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Fuzeon reactions
Apr 27, 2003

Dr.Young, I am starting fuzeon in three weeks. I have read abou the site injections as being painful. I would like to know what other side effects have been associated with this drug. Also, what are other meds are working well with it?Does the site injection pain last as long as you are on the fuzeon or will it go away? Where do you take the shot on your body? Thanks for your help. Todd

Response from Dr. Cohen

This is an answer from me, Dr. Cohen - as I've been working with Fuzeon, also called T-20 or enfuvirtide, for the past 5 years.

First - a bit of background since there are likely many who are not yet aware of this newest antiviral drug. There is a lot of interest in this new drug, and what its role can be for those with HIV infection. It does have several unique features - but ultimately it is still just another antiviral - and has some properties in common with all antivirals -- mainly, that it works only somewhat when given alone -- and like every other drug - will do far more if it is combined with other active antivirals.

How it works is one of the unique features. Unlike all current antivirals, which work once HIV has entered our cells - T-20 works by preventing the entry of HIV into our cells. We have been learning that there are several steps that HIV goes thru in order to first attach onto our cells, and then fuse it's virus envelope with our cell membranes. And we are seeing the development of drugs that work at several of these steps. T-20 works by blocking one of the last steps in the process - when HIV is in the last steps of this process. Once HIV anchors onto our cells it brings itself onto the cell by "zipping" together two proteins - much like a typical zipper works. By zipping these two proteins, HIV becomes close enough to our cells to start the process of fusing with the membrane. But with T20 there - it is like something caught in the zipper - and since HIV can't zip these proteins together - it cannot fuse with our cell membranes. And that is how it works - by blocking the ability of HIV to start the process of taking over the cell machinery after it enters our cells.

Now - the molecule of T20 is very large - much larger than other antivirals. For that reason there is one important difference with this drug. Like insulin, it must be given by self-injection twice a day. Now, we don't have any other HIV antivirals that require self injection, and for some this issue creates a lot of anxiety about the ability to do these injections. But in every medical office is usually a nurse who knows how to teach diabetics how to self-inject insulin - and this skill is something that many have learned successfully. (Indeed, for some, it is exactly this "skill" that led to getting HIV to begin with... ;-)

And we've asked those on T20 about their experiences with the injections - in order to answer your questions. It is clear that almost everyone will notice a small bump at the site of the injection. For half it is described as no big deal - a small bump that might have a little redness or firmness for a day or two. For a few it lasts longer - for only a very few it may last a week. Now for about 90% it is noted but not a big deal - only 10% reported that there was enough discomfort that they felt the need to take something like Tylenol for the pain. And for only 3% was this side effect so uncomfortable that they had to stop the drug. So far, this side effect is a nuisance but one that doesn't cause a lot of trouble for many. And there are several insights of how to self inject that appear to minimize the discomfort - including making sure you inject into the skin or fat and avoid going deeper. And also avoiding injecting anywhere near a current injection site "bump" since that seems to be more tender after the next injection. As for where to inject - most are using either the belly, the thigh, or the upper arm - all seem to work equally well and people find their own comfort with where to inject.

As for what works well with T20 - we can safely state that any HIV antiviral will work will with it, as long as that drug is active. There are no drugs that are antagonistic with T20 since it works in a completely new way. And it is also clear that everyone has a strain of HIV that should respond to T20 since it is a brand new approach without having any T20 resistance as a result of resistance to current drugs.

So - the short answer - is that T20 should be combined with as many drugs as you need to create potent suppression - and that means looking at a recent resistance test if possible on the "pre T20" regimen to see which drugs appear active - and then picking as many as needed that someone can tolerate to make the best of this chance. There is much more to say about this - but this is a short summary of this issue.

Hope that helps - there is much more to say and learn about this new important drug - let us know how it worked.



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