Effect of recombinant human growth hormone in the treatment of visceral fat accumulation in HIV infection.

HIV-associated lipodystrophy often includes excess accumulation of visceral fat. Recombinant human growth hormone (rhGH) is a potential treatment for the excess visceral fat. Prospective, open-label trials of 24 weeks of rhGH 6 mg/d and 24 weeks of 4 mg every other day were conducted with an intervening washout period of 12 weeks. Thirty HIV-positive participants (26 men and 4 women) with visceral adiposity were enrolled. The main outcome measure was change in visceral adipose tissue (VAT) on whole-body magnetic resonance imaging scan. Changes in whole-body subcutaneous adipose tissue and skeletal muscle, glucose metabolism, serum lipids, and quality of life were also assessed. Despite stable body weight, VAT decreased in evaluable subjects an average of 42% with rhGH 6 mg/d (n = 24; p <.001) and 15% with 4 mg every other day (n = 10; p <.01) after 12 weeks, with trends toward further decreases after an additional 12 weeks at each dose. Subcutaneous adipose tissue also decreased, but proportionately less and not significantly on the lower dose. Skeletal muscle increased. Body composition rebounded to or near baseline after the washout period. Effects on lipids were inconsistent. Total cholesterol levels fell on the higher dose only, whereas high-density lipoprotein cholesterol levels increased on the lower dose only, and there was no effect on triglyceride levels. Joint pain was the most common adverse event, and was reflected in subjective quality of life measurements as an increase in bodily pain. Insulin sensitivity fell, and 4 participants developed diabetes. Other adverse events included cancer of unknown relationship to treatment in 3 participants. Levels of distress decreased after 24 weeks on the higher dose. In conclusion, rhGH effectively reduces the excess visceral adipose tissue often associated with HIV fat redistribution/lipodystrophy. However, frequent adverse effects warrant controlled studies and careful patient monitoring, especially regarding glucose tolerance.