Recognizing Excess Visceral Abdominal Fat (EVAF)

With advancements in antiretroviral therapy (ART), PWH now enjoy the same life expectancy as those without the virus, making long-term health management a priority.

However, even in the era of modern ART, studies show that the condition of central adiposity remains a common side effect.1

Central adiposity refers to the localized accumulation of both subcutaneous and visceral adipose tissue (VAT) in and around the abdomen. In PWH, this is often characterized by EVAF.

EVAF is an abnormal buildup of VAT within the abdominal cavity surrounding the internal organs.2

EVAF remains a prevalent condition among PWH on modern ART3

Studies show that up to 60% of PWH on modern ART with virological suppression for over a year were found to have EVAF.3*

* Based on a multi-center observational study in PWH.3

EVAF is associated with the development of various non-AIDS comorbidities

EGRIFTA WRTM is not approved for use in clinical conditions other than the reduction of EVAF.

Recent findings also indicate that a larger VAT surface area is linked to a significantly higher 10-year ASCVD risk.3†

Watch the video to learn more about the mechanism that drives the pathology of EVAF

The location and type of fat matters!

Subcutaneous Fat

CT scan of abdomen at L4

BMI

In typical obesity (BMI >30), weight is carried throughout the body and fat accumulates primarily as subcutaneous adipose tissue (SAT).8,9

Location

Just beneath the skin8,9

Visceral Abdominal Fat

In PWH, weight gain can occur irrespective of a high BMI and is characterized by the buildup of VAT.2,8

Visceral fat surface area in an actual patient. Surface area above 130 cm2 is indicative of lipohypertrophy.8

* Based on a multi-center observational study in PWH.10

CT scan of abdomen at L4

BMI

Poor indicator of EVAF as it is prevalent even in PWH with normal BMI, with rates of:10*

  • 43% in people with BMI 20-25 kg/m2 (normal weight)
  • 47% in people with high BMI 25-29.9 kg/m2 (overweight)

Explore steps to easily and accurately identify EVAF

Learn More

Location

Deep within the abdominal cavity, surrounding the internal organs2,8

Surface area: 155 cm2*

What causes EVAF?

While the exact causes behind developing EVAF remain unknown, there are several factors that can put the patient at increased risk, including:

HIV virus4,11

Duration of ART4,11

Chronic inflammation12

Age: >40 years old11

Assigned female at birth11

Altered growth hormone (GH) secretion3

Recent data highlight a strong correlation between disturbances in GH levels and VAT in PWH.3

Recognizing and diagnosing EVAF

Start identifying EVAF with this simple step:

Measure waist circumference (WC)2

Indicators for EVAF2‡§

Assigned male at birth

WC ≥37.4 in (95 cm)

Assigned female at birth

WC ≥37 in (94 cm)

Studies show that WC measurement is the most reliable predictor of EVAF, outperforming BMI.13

If WC meets the threshold for EVAF, proceed to measure hip circumference and calculate the waist-to-hip ratio (WHR).

Calculate your patient’s waist-to-hip ratio (WHR)†

Ensure both circumferences are entered with the same unit.

Further indicators for EVAF2‡§

Assigned male at birth

WHR ≥0.94

Assigned female at birth

WHR ≥0.88

Support doctor-patient conversations

Equip your patients with an informed approach to discussing EVAF and treatment with EGRIFTA WRTM

Learn about EGRIFTA WRTM and its unique MOA

Explore how EGRIFTA WRTM helps address the reduction in GH concentrations caused by EVAF

† Waist-to-hip ratio = waist circumference/hip circumference.
‡ Based on the Visceral Adiposity Measurement and Observations Study (VAMOS): a cross-sectional, multi-center observational study in PWH with ART-induced virological suppression for ≥1 year and a BMI range of 20 to 40 kg/m2.
§ Reference values are based on inclusion criteria in clinical trials.

ART = antiretroviral therapy; ASCVD = atherosclerotic cardiovascular disease; BMI = body mass index; CVD = cardiovascular disease; EVAF = excess visceral abdominal fat; GH = growth hormone; HC = hip circumference; MOA = mechanism of action; PWH = people with HIV; SAT = subcutaneous adipose tissue; VAT, visceral adipose tissue; WC = waist circumference; WHR = waist-to-hip ratio.

