Monitoring

In patients who don’t meet the local criteria for treatment with antiviral therapy, the aim of monitoring is to identify a change in clinical status that indicates progression to disease state that requires treatment. The aim of monitoring in those who have received antiviral therapy is to evaluate treatment response, side effects, and disease progression or reactivation.[2][38]​​​​​​[171]

The following recommendations are based on American Association for the Study of Liver Diseases guidelines and European Association for the Study of the Liver guidelines.[2][38]​ Local guidelines for monitoring may vary.

Patients not currently on treatment

  • Immune-tolerant chronic hepatitis B virus (HBV) infection (hepatitis B e antigen [HBeAg]-positive, high HBV DNA, and persistently normal alanine aminotransferase [ALT] level): monitor ALT every 3-6 months. Monitor more frequently, along with HBV DNA levels, if ALT level becomes elevated. Check HBeAg status every 6-12 months. Consider starting antiviral treatment in patients with compensated liver disease who remain HBeAg-positive with HBV DNA levels >20,000 IU/mL; after a 3-6 month period of elevated ALT levels greater than 2 times the upper limit of normal. Consider liver biopsy (or alternative non-invasive tests) in patients with persistent borderline normal, or slightly elevated, ALT levels, particularly in patients >40 years of age who have been infected from a young age. Initiate antiviral therapy in patients with moderate to severe inflammation and/or fibrosis.

  • Immune-inactive chronic HBV infection (HBeAg-negative, normal ALT, and HBV DNA <2000 IU/mL): monitor ALT and HBV DNA levels every 3 months during the first year to confirm patient is in the inactive phase, then every 6-12 months thereafter. Monitor more frequently (i.e., every 3-6 months) if ALT level becomes elevated. If ALT elevation is persistent or recurrent, evaluate the patient for other causes of liver disease. If HBV DNA is >2000 IU/mL, assess disease severity with liver biopsy (or non-invasive methods), and initiate treatment in patients with moderate to severe inflammation or significant fibrosis. Evaluate for HBsAg loss annually.

  • Resolved chronic HBV infection: includes patients who have achieved hepatitis B surface antigen (HBsAg) loss spontaneously or with therapy (also known as functional cure). Routine monitoring of ALT and HBV DNA are not required. However, surveillance for hepatocellular carcinoma (HCC) should continue if the person has cirrhosis, a first-degree family member with HCC, or a long duration of infection (i.e., >40 years for males and >50 years for females who have been infected from a young age).

Patients on treatment

  • Nucleoside/nucleotide analogues: perform FBC, hepatic panel, renal function, and HBV DNA tests at baseline and regularly during treatment. Monitor hepatic panel every 3-4 months during the first year, and every 6 months thereafter. Monitor HBV DNA every 3-4 months during the first year, and every 6-12 months thereafter. Check HBsAg status annually. Monitor lactic acid levels if there is a clinical concern for lactic acidosis (i.e., with use of entecavir or tenofovir in patients with decompensated cirrhosis). Consider bone density study at baseline and during treatment if the patient has a history of fracture or risks for osteopenia (tenofovir disoproxil).

  • Peginterferon: monitor full blood count (FBC) every 1-3 months, thyroid-stimulating hormone every 3 months, and hepatic panel every month. Check HBV DNA levels and HBsAg status (as well as HBeAg and antibody to HBeAg in HBeAg-positive patients) at 3, 6, and 12 months during treatment, and at 6 and 12 months after treatment. Monitor patients for development of neuropsychiatric, autoimmune, ischaemic, and infectious complications.

Screening for HCC

  • Treatment with antivirals does not eliminate the risk of HCC and surveillance for HCC should continue. All HBsAg-positive patients with cirrhosis or at high risk for HCC (e.g., Asian or black men aged >40 years, Asian women aged >50 years, people with a first-degree family member with a history of HCC, people with hepatitis D infection) should be screened with an abdominal ultrasound, with or without alpha-fetoprotein (AFP), every 6 months. In areas where ultrasound is not readily available, screen with AFP every 6 months.

Patients who come off long-term tenofovir disoproxil treatment can remain in a low replicative state (i.e., low HBV DNA and normal ALT), but there is approximately a 30% risk of ALT elevation, so patients should be closely monitored.[172]

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