Jul 4 2016
By Shreeya Nanda
Japanese researchers reveal an association between elevated FIB-4 index 24 weeks after the initiation of nucleos(t)ide analogue (NA) therapy and the development of hepatocellular carcinoma (HCC) in patients with chronic hepatitis B virus (HBV) infection.
The FIB-4 index is a noninvasive marker of liver fibrosis for not only patients with chronic HBV, but also those with chronic hepatitis C virus infection and nonalcoholic fatty liver disease, they explain. Therefore, the findings suggest that liver cirrhosis is the "independent risk factor" for HCC in this patient population and the FIB-4 index can help determine HCC risk without an invasive examination or imaging test, the team observes.
Over a median 5.9 years of follow-up beginning from the initiation of treatment, HCC developed in 81 of 539 chronic HBV patients given NA therapy at one of three Japanese hospitals. The cumulative incidence of HCC ranged from 6.5% at 3 years to 21.8% at 10 years.
In univariate analysis, FIB-4 index and α-fetoprotein (AFP) levels at 24 weeks from NA initiation as well as gender were significantly associated with HCC incidence. For instance, the 3-year cumulative incidence in female patients was 2.0% compared with 9.3% for males, while at 10 years the rates were 8.9% and 30.0%, respectively (p<0.001).
Similarly, the cumulative incidence of HCC at various timepoints was higher in patients with FIB-4 index over 2.65 versus at or below this threshold, with 3- and 10-year rates of 16.4% versus 2.7% and 43.2% versus 12.4%, respectively (p<0.001).
Both gender and the FIB-4 index remained significantly associated with HCC incidence (p<0.001 for both factors) in multivariate analysis adjusting for confounding parameters including HBV genotype and AFP levels at 24 weeks.
And time-dependent area under the receiver operating characteristic curve analysis showed that the FIB-4 index at 24 weeks predicted HCC incidence with an accuracy of 76.0%, 75.4%, 73.9% and 74.5% at 3, 5, 7 and 10 years, respectively.
Researcher Toshifumi Tada, from Ogaki Municipal Hospital, and colleagues note in the Journal of Gastroenterology and Hepatology that the "FIB-4 index was superior to AFP for predicting the development of HCC during the entire follow-up period, from 1 to 10 years."
Thus, they consider the FIB-4 index to have "excellent predictive power" for identifying NA-treated chronic HBV patients who are likely to develop HCC.
Moreover, by using the value of the FIB-4 index at 24 weeks from the start of therapy, "we are able to recognize the risk of HCC development as soon as possible after the initiation of treatment" in this patient population, say Tada et al.
However, they caution that their results need to be confirmed in community-based prospective studies and in other populations.
Source: J Gastroenterol Hepatol 2016; Advance online publication
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