HepQuant Tests Accurately Assess Primary Sclerosing Cholangitis Disease Severity

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A new study found HepQuant tests can effectively categorize patients with primary sclerosing cholangitis based on the severity of liver impairment.¹ The results showed those with greater HepQuant test scores had a greater risk of serious liver problems, such as liver failure or the need for a transplant.

Primary sclerosing cholangitis, a rare chronic liver disease, is difficult to monitor and categorize live disease severity by current laboratory tests, imaging, histology, and biomarkers due to concomitant cholestasis and biliary complications. Vibration-controlled transient elastography is a noninvasive option to monitor the disease but has been linked to liver stiffness in some studies.

This disease can lead to many complications, including liver disease and failure, repeated infections, portal hypertension, osteoporosis, bile duct cancer, and colon cancer.² Investigators emphasized the need for new quantitative tools for disease staging and monitoring drug treatments.¹

“By identifying functional subgroups, clinicians may more accurately determine frequency of follow-up visits, appropriate use of laboratory tests, and identify those in need of closer clinical follow-up or earlier evaluation for liver transplant,” wrote investigators, led by Steve Helmke, PhD, from the University of Colorado Anschutz Medical Campus.

The Hepquant tests DuO and SHUNT are minimally invasive and can quantify liver function and portal-systemic shunting by eliminating cholate from systemic and portal circulations. Investigators conducted a study to evaluate the ability of HepQuant Duo and SHUNT tests to characterize liver disease severity, disease progression, and liver function’s association with the risk of liver-related complications.

The study, conducted between 2011 and 2017, included 47 patients at baseline and 40 after a year of follow-up. Most of the sample was White (n = 43), followed by African American (n = 3) and White (n = 1). More participants were male (n = 36) than female (n =11). The sample had a mean age of 48.8 ± 12.9 years, a mean weight of 81.3 ± 14.9 kg, and a mean body mass index (BMI) of 26.2 ± 3.9 kg/m2.

Clinical outcomes, identified based on patient histories and chart reviews, included hepatic decompensation, liver-related death, or liver transplantation after the baseline tests. At baseline, the team collected data on medical history, physical examination, standard laboratory tests, alpha-fetoprotein, CA19-9, CEA, and clinical scores. At the follow-up, investigators examined medical history for clinical outcomes and the same blood test.

A greater SHUNT%, the percentage of cholate that spills over into the systemic circulation, indicates more severe liver impairment. SHUNT% was identified as the strongest predictor of liver complications, with the area under the receiver operating characteristic curves of 0.84 for the DuO test and 0.90 for the SHUNT test.

Among the 40 patients at follow-up, liver conditions worsened for 10 and remained stable for 30. Those who experienced worsened liver conditions at the follow-up had a significantly increased disease severity index from baseline (DuO: 2.4 ± 4.2 vs −0.2 ± 3.0, P = .039; SHUNT: 2.3 ± 4.2 vs −0.4 ± 3.2, P = .042). Investigators observed a nonsignificant increase in SHUNT% (DuO: 4.5%, P = .10; SHUNT: 4.2%, P = .48).

The team ultimately defined 3 subgroups with low, moderate, and high disease severity based on clinical manifestations of liver disease, laboratory tests, clinical scores, and inflammatory cytokines. Investigators noted they plotted Hepquant functional parameters against age.

“Phenotyping of PSC patients by age-related degree of functional impairment may help to target clinical management to those at greatest risk for progression and identify those in need of more urgent liver transplantation,” investigators wrote.

Investigators wrote the findings were limited by the single-center setting, the relatively small sample size, and the short clinical follow-up period.

“Due to ease of administration, DuO is ideally suited for identifying more advanced patients appropriate for enrollment into longer-term clinical outcome studies,” investigators concluded. “Further investigation into the clinical role of HepQuant DuO and SHUNT tests in [primary sclerosing cholangitis] is warranted.”

References

1. ^{Helmke S, Kittelson J, Imperial JC, McRae MP, Everson GT. The Oral Cholate Challenge Test Quantifies Risk for Liver-Related Clinical Outcomes in Primary Sclerosing Cholangitis. Gastro Hep Adv. 2024;3(7):944-953. Published 2024 Jul 14. doi:10.1016/j.gastha.2024.07.005}
2. ^{Primary Sclerosing Cholangitis. Mayo Clinic. https://www.mayoclinic.org/diseases-conditions/primary-sclerosing-cholangitis/symptoms-causes/syc-20355797. Accessed September 20, 2024.}