Are there any options for HIV+ patients who cannot get Egrifta to treat their belly fat?

From : http://www.thebody.com/Forums/AIDS/Nutrition/Q217585.html?ic=700101

Anything Available for Those of us who cannot get Egrita? Oct 4, 2011 Nelson, my insurance company refuses to pay for Egrifta after my doctor wrote a letter. I have a lot of visceral fat (18 pound increase in weight since I started HIV treatment). Is there any other option for me? I have a good job but cannot afford the $2000 per month cost of Egrifta.
		Response from Mr. Vergel I am sorry that you have had such trouble trying to access Egrifta(Tesamorelin)which is indicated for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. Egrifta is a growth hormone releasing hormone that makes your own pituitary gland release physiologic levels of growth hormone. Prior studies using growth hormone (Serostim) showed that visceral fat was effectively decreased by growth hormone, but GH caused side effects that made the FDA reject Serono's application for lipodystrophy for Serostim. So Serono bought the rights of Tesamorelin from a Canadian company (Theracnologies) after it was shown that their growth hormone releasing hormone did not have the same concerning side effects (hypergylcemia, joint aches, edema, and others) that Serostim had. Egrifta got approved by the FDA but the FDA also required the company to engage in post approval studies to prove that the hormone did not increase incidence of cancer, since there is some fear that growth hormone products can do so. I know that Serono is making progress trying to get the product included in different formularies around the country, but there are still insurance companies and Medicare Part D programs that are not paying for it. And sometimes it is difficult for physicians to spend the extra time required to write letters of necessity to try to fight insurance companies. Some Medicare Part D patients who are lucky enough to get the product paid for cannot afford the high copays of over $100 per month, so there are still challenges in access even for those with third party coverage (there is copay assistance for non Medicare patients, though). Hopefully that will get better with time. For those patients with no insurance, Serono has set up a very good compassionate access program to cover the cost of the hormone for those with incomes under $60,000 a year. More on Egrifta.com I remind people that this hormone requires daily injections under the skin. The average visceral fat loss in the studies was around 17%, but when Theratecnologies (the manufacturer) separated responders versus non responders they found out that 30 % of all patients did not respond at all to the injections (their fat did not decrease). But the rest who responded, the fat reductions were as high as 27%. The manufacturer did not control for those who exercised or went on a special diet, however. So, we do not know if patients who responded best were also using other modalities that may have improved that response. As it stands, Serono and Theratecnologies have no idea how to predict who will respond to the daily injections. Also, do not forget that the fat lost will come back if you stop the product, although no one has done a study to see what happens to those patients who made permanent and durable life style modifications through the use of Egrifta. Those patients may retain some of the benefits even after drug cessation, but that is just my opinion. There is a generic option of a growth hormone releasing hormone that acts in the same way as Egrifta but it is a peptide with a shorter molecule chain. It can only be obtained by prescription from a compounding pharmacy. It is called Sermorelin Acetate. Like Egrifta, it stimulates the pituitary gland to naturally produce increased amounts of human growth hormone. The increased volume of human growth hormone produced by the pituitary gland causes an increase in the production of Insulin-Like Growth Factor-1 (IGF-1) by the liver. Increased IGF-1 has been associated with increased lean body mass and decrease fat but as I said before, some skeptics fear that it may also increase growth of malignancies (this is unproven). Sermorelin can cost anywhere from $300-$500 a month depending on the dose used. And insurance companies will not pay for it, so you will have to pay out of your own pocket. Most doctors do not know about this option, however. Like with any option to improve body composition, you should make sure that your thyroid and testosterone hormone levels are OK since that will ensure that your response will not be impaired by deficiencies of both hormones. Resistance/cardiovascular exercise and high fiber-low sugar-high protein diet are also two life style habits that will probably enhance response, although we really do not have controlled data on this combination that intuitively makes sense. You can find a compounding pharmacy close to you at : Compounding pharmacies Depending on the state that you live in, most compounding pharmacies deliver by mail to your home. The price differential among pharmacies is big, so call around. I and a lot of my pozhealth group members have been usingapsmeds for a few years for cheaper testosterone, nandrolone, HCG and other products like Sermorelin. Please let me know if you have any more questions. This is an emerging area that has been of great interest in the community, but one that has lost a lot of funding even as we grow older with HIV and need more data on therapies that can help us live healthier and stronger. Nelson Vergel

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Date: 12 Oct 2011 16:28:14 -0400

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