奥贝胆酸的效果好吗？

Is the effect good? Obeticholic acid has been proven effective in the treatment of non-alcoholic steatohepatitis (NASH), and the US FDA has granted it Breakthrough Therapy designation. Nonalcoholic steatohepatitis (NASH) is a severe, progressive nonalcoholic fatty liver disease (NAFLD) caused by fat accumulation, often accompanied by liver inflammation, hepatocellular scarring, and liver damage, leading to liver fibrosis and cirrhosis, ultimately leading to liver cancer or liver failure.

Clinical study results show that obeticholic acid can improve liver histological characteristics in patients with non-alcoholic steatohepatitis and also help reduce liver enzymes. Although there were some side effects, all components of the nonalcoholic fatty liver activity score (steatosis, hepatocyte ballooning, lobular inflammation) and liver fibrosis improved.

Results from the REGENERATE trial, a phase 3 trial, studying its investigational new drug obeticholic acid (OCA) versus placebo in the treatment of patients with liver fibrosis caused by nonalcoholic steatohepatitis (NASH). In terms of primary efficacy, a planned 18-month interim analysis showed that OCA 25 mg once daily met the primary endpoint of improvement in fibrosis (≥Grade 1) with statistical significance without worsening of NASH. The trial showed that in the primary efficacy analysis, a greater proportion of patients in the obeticholic acid group achieved the primary endpoint of NASH resolution without worsening of liver fibrosis compared with placebo, but this did not reach statistical significance. The REGENERATE data tell us that obeticholic acid is expected to be the first approved drug for patients with liver fibrosis caused by NASH. Currently, in the research field of fibrosis caused by NASH, it is still the only drug under development that has been designated as a breakthrough therapy by the FDA.