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Randomized Controlled Trial
. 2024 Oct 1;38(12):1758-1764.
doi: 10.1097/QAD.0000000000003965. Epub 2024 Jun 20.

Efficacy and safety of tesamorelin in people with HIV on integrase inhibitors

Samuel C Russo  1 , Mollie W Ockene  1 , Allison K Arpante  1 , Julia E Johnson  1 , Hang Lee  2 , Mabel Toribio  1 , Takara L Stanley  1 , Colleen M Hadigan  3 , Steven K Grinspoon  1 , Kristine M Erlandson  4 , Lindsay T Fourman  1
Affiliations
Randomized Controlled Trial

Efficacy and safety of tesamorelin in people with HIV on integrase inhibitors

Samuel C Russo et al. AIDS. .

Abstract

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.

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Conflict of interest statement

Conflicts of Interest: L.T.F. serves as a consultant to Theratechnologies and Amryt Pharma and receives grant funding to her institution from Amryt Pharma outside of this work. T.L.S. serves as a consultant to RosVivo Therapeutics and has grant funding to her institution from Pfizer, Inc. outside of this work. S.K.G. is the inventor on a patent for GHRH or Analogues Thereof For Use in Treatment of Hepatic Disease (application 16832128). For the remaining authors, no conflicts were declared.

Figures

Figure 1:
Figure 1:. Effects of Tesamorelin on Body Composition Among Participants on INSTI-Based Regimen.
Tesamorelin led to a reduction in A) visceral fat (median [interquartile range]: −25 [−93, −2] vs. 14 [3, 41] cm2, P=0.001) with B) no change in subcutaneous fat compared to placebo over 12 months. Tesamorelin also led to declines in C) hepatic fat fraction (−4.2% [−12.3%, −2.7%] vs. −0.5% [−3.9%, 2.7%], P=0.01) and D) trunk-to-appendicular fat ratio (−0.1 [−0.3, 0.0] vs. 0.0 [−0.1, 0.1], P=0.03) versus placebo over the study period. Box and whisker plots are shown with the center line denoting the median, the box denoting the 25th to 75th percentiles, and the whiskers denote the minimum and maximum values. *P<0.05, **P≤0.01, ***P≤0.001. Abbreviations: SAT, subcutaneous adipose tissue; VAT, visceral adipose tissue.
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References

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