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Abstract Details
Very low probability of significant liver inflammation in chronic hepatitis B patients with low ALT levels in the absence of liver fibrosis
Milan J Sonneveld1, Willem P Brouwer1, Bettina E Hansen2, Henry L-Y Chan3, Teerha Piratvisuth4, Ji-Dong Jia5, Stefan Zeuzem6, Rong-Nan Chien7, Hannah Choi2, Robert J de Knegt1, Cynthia Wat8, Vedran Pavlovic8, Anuj Gaggar9, Qing Xie10, Maria Buti11, Robert A de Man1, Harry L A Janssen12, SONIC-B Study Group
Author information
1Rotterdam, The Netherlands.
2Toronto, Canada.
3Hong Kong SAR, China.
4Hat Yai, Thailand.
5Beijing, China.
6Frankfurt, Germany.
7Taipei, Taiwan.
8Welwyn Garden City, UK.
9Foster City, CA, USA.
10Shanghai, China.
11Barcelona, Spain.
Abstract
Background: Guidelines recommend liver biopsy to rule out significant inflammatory activity in chronic hepatitis B (CHB) patients with elevated hepatitis B virus (HBV) DNA but without other indications for treatment.
Aim: To study rates and determinants of clinically significant liver inflammation.
Methods: We selected patients with HBV DNA > 2000 IU/mL from the SONIC-B database. The presence of significant inflammation (METAVIR ≥ A2 or HAI ≥ 9) was assessed by liver biopsy and correlated with alanine aminotransferase (ALT) levels (according to AASLD upper limits of normal [ULN]) and stratified by the presence of significant liver fibrosis (Ishak ≥ 3 or METAVIR ≥ F2).
Results: The cohort included 2991 patients; 1672 were HBeAg-positive. ALT was < ULN in 270 (9%), 1-2 times ULN in 852 (29%) and > 2 times ULN in 1869 (63%). Significant fibrosis was found in 1419 (47%) and significant inflammatory activity in 630 (21%). Significant inflammatory activity was found in 34% of patients with liver fibrosis, compared to 9.5% of those without (P < 0.001). Among patients without fibrosis, significant inflammatory activity was detected in 3.6% of those with normal ALT, 5.0% of those with ALT 1-2 times ULN and in 13% of those with ALT > 2 times ULN (P < 0.001). ALT < 2 times ULN had a negative predictive value of 95% for ruling out significant inflammatory activity among patients without liver fibrosis.
Conclusions: Among patients without significant fibrosis, an ALT level < 2 times ULN is associated with < 5% probability of significant inflammatory activity. If fibrosis can be ruled out using non-invasive methods, liver biopsy solely to assess inflammatory activity should be discouraged.