Tesamorelin in Women with HIV-Associated Lipodystrophy
Tesamorelin is indicated for reducing excess visceral abdominal fat in women with HIV-associated lipodystrophy, as it is the first and only FDA-approved treatment specifically for this condition, with demonstrated efficacy in reducing visceral adipose tissue (VAT) by 26 weeks of therapy. 1, 2, 3
Primary Indication and Mechanism
Tesamorelin is a synthetic growth hormone-releasing hormone analog that stimulates endogenous growth hormone synthesis and release, specifically targeting visceral fat accumulation in HIV-infected patients on antiretroviral therapy 2, 3
HIV-associated lipodystrophy affects 25-75% of patients on antiretroviral therapy, with fat accumulation commonly occurring in the abdomen, dorsocervical fat pad, and breasts in both men and women 4, 5
Prior to tesamorelin's approval, no clearly effective therapy existed for HIV-associated fat accumulation 4, 1
Treatment Efficacy in Women
Tesamorelin significantly reduces visceral adipose tissue without clinically significant effects on subcutaneous adipose tissue, as demonstrated in two well-designed 26-week clinical trials 2, 3
VAT reduction is maintained through 52 weeks in patients who continue therapy, but discontinuation results in reaccumulation of visceral fat 2, 3
Additional benefits include significant improvements in trunk fat, waist circumference, and body image parameters (particularly belly image distress) 2, 3, 6
Predictors of Treatment Response
Women with metabolic syndrome (NCEP criteria), triglyceride levels >1.7 mmol/L, or white race are most likely to experience VAT reductions after 6 months of treatment 7
The odds of achieving VAT <140 cm² (a threshold associated with lower cardiovascular risk) are 3.9 times greater with tesamorelin compared to placebo 7
Response assessment should occur at 6 months, as no reliable predictive factors have been identified at 3 months 7
Monitoring Requirements
The CDC recommends monitoring lipid panels (triglycerides, cholesterol, HDL) for metabolic improvements during tesamorelin therapy 1, 8
Baseline assessment should include VAT measurement, metabolic syndrome criteria, and lipid panel 7
Monitor for glucose tolerance changes, as HIV-associated lipodystrophy is associated with glucose intolerance and insulin resistance 4, 5
Safety Profile
Tesamorelin is generally well tolerated, with treatment-emergent serious adverse events occurring in <4% of patients during 26 weeks 2, 3
Most common adverse events are injection-site reactions and growth hormone-related effects (arthralgia, headache, peripheral edema) 2, 3, 6
No adverse impact on blood glucose or lipid parameters was observed in extension studies through 52 weeks 6
Clinical Algorithm for Use
Confirm HIV-associated lipodystrophy with excess visceral abdominal fat (clinical examination and ideally VAT measurement) 2, 3
Assess baseline metabolic parameters: lipid panel, glucose tolerance, presence of metabolic syndrome 1, 7
Monitor lipid panels at regular intervals for metabolic improvements 1, 8
Assess treatment response at 6 months with VAT measurement and clinical parameters 7
Continue therapy if beneficial, as discontinuation leads to VAT reaccumulation 2, 3
Important Caveats
Tesamorelin does not address peripheral lipoatrophy (facial and extremity fat loss), which is a separate component of HIV-associated lipodystrophy 4
The medication requires daily subcutaneous injection, which may affect adherence 6
Cost considerations are significant, as this is a specialized biologic therapy 6
Women with baseline metabolic syndrome or elevated triglycerides are the best candidates for treatment response 7