New Drug for Nonalcoholic Steatohepatitis

Obeticholic Acid is being used with some success to treat patients with nonalcoholic steatohepatitis (NASH), researchers reported April 25 in a poster session at the International Liver Congress in Vienna, Austria. The drug was originally targeted to treat diabetes.

Brent Neuschwander-Tetri, MD, of St. Louis University, St. Louis, MO., and Arun Sanyal, MD former president of the American Association of the Study of Liver Disease reported that the efficacy of obeticholic acid (OCA) was tested in patients with early NASH and risk factors that included diaetes, obesity, or elevated ALT. Those conditions put NASH patients at high risk of developing cirrhosis.

The drug was earlier evaluated in a trial known as FLINT, which looked at high-risk patients.

In their post-hoc analysis of the FLINT data, the researchers found that after 72 weeks of treatment, the 84 patients getting OCA did better than a control group of 76 patients getting a placebo.

The OCA patients had better odds of seeing their fibrosis go away (15% vs. 4% on placebo.)

The team also looked at the impact of statin use in the FLINT trial of NASH patients.

In the newer analysis, the researchers found that patients who got OCA and statins saw a rapid reversal of the LDL increase to below baseline, with a mean decrease after 72 weeks of -18.9ml/dL.

It was a very different story for OCA patients who did not take statins. Their LDL increased, peaking at week 12 of the study and staying at those levels throughout the study period.

“These data add to our understanding of the potential for OCA treatment to reverse fibrosis and prevent progression to cirrhosis,” said Neuschwander-Tetri, a finding that was not previous confirmed in NASH patients.

Adverse events were mild to moderate.

But OCA-treated patients more commonly developed pruritus (23% vs. 6% in controls) a condition that caused one patient to drop out of the trial.

Two patients getting OCA died during the study, but the deaths were not considered related to the treatment.

The original trial, Farnesoid X Receptor Ligand Obeticholic Acid in Nonalcoholic Steatohepatitis Treatment was sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases and involved 283 NASH patients in 8 US centers. The drug is made by Intercept Pharmaceuticals, New York, NY.