
Growth hormone (GH) helps the body break down and "burn" fat. Before the lipodystrophy syndrome first appeared, researchers found that PHAs had, in general, less-than-normal levels of GH. So when the body-shape changes associated with lipodystrophy, particularly fat gain, became apparent, doctors and researchers speculated that injections of high doses of GH might help reverse fat gain, at least in the belly. While this has been borne out in some experiments, GH has also "burned" fat in areas other than the belly, including fat just under the skin (subcutaneous fat). Thus GH can have the unintended consequence of making the appearance of fat wasting worse.
A different approach to increasing GH levels is to stimulate the body's production of this hormone. Theratechnologies, a Montreal-based company, is investigating the use of a small molecule called TH9057. This product is a peptide that stimulates the brain to produce GH in small amounts as is naturally found in the body. This is in contrast to the high levels used when GH is injected. Smaller, more natural increases in GH levels may not stimulate the loss of subcutaneous fat. Experiments on HIV negative people with mild diabetes suggest that this drug appears to be safe. Results from a study done on PHAs and presented at this conference also suggest that the peptide is safe in the short term and can reduce abdominal fat.
Researchers in Canada and the United States recruited 61 PHAs, all of whom had excess abdominal fat as a feature of the lipodystrophy syndrome. All were on stable HAART regimens and had somewhat raised blood sugar levels suggesting mild diabetes. Their average age was 45 years and the average CD4+ cell count was 541 cells. CAT-scans of their bellies were used to assess fat levels.
Participants received one of the following injections under the skin, once daily for four months:
Participants who received the 2 mg/day dose had the greatest measurable decrease in abdominal fat. They lost at least 1 kg of fat in general and had a 16% decrease in abdominal fat. There was no significant decrease in subcutaneous fat. Researchers noted that similar results were seen in HIV negative people when GH was first used at very low doses in the 1980s.
Among PHAs who received the 2 mg/day dose, some reported side effects including headache and rash as well as bone and joint pain. The pain has sometimes occurred in people taking GH, so its development is not surprising. Researchers cannot, however, explain why headache occurred in some people who received the peptide. No participants developed diabetes.
Further research is needed to assess the effectiveness of this peptide over a much longer period of time and to be sure of its safety. Theratechnologies is planning a larger and longer study in PHAs using the 2 mg/day dose of its peptide.
REFERENCE
Grinspoon S, Kotler D, Allas S, et al. Effects of a growth hormone releasing factor (GRF) analogue in HIV patients with abdominal fat accumulation: a randomized placebo-controlled trial. International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV. 2004 October 25-28;6th: Abstract No. 2
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