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The guidelines from the AASLD and the Asian-Pacific Association for the Study of the Liver (APASL) advocate treatment for patients with HBeAg-positive chronic HBV infection with serum HBV DNA levels ≥ 20,000 IU/mL and persistently elevated alanine aminotransferase (ALT) levels (≥ 2 times the upper limit of normal [ULN] over a 3- to 6-month period) or, as noted by the APASL guidelines, if there is moderate to severe inflammation or significant fibrosis (Table 1). In the AASLD guidelines, normal ALT levels have been established at 35 U/L for men and 25 U/L for women. By contrast, the APASL guidelines recommend using a conventional ALT level of 40 IU/mL.
According to the AASLD and APASL guidelines, therapy is recommended for HBeAg-negative patients with HBV DNA ≥ 2000 IU/mL and ALT ≥ 2 x ULN or significant histological disease and for all patients with HBV DNA > 2000 IU/mL and cirrhosis, regardless of ALT level.[3,9] However, the guidelines note that for patients with ALT > ULN but < 2 x ULN, deciding whether or not to treat should involve consideration of liver disease severity. Other factors to consider in this setting include patient age, family history of hepatocellular carcinoma (HCC), presence of extrahepatic HBV manifestations (in which case treatment is indicated regardless of liver disease severity), and previous treatment history. In addition, the AASLD advises that recommended HBV DNA thresholds be considered as sufficient, but not essential, requirements for treatment candidacy.
According to the 2017 HBV guidelines from the EASL, antiviral therapy is indicated as follows (Table 1).
Table 1. Treatment Criteria for Chronic HBV Infection: Comparison of Guidelines