Top Highlights in Hepatology: The Liver Meeting 2014

The Liver Meeting 2014: American Association for the Study of Liver Diseases (AASLD)

William F. Balistreri, MD


January 07, 2015

In This Article

Primary Biliary Cirrhosis

Studies also suggested that OCA may be beneficial in patients with primary biliary cirrhosis (PBC).

In an international, double-blind, placebo-controlled trial, Nevens and colleagues[11] reported that OCA (10-50 mg) was superior to placebo in patients with PBC. OCA produced statistically and clinically meaningful improvements in biochemical markers of cholestasis.

The efficacy and safety of OCA were also evaluated byLuketic and colleagues[12] in a double-blind, placebo-controlled trial.The primary endpoint was achieved in a significantly higher proportion of OCA-treated patients with PBC. Pruritus, a hallmark of PBC, was the most frequently occurring dose-related adverse event, resulting in early discontinuation in up to 24% of patients receiving 50 mg. OCA titration to 10 mg, by clinical response, appeared to be an appropriate dosing strategy.[13] Bowlus and colleagues[14] also reported that titration of OCA would improve tolerability while remaining efficacious.

In another study, OCA given to patients with PBC who had an inadequate response to or unable to tolerate UDCA produced highly statistically and clinically meaningful improvements in liver biochemistry variables.[15] The effect of OCA was consistent regardless of age at diagnosis and duration of PBC.

The efficacy and safety of OCA, given as monotherapy, in a 12-week, phase 2, double-blind, placebo-controlled trial, documented significant improvement in alkaline phosphatase level; bilirubin level; and other indices of cholestasis, inflammation, and hepatic function. This was followed by an open-label, long-term extension period in which patients either continued OCA or were switched from placebo to OCA through about 4 years of treatment.[16] Long-term OCA treatment in this study maintained a durable improvement in markers of cholestasis and other hepatic biochemistry analytes, with no new safety signals and improved tolerability.


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