What is known about side effects?

? Skin irritation (e.g., itchiness and swelling) at the site where Fuzeon is injected has
been the most common side effect reported in studies. Less than 5% of patients taking
Fuzeon have stopped injections of this drug because of this skin irritation.
? Other side effects may occur as a result of taking Fuzeon, including fatigue, insomnia,
and peripheral neuropathy.

Who should not take Fuzeon?

? It is not known whether Fuzeon will harm an unborn baby. It is very important to treat
HIV/AIDS during pregnancy to reduce the risk of infecting your baby. Talk to your doctor
about your treatment options.
? It is not known whether Fuzeon passes into breast milk and what effect it may have on a
nursing baby. To prevent transmission of the virus to uninfected babies, it is recommended
that HIV-positive mothers not breast-feed.

Where can I learn more about clinical trials of Fuzeon?

? If you would like to find out if you are eligible for any clinical trials that include
Fuzeon, there is an interactive web site run by amfAR, the American Foundation for AIDS
Research.
? Another useful service for finding clinical trials is AIDSinfo.nih.gov, a site run by
the U.S. National Institutes of Health. They have "health information specialists" you can
talk to at their toll-free number at 1-800-HIV-0440 (1-800-448-0440).

Last Revised: 3/20/2003

This content is written by the Founder & Writers of AIDSmeds.com, and reviewed by Dr.
Howard Grossman, our Medical Editor.
Copyright (c) 2001 by AIDSmeds. All rights reserved.

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OTHER POSSIBLE LINKS

Fuzeon (T-20) an overview
www.aidsmeds.com

Enfuvirtide (Fuzeon) | The New Mexico Aids Info Net
www.aidsinfonet.org/articles.php?articleID=461

FDA to Review New AIDS Drug Fuzeon
www.immunecentral.com/templates/

Pipeline - FUZEON(tm)
www.trimeris.com/pipeline/t-20.html

PR 030210 - Latest Research On Fuzeon And T-1249, HIV Fusion ...
www.trimeris.com/news/pr/2003/030210.html

Fuzeon (T-20): a complete guide from AIDSmeds.com
www.aidsmeds.com/drugs/T-20.htm

tpan.com - Drug Guide 2003 - Fuzeon
www.tpan.com/publications/drug_guide/fuzeon.html

T-20 (FUZEON) Gets Priority Review - AIDS Treatment News
www.aids.org/immunet/atn.nsf/page/a-384-02

LATEST RESEARCH ON FUZEON AND T-1249, HIV FUSION INHIBITORS, TO ...
www.rocheusa.com/newsroom/current/2003/pr2003021001.html

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