VHL logo
BIGG Rec logo
Guideline

Guidelines for the prevention, diagnosis, care and treatment for people with chronic hepatitis B infection.

Year of Publication
2024
Issuing Institution
WHO
Links
DOI,WHO IRIS

Recommendations

38 included recommendations

Non-invasive assessment of liver disease stage at baseline and during follow-up. Thresholds to establish the presence of significant fibrosis (≥F2) or cirrhosis (F4) in adults. Evidence of significant fibrosis (≥F2) should be based on an APRI score of >0.5 or transient elastography value of >7.0 kPa, and cirrhosis (F4) should be based on clinical criteria (or an APRI score of >1.0 or transient elastography (FibroScan®) value of >12.5 kPa ). These cut-offs apply to FibroScan® – other elastography techniques do not necessarily have the same cut-offs. Clinical features of decompensated cirrhosis: portal hypertension (ascites, variceal haemorrhage and hepatic encephalopathy), coagulopathy, or liver insufficiency (jaundice). Other clinical features of advanced liver disease/cirrhosis may include: hepatomegaly, splenomegaly, pruritus, fatigue, arthralgia, palmar erythema or oedema.

Status
New

Recommended in favor

Strong

Non-invasive assessment of liver disease stage at baseline and during follow-up. Thresholds to establish the presence of significant fibrosis (≥F2) or cirrhosis (F4) in adolescents. Evidence of significant fibrosis (≥F2) should be based on an APRI score of >0.5 or transient elastography value of >7.0 kPa, and cirrhosis (F4) should be based on clinical criteria (or an APRI score of >1.0 or transient elastography (FibroScan®) value of >12.5 kPa ). These cut-offs apply to FibroScan® – other elastography techniques do not necessarily have the same cut-offs. Clinical features of decompensated cirrhosis: portal hypertension (ascites, variceal haemorrhage and hepatic encephalopathy), coagulopathy, or liver insufficiency (jaundice). Other clinical features of advanced liver disease/cirrhosis may include: hepatomegaly, splenomegaly, pruritus, fatigue, arthralgia, palmar erythema or oedema.

Status
New

Recommended in favor

Strong

Treatment is recommended for all adults with chronic hepatitis B (CHB) (including pregnant women and girls and women of reproductive age) with presence of coinfections (such as HIV, hepatitis D or hepatitis C); family history of liver cancer or cirrhosis; immune suppression (such as long-term steroid use, solid organ or stem cell transplant); comorbidities (such as diabetes or metabolic dysfunction–associated steatotic liver disease); or extrahepatic manifestations (such as glomerulonephritis or vasculitis), regardless of the APRI score or HBV DNA or ALT levels

Status
New

Recommended in favor

Strong

Treatment is recommended for all adolescents (aged ≥12 years) with chronic hepatitis B (CHB) (including pregnant women and girls and women of reproductive age) with presence of coinfections (such as HIV, hepatitis D or hepatitis C); family history of liver cancer or cirrhosis; immune suppression (such as long-term steroid use, solid organ or stem cell transplant); comorbidities (such as diabetes or metabolic dysfunction–associated steatotic liver disease); or extrahepatic manifestations (such as glomerulonephritis or vasculitis), regardless of the APRI score or HBV DNA or ALT levels

Status
New

Recommended in favor

Conditional

First-line antiviral therapies for chronic hepatitis B. For all adults, adolescents and children (two years or older) for whom antiviral therapy is indicated, the nucleos(t)ide analogues that have a high genetic barrier to drug resistance – tenofovir disoproxil fumarate (TDF) or entecavir (ETV) are recommended as preferred regimens. TDF + lamivudine (3TC) or TDF + emtricitabine (FTC) are recommended as alternative regimens (where TDF monotherapy is not available).

Status
Updated

Recommended in favor

Strong

Antiviral prophylaxis among pregnant women and adolescent girls. In settings where HBV DNA or HBeAg testing is available, prophylaxis with tenofovir disoproxil fumarate (TDF) is recommended for all HBV-positive (HBsAg-positive) pregnant women with HBV DNA ≥200 000 IU/mL or positive HBeAg (preferably from the second trimester of pregnancy until at least delivery or completion of the infant HBV vaccination series), to prevent the mother-to-child transmission (MTCT) of HBV.

Status
Updated

Recommended in favor

Strong

Second-line antiviral (for chronic hepatitis B infection) therapies for managing treatment failure. Among people with evidence of treatment failure due to confirmed or suspected antiviral resistance (based on history of previous exposure or primary non-response) to lamivudine, entecavir, adefovir or telbivudine, switching to tenofovir disoproxil fumarate is recommended. Tenofovir alafenamide may be considered as an alternate regimen, if available

Status
Maintained

Recommended in favor

Strong

Where available, Reflex HBV DNA testing (for chronic hepatitis B infection) for those testing positive on HBsAg may be used as an additional strategy to promote linkage to care and treatment. This can be achieved through either laboratory-based reflex HBV DNA testing using a sample already held in the laboratory or clinic-based reflex testing in a health-care facility through immediate sample collection following a positive HBsAg rapid diagnostic test (RDT).

