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Management of Hepatitis B Infection

Stefan Zeuzem, MD
Program Director
Harry L. A. Janssen, MD, PhD
Milan J. Sonneveld, MD, PhD, MSc
Released: June 17, 2019

Treatment Indications for Chronic HBV Infection

The guidelines from the AASLD[3] and the Asian-Pacific Association for the Study of the Liver (APASL)[9] 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.[3] By contrast, the APASL guidelines recommend using a conventional ALT level of 40 IU/mL.[9]

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.[3]

According to the 2017 HBV guidelines from the EASL, antiviral therapy is indicated as follows (Table 1).[4]

  • HBeAg-positive or HBeAg-negative disease with HBV DNA > 2000 IU/mL, ALT > ULN (~ 40 IU/mL) and/or at least moderate liver necroinflammation or fibrosis
  • Compensated or decompensated cirrhosis with any detectable HBV DNA level, regardless of ALT level
  • HBV DNA > 20,000 IU/mL and ALT > 2 x ULN, regardless of fibrosis score
  • HBeAg-positive disease, defined by persistently normal ALT and high HBV DNA levels; may treat if older than 30 years of age regardless of liver histology
  • HBeAg-positive or HBeAg-negative disease with family history of HCC or cirrhosis and extrahepatic manifestations; can be treated even if standard treatment indications not fulfilled

Table 1. Treatment Criteria for Chronic HBV Infection: Comparison of Guidelines

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