Tesamorelin for HIV-Associated Lipodystrophy
Tesamorelin is the first and only FDA-approved treatment specifically indicated for reducing excess visceral abdominal fat in HIV-infected adults with lipodystrophy, and should be considered for patients with metabolic syndrome, elevated triglycerides, or white race who are most likely to respond. 1, 2, 3, 4
Clinical Context and Indication
HIV-associated lipodystrophy affects 25-75% of patients on antiretroviral therapy, with fat accumulation commonly occurring in the abdomen, dorsocervical fat pad, and breasts. 1, 2 Prior to tesamorelin's approval, no clearly effective therapy existed for HIV-associated visceral fat accumulation. 1, 2
Mechanism and Efficacy
Tesamorelin is a synthetic analogue of human growth hormone-releasing hormone that stimulates endogenous growth hormone synthesis and release. 3, 5 The drug specifically reduces visceral adipose tissue (VAT) without significantly affecting subcutaneous adipose tissue. 3, 5
Expected Treatment Outcomes:
- VAT reduction is maintained through 52 weeks of continuous therapy 3, 5
- Discontinuation results in reaccumulation of VAT, requiring ongoing treatment 3, 5
- Additional improvements include trunk fat reduction, decreased waist circumference, and improved body image parameters 3, 5
- Systematic review data shows mean VAT reduction of 25.20 cm² compared to placebo 6
Patient Selection: Who Responds Best
The strongest predictors of treatment response at 6 months are: 4
- Presence of metabolic syndrome (NCEP criteria)
- Triglyceride levels >1.7 mmol/L (>150 mg/dL)
- White race
Women with metabolic syndrome or elevated triglycerides are particularly good candidates for treatment response. 1
Target Population Achievement:
Patients treated with tesamorelin have 3.9 times greater odds of achieving VAT <140 cm² (a threshold associated with lower cardiovascular risk) compared to placebo (95% CI 2.03-7.44). 4
Monitoring Requirements
Monitor the following parameters during tesamorelin therapy: 1
- Lipid panel (triglycerides, cholesterol, HDL) for metabolic improvements
- Glucose tolerance given the association between lipodystrophy and insulin resistance
- Weight and BMI every 6 months for patients on concurrent antiretroviral therapy 7
Dosing and Administration
Subcutaneous tesamorelin 2 mg daily is the established regimen based on Phase 3 trial data. 3, 5, 4
Safety Profile
Tesamorelin is generally well tolerated with treatment-emergent serious adverse events occurring in <4% of patients during 26 weeks of therapy. 3, 5
Common adverse effects include: 3, 5
- Injection-site reactions
- Arthralgia
- Headache
- Peripheral edema
These are consistent with growth hormone-related effects and are typically manageable. 3, 5
Critical Clinical Considerations
Do not expect subcutaneous fat reduction—tesamorelin specifically targets visceral adipose tissue, not subcutaneous fat deposits. 3, 5 This is an important counseling point for patients who may have expectations about lipoatrophy improvement.
Plan for long-term therapy—VAT reaccumulates upon discontinuation, so tesamorelin requires ongoing administration to maintain benefits. 3, 5 This has cost and adherence implications that should be discussed upfront.
Prioritize patients with metabolic risk factors—those with metabolic syndrome or elevated triglycerides derive the greatest benefit and may experience dual improvements in both body composition and metabolic parameters. 1, 4