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Hepatitis B (chronic)

About

What is covered

This pathway covers the diagnosis and management of chronic hepatitis B in children, young people and adults.
Chronic hepatitis B describes a spectrum of disease usually characterised by the presence of detectable hepatitis B surface antigen (HBsAg) in the blood or serum for longer than 6 months. In some people, chronic hepatitis B is inactive and does not present significant health problems, but others may progress to liver fibrosis, cirrhosis and hepatocellular carcinoma (HCC). The progression of liver disease is associated with hepatitis B virus (HBV) DNA levels in the blood. Without antiviral treatment, the 5-year cumulative incidence of cirrhosis ranges from 8 to 20%. People with cirrhosis face a significant risk of decompensated liver disease if they remain untreated. Five-year survival rates among people with untreated decompensated cirrhosis can be as low as 15%. Chronic hepatitis B can be divided into e antigen-(HBeAg) positive or HBeAg-negative disease based on the presence or absence of e antigen. The presence of HBeAg is typically associated with higher rates of viral replication and therefore increased infectivity.
The goal of treatment for chronic hepatitis B is to prevent cirrhosis, HCC and liver failure. In clinical practice surrogate markers are used to monitor progression of disease and treatment response, and include normalisation of serum alanine aminotransferase (ALT) levels, decrease in inflammation scores with no worsening or improvement in fibrosis on liver biopsies, suppression of serum HBV DNA to undetectable levels, loss of HBeAg and seroconversion to HBe antibody (anti-HBe), and loss of HBsAg and seroconversion to HBs antibody (anti-HBs).
Antiviral therapy suppresses HBV replication and decreases hepatic inflammation and fibrosis, thereby reducing the likelihood of serious clinical disease. Since the introduction of effective treatment in the form of interferon alfa, several nucleoside and nucleotide analogues are now approved for use in adults with chronic hepatitis B, together with a pegylated form of interferon alfa. With multiple treatment options that are efficacious and safe, the key questions are which patients need immediate treatment and what sequence and combination of drug regimens should be used, and which patients can be monitored and delay treatment.
In this pathway we cover the following:
  • information needs of people with chronic hepatitis B and their carers
  • where children, young people and adults with chronic hepatitis B should be assessed
  • assessment of liver disease, including the use of non-invasive tests and genotype testing
  • criteria for offering antiviral treatment
  • the efficacy, safety and cost effectiveness of currently available treatments
  • selection of first-line therapy
  • management of treatment failure or drug resistance
  • whether there is a role for combination therapy
  • when it is possible to stop treatment
  • managing the care of pregnant and breastfeeding women and prevention of vertical transmission
  • prophylactic treatment during immunosuppressive therapy
  • monitoring for treatment response, severity of fibrosis and development of hepatocellular carcinoma.
In this pathway, children and young people are defined as aged up to 18 years. Please follow recommendations on pregnancy for young people with chronic hepatitis B who are pregnant.

Co-infection with hepatitis C, hepatitis D or HIV

This pathway describes management of hepatitis B mono-infection. Management of co-infection with hepatitis C, hepatitis D or HIV will differ. Specific recommendations for hepatitis C or hepatitis D co-infection in adults can be found in treatment options for hepatitis C or hepatitis D co-infection in this pathway.

Updates

Updates to this pathway

22 September 2015 Virtual Touch Quantification to diagnose and monitor liver fibrosis in chronic hepatitis B and C (NICE medical technology guidance 27) added to assessment in children and young people and assessment in adults.
24 March 2015 Rifaximin for preventing episodes of overt hepatic encephalopathy (NICE technology appraisal guidance 337) added to hepatic encephalopathy.
12 August 2014 Hepatitis B: support for commissioning added.
28 July 2014 Hepatitis B quality standard (QS65) added.
9 January 2014 A correction has been made to the units used for abnormal alanine aminotransferase (ALT) in men and women. The abnormal ALT levels should read greater than or equal to 30 IU/L for males and greater than or equal to 19 IU/L for females, not IU/ml. This has been changed in the Assessment in children and young people, Transient elastography score below 6 kPa, Children and young people, Adults with HBeAg-positive immune-tolerant disease, Adults with inactive chronic hepatitis B, and Treatment in children and young people with compensated liver disease nodes.

