What is the recommended treatment and dosage of Tesamorelin (growth hormone-releasing factor) for HIV-associated lipodystrophy?

Tesamorelin for HIV-Associated Lipodystrophy

Tesamorelin 2 mg administered subcutaneously once daily is the recommended treatment for HIV-associated lipodystrophy with excess abdominal fat, as it significantly reduces visceral adipose tissue by approximately 15% after 26 weeks of treatment. 1, 2

Mechanism and Indication

• Tesamorelin is a synthetic analogue of human growth hormone-releasing hormone (GHRH) that stimulates the synthesis and release of endogenous growth hormone 3
• It is the first and only FDA-approved treatment specifically indicated for the reduction of excess abdominal fat in patients with HIV-associated lipodystrophy 3, 4

Dosage and Administration

• The recommended dosage is 2 mg administered as a subcutaneous injection once daily 2
• Treatment should be continued daily as discontinuation results in reaccumulation of visceral adipose tissue (VAT) 3
• Injections should be administered in the abdomen, rotating injection sites to minimize local reactions 2

Efficacy

• Tesamorelin reduces visceral adipose tissue (VAT) by approximately 15% after 26 weeks of treatment 1
• The treatment does not significantly affect subcutaneous adipose tissue, preserving this compartment 2
• Continued treatment for 52 weeks maintains VAT reduction (-17.5%) 2
• Patients have approximately 3.9 times greater odds of achieving VAT <140 cm² (a level associated with lower health risks) compared to placebo 5

Metabolic Benefits

• Treatment with tesamorelin is associated with significant improvements in:
  • Triglyceride levels (decrease of approximately 50 mg/dL) 1
  • Total cholesterol to HDL cholesterol ratio (decrease of 0.31) 1
  • Overall lipid profile 2

Patient Selection and Response Predictors

• Patients most likely to respond to tesamorelin after 6 months include:
  • Those with metabolic syndrome as defined by NCEP criteria 5
  • Patients with elevated triglyceride levels >1.7 mmol/L 5
  • White race patients 5

Monitoring

• Baseline and follow-up assessment of:
  • Visceral adipose tissue (ideally by CT scan) 1
  • Lipid parameters including triglycerides, total cholesterol, and HDL 2
  • Glucose parameters (fasting glucose, insulin) 2
  • IGF-I levels 2

Safety and Adverse Effects

• Tesamorelin is generally well tolerated with treatment-emergent serious adverse events occurring in <4% of patients during 26 weeks of therapy 3
• Common adverse events include:
  • Injection site reactions 3
  • Arthralgia, headache, and peripheral edema 3
• No clinically meaningful changes in glucose parameters were observed at 26 and 52 weeks 2

Important Considerations

• Treatment is continuous - discontinuation leads to reaccumulation of VAT 3
• Prior to tesamorelin, no clearly effective therapy for fat accumulation in HIV-associated lipodystrophy was available 4
• HIV-associated lipodystrophy affects approximately 25-75% of patients on antiretroviral therapy, with prevalence increasing with treatment duration 4