Study summary · research use only
Efficacy and safety of tesamorelin in people with HIV on integrase inhibitors
Plain-language summary
Paraphrased from the published abstract below — not a verdict on whether anything works.
This randomized, double-blind trial examined tesamorelin, an FDA-approved therapy for abdominal fat accumulation in people with HIV (PWH), among a subset of 38 participants on integrase inhibitor (INSTI)-based antiretroviral regimens at baseline, drawn from a parent trial of 61 PWH with metabolic dysfunction-associated steatotic liver disease. Participants (human) received tesamorelin 2 mg once daily or placebo; 15 on tesamorelin and 16 on placebo completed 12 months. Using MRI, proton MR spectroscopy, and DXA, tesamorelin was associated with declines in visceral fat (median -25 vs. 14 cm2), hepatic fat (-4.2% vs. -0.5%), and trunk-to-appendicular fat ratio (-0.1 vs. 0.0), with a similar frequency of adverse events, including hyperglycemia, between arms.
Abstract
Tesamorelin is the only FDA-approved therapy to treat abdominal fat accumulation in people with HIV (PWH). Phase III clinical trials were conducted prior to the introduction of integrase inhibitors (INSTIs), which are now a mainstay of HIV antiretroviral therapy. We leveraged a randomized double-blind trial of 61 PWH and metabolic dysfunction-associated steatotic liver disease to evaluate the efficacy and safety of tesamorelin 2 mg once daily vs. identical placebo among participants on INSTI-based regimens at baseline. In the parent clinical trial, visceral fat cross-sectional area, hepatic fat fraction, and trunk-to-appendicular fat ratio were quantified using magnetic resonance imaging, proton magnetic resonance spectroscopy, and dual-energy x-ray absorptiometry, respectively, at baseline and 12 months. Metabolic and safety outcomes were compared between treatment arms. Among 38 participants on INSTI-based regimens at baseline, 15 individuals on tesamorelin and 16 individuals on placebo completed the 12-month study. Tesamorelin led to significant declines in visceral fat (median [interquartile range]: -25 [-93, -2] vs. 14 [3, 41] cm 2 , P = 0.001), hepatic fat (-4.2% [-12.3%, -2.7%] vs. -0.5% [-3.9%, 2.7%], P = 0.01), and trunk-to-appendicular fat ratio (-0.1 [-0.3, 0.0] vs. 0.0 [-0.1, 0.1], P = 0.03). Tesamorelin was well tolerated with a similar frequency of adverse events, including hyperglycemia, between groups. The current analysis provides the first dedicated data on the efficacy and safety of tesamorelin among PWH on INSTI-based regimens. Despite the association of INSTI use with weight gain and adipose tissue dysfunction, tesamorelin had beneficial effects on body composition with no exacerbation of glycemic control.
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