What to Do with the Patient With Abnormal Liver Enzymes? Nizar N. Zein, M.D. The Cleveland Clinic

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1 What to Do with the Patient With Abnormal Liver Enzymes? Nizar N. Zein, M.D. The Cleveland Clinic

2 Introduction Elevated liver enzymes is often not a clinical problem by itself. However it is a warning sign of potential future problem.

3 Hepatic Fibrosis is a Natural Response to Chronic Injuries Hepatitis Viruses Inherited Metabolic Disorders NASH FIBROSIS Alcohol Drugs Schistosomiasis Cholestatic Disorders Immune Disorders

4 The Problem

5 Clinically

6 The Three most important Clues! Liver enzyme or liver function Acute or chronic Hepatocelluar or cholestatic

7 Hepatic Panel Liver Enzymes ALT AST Alkaline Phosphatase GGT Liver Function Bilirubin Albumin Prothrombine Time

8 Liver Enzymes Sensitive for hepatic injury Not very specific to identify the cause of liver injury

9 Albumin The Child-Turcotte Turcotte-Pugh classification 1 point* 2 points 3 points > 3.5 g/dl g/dl <2.8 g/dl INR < >2.25 Bilirubin Ascites Encephal- opathy <2 mg/dl 2-33 mg/dl >3 mg/dl None None Mild Stage I-III II Severe Stages III- IV

10 Acute vs. chronic? Traditionally chronic: elevation of liver test for six months It could be a new onset elevation of LFT in a chronic condition.

11 Acute Viral infection (HAV) Drug-induced injury Autoimmune liver disease Ischemic Chronic NAFLD Hemochromatosis A1AT deficiency

12 Biochemical patterns Hepatocellular injury: Predominantly ALT/AST elevation Cholestatic injury: Predominantly AP elevation (+/ elevated bilirubin) Mixed pattern

13 What to do? Assessment of etiology Laboratory tests: Biochemical Serological Virological Genetic testing Imaging studies (US, CT, MR, nuclear) Assessment of degree of liver injury Liver biopsy Endoscopy

14 Liver biopsy

15 Utility of Liver Biopsy Confirm Clinical Diagnosis Assess Severity of Necroinflammation Role of Liver Biopsy Evaluate Possible Concomitant Disease Processes Assess Fibrosis Assess Therapeutic Intervention Brunt. et al. Hepatology ;31:

16 However Cost Complications Patient do not like it and may refuse it. Not all patients are candidates.

17 Non-invasive Prediction

18 The Non-invasive Tools Routine Laboratory Tests ALT, AST, ALT/AST ratio, Platelate. Examples: Forns tets, APRI, Metwally Specialized tests Fibrotests PGA index CK 18 Imaging

19 Routine Lab Tests Prediction model used three simple lab value to design the model: Platelet count (score 0-4) 0 Serum albumin (score 0-2) 0 Serum AST (score 0-3) 0 Total maximum score is 9 Zein NN et al. DDS, 2006

20 50 40 Nonsevere fibrosis Severe fibrosis Number of patients Score 0-1 Score 2-3 Score 4-8

21 ROC Curve of a Model to Predict Hepatic Fibrosis Sensitivity Specificity 1 0 Zein NN et al. DDS, 2006

22 Specialized Tests: Fibrotests Alpha 2 macroglobulin Haptoglobin GGT Apolipoprotein A1 Acute Inflammation Total bilirubin Gilbet s

23 Hepatocyte Apoptosis Correlates with Stage of Fibrosis in NASH TUNEL Pos cells/field * p = 0.02 compared to stage 1/2 # p = 0.01 compared to no fibrosis Control (n=28) No Fibrosis (n=4) Stage 1/2 (n=20) * # Stage 3/4 (n=10) NASH Feldstein A, Zein NN, et al. Gastro 2004

24 Specialized Tests In Vivo Assessment of Liver Cell Apoptosis as a Novel Biomarker of fibrosis stage M30 Apoptosense ELISA Kit Quantitative measurement of caspase-generated CK-18 fragments in serum Wiekowska A, Zein NN, et al. Hepatology 2006

25 Imaging-based techniques Promising Good reproducibility and low inter- observer variability Difficult to use in obese patients May not differential fat from fibrosis

26 Elastography (Liver Stiffness)

27 Poynard et al, Gastroenterology 2002; 122: Reversibility of Cirrhosis Following Treatment of Hepatitis C No. Patients Before Treatment After Treatment Stage 4 Stage 3 Stage 2 Stage 1 Normal

28 Making the case for perusing workup of patients with elevated liver enzymes: The HCV example

29 Mortality from Hepatitis C: US Mortality from Hepatitis C: US Number of Deaths Calendar Year UNOS: United Network for Organ Sharing

30

31 Natural History of HCV Cirrhosis 100 Survival probability (%) Deaths Liver-related (70%) Other causes (30%) Compensated After 1st complication Time (years after diagnosis) Fattovich G, et al. Gastroenterology. 1997;112:

32 Early Identification and Monitoring 1000 HCC ALT (U/L) ALT 1+ Anti-HCV Fibrosis Cirrhosis 200 HCV RNA Years After Exposure Hoofnagle JH. Hepatology 2002;36:S21-S29.

33 Rising Incidence of HCC: US Age adjusted incidence of HCC in the US, Incidence (per 100,000 population) Black men White men Black women White women El Serag H, et al. NEJM, 1999

34 Outcome of Current Therapy (SVR) % Overall Response P = 0.01 P = % 56% 44% 10 0 n = 505 n = 511 IFN α-2b 3 MIU/RBV PEG-IFN α-2b 1.5 µg/kg/rbv n = 444 IFN α-2b 3 MIU/RBV n = 453 PEG-IFN α-2a 180 µg/rbv Manns MP et al. Lancet 2001;358: Fried MW et al. NEJM 2002;347:

35 Cumulative Incidence of Cirrhosis and HCC According to Response to IFN Therapy Nonresponders Transient Responders Sustained Responders Liver cirrhosis (%) P=0.005 HCC (%) P= Time (mo) Time (mo) Kasahara A, et al. Hepatology. 1998;27:

36 20 Year Risks, Life Expectancy, and Quality Adjusted Life Expectancy: Treated vs. Untreated HCV 20-Year Risk (%) Compensated cirrhosis Decompensated cirrhosis Hepatocellular carcinoma Liver transplantation* Liver-related related death No Antiviral Treatment PegIFN Plus Wt- Based RBV Life expectancy (years) Quality Adjusted Life Expectancy (QALY) *Only first transplantations included (no retransplantations). Siebert U et al. Gut. 2003;52:

37 Novel Agents Dropped Out Ribozymes Anti-sense therapy Several polymerases Inh Toll-like receptor anta Still In The Race VX-950 Infliximab Nitazoxanide Albuferon

38 Conclusions Approach to patients with elevated liver enzymes is evolving with newer molecular assays and diagnostic techniques. Advances in diagnostics has primarily been driven by improved therapeutic modalities in patients with acute and chronic liver diseases.

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