Limited · human
This case report describes two adults living with well-controlled HIV-1 who presented with excess visceral abdominal fat (EVAF) under distinct clinical phenotypes. The first patient had a non-obese visceral adiposity phenotype (BMI 27 kg/m²) with increased waist circumference; treatment with tesamorelin, a growth hormone-releasing hormone analog, was associated with reductions in waist circumference, improved lipid levels, and enhanced functional well-being. The second patient had obesity (higher BMI) and received a GLP-1 receptor agonist; intermittent medication access led to fluctuating weight and persistent abdominal fat, after which the addition of tesamorelin was reported to provide more targeted visceral fat reduction. The authors argue that EVAF in people living with HIV can occur across BMI categories and may not be adequately captured by weight-based assessments alone. They conclude that individualized management informed by fat distribution patterns—rather than BMI or weight—is warranted. Key limitations include the single case-report design (n=2), absence of a control condition, lack of imaging-based visceral fat quantification reporting, and inability to draw generalizable conclusions about comparative efficacy.
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · May 2026DOI ↗ Limited · human
This 6-month phase 2 randomized open-label clinical trial investigated whether tesamorelin, a growth hormone-releasing hormone analog, could improve neurocognitive impairment (NCI) in people with HIV who were virally suppressed on antiretroviral therapy and had abdominal obesity (elevated waist circumference). Seventy-three participants were randomized 3:2 to tesamorelin or standard of care (SOC). The primary outcome was change in neurocognitive performance at 6 months; secondary outcomes included waist circumference, mood, and daily functioning. The tesamorelin group showed a non-significant trend toward improved neurocognitive performance (mean change 0.146; P=.060), while the SOC group did not improve (P=.295); crucially, the between-group difference was not statistically significant (P=.673). Tesamorelin did produce a significantly greater reduction in waist circumference versus SOC (median difference −2.7 cm; P=.015). IGF-1 levels rose in the tesamorelin group but did not correlate with cognitive or waist circumference changes. Key limitations include an open-label (non-placebo-controlled) design, modest sample size resulting in insufficient statistical power, and the relatively short 6-month follow-up. The authors concluded there was no clear cognitive benefit from short-term abdominal obesity reduction with tesamorelin in this population.
The Journal of infectious diseases · Jun 2025DOI ↗ Limited · human
This retrospective pharmacovigilance study examined whether specific drugs are disproportionately associated with carpal tunnel syndrome (CTS) reports in the FDA Adverse Event Reporting System (FAERS) database between October 2003 and September 2024. Using OpenVigil 2.1, researchers applied disproportionality analysis—primarily reporting odds ratios (RORs)—supplemented by Bayesian confidence propagation neural network algorithms to identify significant drug-CTS signals. Out of nearly 13 million adverse event reports, 6,837 (0.05%) involved CTS, with female patients comprising 69.5% of cases and a mean age of 57 years. Ten drugs showed strong, statistically significant associations with CTS reports: enzyme replacement therapies (idursulfase, galsulfase, laronidase), the growth hormone-releasing factor analog tesamorelin, the aromatase inhibitor anastrozole, bisphosphonates (alendronic acid, alendronate), gamma-hydroxybutyric acid (GHB), the COX-2 inhibitor rofecoxib, and the transthyretin stabilizer tafamidis. The study's key limitations include its reliance on spontaneous reports (subject to underreporting, reporting bias, and confounding), an inability to establish causality, and lack of exposure-denominator data. The authors conclude that clinicians should be alert to CTS symptoms in patients prescribed these medications.
Limited · human
This sub-analysis leveraged a randomized, double-blind, placebo-controlled trial of 61 people with HIV (PWH) and metabolic dysfunction-associated steatotic liver disease to assess whether tesamorelin remains effective and safe among those specifically on integrase inhibitor (INSTI)-based antiretroviral regimens. Of 38 participants on INSTIs at baseline, 15 (tesamorelin) and 16 (placebo) completed 12 months of follow-up. The study used MRI, proton MR spectroscopy, and DEXA to quantify visceral fat area, hepatic fat fraction, and trunk-to-appendicular fat ratio. The tesamorelin group showed statistically significant reductions in all three body composition endpoints compared to placebo. Metabolic safety outcomes, including rates of hyperglycemia, were similar between arms, and the drug was generally well tolerated. The authors note this is the first dataset specifically addressing tesamorelin use in PWH on INSTI-based regimens—an important gap given that phase III approval trials predated widespread INSTI use. Key limitations include the small sub-group sample size, the sub-analysis design (not powered for this specific comparison), and the predominantly research-selected population, which may limit generalizability.
AIDS (London, England) · Jun 2024DOI ↗ Limited · human
This study developed and validated a unified chromatographic-mass spectrometric (LC-MS) method for detecting a broad range of prohibited peptide drugs (molecular mass 2–10 kDa) in doping control urine samples. The target analytes spanned five categories: insulins (human and animal-derived, including several analogues and a metabolite), growth hormone-releasing hormones (GHRHs) and their metabolites, insulin-like growth factors (IGF variants), synacthen, gonadorelin, and mechano growth factors. A key goal was simplifying sample preparation by consolidating what are traditionally separate, complex analytical workflows into a single procedure, controlled by five internal standards—one per peptide category. The method was validated as an initial testing procedure and shown to meet nearly all World Anti-Doping Agency (WADA) Minimum Required Performance Levels (MRPLs). As a proof of principle, the method was applied to authentic post-administration urine samples from human subjects dosed with insulins and gonadorelin, demonstrating real-world detection capability. Limitations include that human subject data are limited to proof-of-concept post-administration samples rather than a controlled efficacy or pharmacological trial, and the study's primary focus is analytical method development rather than clinical outcomes.
Journal of mass spectrometry : JMS · Jan 2024DOI ↗ Limited · human
This study investigated a method for detecting a broad range of peptide-based doping agents (molecular mass 2–10 kDa) in blood samples collected for anti-doping control purposes. Researchers developed a simplified, generic sample preparation workflow using mixed-mode solid-phase extraction (SPE), coupled with liquid chromatography and high-resolution mass spectrometry (HRMS; resolution >100,000 FWHM) as an initial testing procedure. The target analytes included multiple insulin variants (human and synthetic analogues such as lispro, aspart, glulisine, detemir, glargine, and others), growth hormone–releasing hormones (sermorelin, CJC-1295, tesamorelin), insulin-like growth factors (Long-R3-IGF-I, R3-IGF-I, Des1-3-IGF-I), and mechano growth factors. The study demonstrated that the method met WADA's Technical Document 2022 (TD2022 MRPL) requirements for minimum required performance levels. Proof-of-principle was shown using real post-administration blood samples from subjects treated with synthetic insulin analogues. A key advantage noted was that blood, unlike urine, contains intact peptide hormones at relatively higher concentrations, simplifying detection. Limitations include the study's primarily analytical/methodological scope and the small number of post-administration samples used for validation.
Analytical science advances · Aug 2022DOI ↗