Question

HI Nelson, There was an article in the Frida July 23rd New York Times ab out Lipodistopy in non HIV positive people . They talked about the drug Leptin, have you heard of it are there any studies being done with Leptin and HIV positive people. ? Thanks, W. in Toronto

Answer

Hi W

I think you refer to this article:

Skinny and 119 Pounds, but With the Health Hallmarks of Obesity

Leptin was actually studied by Dr Kathy Mulligan and her team in people with HIV related lipodystrophy in a very small pilot study with promising results.

This hormone, discovered in 1994, is produced by fat cells. Leptin levels in the blood are generally proportional to the level of body fat. In the hypothalamus (the part of the brain that controls appetite), high levels of leptin suppress the appetite and stimulate fat-burning. Like Serostim and Egrifta (two hormones studied in HIV Lipodystrophy), it is taken as an injection you administer under the skin, but it requires two injections a day, though other doses may be studied in the future. In a study of eight men with HIV and lipodystrophy, visceral fat decreased by 32% after 6 months, with no change in subcutaneous fat. Bad (LDL) cholesterol decreased by 16% and good (HDL) cholesterol increased by 19%, with a significant decrease of triglycerides. Leptin was well tolerated but it decreased lean mass. Early, small studies have not shown leptin to have negative effects on blood sugar, as Serostim can cause (Egrifta does not cause significant glucose elevations).

I am part of a small group of activists are asking its manufacturer to do larger studies in people with HIV to determine if leptin is useful and if it will be cost-effective. So far, the company feels like more data needs to be produced in non-HIV indications since they fear that leptin may have negative effects on the immune system.

In January of 2015, a company called Aegerion Pharmaceuticals, Inc. announced it had completed the acquisition of MYALEPT® (metreleptin, the generic and brand names for leptin) for injection, an orphan drug product that is indicated to treat complications of leptin deficiency in patients with generalized lipodystrophy (GLD) (non-HIV).

The company lists these potential side effects of the drug in their product label:

WARNING: RISK OF ANTI-METRELEPTIN ANTIBODIES WITH NEUTRALIZING ACTIVITY AND RISK OF LYMPHOMA

Anti-metreleptin antibodies with neutralizing activity have been identified in patients treated with MYALEPT. The consequences of these neutralizing antibodies are not well characterized but could include inhibition of endogenous leptin action and/or loss of MYALEPT efficacy. Severe infection and/or worsening metabolic control have been reported. Test for anti-metreleptin antibodies with neutralizing activity in patients who develop severe infections or show signs suspicious for loss of MYALEPT efficacy during treatment.

T-cell lymphoma has been reported in patients with acquired generalized lipodystrophy, both treated and not treated with MYALEPT. Carefully consider the benefits and risks of treatment with MYALEPT in patients with significant hematologic abnormalities and/or acquired generalized lipodystrophy.

Source: Aegerion Pharmaceuticals Completes Acquisition of MYALEPT(R)

I have a few concerns about leptin. The most important one is that this hormone can decrease testosterone blood levels and lean body mass, so if any further studies are done I would like to have the company include testosterone replacement as a way to compensate for this issue.

Currently, the only product approved for the reduction of abdominal fat accumulation in HIV disease is Egrifta. Interview with Dr Grinspoon about lipodystrophy and tesamorelin (Egrifta)

I will inform the community via TheBody.com if and when there is progress in getting more studies related to HIV lipodystrophy once the safety concerns have been completely assessed in people like us with immune dysfunction.

Thanks for the great question. Stay tuned!

Nelson Vergel