Clinicians need a reliable, non-invasive predictor of future liver-related events with which to monitor disease progress and alert untreated patients to start therapy before treatment effectiveness is compromised. This study documents the impact of FIB-4 > 3.25 [probable fibrosis] on mortality risk and evaluates if treatment effectiveness is compromised if initiated after fibrosis is detected.
Data from a large sample of U.S. veterans were selected using the Veterans Administration’s HCV clinical registry [CCR] which compiles patients EMR data from 1999 to present. Selection criteria required data on viral genotype and sufficient laboratory data with which to calculate FIB-4 scores. Time to death was analyzed with Cox proportional hazards models using treatment before/after FIB-4 > 3.25, age, genotype, gender, race, diabetes and other patient characteristics as independent risk factors.
150,958 out of 360,857 unique HCV CCR patients met study inclusion criteria. Patients with FIB-4 > 3.25 experienced a 4-fold increase in the risk of death [H.R.=4.23 (4.08-4.38)]. Initiating treatment significantly reduced this risk 25% both before the development of fibrosis [H.R.=0.748 (0.70-0.78) and after [H.R.= 0.7537 (0.71-0.81)][p=0.6896 for the difference].
A FIB-4 score > 3.25 is a strong predictor of mortality risk in patients with HCV and the effectiveness of treatment is not adversely impacted once patients cross this threshold for monitoring fibrosis. While our results may under-estimate treatment effectiveness if treatment initiation is correlated with illness severity, an FIB-4 > 3.25 can be used to motivate patients to initiate treatment before effectiveness in impaired.
© 2014 Published by Elsevier Inc.