MASAC Recommendation #108
MASAC Recommendation Regarding Treatment of AIDS Wasting
The following recommendation was approved by the Medical and Scientific Advisory Council (MASAC) on November 11, 2000, and adopted by the NHF Board of Directors on November 12, 2000.
As many as 50% of patients with advanced HIV/AIDS have evidence of hypogonadism (low testosterone) (1). Among individuals with hemophilia, the proportion with low testosterone is not known but is of particular concern, especially among those who became infected with HIV during adolescence and/or suffered delayed puberty (2). Studies have found that low testosterone levels are associated with loss of lean body mass (1) and among patients with HIV/AIDS, with poorer survival.
A recent study has shown the administration of testosterone to men with AIDS wasting to be effective for increasing lean body mass, fat-free mass, muscle mass, and quality of life (3). Studies are currently ongoing to determine the optimal length of treatment and whether those with low-normal or borderline testosterone levels may benefit from such treatment.
Therefore, it is recommended that serum testosterone levels be screened in hemophilia patients with AIDS wasting. For those with low testosterone levels, testosterone replacement should be considered. For those with borderline or low-normal levels, repeat testing is recommended. The duration of treatment remains unknown. NHF supports clinical studies to define the optimal dose and duration of treatment and benefit among those with borderline testosterone levels.
Other therapeutics, including recombinant human growth hormone (4) and Megace (5) are being used anecdotally and in clinical trials for the treatment of AIDS wasting. Of note, the mechanism of action of these agents may differ from that of testosterone. For example, recombinant human growth hormone improves lean body mass while Megace does not. MASAC recommends close monitoring of these studies to relate their findings to the hemophilia population, many of whom are coinfected with hepatitis C virus and therefore might not be good candidates for testosterone therapy.
- Grinspoon S, Corcoran C, Lee K, et al. Loss of lean body mass and muscle mass correlates with androgen levels in hypgonadal men with acquired immunodeficiency syndrome and wasting. J Clin Endocrinol Metab 1996; 81:4051-8.
- Mahoney EM, Donfield SM, Howard C, Kaufman F, Gartner JM. HIV-associated immune dysfunction and delayed pubertal development in a cohort of young hemophiliacs. JAIDS 1999; 21: 333.
- Grinspoon S, Corcoran C, Hasan A, et al. Effects of androgen administration in men with the AIDS wasting syndrome: a randomized, double-blind, placebo-controlled trial. Ann Int Med 1998; 129:18-26.
- Schambelan M, Mulligan K, et al. Recombinant human growth hormone in patients with HIV-associated wasting: a randomized, placebo-controlled trial. Ann Int Med 1996; 125:873-82.
- Von Roenn RH, Armstrong D, Kotler DP, Cohn DL, et al. Megestrol acetate in patients with AIDS-related cachexia. Ann Int Med 1994; 121:393-9.