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HIV lipodystrophy is a syndrome of abnormal central fat accumulation and/or localized loss of fat tissue that occurs in patients taking antiretroviral drugs. Tesamorelin (Egrifta), a growth hormone–releasing factor, was approved by the US Food and Drug Administration in 2010 to reduce excess visceral abdominal fat in HIV-infected patients with lipodystrophy.
FDA approval of tesamorelin was based on 2 studies in which visceral adipose tissue was significantly decreased from baseline at 26 weeks and sustained at 52 weeks.[134, 135, 136] These multicenter, randomized, double-blind, placebo-controlled phase 3 studies consisting of a 26-week main phase and a 26-week extension phase in 816 HIV-infected patients with excess abdominal fat associated with lipodystrophy. In phase III, randomized, double-blind studies that assessed the effect of tesamorelin on HIV-associated abdominal fat accumulation, a reduction in adiposity correlated with overall improved metabolic profiles of lipids and glucose.