Tesamorelin Dosing for HIV-Associated Lipodystrophy
Administer tesamorelin 2 mg subcutaneously once daily for the reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy. 1, 2, 3
Standard Dosing Protocol
The recommended dose is 2 mg administered subcutaneously once daily, which has been validated in large phase 3 trials involving over 800 patients. 3, 4
This dosing regimen produces a clinically significant 15-24% reduction in visceral adipose tissue (VAT) at 26 weeks compared to placebo. 3, 4
Treatment must be continued long-term to maintain benefits—discontinuation results in reaccumulation of visceral fat. 1, 2
Expected Treatment Response Timeline
Significant VAT reduction becomes evident at 6 months (26 weeks), with mean decreases of approximately 24 cm² in visceral adipose tissue. 3
At 52 weeks of continuous therapy, VAT reductions are maintained at approximately 35 cm² (-17.5%) from baseline. 3
No predictive factors for treatment response can be reliably identified at 3 months, so early discontinuation based on perceived lack of response should be avoided. 5
Patient Selection and Predictors of Response
Patients with metabolic syndrome (NCEP criteria), elevated triglycerides >1.7 mmol/L (>150 mg/dL), or white race demonstrate the greatest likelihood of VAT reduction after 6 months of therapy. 5
The odds of achieving VAT <140 cm² (a threshold associated with lower cardiovascular risk) are 3.9 times greater with tesamorelin compared to placebo. 5
Prior to tesamorelin's approval, no clearly effective therapy existed for HIV-associated fat accumulation, making this the only FDA-approved option for this indication. 6, 7
Metabolic Monitoring Requirements
Monitor lipid panels (triglycerides, total cholesterol, HDL cholesterol) for metabolic improvements during therapy, as recommended by the Centers for Disease Control and Prevention. 6, 8
Expect triglyceride reductions of 37-50 mg/dL at 26-52 weeks of treatment. 3, 4
The ratio of total cholesterol to HDL cholesterol improves significantly, decreasing by approximately 0.31 compared to an increase of 0.21 with placebo. 3, 4
Monitor glucose parameters (fasting glucose, insulin levels) at baseline and periodically, though clinically meaningful changes in glycemic control have not been observed in clinical trials. 3, 4
IGF-I levels increase substantially (approximately 81-108%) during treatment, which is expected with growth hormone-releasing factor therapy. 3, 4
Administration Technique
Administer as a subcutaneous injection daily, typically in the abdominal area. 1, 2
Injection-site reactions are the most common adverse events, occurring in a small percentage of patients. 1, 2
Common Pitfalls and Caveats
Do not expect significant changes in subcutaneous adipose tissue—tesamorelin specifically targets visceral fat, with minimal clinically significant effects on subcutaneous fat stores. 1, 2, 3
Competing priorities must be addressed first: interventions for advanced immunosuppression, opportunistic infections, malignancies, and HIV-associated wasting should take precedence before initiating lipodystrophy treatment. 9
Patients with advanced HIV disease and wasting should have their wasting addressed before their dyslipidemia or lipodystrophy. 9
Other adverse events associated with growth hormone therapy include arthralgia, headache, and peripheral edema, though serious adverse events occur in <4% of patients. 1, 2
Additional Body Composition Benefits
Significant improvements occur in trunk fat, waist circumference (approximately -3.4 cm at 52 weeks), and patient-reported body image parameters including belly appearance distress and belly profile ratings. 3, 4
These improvements in body image may enhance quality of life for patients experiencing distress from HIV-associated central fat accumulation. 1, 2