De Vincentis et al evaluated patients with primary biliary cholangitis (PBC) who were treated with obeticholic acid (OCA). While about 30% of patients with cirrhosis benefit from therapy, some patients may not respond or may have adverse effects. The authors are from multiple institutions in Italy.
Patient selection: cirrhosis due to primary biliary cholangitis (PBC)
Hepatic adverse events: death, ascitic decompensation, variceal hemorrhage, jaundice
Predictors of severe adverse events associated with obeticholic acid (OCA) therapy:
(1) ascites (aRR 3.5)
(2) elevated INR (aRR 1.9)
(3) Child-Pugh score (aRR 2.4), from 5 to 15, with cut-off >= 6
(4) MELD score (aRR 1.2), with cut-off >= 7.6
(5) serum total bilirubin in mg/dL (aRR 1.3), with cut-off >= 1.4 mg/dL
Protective factors:
(1) serum albumin in g/dL (aRR 0.2), with cut-off < 3.7 g/dL associated with adverse events
If the serum total bilirubin is >= 1.4 mg/dL, then use of OCA is discouraged.
