Regression of liver fibrosis after HBsAg loss: a prospective matched case-control evaluation using transient elastography and serum Enhanced Liver Fibrosis (ELF) test

Abstract

Background: We assessed the effect of hepatitis B surface antigen (HBsAg) seroclearance on liver fibrosis regression in patients with chronic hepatitis B (CHB). Method: CHB patients with recent spontaneous HBsAg seroclearance (cases) were age- and gender-matched with treatment-naïve HBeAg-negative CHB infection (controls). Paired transient elastography (TE) and Enhanced Liver Fibrosis (ELF) measurements were performed at baseline and 3-year. Fibrosis progression and regression were defined as increase and decrease in ≥ 1 fibrosis stage, respectively. Results: In this interim analysis, 40 cases and 142 controls were recruited [median age 55.6 (interquartile range IQR 49.8–60.9), 53.8% male]. The median liver stiffness (LS) values were similar between the two groups at baseline (5.4 vs. 5.2 kPa, p = 0.765) and at 3-years (5.9 vs. 5.5 kPa, p = 0.455) respectively. The baseline controlled attenuation parameter values were significantly higher in cases vs controls (288 vs 251 dB/m, respectively, p = 0.001). The median ELF at 3-year was significantly higher than baseline in the controls (8.6 vs. 8.4, p = 0.033). All patients with severe steatosis had significantly higher baseline LS (5.9 vs. 4.8 kPa; p < 0.001), 3-year LS (6.4 vs 5.2 kPa; p < 0.001), and baseline ELF (8.8 vs. 8.3, p = 0.028). The proportion of patients with fibrosis progression (25.6% vs. 15.5%, respectively, p = 0.111) and regression (10.3% vs. 14.8%, p = 0.604) was similar in cases vs controls. Conclusion: Over a period of 3 years, fibrosis regression and progression were observed at a similar rate in patients with HBsAg seroclearance compared to patients with inactive CHB. Severe hepatic steatosis was associated with higher LS and ELF.