CROI: Experimental Hormone Reduces Visceral Fat in HIV Patients

February 27, 2007

LOS ANGELES -- An investigational synthetic hormone significantly reduces visceral fat in patients treated for HIV, researchers reported here.

LOS ANGELES, Feb. 27 -- An experimental synthetic hormone significantly reduces visceral fat in patients treated for HIV, Harvard researcher said here.

Compared with placebo, the growth hormone releasing analog TH9507 reduced visceral fat by about 20%, Steven Grinspoon, M.D., of Harvard Medical School, and colleagues, reported at the annual Conference on Retroviruses and Opportunistic Infections.

The net change of 20% in just six months is "a very potent effect," Dr. Grinspoon told an oral abstract session. The difference amounts to about a 3 cm change in waist size, Dr. Grinspoon added.

At the same time, there was little effect on subcutaneous fat or glucose transport and lipid metabolism was improved, he said. The compound also was safe and "generally well-tolerated."

The findings come from a placebo-controlled phase III study, in which 410 patients on stable HIV treatment were randomized to either 2 mg a day of TH9507, injected subcutaneously, or placebo.

The main endpoint was change in visceral adipose tissue, and the study found that patients getting the compound had a 15% reduction in visceral fat, compared with a 5% increase for patients getting placebo.

In absolute terms, patients getting TH9507 lost an average of 28.7 cm2, compared with an increase of 4.9 cm2 for those on placebo. The difference in the arms was significant at P

The so-called nucleoside-minimizing regimen was compared to what is considered the standard of care - efavirenz (Sustiva) plus zidovudine and lamivudine - in a randomized, prospective study including treatment-nave 155 patients.

The researchers used dual-photon absorptiometry scans to measure the prevalence of lipatrophy (defined as more than a 20% decrease in limb fat mass) and lipohypertrophy (defined as more than a 20% increase in trunk fat mass).

The nucleoside-sparing regimen showed significantly (at P