References:

  1. Koethe JR, et al. HIV and antiretroviral therapy-related fat alterations. Nat Rev Dis Primers. 2020;6(1):48.
  2. Lake JE, et al. Practical review of recognition and management of obesity and lipohypertrophy in human immunodeficiency virus infection. Clin Infect Dis. 2017;64(10):1422-1429.
  3. Mounzer K. Cardiovascular Risk Scores and Insulin Resistance are Higher with Excess Visceral Abdominal Fat in People with HIV in the Modern Antiretroviral (ART) Era. Presented at: IDWeek; October 16-19, 2024; Los Angeles, California.
  4. Lake JE. The Fat of the Matter: Obesity and Visceral Adiposity in Treated HIV Infection. Curr HIV/AIDS Rep. 2017;14(6):211-219.
  5. Cesaro A, et al. Visceral adipose tissue and residual cardiovascular risk: a pathological link and new therapeutic options. Front Cardiovasc Med. 2023;10:1187735.
  6. Wondmkun YT. Obesity, Insulin Resistance, and Type 2 Diabetes: Associations and Therapeutic Implications. Diabetes Metab Syndr Obes. 2020;13:3611-3616.
  7. Scherzer R, et al. Decreased limb muscle and increased central adiposity are associated with 5-year all-cause mortality in HIV infection. AIDS. 2011;25(11):1405-1414.
  8. Ibrahim MM. Subcutaneous and visceral adipose tissue: structural and functional differences. Obes Rev. 2010;11(1):11-18.
  9. National Heart Lung and Blood Institute. Assessing Your Weight and Health Risk. Available at: https://www.nhlbi.nih.gov/health/educational/lose_wt/risk.htm. Retrieved 18 December, 2024.
  10. Mounzer K, et al. BMI is a poor surrogate for excess visceral adiposity and cardiovascular risk in people with HIV (PWH) presented at: CROI 2025 Conference; March 9-12, 2025; San Francisco, California.
  11. Lichtenstein KA. Redefining lipodystrophy syndrome: risks and impact on clinical decision making. J Acquir Immune Defic Syndr. 2005;39(4):395-400.
  12. Guzman N, et al. HIV-Associated Lipodystrophy. StatPearls. Treasure Island (FL); 2024.
  13. Zogheib M., et al. Performance of Waist Circumference and Waist to Hip Ratio for Excess Visceral Abdominal Fat Screening in People with HIV in the Modern ART Era – Findings from the VAMOS STUDY. Presented at: IDWeek; October 16-19; Los Angeles, California.

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IMPORTANT SAFETY INFORMATION ABOUT EGRIFTA WRTM (TESAMORELIN) FOR INJECTION

Indication

EGRIFTA WRTM is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.

Limitations of Use:

  • The impact and safety of EGRIFTA WRTM on cardiovascular health has not been studied.
  • EGRIFTA WRTM is not indicated for weight loss management.
  • It is not known whether taking EGRIFTA WRTM helps improve compliance with anti-retroviral medications.

Contraindications:

Do not use EGRIFTA WRTM if patient:

  • Has a pituitary gland tumor, has had pituitary gland surgery, has other problems related to their pituitary gland, or has had radiation treatment to their head or a head injury.
  • Has active cancer.
  • Is allergic to tesamorelin or any of the ingredients in EGRIFTA WRTM.
  • Is pregnant or planning to become pregnant.

Warnings and Precautions

  • Increased risk of neoplasms: Preexisting malignancy should be inactive and its treatment complete prior to starting EGRIFTA WRTM. EGRIFTA WRTM should be discontinued if the patient has evidence of recurrent malignancy.
  • Elevated IGF-1: Regularly monitor IGF-1 levels in all patients during EGRIFTA WRTM therapy. Consider discontinuing in patients with persistent elevations (e.g., >3 SDS).
  • Fluid retention: May include edema, arthralgia, and carpal tunnel syndrome.
  • Glucose intolerance or diabetes mellitus: May develop with EGRIFTA WRTM treatment. Evaluate glucose status prior to and during therapy with EGRIFTA WRTM.
  • Hypersensitivity reactions: Advise patients to seek immediate medical attention if suspected.
  • Injection site reactions: Advise patients to rotate sites to different areas of the abdomen to decrease injection site reactions.
  • Increased mortality in patients with acute critical illness: Consider discontinuation in critically ill patients.

Drug Interactions

  • EGRIFTA WRTM had no significant impact on the pharmacokinetic profiles of simvastatin in healthy subjects.
  • Monitor patients for potential interactions when administering EGRIFTA WRTM in combination with other drugs known to be metabolized by CYP450 liver enzyme.
  • Patients on glucocorticoids may require dosage adjustment upon initiation of EGRIFTA WRTM.

Use in Specific Populations

  • Lactation: Mothers should not breastfeed if they receive EGRIFTA WRTM.
  • Pediatric use: Safety and effectiveness in pediatric patients have not been established.
  • Geriatric use: There is no information on the use of EGRIFTA WRTM in patients greater than 65 years of age.

Adverse Reactions

The most commonly reported adverse reactions include injection site reactions, arthralgia, pain in extremity, myalgia, and peripheral edema.

For complete disclosure of EGRIFTA WRTM product information, please read the Full Prescribing Information, Patient Information, and Patient Instructions for Use.

For more information about EGRIFTA WRTM, contact THERA patient support® program toll-free at 1-833-23THERA (1-833-238-4372). To report suspected adverse reactions, contact THERA patient support® program or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.