Clinical Insights on HIV-Associated Visceral Fat Following FDA Approval of Tesamorelin F8
David Wohl, MD, discusses the complexities of diagnosing and the importance of managing ectopic fat in HIV patients.
The FDA has approved Theratechnologies’ supplemental Biologics License Application (sBLA) for EGRIFTA WR (Tesamorelin F8), a new formulation designed to treat excess visceral abdominal fat in adults with HIV-associated lipodystrophy. This version replaces EGRIFTA SV, reducing dosing frequency from daily to weekly reconstitution, improving patient convenience.
Tesamorelin F8 maintains bioequivalence to its predecessor while requiring less than half the injection volume. As a growth hormone-releasing factor (GHRF) analog, it stimulates endogenous growth hormone to decrease visceral adipose tissue. Reported side effects include arthralgia, injection site reactions, extremity pain, peripheral edema, and myalgia.
In our interview with David Wohl, MD, professor of medicine in the Division of Infectious Diseases at the University of North Carolina in Chapel Hill discussed the challenges of diagnosing and managing ectopic fat (EFA) in HIV patients.
"What we're talking about is deep down fat that is not the pinch-an-inch fat that many people get around their midsection. This is deeper down. It's around our organs and intestines, and there is fat there, and that kind of fat is different than the subcutaneous fat that we think of, that we pinch, and it's more metabolically active, and it has been associated with some adverse outcomes, including cardiovascular disease, type 2 diabetes, even cancers and all-cause mortality in general. So having a lot or excessive deep down fat is not good for anyone," Wohl explained.
He noted that HIV treatments used two decades ago contributed to this issue, "About 20 years ago, some of the medicines we were using to treat HIV, not currently, but in the past, would preferentially, for reasons we don't completely understand, cause an excess of deep down visceral adipose tissue or visceral fat. And so that is a concern. And we saw a lot of this big belly, like a basketball in your belly, where everything else was skinny because the medicines also wasted subcutaneous fat. So think of it like an apple with toothpicks sticking out for limbs. That's kind of the phenotype we're talking about."
Managing EFA in HIV patients differs from general adiposity treatment strategies. "Diet and exercise can get you kind of far, but it takes a lot, a lot of work and a lot of reduction in calories and weight loss, which, of course, we know is pretty challenging," Wohl explained.
He emphasized that reducing visceral fat without impacting subcutaneous fat is crucial, particularly in HIV patients. "Sometimes people lose weight, and they lose probably fat all over, but their faces get skinnier, and it could be almost disfiguring. And in HIV, we've seen that for quite a number of years, so we don't want to do anything that makes subcutaneous fat go away. So that's where Egrifta has come in, and we've been using Egrifta in some of our cases to try to reduce that waist circumference and that visceral adiposity."
While Egrifta may be an option for some patients, Wohl stressed the importance of a holistic approach. "This is really filling a need for a very specific type of problem. We talk about BMI as being an indicator. It turns out BMI is not very good for telling you whether or not someone has visceral adiposity. So you could have a big BMI but not have a whole lot of visceral adiposity, and you could be skinnier and your BMI is lower."
He suggested that waist circumference might be a more practical metric for identifying VAT. "Now, I wear a stethoscope. I don't have a tape measure. Maybe we should be carrying tape measures a little bit more often with us in clinic."
