Egrifta (Tesamorelin) Dosing for HIV-Associated Lipodystrophy
The recommended dose of Egrifta (tesamorelin) is 2 mg administered subcutaneously once daily for ongoing treatment of excess abdominal fat in HIV-infected patients with lipodystrophy. 1, 2
Dosing Regimen
- Standard dose: 2 mg subcutaneously once daily 1, 2
- Route: Subcutaneous injection into the abdomen 1, 2
- Timing: Administered daily, typically at the same time each day 1, 2
Treatment Duration and Response Assessment
Treatment should be continued long-term as discontinuation results in reaccumulation of visceral adipose tissue (VAT). 1, 2
Expected Timeline for Response:
- Initial assessment at 3 months: Evaluate for reduction in VAT, though predictive factors for response are not reliably identified at this timepoint 3
- Definitive assessment at 6 months: By 26 weeks, significant reductions in VAT should be evident if the patient is responding to therapy 1, 2, 3
- Long-term maintenance: Patients who continued treatment to 52 weeks maintained VAT reduction, while those who discontinued experienced VAT reaccumulation 1, 2
Predictors of Better Response:
Patients most likely to achieve significant VAT reduction at 6 months include those with: 3
- Presence of metabolic syndrome (NCEP criteria)
- Elevated triglyceride levels (>1.7 mmol/L)
- White race
Treatment Goals:
- Primary goal: Reduction of VAT to <140 cm², a threshold associated with lower risk of adverse health outcomes 3
- Patients treated with tesamorelin have 3.9 times greater odds of achieving VAT <140 cm² compared to placebo (95% CI 2.03-7.44) 3
Common Pitfalls and Monitoring
Most adverse events are injection-site reactions and growth hormone-related effects. 1, 2
Expected Adverse Effects:
- Injection-site reactions (most common) 1, 2
- Arthralgia 1, 2
- Headache 1, 2
- Peripheral edema 1, 2
- Treatment-emergent serious adverse events occurred in <4% of patients during 26 weeks 1, 2
Critical Monitoring Parameters:
- Glucose metabolism: Monitor glucose and insulin levels, as tesamorelin increases IGF-1 and could theoretically affect glucose homeostasis, though clinical trials showed no significant changes 4
- Body composition changes: Assess trunk fat, waist circumference, and patient-reported body image parameters 1, 2
- Lipid levels: Monitor triglycerides and other lipid parameters 4
Clinical Efficacy Expectations
Tesamorelin selectively reduces visceral fat without significantly affecting subcutaneous fat. 1, 2
Expected Body Composition Changes:
- Significant reduction in VAT (approximately -19.2 cm² vs +2.3 cm² with placebo) 4
- Increased lean body mass (approximately +0.9 kg vs -0.3 kg with placebo) 4
- Decreased trunk fat (-0.4 kg vs +0.2 kg with placebo) 4
- Improved trunk-to-lower extremity fat ratio 4
- Improved visceral-to-subcutaneous abdominal fat ratio 4
- No clinically significant effect on subcutaneous adipose tissue 1, 2
Patient-Reported Outcomes:
- Improvements in body image parameters, particularly belly image distress 1, 2
- Improvements in physician and patient ratings of lipodystrophy in arms, legs, and abdomen 4
Important Clinical Considerations
Tesamorelin works by stimulating endogenous growth hormone release through IGF-1 pathway activation. 1, 2, 4
- Mean IGF-1 concentrations increase significantly (approximately +104 ng/mL vs +6 ng/mL with placebo, p=0.004) 4
- This mechanism explains both the efficacy and the growth hormone-related adverse effects 1, 2, 4
- The medication is generally well tolerated with a favorable safety profile in clinical trials 1, 2
Discontinuation of therapy results in loss of benefits, making this a long-term commitment for patients who respond to treatment 1, 2