DOI: 10.1177/23259582261475549 ISSN: 2325-9582

Efficacy and Safety of Tesamorelin in People Living With HIV (PLWH) With Lipodystrophy: A Systematic Review and Meta-Analysis

Aqsa Mohammed Ditta, Ruqaiya Muhammad Naeem, Muhammad Mohsin Sami, Muhammad Abdul Rafey, Hunain Ali, Muhammad Waqar Amjad, Fahad Jahangir, Kehan Ali Rizvi, Fatima Mohammad, Husam Abu Dawood, Muhammad Suleman, Muhammad Nabeel Saddique
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Background

HIV-associated lipodystrophy, a complication of combined antiretroviral therapy (CART), causes significant physical and psychological distress in people living with HIV (PLWH), compromising treatment adherence. Tesamorelin, a growth hormone-releasing hormone (GHRH) analogue, has emerged as a therapeutic option.

Objective

To systematically evaluate the efficacy and safety of tesamorelin in HIV-infected individuals with lipodystrophy receiving CART, incorporating GRADE assessment.

Methods

We searched PubMed, https://ClinicalTrials.gov , and Scopus from inception to February 9, 2026, for randomized controlled trials evaluating tesamorelin in HIV-associated lipodystrophy. Mean differences (MD) and risk ratios (RR) with 95% confidence intervals (CI) were calculated using random-effects models with heterogeneity assessed by I 2 .

Results

Four RCTs (909 patients) were included. Tesamorelin 2mg significantly reduced visceral adipose tissue (MD= -21.47, 95%CI[-34.73,-8.22],I 2 =74%,p=0.002), waist circumference (MD-1.61cm,95% CI[-2.28,-0.95],I 2 =0%,p<0.00001), trunk fat (MD-1.20kg, 95%CI[-1.47,-0.93],I 2 =0%,p<0.00001), and increased lean body mass (MD1.42kg,95% CI[1.13,1.71],I 2 =0%,p<0.00001). Modest lipid improvements occurred in total cholesterol (MD-0.16mmol/L,95%CI[-0.27,-0.06],I 2 =0%,p=0.003). Growth hormone-related adverse effects and higher discontinuation rates (RR2.25,95%CI[0.98,5.17],p=0.06) were observed.

Conclusions

Tesamorelin demonstrates efficacy in reducing visceral adiposity in PLWH with lipodystrophy on CART. However, limited data on long-term safety, optimal dosing strategies, and durability of treatment effects warrant caution. Future research should evaluate extended treatment duration, dose-response relationships, and patient-reported outcomes to establish comprehensive clinical utility.

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