Bibliographic information

GuidelineGuidelines for the prevention, diagnosis, care and treatment for people with chronic hepatitis B infection.
Year of Publication2024
Issuing InstitutionWHO

Recommendation

Maintained

For people receiving treatment (for chronic hepatitis B infection), the following are recommended to be monitored at least annually:• non-invasive tests (APRI score or transient elastography) to assess stage of disease and progression of fibrosis or cirrhosis; and • ALT levels (and AST for APRI), HBV DNA levels (when HBV DNA testing is available), HBsAg and HBeAg/anti-Hbe; • Treatment adherenced should be monitored regularly and at each visit.

Recommended in favor

Strong

Notes and Remarks

a ALT levels fluctuate among people with CHB, and longitudinal monitoring is required to determine the trend. The ULN for ALT has been defined as below 30 U/L for men and boys and 19 U/L for women and girls. Persistently abnormal or normal may be defined as two ALT determinations above or below the ULN at unspecified intervals during a 6- to 12-month period or predefined intervals during a 12-month period. b Among people receiving treatment, monitor for HBsAg loss (although this occurs rarely) and for seroreversion to HBsAg positiv ity after discontinuing treatment. Quantitative HBsAg, if available, can be used to determine whether HBsAg concentrations are declining, or more rarely, seroclearance. c Monitoring of HBeAg and anti-HBe mainly applies to those who are initially HBeAg positive. However, those who have already achieved HBeAg seroconversion and are HBeAg negative and anti-HBe positive may subsequently serorevert. d Decompensated cirrhosis is defined by the development of portal hypertension (ascites, variceal haemorrhage and hepatic encephalopathy), coagulopathy or liver insufficiency (jaundice). Other clinical features of advanced liver disease or cirrhosis may include: hepatomegaly, splenomegaly, pruritus, fatigue, arthralgia, palmar erythema and oedema. Among people receiving treatment The aim of monitoring people receiving treatment is to evaluate the effectiveness of treatment response, treatment adherence, adverse effects of treatment, progression of liver disease and development of HCC. HBV DNA testing is important for monitoring treatment response, even when HBV DNA measurement was not part of initial assessment for treatment eligibility. Very rarely it can indicate the potential for ending treatment. If antiviral therapy is discontinued, liver function should be monitored closely, since severe acute exacerbations of hepatitis have been reported, and antiviral therapy may need to be resumed. Among people who do not meet the criteria for antiviral therapy or want to defer therapy The aim of monitoring in people not on antiviral therapy is to identify an early change in clinical status (levels of HBV DNA or serum ALT or increasing APRI or transient elastography score) that indicates a risk of progressive liver disease and need for antiviral therapy, but before advanced hepatic fibrosis or cirrhosis develops. Monitoring of adherence and completeness of HBV DNA suppression requires periodically measuring HBV DNA levels. There are cost implications to regular ALT and HBV DNA monitoring for those receiving treatment or who do not yet meet criteria for treatment.

  • The introduction of multi-disease testing platforms, both high-throughput laboratory-based and POC devices, represents an additional opportunity for integration that may further expand access and achieve significant system efficiency and cost savings.
  • There is potential for adopting differentiated care models with primary or community care and nurse-led services for people with stable disease receiving treatment and specialist referral and care for people with advanced disease and cirrhosis.
  • Additional training of health-care workers will be required for interpreting laboratory results and decision-making, especially when non-specialist physicians or nurses provide care and follow-up (see Chapter 15).

Also Featured In

This recommendation also appears in the following guidelines:

Originally Developed
Guideline

Guidelines for the prevention, care and treatment of persons with chronic hepatitis B infection

Year2015
InstitutionWorld Health Organization
Guideline

WHO guidelines on hepatitis B and C testing.

Year2017
InstitutionWHO