Your responsibility

Guidelines

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients or service users. The application of the recommendations in this interactive flowchart is not mandatory and does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Local commissioners and/or providers have a responsibility to enable the interactive flowchart to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this interactive flowchart should be interpreted in a way that would be inconsistent with compliance with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Technology appraisals

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this interactive flowchart is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Commissioners and/or providers have a responsibility to provide the funding required to enable the recommendations to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Medical technologies guidance, diagnostics guidance and interventional procedures guidance

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take these recommendations fully into account. However, the interactive flowchart does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Commissioners and/or providers have a responsibility to implement the recommendations, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this interactive flowchart should be interpreted in a way that would be inconsistent with compliance with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Person-centred care

People have the right to be involved in discussions and make informed decisions about their care, as described in your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Short Text

Diagnosis and management of chronic hepatitis B in children, young people and adults

What is covered

This pathway covers the diagnosis and management of chronic hepatitis B in children, young people and adults.
Chronic hepatitis B describes a spectrum of disease usually characterised by the presence of detectable hepatitis B surface antigen (HBsAg) in the blood or serum for longer than 6 months. In some people, chronic hepatitis B is inactive and does not present significant health problems, but others may progress to liver fibrosis, cirrhosis and hepatocellular carcinoma (HCC). The progression of liver disease is associated with hepatitis B virus (HBV) DNA levels in the blood. Without antiviral treatment, the 5-year cumulative incidence of cirrhosis ranges from 8 to 20%. People with cirrhosis face a significant risk of decompensated liver disease if they remain untreated. Five-year survival rates among people with untreated decompensated cirrhosis can be as low as 15%. Chronic hepatitis B can be divided into e antigen-(HBeAg) positive or HBeAg-negative disease based on the presence or absence of e antigen. The presence of HBeAg is typically associated with higher rates of viral replication and therefore increased infectivity.
The goal of treatment for chronic hepatitis B is to prevent cirrhosis, HCC and liver failure. In clinical practice surrogate markers are used to monitor progression of disease and treatment response, and include normalisation of serum alanine aminotransferase (ALT) levels, decrease in inflammation scores with no worsening or improvement in fibrosis on liver biopsies, suppression of serum HBV DNA to undetectable levels, loss of HBeAg and seroconversion to HBe antibody (anti-HBe), and loss of HBsAg and seroconversion to HBs antibody (anti-HBs).
Antiviral therapy suppresses HBV replication and decreases hepatic inflammation and fibrosis, thereby reducing the likelihood of serious clinical disease. Since the introduction of effective treatment in the form of interferon alfa, several nucleoside and nucleotide analogues are now approved for use in adults with chronic hepatitis B, together with a pegylated form of interferon alfa. With multiple treatment options that are efficacious and safe, the key questions are which patients need immediate treatment and what sequence and combination of drug regimens should be used, and which patients can be monitored and delay treatment.
In this pathway we cover the following:
  • information needs of people with chronic hepatitis B and their carers
  • where children, young people and adults with chronic hepatitis B should be assessed
  • assessment of liver disease, including the use of non-invasive tests and genotype testing
  • criteria for offering antiviral treatment
  • the efficacy, safety and cost effectiveness of currently available treatments
  • selection of first-line therapy
  • management of treatment failure or drug resistance
  • whether there is a role for combination therapy
  • when it is possible to stop treatment
  • managing the care of pregnant and breastfeeding women and prevention of vertical transmission
  • prophylactic treatment during immunosuppressive therapy
  • monitoring for treatment response, severity of fibrosis and development of hepatocellular carcinoma.
In this pathway, children and young people are defined as aged up to 18 years. Please follow recommendations on pregnancy for young people with chronic hepatitis B who are pregnant.

Co-infection with hepatitis C, hepatitis D or HIV

This pathway describes management of hepatitis B mono-infection. Management of co-infection with hepatitis C, hepatitis D or HIV will differ. Specific recommendations for hepatitis C or hepatitis D co-infection in adults can be found in treatment options for hepatitis C or hepatitis D co-infection in this pathway.

