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Belly Fat Drug
May 31, 2010

Nelson, I just read there is a new belly fat drug for HIV..can you tell me more please?

Response from Mr. Vergel

Egrifta (the brand name for Tesamorelin) is a growth hormone releasing hormone that makes your own body produce "normal" growth hormone levels. Growth hormone has been shown to decrease fat, and increase volume of muscle cells. It requires injections under the skin every day. Its fat lowering effects disappear once the drug is stopped.

This product was approved last week by a review panel at the FDA for the treatment of visceral fat accumulation related to HIV lipodystrophy. We are waiting for the final decision and indication from the FDA. We are also curious how insurance companies will consider this product for reimbursement. Hopefully, it will not be perceived as "cosmetic" so that we can get it paid for in HIV side effect management.

The company that makes it is Theratecnologies (based in Montreal, Canaada) but the company that will be selling and marketing it in the U.S. is Serono, a company that is yet to prove to the HIV clinician and patients community that they will be conscious of good pricing and marketing principles. Serono is the company behind Serostim, the growth hormone approved to treat HIV wasting syndrome.

We are anxiously waiting to see information on pricing, patient assistance program, and doctor/patient education. The drug seems to have very few side effects, with increases in blood sugar in around 4% of patients. It does not cause as many body and joint aches as Serostim, but it also does not decrease visceral fat surrounding organs as well either (an average of 15% in 26 weeks). But it is a welcomed approval for a problem that does not have a single drug for its treatment.

I will be happy to see this drug get approved, but now we will see if the company and insurers (including Medicare part D and Medicaid) will handle it for the best of the patients with HIV lipodystrophy. Stay tuned to my writings about it as developments arise. So far, 2010 has been a good year for HIV lipodystrophy. In January, Medicare decided they will reimburse HIV facial lipoatrophy (fat loss on the face)products and now we have a product to treat fat accumulation in the belly. But we will see how everything gets implemented surrounding payment for these options!

Nelson



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