Changes of FIB-4 index in HBeAg-negative treatment-naive chronic hepatitis B patients receiving 4-year entecavir therapy

Abstract

Objective Antiviral therapy should be adopted for chronic hepatitis B (CHB) patients with significant liver fibrosis to decrease the risk of liver related complications. Fibrosis assessment during antiviral treatment is a key step in antiviral therapy evaluation. Liver biopsy is the gold standard for assessing the degree of liver fibrosis. However, liver biopsy is difficult to perform more than one time after a long-term effective treatment because of the cost and risk of life-threatening complications. In this study we aimed to evaluate changes of liver fibrosis during 4 years of entecavir(ETV)treatment by non-invasive fibrosis markers in CHB patients who need antiviral therapy. Methods Totally 268 HBeAg negative treatment-naive CHB patients were enrolled and liver biopsy were performed before starting antiviral therapy in this study. Totally173 patients who needed antiviral therapy (liver fibrosis stages≥F2, Metavir scoring system) were treated with ETV for at least 4 year. A clinical and virological evaluation was performed at baseline and again at 12, 24, 36 and 48 months during ETV treatment. Fibrosis-4 (FIB-4) index was used to assess dynamic changes of liver fibrosis in HBeAg negative CHB patients after 1, 2, 3 and 4 years of ETV treatment. Results Liver biopsy was performed for all enrolled patients at baseline. According to Metavir fibrosis stages, numbers of patients with F1, F2, F3 and F4 were 95, 108, 50 and 15, respectively. The FIB-4 index enabled the effective identification of patients with severe fibrosis (Metavir F3-F4) with an area under the ROC curve of 0.775 (95%CI 0.716-0.834). The FIB-4 values significantly decreased in F2 and F3 patients after 1 and 2 years ETV therapy (P<0.01), respectively. But for F4 patients, FIB-4 values decreased significantly at year 4 (P<0.05). Conclusions FIB-4 values decreased significantly during 4-year ETV treatment in HBeAg-negative CHB patients indicating that these noninvasive fibrosis tests might be useful for monitoring improvement of liver fibrosis and assessing treatment efficacy during long-term ETV treatment. Key words: Chronic hepatitis B; Liver fibrosis; Entecavir; FIB-4