Updates

Updates to this pathway

22 September 2015 Virtual Touch Quantification to diagnose and monitor liver fibrosis in chronic hepatitis B and C (NICE medical technology guidance 27) added to assessment in children and young people and assessment in adults.
24 March 2015 Rifaximin for preventing episodes of overt hepatic encephalopathy (NICE technology appraisal guidance 337) added to hepatic encephalopathy.
12 August 2014 Hepatitis B: support for commissioning added.
28 July 2014 Hepatitis B quality standard (QS65) added.
9 January 2014 A correction has been made to the units used for abnormal alanine aminotransferase (ALT) in men and women. The abnormal ALT levels should read greater than or equal to 30 IU/L for males and greater than or equal to 19 IU/L for females, not IU/ml. This has been changed in the Assessment in children and young people, Transient elastography score below 6 kPa, Children and young people, Adults with HBeAg-positive immune-tolerant disease, Adults with inactive chronic hepatitis B, and Treatment in children and young people with compensated liver disease nodes.

Sources

NICE guidance and other sources used to create this interactive flowchart.
Rifaximin for preventing episodes of overt hepatic encephalopathy (2015) NICE technology appraisal guidance 337
Tenofovir disoproxil fumarate for the treatment of hepatitis B (2009) NICE technology appraisal guidance 173
Telbivudine for the treatment of chronic hepatitis B (2008) NICE technology appraisal guidance 154
Entecavir for the treatment of chronic hepatitis B (2008) NICE technology appraisal guidance 153
Hepatitis B (2014) NICE quality standard 65

Quality standards

Quality statements

Testing and vaccination for hepatitis B

This quality statement is taken from the hepatitis B quality standard. The quality standard defines clinical best practice in hepatitis B care and should be read in full.

Quality statement

People who are at increased risk of hepatitis B infection are offered testing and vaccination.

Rationale

Children, young people and adults who are at increased risk of hepatitis B infection should be offered testing in a range of settings (for example, in GP practices including new registrations, prisons or immigration removal centres, drug services, sexual health and genitourinary medicine clinics) alongside appropriate vaccination. This is essential for ensuring early diagnosis, prompt treatment and prevention of infection.

Quality measures

Structure
Evidence of local arrangements to ensure that people who are at increased risk of hepatitis B infection are offered testing and vaccination.
Data source: Local data collection.
Process
a) Proportion of new GP registrants who belong to a group at increased risk of infection who are offered testing for hepatitis B.
Numerator – the number in the denominator offered testing for hepatitis B.
Denominator – the number of new GP registrants who belong to a group at increased risk of infection.
Data source: Local data collection.
b) Proportion of new GP registrants who test negative for hepatitis B but remain at increased risk of infection who are offered vaccination for hepatitis B.
Numerator – the number in the denominator offered vaccination for hepatitis B.
Denominator – the number of new GP registrants who test negative for hepatitis B but remain at increased risk of infection.
Data source: Local data collection.
c) Proportion of prisoners/immigration detainees who are offered vaccination for hepatitis B when entering prison or an immigration removal centre.
Numerator – the number in the denominator offered vaccination for hepatitis B.
Denominator – the number of prisoners/immigration detainees entering prison or an immigration removal centre.
Data source: Local data collection.
d) Proportion of prisoners/immigration detainees who are offered testing for hepatitis B when entering prison or an immigration removal centre.
Numerator – the number in the denominator offered testing for hepatitis B.
Denominator – the number of prisoners/immigration detainees entering a prison or an immigration removal centre.
Data source: Local data collection.
e) Proportion of prisoners/immigration detainees who are offered testing for hepatitis B during their detention in prison or an immigration removal centre.
Numerator – the number in the denominator offered testing for hepatitis B.
Denominator – the number of prisoners/immigration detainees detained in a prison or an immigration removal centre.
Data source: Local data collection.
f) Proportion of people using drug services who are offered vaccination for hepatitis B.
Numerator – the number in the denominator offered vaccination for hepatitis B.
Denominator – the number of people using drug services.
Data source: Local data collection.
g) Proportion of people using drug services who are offered testing for hepatitis B.
Numerator – the number in the denominator offered testing for hepatitis B.
Denominator – the number of people using drug services.
Data source: Local data collection.
h) Proportion of people at increased risk of infection using sexual health and genitourinary medicine clinics who are offered vaccination for hepatitis B.
Numerator – the number in the denominator offered vaccination for hepatitis B.
Denominator – the number of people at increased risk of infection using sexual health and genitourinary medicine clinics.
Data source: Local data collection.
i) Proportion of people at increased risk of infection using sexual health and genitourinary medicine clinics who are offered testing for hepatitis B.
Numerator – the number in the denominator offered testing for hepatitis B.
Denominator – the number of people at increased risk of infection using sexual health and genitourinary medicine clinics.
Data source: Local data collection.

