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Real world data confirmed the efficacy and safety of OCA in PBC with lower efficacy and reduced tolerability in patients with cirrhosis.98 99 Notably, use of OCA was associated with an increase in hepatic decompensation in patients with compensated PBC cirrhosis.100 which led to an update of the PBC label with a contraindication for use in patients with decompensated cirrhosis, a prior decompensation event or with compensated cirrhosis and evidence of portal hypertension