Tuesday’s Leon Schiff State-of-the-Art Lecture is taking on what the lecturer calls “the disease of the day” in hopes of shining a light on unmet needs in the race for a cure of nonalcoholic steatohepatitis (NASH).
“This topic of NASH was selected simply because it is the big disease of the day. We can cure hepatitis C in close to 99 percent of patients, but there’s still a lot to be done for NASH. So this is clearly an area where there’s a lot of energy being poured into to get drugs approved and much of that has been derived from the science in terms of the mechanisms of disease,” said Arun Sanyal, MD, FAASLD, professor at Virginia Commonwealth University and this year’s Schiff Lecturer.
NASH has a growing footprint in terms of burden of disease, and there’s still no approved drugs. Dr. Sanyal said his talk will focus on the progress made in the treatment of NASH from a clinical standpoint. He will also provide a vision for where the field needs to go in the future.
“The first wave of drugs are coming through and hopefully will get approved in the next two years,” he said. “Like most other disease states, the first set of drugs to come through really breaks down a lot of barriers and establishes a path for drugs with better efficacy and greater safety and tolerability to follow. These are very important first advances, but there’s a huge second wave coming and an even bigger third wave behind it.”
The possibility of combination therapeutics to develop treatment regimens with greater efficacy, the possibility of precision medicine to individualize therapeutics for each patient, and the possibility of innovations in trial design so that clinical trials can be performed faster and more efficiently are all going to be critically important to the future of NASH, said Dr. Sanyal, who said he plans to share a vision that incorporates all of these.
“I think the biggest challenge in this area is the development of simple tools to identify the patients in the community who are at particular risk of progression to cirrhosis and targeting them for therapy,” he said.
He noted that not everyone with fat in their liver will have bad outcomes. Negative outcomes are linked to a subset of people who have more aggressive liver injury and scarring of the liver.
“Right now the only way to identify those people is with a liver biopsy, but that’s really not a practical approach for the whole country because liver biopsies are invasive, they carry some risk, and they are not foolproof,” he said.
Better diagnostics, such as noninvasive biomarkers, that can be deployed in a routine family practice type setting are the current biggest unmet need, he added.
Dr. Sanyal said he hopes his Schiff Lecture will leave attendees feeling energized by the amount of movement in the field.
“I also would like to inspire some young people to continue to pick up the torch and carry on and maybe find new paradigms and to focus the people in the field around the areas where there are still the greatest unmet need,” he said.