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Keywords:

  • alanine aminotransferase;
  • antiviral therapy;
  • HBV DNA;
  • HBsAg;
  • liver stiffness measurement

Abstract

Background and Aims

The European Association for the Study of the Liver (EASL) defines the inactive hepatitis B virus (HBV) carrier state based on HBV DNA and alanine aminotransferase (ALT) levels. This study aimed to evaluate the risk of disease progression in such patients.

Methods

Three hundred sixty-one patients negative for hepatitis B e antigen (HBeAg) with HBV DNA levels < 20 000 IU/mL and normal ALT and without advanced fibrosis at baseline underwent liver stiffness measurement (LSM) by transient elastography between 2006 and 2008 and again between 2010 and 2012. Liver fibrosis progression was defined as an increase in LSM by 30% or more at the second assessment to levels suggestive of advanced fibrosis.

Results

At baseline, the mean age was 48 ± 11 years and 51% were males; ALT level was 28 ± 11 IU/L, HBV DNA level was 2.7 ± 1.0 log10 IU/mL, and LSM was 5.4 ± 1.5 kPa. After an interval of 44 ± 7 months, liver fibrosis progression was observed in 10 (2.8%) patients, and 49 (13.6%) started antiviral therapy. Gender, age, and levels of ALT, HBV DNA, and HBsAg were shown not to be associated with liver fibrosis progression. Among 244 patients with baseline HBV DNA < 2000 IU/mL, 2.9% had liver fibrosis progression, 8.2% started antiviral therapy, and 4.1% had HBV DNA ≥ 20 000 IU/mL during follow-up. Corresponding figures in 117 patients with baseline HBV DNA levels of 2000–20 000 IU/mL were 2.6%, 24.8%, and 7.7%, respectively (P = 1.0, < 0.001 and = 0.21 respectively).

Conclusions

Liver fibrosis progression within 3–4 years is rare in HBeAg-negative patients with HBV DNA <20 000 IU/mL and normal ALT, but a significant proportion of patients develop treatment indications during follow-up. The study supports the EASL's definition of inactive carriers and its recommendation of regular monitoring.