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interview

with

Juan

Pablo

Frias

1. First, in performing the actual study. Sometimes we are required to have the FibroScan^® in the measures.
2. Second, to help us select patients who will more likely qualify, either based on the amount of fat or the degree of fibrosis on their liver biopsy.

If the screen failed, it could be a number of other factors that don’t necessarily have anything to do with liver. It could be a thyroid or a glucose issue. In general, it is liver-related criteria, either the degree of steatosis, the degree of fat in the liver or often the degree of fibrosis. A lot of times, the patient may not even have NASH.

This is where it’s very useful to have the capability of a FibroScan^® exam that helps us to predict not only steatosis, but also the level of fibrosis in these patients that may or may not be predicted during a biopsy.

We have found it very useful to have the capability to perform a FibroScan^® because it not only helps us predict the degree of steatosis, but also the stage of fibrosis that may be found upon liver biopsy.

The results of a FibroScan^® play a very important role in overcoming perhaps the most important challenge with respect to finding appropriate patients for many NAFLD/NASH clinical trials: identifying patients with advanced hepatic fibrosis. It’s a very important tool as we’re putting the picture together to help predict which patients will meet study eligibility criteria, which lowers screen failure rates.

In our clinic, since we have the FibroScan^®, we scan everybody.

We use FibroScan^® when patients come to our outpatient clinic whether they are obese or have Type 2 diabetes. Most of these patients are high risk of having metabolic liver disease.

We perform several tests. We draw fasting glucose and do an A1C, lipid panels, etc. But as part of our routine clinical practice, we assess the liver with FibroScan^® to help assess a patient’s liver health. I think it is very important not only for the clinical care of our patients, but also when selecting patients who are most appropriate for clinical trials.

I can go to a sponsor and say that not only do we have Hispanic patients who are obese and have Type 2 diabetes — and often will have fatty liver disease as well – but we can also characterize these patients even further. We can divide them into those that are higher risk of having NASH with fibrosis, and those who may just have fatty liver but not have fibrosis and may not even be worth screening.

It helps that we can be more selective with respect to which patients we enter into a clinical trial, which is ultimately more cost effective for the trial’s sponsor. This helps obviate a lot of screen failures and performing unnecessary tests on patients that may have little chance of meeting biopsy-related eligibility criteria.

FibroScan^® is very helpful to build our database and enables us to say, “I’ve got X number of patients with liver stiffness that measure over nine or 10 kilo pascals.” I think that’s very helpful.

And I think it’s helpful for us, [as doctors] too, to ensure — to the extent we can — that the medications are actually working to improve patient outcomes. It depends upon the drug and, quite frankly, also on what the insurance company is demanding.

For example, does the payer need to have biopsy-proven fibrosis for them to pay for the drug, or could it be based on FibroScan^® or other tests? So, it will depend.

But I see FibroScan^® as a tool to potentially be used to help decide who should receive treatment, and then to monitor how the patient is responding to therapy as well. It is an important part of the overall picture.

Generally, these patients are obese so that when they lose weight, the score should go down. It is nice to confirm that they’re having an improvement in steatosis.

So I think this could be important but probably not as important as seeing reductions in fibrosis or halting the progression of fibrosis.

The doctor’s explanation to them can play a big role. I think if it is explained well, it will have an impact. For example, explanations such as these are helpful: “Here’s your target.” “This is normal.” “This is where you are.” “This is what this means,” etc.

This is particularly valuable for patients who have CAP™ scores of 380-400. They respond very well to seeing that they are not only losing weight, but also improving other measures. We do that with many other labs. The report is set up to easily explain these measures to a patient, which I personally think is very important.

Patients obviously respond very well when they get on a scale and see that they’ve lost 10 kilograms. It’s helpful to back that up and say, “Hey, not only did you lose weight, but now you also have less fat in your liver, which is very important as well.”

I wouldn’t underestimate that at all. It’s a nice report, and a lot of patients even want copies of their report.

Some patients have normal liver function tests, although they may be high normal. But many clinicians who don’t see a lot of liver patients or know much about this think that if it falls within the normal range, it is okay. But I’ve had a lot of patients who have mostly “normal” LFTs who have had significant liver stiffness measures in the high teens to twenties and ended up having cirrhosis.

Patients are pleased that FibroScan^® is non-invasive and very quick to perform. Given this, and the information they receive from the test, they don’t mind getting a screening done at all.

We need more research on combining a non-invasive imaging modality, like a FibroScan^®, with some blood tests. I think that’s probably where things will end up. Longer-term studies are being conducted that are looking at this and able to make correlations with the biopsy. Hopefully, that is where we will be in the future.

Being able to prevent a biopsy from being performed is a very important issue. A biopsy is very invasive and relatively expensive – and not without complications.