Tesamorelin Dosing for HIV-Associated Lipodystrophy
The recommended dose of tesamorelin is 2 mg administered subcutaneously once daily for the reduction of excess visceral adipose tissue in HIV-infected patients with lipodystrophy. 1, 2, 3
Standard Dosing Protocol
Administer 2 mg subcutaneously once daily as the established therapeutic dose for all patients with HIV-associated lipodystrophy and excess abdominal fat. 1, 2, 3
This dosing regimen has been validated in multiple Phase 3 clinical trials demonstrating significant reductions in visceral adipose tissue (VAT) over 26 weeks, with maintained benefits through 52 weeks of continuous therapy. 1, 2
Discontinuation of therapy results in reaccumulation of VAT, indicating the need for ongoing treatment to maintain therapeutic benefits. 1, 2
Patient Selection and Timing Considerations
Prioritize treatment of advanced HIV disease, opportunistic infections, malignancies, and wasting before initiating tesamorelin therapy. 4, 5
Patients with metabolic syndrome (defined by NCEP criteria) are significantly more likely to respond to tesamorelin, with the greatest reductions in VAT and triglycerides. 5, 6
Patients with baseline triglyceride levels >1.7 mmol/L (>150 mg/dL) demonstrate enhanced treatment response compared to those with normal triglycerides. 6
White race was associated with significantly better treatment response in clinical trials (interaction p-value 0.025). 6
Address HIV-associated wasting before treating lipodystrophy or dyslipidemia, as competing nutritional needs may limit treatment options. 4, 5
Glucose Monitoring Requirements
Monitor glucose levels vigilantly during treatment initiation, particularly in patients with pre-existing diabetes or glucose intolerance. 5
Expect transient early glucose elevation at 2 weeks (mean increase of 9 mg/dL in treatment group vs 2 mg/dL in placebo), but this effect stabilizes by 6 months with no significant difference from baseline. 5, 3
At 6 months, fasting glucose changes are not significantly different between tesamorelin and placebo groups (treatment effect 2 mg/dL, p=0.72). 3
The Endocrine Society emphasizes that glucose effects are transient and stabilize by 6 months, but heightened monitoring is essential during the first 2-4 weeks of therapy. 5
Expected Treatment Outcomes
VAT reduction averages approximately 34 cm² after 6 months of therapy compared to placebo (treatment effect -42 cm²). 3
Triglycerides decrease by approximately 37-50 mg/dL at 26-52 weeks. 5
Liver fat is reduced by a median of 2.0% (lipid to water percentage) compared to placebo, representing a net treatment effect of -2.9%. 3
The odds of achieving VAT <140 cm² (a threshold associated with lower cardiovascular risk) are 3.9 times greater with tesamorelin than placebo after controlling for baseline characteristics. 6
Monitoring Parameters
Monitor lipid panels (triglycerides, cholesterol, HDL) for metabolic improvements during therapy. 5, 7
Assess glucose tolerance changes, as HIV-associated lipodystrophy is inherently associated with glucose intolerance and insulin resistance. 7
Track body composition measures including waist circumference and trunk fat, which show significant improvements with therapy. 1, 2
Common Adverse Effects
Injection-site reactions are the most common adverse events. 1, 2
Growth hormone-related effects including arthralgia, headache, and peripheral edema occur but serious adverse events affect <4% of patients during 26 weeks of therapy. 1, 2
Treatment is generally well tolerated with a favorable safety profile in clinical trials extending to 52 weeks. 1, 2