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Belly Fat Drug Debated Even Before FDA Approval

February 22, 2010

Drugs into bodies ... not as clearcut as it sounds.
Drugs into bodies ... not as clearcut as it sounds.
Tesamorelin (expected to be called "Egrifta" if and when it is marketed and sold in the United States by the company EMD Serono) is an experimental drug that seeks to limit or reduce belly fat caused by Lipodsytrophy. The new drug, awaiting FDA approval to be marketed to people with HIV (and expected to be sold off label as well) will have an expected $25,000 a year price tag if approved. While an FDA hearing has been scheduled, it's unclear if the drug will be approved solely for cosmetic reasons.This would greatly limit access to the drug among those who can't afford the cost, and all but nix cash-strapped public benefits programs from covering it. Treatment advocates question how much effort -- or ADAP or Medicaid money -- should be spent on drugs combating lipodystrophy.

Lipodystrophy is a condition resulting from the effects of certain medications, or even HIV itself, on how the body metabolizes and stores lipids (fat) in the body and in the bloodstream. Lipodystrophy causes wasting such as "sunken cheeks" -- facial lipoatrophy -- or the redistribution of body fat such as "truncal obesity" -- belly fat.

"This drug was tested on people with AIDS, so people with AIDS should have the ability to use and afford this drug," said Ken Fornataro, E-Access to Care Director of Housing Works. Fornataro and some advocates are skeptical about the emphasis being placed on this drug. A patient assistance program is expected, but details have not yet emerged.

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Tesamorelin wasn't developed because people with HIV/AIDS saw a need. Theratechnologies, the biocompany that developed this weight-loss technology, viewed this as a strategy to get it to market quickly. "We are a small company, and we wanted something that had a manageable clinical program," said Andrea Gilpin, Theratechnologies Vice President of Investor Relations.

The FDA is expected to approve this drug only for use by people living with HIV/AIDS, although Gilpin said Theratechnologies is in the process of testing the drug for use of people with Growth hormone deficient abdominal obesity and diabetes. Still, off-label use for those looking for an anti-aging effect could be significant.


How Important Is Tesamorelin?

There are no drugs on the market specifically to fight lipodystrophy. Tim Horn, the editor of AIDSMeds.com who has been following the drug since its inception, said, it's hard to determine how well tesamorelin works against other agents, purely experimental or otherwise, without head-to-head studies.Tesamorelin trials show patients receive a reduction in fat deep within the belly by 15 to 18 percent.

"We know that Serostim ( a growth hormone) reduced VAT by around 21 to 24 percent in clinical trials, compared with tesamorelin's average 15 to 18 percent reduction in its own studies. Though Serostim may be more effective, tesamorelin's moderate efficacy and good safety profile is notable," Horn said.

Still, some are skeptical of the drug's importance. Jeff Taylor, a patient advocate on AIDS Treatment Activists Coalition's (ATAC) drug development committee was a trial participant in the drug development, and said "it's an okay drug." I've been on the drug for wasting before. Tesamorelin took longer and the results weren't better. It wouldn't be the complete answer to the problem," Taylor said.

"If it gets branded for 'cosmetic usage' nobody's going to pay for it. We're hoping it's going to be looked at the same way as radical mastectomies for cancer patients. We think this should be considered in the same light," Taylor said. If tesamorelin is only approved for cosmetic purposes, that means patients could need to get a doctor's note saying their lipodystrophy is making them depressed.

Patient advocate Jules Levin also has some doubts. "I'm not extremely excited about the drug. It needs to be studied extensively. I wish patients would do exercise and diet more," said Levin. He said he wished more focus was put on increasing access to antiretrovirals, or developing treatments for African-Americans.

The FDA was supposed to conduct an advisory hearing on February 24, but recently announced the meeting will be postponed until May 29 for procedural reasons. Horn retains an optimistic stance.

"To say this is a drug to make people look beautiful misses the point. This is someone who's had something taken from them from medications," said Horn. "It improves quality of life and mental health. It allows them to take HIV medication. I equate this to women who have had breast reconstruction after mastectomies. I think it helps the emotional healing process."

Housing Works does not manufacture, endorse, promote, or sell any specific drug or therapy for any medical condition Consult with your Housing Works health care provider or another qualified professional who knows your specific medical history before making any treatment decisions. This information is intended for educational purposes only.



  
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This article was provided by Housing Works. It is a part of the publication Housing Works AIDS Issues Update. Visit Housing Works' website to find out more about their activities, publications and services.
 
See Also
An HIVer's Guide to Metabolic Complications
More on Egrifta (Tesamorelin)

Reader Comments:

Comment by: Bruce (Dallas, TX) Fri., Apr. 2, 2010 at 4:43 pm EDT
correction- the Dallas study ended Sept, 2008
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Comment by: Bruce (Dallas,TX) Fri., Apr. 2, 2010 at 3:23 am EDT
This drug works ! I was in the Dallas study for 1 year ending Sept 2080....with the results increasing in the 2nd 6 months.....less belly fat, more muscle growth.....with zero side effects..

I tried Serostim before that & could not tolerate the stiffness in the joints even with reduction of the amt to 1days worth per week.

I really am excited to start this drug again if approved !
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Comment by: schmoo (pittsburgh, PA) Mon., Mar. 15, 2010 at 1:21 pm EDT
I hate it when people disregard the importance of some of the side effects some sufferers have to live with. Sure people are living longer with these meds but who needs a long life with all the signs of this disease and its side effects written all over them for all to see? The quality of ones life has a lot to do with ones appearance. So dont ever regard the treatment as cosmetic when people are stigmatised everyday. Fighting the disease is one fight too many already, thank you!
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Comment by: TrialParticipant (NJ) Fri., Mar. 12, 2010 at 7:41 pm EST
My partner and I were in one of the initial studies for this drug. We both saw great results but adverse side effects cause us both to have to drop out of the study. In my case it was a life threatening allergic reaction. The other draw back is that it's an injectable drug that you must inject into your belly every day.

The drug works but just be careful of side effects. Lipodystrophy sucks but some of the side effects are even worse.

Just educate yourselfs before starting any new med.
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Comment by: igotit (michigan) Thu., Mar. 11, 2010 at 11:56 pm EST
i fit the above comments i never knew this condition exists just thought i was fat the comments i get is when is the baby due (i'm male)reading this article makes me feel a lot better i've been to dieticians and told them of my dianogis noone ever mentioned this condition the word needs to get out
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Comment by: Ted (New Jersey) Thu., Mar. 11, 2010 at 4:04 pm EST
I exersize my butt off and watch my diet and nothing gets rid of the belly fat and hump that emerged quickly with the PI's years ago. This drug IS important. Lipodystropy is a stigmatizing condition resulting from non-optional treatment of a life threatening disease. Just like the mastectomy argument.
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Comment by: JerryMc (Ontario, CA) Thu., Mar. 11, 2010 at 2:14 pm EST
This is a very important step in emotional health. Having my huge gut, even though I work out extensively 5X/week, is disheartening and VERY depressing. I am very muscular and slim in the extremities, yet fat in the mid-section. I do lots of cardio and eat very healthy too. The pain in my gut, back, and sides is very bothersome. It is NOT just cosmetic!

I hope this is approved, safe, and affordable!

JerryMc
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