Efficacy and Safety of Tesamorelin in People Living With HIV (PLWH) With Lipodystrophy: A Systematic Review and Meta-Analysis.
Level 1 - systematic review of randomized trials
Systematic review and meta-analysis of randomized controlled trials
PubMed 42538058 · doi:10.1177/23259582261475549
What was done
A systematic review and meta-analysis searched PubMed, ClinicalTrials.gov, and Scopus through February 9, 2026, for randomized controlled trials (RCTs) evaluating tesamorelin in people living with HIV with lipodystrophy receiving combined antiretroviral therapy (cART). Mean differences (MD) and risk ratios (RR) with 95% confidence intervals were pooled using random-effects models, with GRADE certainty assessment.
What was found
Across 4 RCTs (909 patients), tesamorelin 2 mg significantly reduced visceral adipose tissue (MD = -21.47, 95% CI [-34.73, -8.22], I² = 74%, p = 0.002), waist circumference (MD -1.61 cm, 95% CI [-2.28, -0.95], I² = 0%, p < 0.00001), and trunk fat (MD -1.20 kg, 95% CI [-1.47, -0.93], I² = 0%, p < 0.00001). Lean body mass increased (MD 1.42 kg, 95% CI [1.13, 1.71], I² = 0%, p < 0.00001) and total cholesterol slightly improved (MD -0.16 mmol/L, 95% CI [-0.27, -0.06], I² = 0%, p = 0.003). Growth hormone-related adverse effects were observed, and discontinuation rates trended higher without statistical significance (RR 2.25, 95% CI [0.98, 5.17], p = 0.06).
Why it matters
Tesamorelin reduces central adiposity, waist circumference, and trunk fat while preserving or building lean mass in people living with HIV-associated lipodystrophy.
Limits
The analysis included only 4 RCTs with 909 total participants. The primary outcome of visceral adipose tissue reduction showed substantial heterogeneity (I² = 74%), and units were not specified in the abstract. Data regarding long-term safety, optimal dosing, effect durability after discontinuation, and patient-reported outcomes remain limited.
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