Researchers conducted a post-hoc analysis of data from two phase 3 trials of tesamorelin in people with the virus. Those taking part were randomly given placebo or a 2mg dose subcutaneously for 26 weeks.
Analysing the 400 assigned to take tesamorelin, the investigators defined responders as those with a reduction of EVAF of at least 8%.
The five components evaluated and classified for metabolic syndrome by its five components – elevated waist circumference, high triglycerides, low HDL cholesterol, increased blood pressure and elevated fasting blood glucose.
The study found tesamorelin may improve metabolic rates after researchers reported an association between EVAF reduction and positive change in metabolic syndrome classification in people with HIV treated with tesamorelin.
Metabolic syndrome is a condition characterized by central adiposity, high levels of fasting blood glucose, high blood levels of triglycerides, low blood levels of high-density lipoprotein (HDL) cholesterol, and hypertension (high blood pressure).
There is an increased risk of cardiovascular disease, stroke and type 2 diabetes associated with metabolic syndrome. EVAF is an important component of central adiposity contributing to obesity-related disorders and is also associated with ectopic or abnormal fat accumulation in the liver, including non-alcoholic fatty liver disease (NAFLD).
Some individuals with liver fat can develop non-alcoholic steatohepatitis (NASH), an aggressive form of fatty liver disease, marked by liver inflammation that can progress to advanced scarring – cirrhosis – and liver failure.
“Our findings of EVAF reduction and reversal of metabolic syndrome classification following treatment with tesamorelin are consistent with previous data indicating an association between visceral fat reduction and improved metabolic profiles in PWHIV,” stated lead investigator Roger Bedimo.
“Given the relationship between EVAF and metabolic syndrome, these data appear to suggest that tesamorelin could improve metabolic profiles in individuals with HIV who have central adiposity.”
More than a third of participants had metabolic syndrome and the prevalence did not differ significantly between responders and non-responders. However, after the 26 weeks of tesamorelin treatment, the prevalence of metabolic syndrome decreased in responders, resulting in a significantly lower prevalence compared to non-responders.
The researchers noted: “While the overall prevalence of metabolic syndrome was lower than when evaluated, the positive tesamorelin treatment effect remained positive across both definitions. Differences in metabolic syndrome status were driven predominantly by resolution of triglycerides and waist circumference decrease.”
Tesamorelin, a stabilized synthetic peptide analogue of GHRH1–44 received US Food and Drug Administration (FDA) approval in 2010 for the treatment of lipodystrophy in HIV patients under highly active antiretroviral therapy and was investigated for effects on certain cognitive functions in adults with cognitive impairment and healthy older adults. It was first discovered in 1995.
Christian Marsolais, chief medical officer at Theratechnologies, said: “Since our scientists discovered tesamorelin in 1995, the development and use of this innovative treatment for lipodystrophy – specifically excess visceral abdominal fat in people with HIV. Given tesamorelin’s unique ability to target ectopic fat, these latest data bolster our confidence as we continue to explore its potential treatment as a treatment for NASH in the general population.”