New Tests Predict Clinical Outcomes in Chronic Hepatitis C Virus

Current methods to stage liver disease and assess liver function are inaccurate (especially in patients with early disease) or invasive. In the current study, investigators test the ability of a recently developed battery of quantitative liver-function tests (QLFTs) to predict hepatic decompensation and liver-related death.

The study cohort was derived from a prospective long-term study to evaluate the benefits of low-dose peginterferon in improving clinical outcomes in patients with hepatitis C virus (HCV) infection with either advanced fibrosis or compensated cirrhosis (the HALT-C Trial; JW Gastroenterol Dec 5 2008); it comprised 227 patients who had baseline QLFTs performed. The QLFTs included monoethylglycine xylidide concentration; methionine breath test; galactose elimination capacity; caffeine elimination rate; antipyrine clearance; dual cholate clearances and shunt; liver and spleen volumes; and perfused hepatic mass. The QLFTs were repeated at month 24 in 196 patients and at month 48 in 165 patients. Patients were followed for a median of 5.5 years to determine the following clinical outcomes: Child-Turcotte-Pugh score progression (≥7 on 2 consecutive evaluations), variceal bleeding, ascites, encephalopathy, and liver-related death.

Overall, 24% of the cohort developed at least one of the clinical outcomes. Baseline QLFTs were all significantly worse in the 54 patients who eventually experienced a clinical outcome than in those who did not. In multivariate analysis, QLFTs independently predicted outcomes after adjustment for fibrosis score, platelet count, and standard laboratory tests. QLFT cutoffs were developed that characterized patients as high risk and low risk for clinical events. Of note, the risk for a clinical event was <5% in low-risk patients.