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Background Chronic hepatitis B ( CHB) may lead to cirrhosis, hepatocellular carcinoma and premature death. Elevated alanine transaminase ( ALT) levels ≥ the upper limit of normal ( ULN) are a major determinant for initiating anti-viral therapy; however, ALT levels alone may not be predictive of hepatic fibrosis. Aim To determine the proportion of CHB patients with ALT ≤40 IU/L and liver fibrosis stage ≥2. Secondary goals include subgroup analysis by hepatitis B e antigen ( HBeAg) status, high hepatitis B virus ( HBV) DNA levels, Asian ethnicity, lower ULN of ≤30 IU/L (males) and 19 IU/L (females), and advanced age. Methods Studies identified in EMBASE and MEDLINE (1/1990-6/2012) using the search criteria: 'Hepatitis B'[Mesh] OR 'Hepatitis B virus'[Mesh] OR 'Hepatitis B, Chronic'[Mesh])) AND 'Alanine Transaminase'[Mesh]) and abstracts containing the term 'hepatitis' from recent major U.S. gastroenterology and liver society meetings were considered. Results Among nine studies ( N = 830 patients), a significant proportion (20.7%; 95% CI: 16.2-26.0%) of CHB patients with ALT levels ≤40 IU/L had significant fibrosis irrespective of HBeAg status, high HBV DNA levels, ethnicity or age, although this proportion may be higher in patients older than 30-40 years old. The corresponding proportion was 27.8% even when the newer ULN of 30 IU/L (males) and 19 IU/L (females) was applied. Conclusions Approximately one fifth of CHB patients with ALT ≤40 IU/L may have significant hepatic fibrosis. The approach to such patients should be individualised, as further evaluation and treatment may be appropriate. [ABSTRACT FROM AUTHOR]