Theratechnologies CROI Presentation Highlights Limitations of Using BMI to Assess Cardiovascular (CV) Risk in People with HIV

MONTREAL, March 12, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, today presented data highlighting the limitations of using body mass index (BMI) alone in assessing cardiovascular (CV) risk in people with HIV (PWH). The study underscores the need to incorporate screening for excess visceral abdominal fat (EVAF) to better identify PWH at risk of CV disease.

In a poster presentation at the 2025 Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco, Calif., investigators from the Visceral Adiposity Measurement and Observation Study (VAMOS) characterized BMI as a poor independent surrogate for excess visceral adiposity and CV risk in PWH, particularly given the high CV risk observed in study participants with a normal or overweight BMI (“low BMI”) but high levels of EVAF. The investigators that EVAF is one of several risk factors that contribute to heightened CV risk in PWH who are on modern antiretroviral therapy (ART) regimens.

“There is abundant evidence of substantial weight gain and a high prevalence of obesity among people with HIV in the modern antiretroviral era,” commented lead VAMOS investigator Karam C. Mounzer, MD, Chief Scientific Officer at Philadelphia FIGHT Community Health Centers in Philadelphia, Pa. “Clinicians routinely use BMI as a marker to assess the risk of cardiovascular disease and other comorbidities in this population, but often overlook the importance of identifying excess visceral abdominal fat, or EVAF. Our findings not only suggest that relying solely on BMI underestimates cardiovascular risk but show a high prevalence of EVAF among patients with normal BMI which is an actual driver of such risk in people with HIV, that many clinicians fail to capture in their clinics.”

VAMOS is a cross-sectional, multicenter, observational study investigating the relationships between BMI, EVAF (defined as a visceral adipose tissue [VAT] surface area ≥130 cm²), and CV risk factors in 170 PWH who had attained virological suppression on ART for at least one year. The investigators compared 10-year atherosclerotic cardiovascular disease (ASCVD) risk scores across four distinct groups:

• Low BMI (20-29 kg/m²) without EVAF (VAT <130 cm²) (n=62)
• Low BMI with EVAF (VAT >130 cm²) (n = 52)
• High BMI (30-40 kg/m²) without EVAF (n = 10)
• High BMI with EVAF (n = 46)

Unsurprisingly, obese individuals (BMI 30-34.9 kg/m²) had the highest prevalence of EVAF (88%) in the study, followed by class II obese PWH (BMI 35-40 kg/m²; 69%). However, EVAF was still present in a substantial portion of PWH with normal BMI (20-25 kg/m²; 43%) and those classified as overweight (BMI 25-29.9 kg/m²; 47%).

Notably, PWH with EVAF had higher 10-year ASCVD risk scores than those without EVAF, irrespective of BMI (p=0.0019). Additionally, high levels of pericardial fat volume (PFV, fat within the heart muscle) were found predominantly in participants with high EVAF, compared to those with low EVAF levels (p <0.0001). In a related finding, VAT area was more strongly correlated with PFV (Spearman r value = 0.73; p <0.0001) than with subcutaneous fat area (Spearman r = 0.2; p = 0.0109).

“In addition to providing a predictive estimate of cardiovascular risk, the VAMOS findings show a substantial, real-time impact of fat in the body, as evidenced by the levels of pericardial fat volume,” noted Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer of Theratechnologies. “The results also underscore that if healthcare providers focus solely on BMI, a sizeable population of normal-weight and overweight individuals with HIV and EVAF will be missed. We hope this study encourages the use of simple and more precise tools for assessing EVAF, such as measuring waist circumference, as a proven means of identifying people with HIV who are at risk of cardiovascular disease.”

About Theratechnologies

Theratechnologies (TSX: TH) (NASDAQ: THTX) is a specialty biopharmaceutical company focused on the commercialization of innovative therapies that have the potential to redefine standards of care. Further information about Theratechnologies is available on the Company's website at , on SEDAR+ at  and on EDGAR at . Follow Theratechnologies on  and .

Forward-Looking Information

This press release contains forward-looking statements and forward-looking information (collectively, the “Forward-Looking Statements”), within the meaning of applicable securities laws, that are based on our management’s beliefs and assumptions and on information currently available to our management. You can identify Forward-Looking Statements by terms such as "may", "will", "should", "could", “promising”, “would”, "outlook", "believe", "plan", "envisage", "anticipate", "expect" and "estimate", or the negatives of these terms, or variations of them. The Forward-Looking Statements contained in this press release include, but are not limited to, statements regarding the use of tools to measure EVAF, such as waist circumference. Forward-looking statements involve a number of assumptions, risks and uncertainties. Some of these assumptions include, but are not limited to, the fact that healthcare providers will rely on the data and evidence presented for screening for EVAF to better identify PWH at risk of CV disease. The Company refers current and potential investors to the “Risk Factors” section of the Company’s Annual Information Form filed on Form 20-F dated February 26, 2025 available on SEDAR+ at  and on EDGAR at  under Theratechnologies’ public filings for the risks associated with the business of Theratechnologies. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-Looking Statements reflect current expectations regarding future events and speak only as of the date of this press release and represent the Company’s expectations as of that date.

The Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.

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