New Data from the Interim Analysis of REGENERATE Show OCA Improved Noninvasive Measures of Fibrosis in a Subgroup of High-Risk Patients with Fibrosis Due to NASH - Seite 2

Additional Analyses Support the Role of NITs for Management of Advanced Fibrosis Due to NASH

Multiple additional analyses being presented at the virtual Liver Meeting reinforce the value of noninvasive strategies for managing patients with advanced fibrosis due to NASH:

• In an oral presentation (Abstract 56), an analysis of more than 4,000 patients screened for the REGENERATE study found that application of two sequential NITs improved the accuracy of identification and reduced misclassification of disease as compared to two simultaneous NITs. The authors concluded that sequential NIT strategies may decrease the need for liver biopsy, while maintaining the accuracy of diagnosis in patients with advanced fibrosis due to NASH.
  
  
• An analysis (Abstract 1589) comparing FIB-4, liver stiffness measurement by transient elastography, and liver biopsy to predict the incidence of liver-related outcomes (e.g., cirrhosis complications and/or hepatocellular carcinoma) in patients with nonalcoholic fatty liver disease concluded that the predictive accuracy of FIB-4 and transient elastography is similar to that of liver biopsy for predicting liver-related events.
  
  
• A review (Abstract 1576) of data from a large U.S. claims database that included approximately 21,500 patients diagnosed with NASH who met the study’s inclusion criteria found that only 11% had a liver biopsy, underscoring the fact that liver biopsy is infrequently performed in the real world clinical practice setting. 
  

“Strong collaboration among patient groups, academic centers and industry, coupled with large datasets from Phase 3 clinical trials have accelerated our ability to identify and validate noninvasive alternatives to biopsy for our patients with fibrosis due to NASH,” said Jerome Boursier, M.D., Ph.D., professor of Medicine, Hepato-Gastroenterology Department of Angers University Hospital, and head of HIFIH laboratory, Angers University in France. “The new NIT data from the interim analysis of the REGENERATE study being presented at the Liver Meeting represent a major step forward. Clearly, the field is coalescing around a sequential testing strategy that combines two commonly used NITs; this approach addresses the major limitations of liver biopsy because it is both scalable and patient-friendly without appearing to sacrifice predictive accuracy. Sequential use of NITs starting with a simple test confirmed by a specialized one will also help to organize and optimize the patient pathway.”