What is the treatment for an adult HIV patient with lipodystrophy using Egrifta (tesamorelin)?

Tesamorelin (Egrifta) for HIV-Associated Lipodystrophy

Tesamorelin is administered as a 2 mg subcutaneous injection daily for the reduction of excess visceral abdominal fat in HIV patients with lipodystrophy, and represents the only FDA-approved pharmacologic therapy specifically indicated for this condition. 1, 2

Patient Selection and Timing

• Prioritize treatment of advanced immunosuppression, opportunistic infections, malignancies, and HIV-associated wasting before initiating tesamorelin therapy. 3
• Address wasting syndromes before treating lipodystrophy or dyslipidemia. 3
• Women with metabolic syndrome or elevated triglycerides are the best candidates for treatment response, showing more significant reductions in visceral adipose tissue and triglycerides. 2, 3

Administration Protocol

• Administer 2 mg subcutaneously daily as the standard dosing regimen. 4, 5, 6
• Tesamorelin stimulates endogenous growth hormone release rather than providing exogenous growth hormone directly. 4, 5
• Treatment must be continuous—discontinuation results in reaccumulation of visceral adipose tissue. 4, 5

Expected Clinical Outcomes

• Visceral adipose tissue (VAT) reduction occurs by 26 weeks and is maintained through 52 weeks with continued therapy. 4, 5, 6
• Triglycerides decrease by approximately 37-50 mg/dL at 26-52 weeks. 3
• Trunk fat and waist circumference show significant improvements. 4, 5, 6
• Subcutaneous adipose tissue is NOT significantly affected, so patients should not expect improvement in peripheral lipoatrophy. 4, 5
• Body image parameters, particularly belly image distress, improve with treatment. 4, 5, 6

Critical Monitoring Requirements

Glucose Monitoring (Most Important Safety Concern)

• Tesamorelin causes transient early glucose elevation that typically stabilizes by 6 months. 3
• Patients with pre-existing diabetes or glucose intolerance require particularly vigilant glucose monitoring during initiation. 3
• Monitor for development of glucose intolerance throughout treatment, as HIV-associated lipodystrophy itself is associated with insulin resistance. 1, 3

Metabolic Panel Monitoring

• Monitor lipid panels (triglycerides, cholesterol, HDL) for metabolic improvements during therapy. 2, 3
• Lipid improvements are part of the therapeutic benefit, particularly in patients with metabolic syndrome. 2, 3

Common Adverse Effects

• Injection-site reactions are the most frequent adverse events. 4, 5
• Growth hormone-related effects including arthralgia, headache, and peripheral edema occur but are generally manageable. 4, 5
• Treatment-emergent serious adverse events occur in <4% of patients during 26 weeks of therapy. 4, 5

Key Clinical Pitfalls

• Do not expect reversal of peripheral lipoatrophy—tesamorelin only reduces visceral fat, not subcutaneous fat loss in the face or extremities. 4, 5
• Do not discontinue therapy expecting maintained benefits—VAT reaccumulates upon cessation. 4, 5
• Do not initiate in patients with active malignancy or uncontrolled diabetes without careful risk-benefit assessment given growth hormone effects. 3
• Prior to tesamorelin's approval, no clearly effective pharmacologic therapy existed for HIV-associated fat accumulation, making this the definitive treatment option. 1, 2, 3