HIV Management In Depth

A Closer Look at Tesamorelin (Egrifta), a Newly Approved Treatment for HIV-Associated Lipohypertrophy

A Podcast Discussion With Daniel Berger, M.D.

November 12, 2010

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How often do people need to take the drug, and how is it taken?

Patients in the study were taking two milligrams of Egrifta by subcutaneous injection every day.

Where specifically did they inject?

They were injecting into their subcutaneous belly, or abdomen. In other words, they pinch their abdomen and just give themselves a small injection, not unlike an insulin shot.

Are there any particular concerns about the time of day you need to take it, whether it needs to be stored in a particular way, or whether it interacts with any other drugs?

I'm not sure much about drug interactions. There may have to be more studies looking at all the specific medications, but understand that growth hormone-releasing factor, or Egrifta, is mediated by insulin-like growth factor, or IGF-1, which is also not unlike Serostim. And that agent is being used widely without any concerns about drug interactions. I believe that this agent would also be safe to use with many medications and all the antiretroviral agents. From the study, patients were taking a wide variety of different varying antiretroviral regimens and it wasn't any problem in terms of what their regimens were.

This drug was specifically studied in people with excess abdominal fat. What's the extent of knowledge as far as how well or not well it will work for any other form of fat gain throughout the body?

Oh, there's been a lot of questions about people with different types of fat accumulation. Normal people that have, for example, subcutaneous fat as opposed to visceral fat -- obviously this drug has not been studied for that situation. But suffice it to say that the medication Egrifta, it showed a very specifically targeted effect on visceral fat with reductions. It didn't show any specific changes with limb fat that was significant in any way, nor in terms of subcutaneous fat.

You were referring to buffalo hump a little bit before. Is there any indication that it could help with that kind of complication?

In the study, and it hasn't been studied significantly, there have been some reports of one or two patients that have had fat accumulation such as buffalo hump that did get benefit when they were on the Egrifta. But again, this wasn't studied and it's hard to make any big conclusions from that.

True. And regardless, we're talking about a situation here where, if you have a very large belly, it doesn't sound like this drug is going to eliminate it completely. It just may make it better enough that it causes a significant improvement in your quality of life, from the sounds of it.


Absolutely. I think that patients often have depression and feelings of isolation when their body image has been altered to that degree. And it is my personal opinion that patients concerned about fat changes may have reasons not to take their antiviral medications. In my mind, in other words, lipodystrophy may be associated with poor adherence to medications.

So if there were medication or treatment that could combat the problem of fat accumulation or body image problems, then patients should have less depression, less feelings of isolation and better adherence to medications. I think that this was highlighted during the FDA meeting when several patients came forward and testified about how they felt about the fact that they were on Egrifta during the studies and what they got out of being on treatment.

What is the threshold then? How does a person with HIV, or a doctor who's treating a person who's HIV positive, know when a drug like Egrifta is worth trying?

We know that Egrifta causes, or has a potential to cause, a reduction in visceral fat accumulation. And we know that visceral fat accumulation is a part of the syndrome of lipodystrophy that has also been associated with increased cardiovascular risk. We know that, as they live longer and are aging, we're seeing higher rates of cardiovascular problems in this patient population.

So a physician that's seen patients with HIV infection, if he or she sees a patient who's developing the problem -- the patient's complaining about it or the patient's already noticing it, which is often how the problem emerges in the exam room -- I think it behooves the physician to consider what the patient is experiencing and to weigh out the benefits versus the downsides, which appear, at least from studies, to be minimal.

Patients who have the problem and are somewhat concerned about it and a little frustrated by it, any patient with visceral fat accumulation, can be a candidate for treatment with Egrifta -- and even patients that have mild diabetes problems can be a candidate. Although the study hasn't looked at specific patients with diabetes that require treatment, there is some foundation from which to believe that Egrifta or tesamorelin can be used to treat even those patients safely.

And you can't look away from the fact that Egrifta, by reducing visceral fat adiposity, may also have some benefits in terms of reducing the overall cardiovascular risks of patients -- but we cannot assuredly state this from the data, since the study wasn't designed to look at this. However, if one looks at the published articles of the studies, there were some reductions in triglycerides as well as cholesterol levels. So I believe that Egrifta will be useful in many patients with HIV infection who have visceral fat accumulation.

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This article was provided by TheBodyPRO. It is a part of the publication HIV Management in Depth.


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