A Podcast Discussion With Daniel Berger, M.D.
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So is this drug most likely to be used by people who have been on treatment for a long period of time?
Yes, but there's strong evidence that both HIV infection as well as specific medications are associated with the problem. In fact, an early study showed that abdominal fat changes occurred in patients even before starting on treatment. Fat accumulation such as posterior or neck fat, or buffalo humps, have even been seen in people before they started on their medications.
We also know that there are a lot of host factors that are also associated with the problem and are probably independent of the type of medications that the person uses. So for example, if one is an older-aged individual, there are high rates of lipodystrophy. We often see more lipodystrophy in Caucasians as opposed to other races. Although both males and females can show either or any of the manifestations of lipodystrophy, females have a greater instance of having fat accumulation and men are more apt to have facial atrophy. And we also know that the lower CD4 counts and higher viral loads that patients have before they get started on treatment, in some studies, have also been shown to be a factor.
All in all, the fat changes in HIV are fairly common and its causes are multiple and complicated. Regardless of the fact that people are on certain types of medications, we believe that some individuals are still going to develop this problem. And since many people are also living longer and have been HIV positive for a very long time, most of the individuals already have the manifestations. So I believe that Egrifta's going to be used widely and hopefully provide benefit to a wide number of individuals that are HIV positive on treatment.
Alright, so let's get into the nitty a bit, if not the gritty as well. How well does Egrifta actually work against people with HIV who have developed this abdominal, visceral fat?
There were two studies that were designed to look at patients with HIV. Those studies basically looked at patients that were on stable antiviral therapy and had fat accumulation problems -- that was measured in waist circumference that was at least 95 centimeters, and a waist-to-hip ratio that was at least a certain measurement ratio of .94. And those patients could also have some mild type of diabetes. In other words, diabetes that didn't require medication treatment.
What was seen in the study was that patients that were on Egrifta were likely to get somewhere between a 17% and 18% reduction in visceral fat. In other words, there was a significant loss of visceral fat compared to the control arm or the placebo.
The way that the study was designed was very interesting in that for the first 24 weeks, patients were randomized with two to one being on Egrifta versus a placebo. But at 24 weeks, patients that were on placebo automatically were then put on Egrifta treatment. And the patients that were on the Egrifta treatment arm at the start of the study, they were re-randomized three to one to staying on Egrifta versus going to a placebo.
The visceral fat loss that was observed in the patients was seen, then persisted throughout the course of the study, as long as one was on [Egrifta]. Patients that went off of [Egrifta] and were re-randomized to the control arm, a placebo, then tended to show a reversal of those improvements.
So this is a drug that, once you start taking it, you need to keep taking it in order for it to be effective.
We believe that. However, studies haven't been done looking at the long-term usage of Egrifta. And this is one question or concern in clinicians' or physicians' minds, as to how long you need to keep your patients on Egrifta -- whether you can stop. Or can you put a patient on a lower-maintenance dose in order to maintain the benefits? But as I mentioned, these studies haven't been done. I'm hopeful that there will be more studies designed looking at these questions.
You said that the drug appeared to reduce excess abdominal fat by around 18%. What does that translate to in real terms? If people have that kind of fat gain and look at themselves in the mirror after having taken Egrifta for, let's say, a 26-week period, are they really going to notice that 18% difference?
Yes, it's actually a dramatic change. And actually, study patients who had more fat accumulation tended to do even better. Body image was also studied, with patients themselves having to answer questionnaires. Patients were able to say, or at least it was seen in the study, that body image, what's called "body image distress" or "belly profile," improved more with Egrifta use than with placebo.
Oh, so it's almost a mental health impact there.
Yes. When I saw patients after they experienced this drop in belly fat, it was very remarkable and sometimes often dramatic for me to see. And patients were extremely happy. It wasn't just noticeable, they were very happy with their results.
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