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In the many patients with primary biliary cholangitis (PBC) who have inadequate response or intolerance to first-line treatment with ursodeoxycholic acid (UDCA), obeticholic acid (OCA) is FDA approved and has demonstrated some sustained biochemical improvements. However, histologic outcome data are lacking.
In a substudy of an industry-funded, phase III trial in patients with PBC who were inadequately responsive or intolerant to UDCA, researchers examined paired liver biopsy findings in 17 patients receiving OCA (5 mg or 10 mg daily) during a 5-year open-label extension. Biopsies were performed at baseline and after 3 years of OCA therapy. Histologic evaluation was performed by two pathologists in a blinded fashion.
During the 3-year period, …