Tesamorelin Dosing for HIV-Associated Lipodystrophy
The recommended dosage of tesamorelin for HIV-associated lipodystrophy is 2 mg administered subcutaneously once daily. This dosing regimen has been validated in large-scale clinical trials and represents the only FDA-approved treatment specifically indicated for reducing excess visceral abdominal fat in this population 1, 2, 3, 4.
Standard Dosing Protocol
- Dose: 2 mg subcutaneously once daily 1, 4
- Route: Subcutaneous injection 1, 2, 3
- Timing: Daily administration without dose escalation or titration required 1
- Duration: Treatment effects are maintained with continuous therapy; discontinuation results in reaccumulation of visceral adipose tissue (VAT) 1, 2, 3
Expected Treatment Response
Visceral fat reduction becomes evident by 26 weeks and is maintained through 52 weeks of continuous therapy:
- VAT decreases by approximately 15-24% at 26 weeks compared to placebo 1, 4
- At 52 weeks, patients maintaining therapy show sustained VAT reduction of approximately 17.5% from baseline 1
- Subcutaneous adipose tissue is preserved (no clinically significant changes) 1, 2, 3
- Waist circumference decreases by approximately 3.4 cm at 52 weeks 1
Metabolic Monitoring Requirements
The Centers for Disease Control and Prevention recommends monitoring lipid panels (triglycerides, cholesterol, HDL) for metabolic improvements during tesamorelin therapy 5:
- Triglycerides decrease by approximately 37-50 mg/dL at 26-52 weeks 1, 4
- Total cholesterol to HDL ratio improves significantly (decrease of 0.18-0.31) 1, 4
- IGF-I levels increase by approximately 81-108% (expected pharmacologic effect) 1, 4
- Glucose parameters should be monitored, though no clinically meaningful changes were observed in trials 1
Predictors of Treatment Response
Patients with metabolic syndrome (NCEP criteria), elevated triglycerides >1.7 mmol/L, or white race show the greatest likelihood of VAT reduction after 6 months 6:
- The odds of achieving VAT <140 cm² (a threshold associated with lower cardiovascular risk) are 3.9 times greater with tesamorelin versus placebo 6
- No reliable predictive factors exist at 3 months; response assessment should occur at 6 months 6
Critical Treatment Considerations
Discontinuation results in rapid reaccumulation of visceral fat:
- Patients who stopped tesamorelin during extension phases experienced VAT reaccumulation 1, 2, 3
- This necessitates continuous therapy for sustained benefit 1
Common adverse events (generally well-tolerated):
- Injection-site reactions are most common 2, 3
- Growth hormone-related effects include arthralgia, headache, and peripheral edema 2, 3
- Treatment-emergent serious adverse events occurred in <4% of patients at 26 weeks 2, 3
- Withdrawal rates due to adverse events were higher in the tesamorelin group compared to placebo 4
Clinical Context
Prior to tesamorelin's approval, no clearly effective therapy existed for HIV-associated fat accumulation 7, 5, 8. The prevalence of HIV-associated lipodystrophy ranges from 25-75% in patients on antiretroviral therapy, with fat accumulation commonly affecting the abdomen, dorsocervical fat pad, and breasts 8. This condition is associated with metabolic abnormalities including dyslipidemias and glucose intolerance 8.