What the quality statement means for service providers, health and public health practitioners, and commissioners

Service providers (GP practices, prisons and immigration removal centres, drugs services and secondary care providers of sexual health and genitourinary medicine clinics) ensure that testing and vaccination for hepatitis B are offered to people who are at increased risk of infection. This includes dried blood spot testing for hepatitis B in appropriate service settings for people in whom venous access is difficult.
Health and public health practitioners offer hepatitis B testing and vaccination to people at increased risk of infection and ensure pre- and post-test discussions with appropriate information about their risk of infection. Assurance about confidentiality and privacy should also be given. Healthcare professionals ensure that they have received appropriate training and have been assessed as competent for delivering vaccinations, in line with the recommendations in Public Health England’s Immunisation against infectious disease: the green book, chapter 18: Hepatitis B.
Commissioners (local authority commissioners, NHS England area teams and clinical commissioning groups) work with service provider partners to ensure that testing (including dried blood spot testing) and vaccination for hepatitis B are offered to people who are at increased risk of infection.

What the quality statement means for patients, service users and carers

People at increased risk of hepatitis B infection are offered a blood test to check if they have the infection and a vaccination to help prevent infection.

Source guidance

Definitions of terms used in this quality statement

People at increased risk of hepatitis B infection
People at increased risk of hepatitis B infection compared with the general UK population include:
  • People born or brought up in a country with an intermediate or high prevalence (2% or greater) of chronic hepatitis B. This includes all countries in Africa, Asia, the Caribbean, Central and South America, Eastern and Southern Europe, the Middle East and the Pacific islands.
  • Babies born to mothers infected with hepatitis B.
  • People who have ever injected drugs.
  • Men who have sex with men.
  • People who may have been exposed to sexually acquired infection, particularly:
    • people who have had unprotected sex with multiple sexual partners
    • people reporting unprotected sexual contact in areas of intermediate and high prevalence
    • people presenting at sexual health and genitourinary medicine clinics
    • people diagnosed with a sexually transmitted disease
    • commercial sex workers.
  • Looked-after children and young people, including those living in care homes.
  • Prisoners, including young offenders.
  • Immigration detainees.
  • Close contacts (these could include sexual, close friends, family and household) of someone known to be chronically infected with hepatitis B. [Adapted from NICE public health guidance 43, section on Whose health will benefit?]
Testing and vaccination
Testing strategies for hepatitis B should be implemented alongside hepatitis B vaccination in line with Public Health England’s Immunisation against infectious disease: the green book, chapter 18: Hepatitis B in the following settings:
  • GP practices including new registrations.
  • Prison or an immigration removal centre.
  • Drug services.
  • Sexual health and genitourinary medicine clinics. [NICE public health guidance 43, recommendations 4 to 7]

Equality and diversity considerations

The offer of hepatitis B testing in a range of settings should take into account the age and culture of groups at increased risk, and their needs in relation to the format of the information and the language used. Services should be responsive to social and cultural barriers to testing, vaccination and treatment (for example, stigma). Good communication between healthcare professionals, public health practitioners and the people at increased risk of hepatitis B infection is essential.

Referral for specialist care

This quality statement is taken from the hepatitis B quality standard. The quality standard defines clinical best practice in hepatitis B care and should be read in full.