Status
New

Recommended in favor

Conditional

In settings in which a universal anti-HDV antibody testing approach is not feasible because laboratory capacity or other resources are limited, testing for anti-HDV may be given priority in specific populations of HBsAg-positive individuals, including the following: • people born in HDV-endemic countries, regions and areas; • people with advanced liver disease, those receiving HBV treatment and those with features suggesting HDV infection (such as low HBV DNA with high ALT levels); and • people considered to have increased risk of HDV infection, including haemodialysis recipients, people living with hepatitis C or HIV, people who inject drugs, sex workers and men who have sex with men

Status
New

Recommended in favor

Conditional

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.

Status
Maintained

Recommended in favor

Strong

Monitoring for treatment response among people with chronic hepatitis B infection receiving treatment or not yet receiving treatment. More frequent on-treatment monitoring (every 3–6 months for the first year) may be performed for: people with more advanced disease (compensated or decompensated cirrhosis); during the first year of treatment to assess treatment response and adherence; where treatment adherence is a concern; in HIV-coinfected people; and for people with renal impairment.

Status
Maintained

Recommended in favor

Conditional

Monitoring for people not yet receiving treatment (for chronic hepatitis B infection). People who do not currently meet the criteria for antiviral therapy (persistently normal serum aminotransferase results and HBV DNA levels below 2000 IU/mL (when HBV DNA testing is available) or who have expressed a desire to defer treatment may be monitored annually for disease progression and ALT and HBV DNA levels (when HBV DNA testing is available)

Status
Maintained

Recommended in favor

Conditional

Antiviral therapy (for people with chronic hepatitis B infection) is lifelong. Discontinuation of nucleos(t)ide analogue therapy may be considered exceptionally for: • people without clinical evidence of cirrhosis (or based on a noninvasive test score – APRI or transient elastography – suggesting advanced fibrosis); and • who can be followed carefully after discontinuation and long term for reactivation; and • if there is evidence of HBeAg loss and seroconversion to anti-HBe (for people initially HBeAg-positive) and after completion of at least one additional year of treatmen ; and • in association with persistently normal ALT levelsb and persistently undetectable HBV DNA levels (if HBV DNA testing is available). If HBV DNA testing is not available: discontinuing nucleos(t)ide analogue therapy may be considered for people who have evidence of persistent HBsAg loss and after completion of at least one additional year of treatment, regardless of previous HBeAg status.

Status
Maintained

Recommended in favor

Conditional

WHO TO TEST FOR CHRONIC HBV INFECTION. In settings with a ≥2% or ≥5% HBsAg seroprevalence in the general population, it is recommended that all adults have routine access to and be offered HBsAg serological testing with linkage to prevention, care and treatment services. General population testing approaches should make use of existing community or health facility-based testing opportunities or programmes such as at antenatal clinics, HIV or TB clinics

Status
Maintained

Recommended in favor

Conditional

In all settings (and regardless of whether delivered through facility- or community based testing), it is recommended that HBsAg serological testing and linkage to care and treatment services be offered to the following individuals: • Adults and adolescents from populations most affected by HBV infection (i.e. who are either part of a population with high HBV seroprevalence or who have a history of exposure and/or high-risk behaviours for HBV infection); • Adults, adolescents and children with a clinical suspicion of chronic viral hepatitis (i.e. symptoms, signs, laboratory markers); • Sexual partners, children and other family members, and close household contacts of those with HBV infection; • Health-care workers: in all settings, it is recommended that HBsAg serological testing be offered and hepatitis B vaccination given to all health-care workers who have not been vaccinated previously (adapted from existing guidance on hepatitis B vaccination)

Status
Maintained

Recommended in favor

Strong

For the diagnosis of chronic HBV infection in adults, adolescents and children (>12 months of age), a serological assay (in either rapid diagnostic tests or laboratory-based immunoassay format) that meets minimum quality, safety and performance standards (with regard to both analytical and clinical sensitivity and specificity) is recommended to detect hepatitis B surface antigen (HBsAg). - In settings where existing laboratory testing is already available and accessible, laboratory-based immunoassays are recommended as the preferred assay format. - In settings where there is limited access to laboratory testing and/or in populations where access to rapid testing would facilitate linkage to care and treatment, use of rapid diagnostic tests (RDTs) is recommended to improve access.

Status
Maintained

Recommended in favor

Strong

In settings or populations with an HBsAg seroprevalence of ≥0.4%, a single serological assay for detection of HBsAg is recommended, prior to further evaluation for HBV DNA and staging of liver disease. In settings or populations with a low HBsAg seroprevalence of <0.4%, confirmation of HBsAg positivity on the same immunoassay with a neutralization step or a second different rapid diagnostic test (RDT) assay for detection of HBsAg may be considered.

Status
Maintained

Recommended in favor

Conditional