26 Jan Synthetic Growth Hormone Releaser May Reduce Excess Abdominal Fat in HIV Patients
MedicalResearch.com Interview with:
Julian Falutz, MD
Director, HIV Metabolic Clinic MUHC,
Coordinator of Chronic Viral Illness Service, HIV and Aging Clinic
McGill University Health Center
Medical Research: What is the background for this study? What are the main findings?
Dr. Falutz: The long-term use of antiretroviral therapy (ART) in HIV-infected patients is associated with body composition changes, including visceral adipose tissue (VAT) accumulation. HIV-infected patients with excess VAT may be at increased risk of type 2 diabetes, cardiovascular diseases, and mortality.
Tesamorelin is a synthetic analog of human growth hormone-releasing factor, also known as growth hormone-releasing hormone (GHRH), which is indicated for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.
The objectives of our paper were to
1) evaluate the utility of patient characteristics and validated disease-risk scores, including indicator variables for the metabolic syndrome and the Framingham Risk Score (FRS), as predictors of visceral adipose tissue reduction during tesamorelin therapy, and
2) to explore the characteristics of patients who reached a threshold of VAT <140 cm2, a level associated with lower risk of adverse health outcomes, after 6 months of treatment with tesamorelin.
The basis of the report was a pooled analysis of the two pivotal, randomized Phase 3 trials of tesamorelin in 806 HIV-infected patients with excess abdominal fat. Our results indicate that presence of metabolic syndrome, high triglycerides, and white race are associated with a greater likelihood of responding to 6 months of tesamorelin treatment. The most robust response appears to be in subjects with VAT above 140 cm2, as well as those in the overweight range for body mass index (BMI) measures.
Medical Research: What should clinicians and patients take away from your report?
Dr. Falutz: Our results suggest that presence of metabolic syndrome and high triglycerides can be used by clinicians to identify patients who may be eligible for tesamorelin therapy. We also observed visceral adipose tissue (VAT) increased over the 6-month study period in placebo-treated patients who had metabolic syndrome or a high Framingham risk score. This observation is indicative of a trend for increasing visceral adipose tissue in the untreated, at-risk population.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Falutz: Although the relationship between visceral adiposity and cardiovascular risk is considered as a continuum, it would be interesting to determine if a clinical benefit can be achieved with any amount of visceral adipose tissue reduction in HIV-infected patients.
Alexandra Mangili, Julian Falutz, Jean-Claude Mamputu, Miganush Stepanians, Brooke Hayward. Predictors of Treatment Response to Tesamorelin, a Growth Hormone-Releasing Factor Analog, in HIV-Infected Patients with Excess Abdominal Fat. PLoS One. 2015 Oct 12;10(10):e0140358. doi: 10.1371/journal.pone.0140358. eCollection 2015.
Dr. Falutz: (2016). Synthetic Growth Hormone Releaser May Reduce Excess Abdominal Fat in HIV Patients