Tesamorelin Peptide Injection

With the widespread adoption of antiretroviral therapy (ART), the survival period of people living with HIV (PLHIV) has been significantly prolonged, and the focus of disease management has gradually shifted to the prevention and control of ART-associated complications. HIV-associated lipodystrophy is one of the most common metabolic complications of ART, characterized primarily by abnormal fat distribution. It not only severely impairs patients' quality of life but also markedly increases the risk of adverse outcomes such as cardiovascular diseases and diabetes mellitus.Tesamorelin Peptide Injection as the first FDA-approved injectable growth hormone-releasing hormone (GHRH) analog for this condition, has emerged as a core first-line therapeutic agent for HIV-associated lipodystrophy due to its high targeting efficacy and favorable safety profile.

HIV-associated lipodystrophy is a syndrome of disordered fat metabolism caused by the combined effects of the HIV virus itself and ART medications. Its clinical phenotypes are heterogeneous, mainly categorized into fat accumulation (lipohypertrophy) and fat loss (lipoatrophy), with some patients presenting a mixed phenotype. Among these manifestations, excessive visceral adipose tissue (VAT) accumulation in the abdomen is the most representative. Patients often exhibit increased waist circumference, the clinical sign of "hard abdomen", and some may also have complications such as dorsocervical fat pad thickening (buffalo hump) and breast hypertrophy.

Compared with general obesity, the harms of HIV-associated lipodystrophy are more specific. Pathophysiological studies have demonstrated that visceral adipose tissue is not merely an energy storage organ; its excessive accumulation triggers chronic inflammatory responses, leading to metabolic disorders such as insulin resistance and dyslipidemia (hypertriglyceridemia and low high-density lipoprotein cholesterol). These abnormalities elevate the risk of cardiovascular diseases in PLHIV to more than twice that of the general population. Even in patients with well-suppressed viral load, excessive visceral fat accumulation is significantly positively correlated with the 10-year atherosclerotic cardiovascular disease risk score, making it a key factor limiting healthy aging in this population.

In a phase III double-blind, placebo-controlled study involving 410 PLHIV with HIV-associated abdominal fat accumulation, patients received a daily subcutaneous injection of 2mg it for 26 weeks. Results showed that visceral fat volume decreased significantly by 18% from baseline, compared with only a 2% reduction in the placebo group, with a statistically significant between-group difference (P<0.001). Further subgroup analyses indicated that it exerted consistent visceral fat-lowering effects regardless of whether patients had concurrent dorsocervical fat pad thickening. It also significantly reduced waist circumference and improved the sign of "hard abdomen", suggesting that its efficacy is not affected by specific patient phenotypes.

Long-term efficacy data are equally compelling.The 26-week extension trial of this study revealed that patients who continued it treatment for 52 weeks maintained a visceral fat volume reduction of over 18%. Additionally, their triglyceride levels decreased by 51mg/dl from baseline, total cholesterol levels improved significantly, and metabolic disorders were continuously corrected. In contrast, patients who discontinued treatment experienced rapid visceral fat reaccumulation, confirming the long-term therapeutic value of the drug. Furthermore, pooled analyses demonstrated that it treatment significantly reduced patients' 10-year atherosclerotic cardiovascular disease risk score, providing long-term protection for cardiovascular health.

In terms of indication screening, the clear indications are: adult PLHIV with confirmed excessive visceral fat accumulation via imaging examinations (such as CT or MRI), accompanied by lipodystrophy-related symptoms (e.g., increased waist circumference, metabolic abnormalities), and exclusion of contraindications including pituitary diseases, active tumors, and pregnancy. It should be noted that the core function of this drug is to reduce visceral fat rather than induce systemic weight loss, and thus it is not indicated for PLHIV with simple overweight.

The administration regimen is highly standardized and convenient. The recommended dosage is 2mg per day, administered via subcutaneous injection. The preferred injection site is the periumbilical abdominal area (avoiding the umbilicus, scars, and inflamed areas), and injection sites must be rotated daily to reduce the risk of local reactions. The drug is supplied as a lyophilized powder formulation, which needs to be reconstituted with dedicated sterile water for injection before use. During reconstitution, the ampoule should be gently rolled to dissolve the powder, avoiding vigorous shaking. The reconstituted solution must be clear, colorless, and free of particles before immediate administration.

With HIV treatment entering the era of "functional cure", the long-term quality of life and chronic complication management of patients have become the core focus of clinical practice. The product, with its unique advantages of injectable dosage form (precise drug delivery, adaptation to physiological rhythm), targeted fat-reducing mechanism, and good safety profile, provides an effective therapeutic option for HIV-associated lipodystrophy, significantly filling the gap in clinical treatment. It not only reduces visceral fat, ameliorates metabolic disorders, and lowers the risk of cardiovascular diseases but also improves patients' psychological status and treatment adherence by enhancing their physical appearance, achieving dual physical and psychological benefits.