Tesamorelin Dosing for HIV-Associated Lipodystrophy
The recommended dosage of tesamorelin is 2 mg administered subcutaneously once daily for the reduction of excess abdominal fat in adults with HIV-associated lipodystrophy. 1, 2, 3
Standard Dosing Protocol
Administer 2 mg subcutaneously once daily, which has been validated in large-scale randomized controlled trials involving over 800 patients and represents the only FDA-approved dosing regimen for this indication. 3
The subcutaneous injection should be given daily, with treatment effects becoming evident by 26 weeks and maintained through 52 weeks of continuous therapy. 3
Discontinuation of therapy results in reaccumulation of visceral adipose tissue, making continuous daily administration necessary to maintain therapeutic benefits. 1, 2
Expected Clinical Outcomes with Standard Dosing
At 26 weeks, expect a mean reduction in visceral adipose tissue (VAT) of approximately 24 cm² compared to baseline, representing a treatment effect of -15.4% versus placebo. 3
By 52 weeks of continuous therapy, VAT reduction increases to approximately 35 cm² (-17.5%), with concurrent improvements in waist circumference (-3.4 cm) and triglycerides (-48 mg/dL). 3
Subcutaneous adipose tissue remains largely unaffected, with no clinically significant changes observed at standard dosing. 1, 2, 3
Patient Selection and Predictive Factors
Patients with metabolic syndrome (NCEP criteria), elevated triglycerides >1.7 mmol/L, or white race demonstrate the highest likelihood of treatment response at 6 months of therapy. 4
The odds of achieving VAT reduction to <140 cm² (a threshold associated with lower cardiovascular risk) are 3.9 times greater with tesamorelin versus placebo after controlling for baseline characteristics. 4
Prioritize treating lipodystrophy only after addressing advanced immunosuppression, opportunistic infections, malignancies, and HIV-associated wasting, as these conditions take precedence during initial HIV management. 5
Monitoring Requirements During Therapy
Initiate vigilant glucose monitoring, particularly in patients with pre-existing diabetes or glucose intolerance, as tesamorelin causes transient early glucose elevation that typically stabilizes by 6 months. 5
Monitor lipid panels (triglycerides, cholesterol, HDL) for metabolic improvements, with expected triglyceride reductions of 37-50 mg/dL at 26-52 weeks. 6, 5, 3
Track IGF-1 levels, which increase by approximately 108 ng/mL with treatment, as this reflects the growth hormone-mediated mechanism of action. 3
Assess body composition changes and patient-reported outcomes including belly appearance distress and belly profile ratings at regular intervals. 3
Safety Profile and Common Adverse Events
Treatment-emergent serious adverse events occur in <4% of patients during 26 weeks of therapy at the 2 mg daily dose. 1, 2
Most common adverse events include injection-site reactions (erythema), arthralgia, myalgia, paresthesia, headache, and peripheral edema, all consistent with growth hormone-related effects. 1, 2, 7
No clinically meaningful differences in glucose parameters occur at 26 and 52 weeks despite transient early elevations, and no significant perturbation of CD4+ T-cell counts has been observed. 3, 7
Clinical Context and Treatment Rationale
HIV-associated lipodystrophy affects 25-75% of patients on antiretroviral therapy, with fat accumulation increasing in prevalence with longer treatment duration. 8, 9, 6
Prior to tesamorelin's approval, no clearly effective therapy existed for HIV-associated fat accumulation, with class switching or discontinuation of antiretrovirals showing minimal benefit. 8, 9, 6
Tesamorelin represents the first and only FDA-approved treatment specifically indicated for reduction of excess abdominal fat in this population. 1, 2