Using the Fib-4 Score to Monitor Morbidity and Mortality Risk in Chronic Hepatitis C Patients

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Introduction: In the recent past, many patients with chronic Hepatitis C infections (HCV) delayed treatment until symptoms emerged due to significant, direct and indirect costs associated with older treatments. Physicians may have acquiesced to delays in therapy as clinical research data on new treatment options began to emerge in the literature. However, delaying therapy must be coupled with valid methods for monitoring the patient's disease progression over time to insure that mortality and morbidity risks do not become untenable. This study examined if FIB-4 values can be used to monitor the risk of liver-related events and mortality in HCV patients. Methods: A cohort of patients was selected from the Veterans Health Affairs (VHA) Hepatitis C Clinical Case Registry (Hep C CCR) of confirmed HCV patients. The primary outcomes were time to death and time to a composite for first liver-related clinical events. Cox proportional hazards models were estimated using time to a patient's FIB-4 exceeding 1.45 or 3.25 as the risk factor of interest. Cox models were performed to examine the risk for patients using age, gender, genotype, race, ethnicity, BMI, prior hospitalizations and HIV and hepatitis B co-infection. Results: 187,860 patients met study requirements. Patients whose FIB-4 level exceeded 3.25 were at significantly higher risk of death (Hazard Ratio (HR) = 3.56 (3.47-3.65)) and an adverse liver- related clinical event (HR = 4.01 (3.92-4.10)). Exceeding FIB-4 > 1.45 was also associated with a significant but smaller increased risk of death (HR = 2.27 (2.21-2.33)) and the composite event (HR = 2.23 ((2.18-2.28)). Conclusion: FIB-4 is a significant predictor of risk, even at the lower threshold (1.45).

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