Oxymetholone for the treatment of HIV-wasting

ANADROMED 50 (Oxymetholone) is an anabolic steroid, which is a man-made form of a hormone similar to testosterone. Oxymetholone appears to be very effective in countering wasting among HIV-positive patients taking highly active antiretroviral therapy (HAART).

The U.S. Centers for Disease Control and Prevention (CDC) classified HIV wasting as an AIDS-defining condition in 1987. The "wasting syndrome" is characterized by the following criteria: weight loss of at least 10% in the presence of diarrhea or chronic weakness and documented fever for at least 30 days that is not attributable to a concurrent condition other than HIV infection itself. Wasting (cachexia) should not be confused with simple weight loss. Wasting is the condition characterized by involuntary weight loss, meaning the loss of body size and mass, most notably lean muscle.

Numerous studies have been demonstrated a significant relationship between weight loss, mortality, and disease progression. Because, in addition to weight loss, depleted levels of body cell mass, which contains the metabolically active tissue, have been associated with increased risk of mortality in patients with HIV infection. Weight loss in HIV infection is characterized by the reduction of both fat and lean tissue. Such rapid weight loss has been associated with acute infections, whereas more gradual weight loss has been associated with malabsorptive disorders. Also, patients with HIV infection usually experience periods of weight stability and weight gain.

Double-blind, randomized, placebo-controlled phase III trial of oxymetholone for the treatment of HIV wasting was performed to find out if the Oxymetholone can be considered an effective anabolic steroid in eugonadal male and female patients with AIDS-associated wasting. Despite highly active antiretroviral therapy (HAART), chronic involuntary weight loss remains a very serious problem for HIV patients due to various alterations in energy metabolism and endocrine regulation. Previously, studies in HIV-positive men undergoing androgen replacement therapy or treatment with recombinant growth hormone (rGH) have shown partial restoration of lean body mass (LBM), but these treatments haven’t been sufficiently studied in eugonadal individuals.

The current trial of 89 HIV-positive eugonadal women and men with wasting syndrome, which was assigned either to the anabolic steroid Oxymetholone (50 mg bid or tid) or placebo for 16 weeks, was performed. Following characteristics were analyzed: body weight, bioimpedance measurements, quality of life parameters, and appetite.

Results of the trial outlined that the use of Oxymetholone led to a significant weight gain of 3.0 +/- 0.5 and 3.5 +/- 0.7 kg in the tid and bid groups, respectively (p <.05 for each treatment versus placebo), while individuals in the placebo group gained an average of 1.0 +/- 0.7 kg. Body cell mass (BCM) increased in the oxymetholone bid group (3.8 +/- 0.4 kg; p <.0001) and in the oxymetholone tid group (2.1 +/- 0.6 kg; p <.005). Significant improvements were noted in appetite and food intake, increased wellbeing, and reduced weakness by self-examination. The most important side effect was liver-associated toxicity. Overall, 43% of patients in the tid group, 25% of patients in the bid oxymetholone group, and 8% in the placebo group had a greater than 5 times baseline increase for ALT, AST, or gamma GT, while other adverse events were not increased over placebo.

As a conclusion, that’s must be said, that Oxymetholone can be considered an effective anabolic steroid in eugonadal male and female patients with AIDS-associated wasting. The bid (100 mg/day) regimen appeared to be equally effective to the tid (150 mg/day) regimen in terms of weight gain, LBM, and BCM and was associated with less liver toxicity.