Quality statement

People who test positive for hepatitis B surface antigen (HBsAg) are referred to specialist care for further assessment.

Rationale

Chronic hepatitis B infection affects the liver and can cause serious health problems if left untreated. It is important that people who test positive for HBsAg are referred for specialist care so that they can be assessed for the stage of hepatitis B and for other infections (such as HIV, hepatitis C and hepatitis D). Further assessment in specialist care is essential in determining whether and when to start pharmacological treatment. This statement does not apply to pregnant women who test HBsAg-positive at antenatal screening, which is the focus of quality statement 3.

Quality measures

Structure
Evidence of local arrangements to ensure that people who test positive for HBsAg are referred to specialist care for further assessment.
Data source: Local data collection.

Process

a) Proportion of adults (aged 18 years and over) who test HBsAg positive who are referred to specialist care for further assessment.
Numerator – the number in the denominator who are referred to specialist care for further assessment.
Denominator – the number of adults (aged 18 years and over) who test HBsAg positive.
Data source: Local data collection. NICE Hepatitis B: clinical audit tool – primary care, audit standard 2.
b) Proportion of children and young people (under 18 years) who test HBsAg positive who are referred to specialist care for further assessment.
Numerator – the number in the denominator who are referred to specialist care for further assessment.
Denominator – the number of children and young people (under 18 years) who test HBsAg positive.
Data source: Local data collection. NICE Hepatitis B: clinical audit tool – primary care, audit standard 3.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (GP practices, prisons and immigration removal centres, drug services and secondary care providers of sexual health and genitourinary medicine clinics) ensure that local referral pathways are in place and that people who test positive for HBsAg are referred to specialist care for further assessment.
Healthcare professionals refer people who test HBsAg-positive to specialist care for further assessment.
Commissioners (local authority commissioners, NHS England area teams and clinical commissioning groups) work with providers of testing and vaccination services to ensure that people who test HBsAg-positive are referred to specialist care for further assessment.
Clinical commissioning groups work with partners in secondary care to ensure that specialist services provide further assessment for people who test HBsAg-positive.

What the quality statement means for patients, service users and carers

People who are found to have hepatitis B infection are referred to a specialist for further assessment.

Source guidance

Definitions of terms used in this quality statement

Specialist care
  • Adults who test HBsAg-positive are referred to a hepatologist, or to a gastroenterologist or infectious disease specialist with an interest in hepatology.
  • Children and young people who test HBsAg-positive are referred to a paediatric hepatologist, or to a gastroenterologist or infectious disease specialist with an interest in hepatology. [NICE clinical guideline 165, recommendations 1.2.2 and 1.2.7]

Referral to and assessment by specialist care for pregnant women who are identified as hepatitis B surface antigen-positive at antenatal screening

This quality statement is taken from the hepatitis B quality standard. The quality standard defines clinical best practice in hepatitis B care and should be read in full.

Quality statement

Pregnant women who are identified as hepatitis B surface antigen (HBsAg)-positive at antenatal screening are assessed by a specialist within 6 weeks of receiving the screening test result.

Rationale

Specialist assessment within 6 weeks of receiving the screening test result is important to allow antiviral treatment (tenofovir) in the third trimester if needed to reduce the risk of the baby becoming infected with hepatitis B.

Quality measures

Structure
Evidence of local arrangements to ensure that pregnant women who are identified as being HBsAg-positive at antenatal screening are assessed by a specialist within 6 weeks of receiving the screening test result.
Data source: Local data collection.
Process
Proportion of pregnant women who are identified as being HBsAg-positive at antenatal screening who are assessed by a specialist within 6 weeks of receiving the screening test result.
Numerator – the number in the denominator who are assessed by a specialist within 6 weeks of receiving the antenatal screening test result.
Denominator – the number of pregnant women who are identified as being HBsAg-positive at antenatal screening.
Data source: UK National Screening Committee Key performance indicators – KPI ID2 (Antenatal infectious disease screening – timely referral of hepatitis B-positive women for specialist assessment).
Outcome
Vertical transmission rates from mother to child.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (antenatal care) ensure that healthcare professionals refer all pregnant women who are identified as being HBsAg-positive at antenatal screening to specialist care.
Hospital-based specialist care demonstrates that pregnant women who are referred for specialist care assessment are assessed by a specialist within 6 weeks of receiving the screening test result.
Healthcare professionals refer pregnant women who are identified as being HBsAg-positive at antenatal screening to a specialist within 6 weeks of receiving the screening test result.
Commissioners (clinical commissioning groups) work with partners in secondary care to ensure that specialist services are available to provide pregnant women who are identified as being HBsAg-positive at antenatal screening with specialist assessment within 6 weeks of receiving the test result.
Clinical commissioning groups and NHS England area teams (screening and immunisation teams) work together to ensure that providers of antenatal care refer pregnant women who are identified as being HBsAg-positive at antenatal screening to a specialist.

