Reduction of excess abdominal fat secondary to lipodystrophy in HIV-infected pts.
brand | preparation | manufacturer | route | form | dosage^ | cost* |
Egrifta | Tesamorelin | Theratechnologies, Inc | SQ | vial | 1 mg | $77.50 |
2 mg | $99.70 |
*Costs (rounded to the nearest dollar) are based on usual adult dosing per day, are representative of "Average Wholesale Price" (AWP), and are current within the prior three months.
^Dosage is indicated in mg unless otherwise noted.
No data; usual dose likely
No data; usual dose likely
No data; usual dose likely
No data
No data
No data
Discontinuations due to adverse reactions occurred in 9.6% treated with tesamorelin (vs. 6.8% with placebo).
Tesamoralin, a synthetic analog of human hypothalamic growth hormone-releasing factor (hGRF), acts on the pituitary cells to stimulate synthesis and release of endogenous growth hormone.
< 4%
no data
AUC= 852.8 (CV 91.9) pg.h/mL
38 minutes
Vd= 10.5 L/kg
No data
Category X: contraindicated
Not recommended
Tesamorelin decreases abdominal fat by a modest 14-18% and significantly reduces triglycerides and non-HDL cholesterol in HIV+ pts with lipodystrophy.[3][2] White patients and those with metabolic syndrome and triglycerides >150 mg/dL are more likely to respond.[1] Musculoskeletal adverse effects, local injection site reactions, and cost may prevent routine use of tesamorelin. Benefits tend to reverse with discontinuation of drug. With currently used ARV regimens, most weight gain is due to increased subcutaneous fat rather than visceral fat accumulation.
Comment: Patients with metabolic syndrome and triglyceride levels >1.7 mmol/L at baseline and those of white race were more likely to respond to tesamorelin therapy at 6 months.
Comment: Patients that responded to tesamorelin (defined as at least 8% reduction in visceral adipose tissue) in 2 phase III RCTs experienced significantly greater reductions in triglycerides levels and parameters of glucose homeostasis (hemoglobin A1c, fasting blood glucose) over 52 weeks compared to those nonresponding to tesamorelin.
Comment: RCT of 806 treatment-experienced HIV-positive patients with excessive abdominal fat randomized to receive tesamorelin 2 mg daily or placebo for 26 or 52 weeks. Visceral adipose tissue decreased significantly (15% decrease) in tesamorelin treated patients at 26 weeks. Treatment also resulted in significant reductions in triglycerides levels and cholesterol to HDL ratio.
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