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Quantitative tests detect impaired hepatic function in a high proportion of chronic hepatitis C patients with fibrosis or compensated cirrhosis and may predict risk of cirrhosis, splenomegaly, and varices

, : Quantitative tests detect impaired hepatic function in a high proportion of chronic hepatitis C patients with fibrosis or compensated cirrhosis and may predict risk of cirrhosis, splenomegaly, and varices. Hepatology 38(4 Suppl 1): 304A-305A, October

Background: Conventional clinical blood tests (bilirubin, albumin, prothrombin, platelets) are insensitive measures of hepatic function and do not adequately define risk for cirrhosis and portal hypertensive complications, such as varices. Liver biopsy may be inaccurate due to sampling variability. QLFTs measure the liver's ability to metabolize or extract test compounds, may identify patients with impaired hepatic function at earlier stages of disease, and possibly define risk for cirrhosis, splenomegaly, and varices. Specific Aims: 1. Use 7 QLFTs to define hepatic impairment in patients with chronic hepatitis C and bridging fibrosis or compensated cirrhosis enrolled in the Hepatitis Antiviral Long-Term Treatment to Prevent Cirrhosis Trial (HALT C). 2. Compare test results between those with or without biopsy-proven cirrhosis, splenomegaly on ultrasonography, and varices at endoscopy. Patients: The mean age of the 248 enrolled patients was 49.9+-7.3 yr and 75% were male. Mean BMI was 29.6+-5.3, 40% had cirrhosis, 60% had bridging fibrosis, 93% were infected with HCV genotype 1, and mean serum HCV RNA was 4.39+-4.66X106 copies/ml. 30% had platelet count <140,000/ul, 25% had albumin <3.5 g/dl, 25% had INR >1.1, 10% had bilirubin >1.2 mg/dl, and 25% had AST:ALT >1. Analytical Methods: 13C-methionine (MBT), caffeine (Caf), antipyrine (AP), and 2,2,4,4-2H-cholate (CA) were taken orally and 24-13C-cholate, galactose (Gal), and lidocaine were administered intravenously. These compounds or their metabolites were measured from timed serial samples of blood, saliva, and breath using standard techniques. Elimination rate (kelim), volume of distribution (Vd), clearance (Cl), elimination capacity (Elim), and shunt were calculated from measured analytes. Perfused hepatic mass (PHM) was determined from SPECT liver scan. Mean test results were compared by T statistic and area under the receiver operator curve (ROC) by C statistic. Table results are ordered by T statistic for association with cirrhosis PHM had the highest area under ROC with cirrhosis (C statistic.87), splenomegaly (C statistic.75), and varices (C statistic.832) and correlated best with platelet count, billrubin, prothrombin time, and albumin. Conclusions: QLFTs uncover hepatic impairment in a high proportion of fibrotic patients with chronic hepatitis C, and some tests, particularly CA Cloral, PHM, and CAshunt, identify patients with chronic hepatitis C with cirrhosis, splenomegaly or varices. Long-term followup, as planned in HALT C, will determine whether hepatic impairment as defined by QLFTs predicts risk for clinical deterioration.


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