Saturday, February 19, 2011

Tesamorelin (Egrifta) Part 2

Given the FDA's November 10, 2010 approval of Tesamorelin (Egrifta) for use in HIV-positive patients w/lipodystrophy, I thought that I would give more background information and run through a quick review of this agent.

It's predecessor, Sermorelin (Geref), has been around a while and used in testing for growth hormone (GH) deficiency by attempting to stimulate the pituitary to produce more GH.  Since the end result in most otherwise healthy patients is GH production & release, it was then offered as a less expensive, off-label option to recombinant human GH (rhGH) in the anti-aging and age management medicine arena.  That's where the politics and legal issues surrounding this compound get a bit murky.  It is no longer available since Serono pulled back its marketing support here in the US although some compound pharmacies still make it available for use.

I first stumbled upon this compound when a study was published in December 2007 in the New England Journal of Medicine documenting its ability to decrease visceral fat and improve lipid profiles in HIV-positive patients when used for 26 weeks.  A year ago, another study concluded that tesamorelin could reduce visceral fat in HIV-positive patients without significant side effects or hyperglycemia.  Then last September in the Journal of Clinical Endocrinology & Metabolism, yet another study concluded similarly that tesamorelin would reduce visceral adipose tissue for an additional 26 weeks after the initial 26 week trial and more importantly, without causing hyperglycemia.  It should be noted that up to a quarter of the participants in this last study were also taking testosterone (in some form) concurrently.  Also, note that all reductions in adipose fat have been from the visceral component, not subcutaneous.  However, you'll recall that it's the visceral adipose that leads to the metabolic syndrome, diabetes, and coronary disease.

Which brings me to a rather small but significant study published in JCEM last month.  Specifically, the authors gave tesamorelin to 13 healthy men, average age 45 years old w/body mass index 27.3 (overweight but not obese), for 2 weeks.  Growth hormone levels increased as expected with an increase in IGF-1 (insulin-like growth factor-1) by an astounding 181ug/L (or more common ng/mL) without changing fasting glucose or insulin-stimulated glucose uptake.

My conclusion?  We now have a legal manner in which to increase growth hormone with minimal impact, if any, on sugar control (although I've really downplayed the potential side effects as noted in the product insert).  We still don't have long-term data (longest duration mentioned above was 52 weeks) on large numbers of patients.  What about cost?  Last June, one financial analyst put the cost at $36K/year which is 3x what most growth hormones now cost.  Drugstore.com lists Egrifta at $46/1mg vial.  Since the prescribing information dictates 2mg/day, you'll need 2 vials/day or $92/day.  They do offer volume discount so that 60 vials or a month's worth of Egrifta might go for $2,300, which means $27,600/year.  However, one can't prescribe growth hormone off-label.  Aye - there's the rub!

So there you have it.  All you wanted to know about Tesamorelin but were afraid to ask.

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