Efficacy and safety of tesamorelin in people with HIV on integrase inhibitors.
| Autor: | Russo SC; Metabolism Unit, Massachusetts General Hospital and Harvard Medical School., Ockene MW; Metabolism Unit, Massachusetts General Hospital and Harvard Medical School., Arpante AK; Metabolism Unit, Massachusetts General Hospital and Harvard Medical School., Johnson JE; Metabolism Unit, Massachusetts General Hospital and Harvard Medical School., Lee H; MGH Biostatistics Center, Massachusetts General Hospital, Boston, MA., Toribio M; Metabolism Unit, Massachusetts General Hospital and Harvard Medical School., Stanley TL; Metabolism Unit, Massachusetts General Hospital and Harvard Medical School., Hadigan CM; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD., Grinspoon SK; Metabolism Unit, Massachusetts General Hospital and Harvard Medical School., Erlandson KM; Division of Infectious Diseases, University of Colorado Anschutz Medical Campus, Aurora, CO, USA., Fourman LT; Metabolism Unit, Massachusetts General Hospital and Harvard Medical School. |
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| Jazyk: | angličtina |
| Zdroj: | AIDS (London, England) [AIDS] 2024 Oct 01; Vol. 38 (12), pp. 1758-1764. Date of Electronic Publication: 2024 Jun 20. |
| DOI: | 10.1097/QAD.0000000000003965 |
| Abstrakt: | Objective: 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. Design: 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. Methods: 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. Results: 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. Conclusions: 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. (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.) |
| Databáze: | MEDLINE |
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