What the quality statement means for patients, service users and carers

Pregnant women who are found to have hepatitis B infection during antenatal testing are assessed by a specialist within 6 weeks of receiving the screening test result.

Source guidance

Definitions of terms used in this quality statement

Specialist care assessment
Pregnant women who are identified as HBsAg-positive are seen by a hepatologist, or a gastroenterologist or infectious disease specialist with an interest in hepatology. [NICE clinical guideline 165, recommendation 1.2.4]
Equality and diversity considerations
Pregnant women with complex social needs may be less likely to access or maintain contact with antenatal care services. Examples of women with complex social needs include, but are not limited to, women who:
  • have a history of substance misuse (alcohol and/or drugs)
  • ave recently arrived as a migrant, asylum seeker or refugee
  • have difficulty speaking or understanding English
  • are aged under 20 years
  • have experienced domestic abuse
  • are living in poverty
  • are homeless.
It is therefore appropriate that special consideration is given to these groups of women.

Complete course of neonatal hepatitis B vaccination and blood testing at 12 months

This quality statement is taken from the hepatitis B quality standard. The quality standard defines clinical best practice in hepatitis B care and should be read in full.

Quality statement

Babies born to hepatitis B surface antigen (HBsAg)-positive mothers receive a complete course of hepatitis B vaccination and, at age 12 months, receive a blood test for hepatitis B infection.

Rationale

Hepatitis B infection can be transmitted from mothers with hepatitis B to their babies. Babies who acquire the infection have a very high risk of developing chronic hepatitis B. Vaccination of babies is highly effective in preventing transmission. It is important that the babies of mothers with hepatitis B (whether they are delivered in hospital or at home) are given the first vaccine dose promptly and that the recommended vaccination course is completed at the right time, including, when appropriate, hepatitis B immunoglobulin, in line with Public Health England’s Immunisation against infectious disease: the green book, chapter 18: Hepatitis B.
If vaccinations are delayed or missed, it is more likely that the child will become infected.

Quality measures

Structure
a) Evidence of local commissioning arrangements to ensure that babies born to HBsAg positive mothers are given a complete course of hepatitis B vaccination.
b) Evidence of local arrangements to ensure that there is an identified person responsible for coordinating the local hepatitis B vaccination programme for babies at risk of infection. This person should also be responsible for scheduling vaccinations and follow-up to ensure that babies at risk are vaccinated at the right time.
Data source: Local data collection.
Process
a) Proportion of babies born to HBsAg-positive mothers who receive the complete course of hepatitis B vaccination.
Numerator – the number in the denominator who receive a complete course of hepatitis B vaccination.
Denominator – the number of babies born to HBsAg-positive mothers.
b) Proportion of babies born to HBsAg-positive mothers who receive a blood test for hepatitis B infection at age 12 months.
Numerator – the number in the denominator who receive a blood test for hepatitis B infection.
Denominator – the number of babies at age 12 months born to HBsAg-positive mothers.
Data source: Local data collection. NICE Reducing the differences in the uptake of immunisations: audit support, criterion 3.
Outcome
Vertical transmission rates from mother to child.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (maternity, paediatric, primary care and community support teams) ensure that babies born to HBsAg-positive mothers are given a complete course of hepatitis B vaccination through a coordinated programme that includes an identified person who is responsible for scheduling vaccinations and follow-up to ensure that babies at risk are vaccinated at the right time.
Healthcare professionals give babies born to HBsAg-positive mothers a complete course of hepatitis B vaccination and then, at age 12 months, a blood test for hepatitis B infection.
Commissioners (clinical commissioning groups and NHS England area teams for screening and immunisation) work together to ensure that a coordinated hepatitis B neonatal vaccination programme is in place to vaccinate babies born to HBsAg-positive mothers, which includes scheduling of vaccinations and follow-up to ensure that babies at risk are vaccinated at the right time.

