Treatment with Recombinant Human Growth Hormone

Efficacy in Patients with HIV-Related Wasting

Recombinant human growth hormone (Serostim®) is an effective treatment for patients with HIV-associated wasting. Randomized, placebo-controlled clinical trials of recombinant human growth hormone demonstrate increases in lean body mass and protein synthesis, and decreases in urinary nitrogen excretion).42,43 In addition, patients receiving growth hormone also experience increased work performance, decreased body fat, increased body weight, and an improvement in their overall quality of life. Gains in lean body mass from treatment with growth hormone are also associated with improved survival in patients with HIV-associated wasting, independent of CD4 cell count and viral load.44

In a 12-week trial of recombinant growth hormone, enrollment consisted of 178 patients with HIV infection and weight loss.42 Participants had either documented unintentional weight loss of at least 10% or a weight of less than 90% of the lower limit of ideal body weight. They received either recombinant human growth hormone or placebo. Dosing was 0.1 mg/kg of body weight per day, with an average dose of 6 mg/day.

At week 12, there were significant and sustained increases in weight and lean body mass among patients receiving growth hormone. There were no reported net changes in weight for patients in the placebo group. At week 12, the average increase in lean body mass was nearly twice that of the increase in body weight. Growth hormone also produced significant decreases in body fat, which remained unchanged in the placebo group. When study participants were evaluated on their work output while walking on treadmills with increasing workloads, patients receiving growth hormone displayed greater increases in treadmill work output.

The usual dosage of recombinant human growth hormone in these patients is 6 mg/day. Patients have reported mild-to-moderate side effects, including skin turgor, edema, arthralgias, myalgias, and increases in blood glucose concentrations and glycosylated hemoglobin values. Such side effects tend to resolve when the dose is reduced or the drug is temporarily discontinued.

Initial Treatment with Recombinant Human Growth Hormone with

The Consensus Development Panel also reviewed best practice recommendations in order to guide clinicians on the use of growth hormone to treat HIV-associated wasting. If the patient meets the definition of wasting, an initial 12-week course of therapy is indicated. The clinician should document the response to therapy by obtaining serial body weights and body cell mass assessments. Treatment may continue on a monthly basis if there has been a positive response to therapy (2% increase in body weight and/or body cell mass) and wasting is still evident.

Indications for Stopping Therapy and Retreatment

Once body cell mass stores are normalized, the clinician can stop growth hormone therapy and observe the patient for an 8-week period. During this time, the clinician needs to monitor body weight, body cell mass, and the clinical symptoms of wasting. If, after eight weeks, clinical signs of wasting reappear, re-treatment with growth hormone may be started.