Initial Clinical Experience With the Oral Cholate Challenge Test: Results From the 2023–2024 Early Access Program

ABSTRACT The oral cholate challenge test of liver health, intended for use in compensated advanced chronic liver disease, was launched through an Early Access Program (EAP) in 2023–2024. Tests were provided to 16 clinicians at five liver centres across the US. The tested patients ( n = 129) represented a range of etiologies and stages of disease. Top clinical uses were: (1) informing the decision for endoscopy to test for varices ( n = 56, 43%), (2) defining risk for large oesophageal varices (LEV) ( n = 92, 71%), and (3) baseline for monitoring disease progression or treatment effects ( n = 33, 26%). The test's disease severity index (DSI) stratified patients according to risk for portal hypertension and LEV: 49 (38%) low risk, 31 (24%) moderate risk and 49 (38%) high risk. The potential impact of DSI ≤ 18.3 on EGD avoidance (38%) in clinical practice replicated that which was observed in prior validation studies (41%).