What the quality statement means for patients, service users and carers

Babies born to mothers with hepatitis B infection are given a complete course of hepatitis B vaccinations, and when they are aged 12 months they are given a blood test to check whether they have the infection.

Source guidance

Definitions of terms used in this quality statement

Complete course of hepatitis B vaccination and a blood test for hepatitis B
A complete course consists of an initial dose of vaccine and of hepatitis B immunoglobulin where indicated within 24 hours of birth, with further doses at 1 month, 2 months and 12 months and an additional booster at preschool age. A blood test for HBsAg should be performed at 12 months (at the time of the fourth dose) to check for vaccine failure.
The blood test at age 12 months should be performed regardless of the uptake of the vaccination course. [Public Health England’s Immunisation against infectious disease: the green book, chapter 18: Hepatitis B. Public Health England’s Public health functions to be exercised by NHS England: Neonatal hepatitis B immunisation programme (service specification 1)]
The transfer of care between maternity services and primary care can be a key issue and it is important that there is effective coordination and communication between services.

Equality and diversity considerations

The implications of hepatitis B neonatal vaccination should be understood by all women to enable them to make informed decisions. Information should be provided in an accessible format (particularly for women with physical, sensory or learning disabilities and women who do not speak or read English).
Pregnant women with complex social needs may be less likely to access or maintain contact with antenatal care services. Examples of women with complex social needs include, but are not limited to, women who:
  • have a history of substance misuse (alcohol and/or drugs)
  • have recently arrived as a migrant, asylum seeker or refugee
  • have difficulty speaking or understanding English
  • are aged under 20 years
  • have experienced domestic abuse
  • are living in poverty
  • are homeless.
It is therefore appropriate that special consideration is given to these groups of women.

Personalised care plan

This quality statement is taken from the hepatitis B quality standard. The quality standard defines clinical best practice in hepatitis B care and should be read in full.

Quality statement

People with chronic hepatitis B infection, and their family members or carers (if appropriate), are offered a personalised care plan outlining the proposed treatment and long-term management of their infection.

Rationale

Personalised care plans are important to promote regular discussion and involvement in decision-making about proposed treatment and long-term management between the healthcare professional and the person with chronic hepatitis B infection (and their family members or carers if appropriate).
It is important that people are actively involved in decisions about their care, and that they fully understand their treatment plan. People with hepatitis B should be encouraged to follow their care plan and take an active role in ensuring that any necessary monitoring, treatment and/or screening tests happen in a timely way. Engaging patients in their care planning and management helps to ensure that they adhere to long-term treatment, and minimises non attendance, inadequate monitoring and poor patient outcomes.

Quality measures

Structure
Evidence of local arrangements to ensure that people with chronic hepatitis B infection, and their family members or carers (if appropriate), are given a personalised care plan outlining the proposed treatment and long-term management of their infection.
Data source: Local data collection.
Process
Proportion of people with chronic hepatitis B infection, and their family members or carers (if appropriate), who are given a personalised care plan outlining the proposed treatment and long-term management of their infection.
Numerator – the number in the denominator who receive (or whose family members or carers receive) a personalised care plan outlining the proposed treatment and long-term management of their infection.
Denominator – the number of people with chronic hepatitis B infection.
Data source: Local data collection.
Outcome
People with chronic hepatitis B infection, and their family members and carers (if appropriate) feel informed about their proposed treatment and long-term management plan of their infection.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (within secondary care) ensure that personalised care plans outlining the proposed treatment and long-term management of their infection are given to people with chronic hepatitis B infection, and their family members or carers (if appropriate).
Healthcare professionals offer people with chronic hepatitis B infection, and their family members and carers (if appropriate), a personalised care plan outlining the proposed treatment and long-term management of their infection.
Commissioners (clinical commissioning groups) ensure that secondary care service providers have protocols in place for healthcare professionals to offer personalised care plans to people with chronic hepatitis B infection, and their family members and carers (if appropriate), outlining the proposed treatment and long-term management of their infection.

What the quality statement means for patients, service users and carers

People with chronic hepatitis B infection (infection that has lasted for 6 months or more), and their family members or carers (if appropriate), are offered a personalised care plan that outlines their treatment and long-term care.

Source guidance

Definitions of terms used in this quality statement

Chronic hepatitis B
Chronic hepatitis B infection is defined as persistence of hepatitis B surface antigen (HBsAg) for 6 months or more after acute infection with hepatitis B virus. Chronic hepatitis B infection can be divided into e antigen (HBeAg)-positive or HBeAg-negative disease based on the presence or absence of e antigen. The presence of HBeAg is typically associated with higher rates of viral replication and therefore increased infectivity. [NICE clinical guideline 165]
Personalised care plan
A personalised care plan should outline the proposed treatment and long-term management specific to the patient’s chronic hepatitis B condition (for example, it should include a copy of the hospital consultation summary) to help promote regular discussions between the patient, and their family members or carers (if appropriate), and the healthcare professional. [Adapted from Hepatitis B (chronic) (full guideline)]

Equality and diversity considerations

A personalised care plan should be tailored to the person with chronic hepatitis B infection. For some people with hepatitis B (for example, children, older people and people with learning disabilities), it may be appropriate for a family member or carer to be involved in the review of the personalised care plan.

Monitoring people with chronic hepatitis B infection who do not meet the criteria for antiviral treatment

This quality statement is taken from the hepatitis B quality standard. The quality standard defines clinical best practice in hepatitis B care and should be read in full.

Quality statement

People with chronic hepatitis B infection who do not meet the criteria for antiviral treatment are monitored regularly at intervals determined by their infection status and age.

Rationale

Monitoring starts shortly after a person is diagnosed with chronic hepatitis B infection. For people who do not need antiviral treatment, continuous follow-up is needed to determine the stage of infection, whether treatment needs to be started and if they are at risk of developing fibrosis.

Quality measures

Structure
Evidence of local arrangements to ensure that people with chronic hepatitis B infection who do not meet the criteria for antiviral treatment are monitored regularly at intervals determined by their infection status and age.
Data source: Local data collection.
Process
Proportion of people with chronic hepatitis B infection who do not meet the criteria for antiviral treatment who are monitored regularly at intervals determined by their infection status and age.
Numerator – the number of people in the denominator who are monitored regularly at intervals determined by their infection status and age.
Denominator – the number of people with chronic hepatitis B infection who do not meet the criteria for antiviral treatment.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (hospital-based specialist care) ensure that competent healthcare professionals are in place to meet the commissioned levels of activity through outpatient clinics.
Healthcare professionals ensure that people with chronic hepatitis B infection who do not meet the criteria for antiviral treatment are monitored regularly at intervals determined by their infection status and age.
Commissioners (clinical commissioning groups and hospital-based specialist care providers) ensure that systems and facilities are in place for monitoring and follow-up of people with chronic hepatitis B who do not meet the criteria for antiviral treatment.

What the quality statement means for patients, service users and carers

People with chronic hepatitis B infection (infection that has lasted for 6 months or more) who do not meet the criteria for antiviral treatment are monitored regularly to check the stage of the infection, whether they need to start treatment and if they are at risk of developing fibrosis (scarring of the liver).

Source guidance

Definitions of terms used in this quality statement

Chronic hepatitis B infection
Chronic hepatitis B infection is defined as persistence of hepatitis B surface antigen (HBsAg) for 6 months or more after acute infection with hepatitis B virus. Chronic hepatitis B infection can be divided into e antigen (HBeAg)-positive or HBeAg-negative disease based on the presence or absence of e antigen. The presence of HBeAg is typically associated with higher rates of viral replication and therefore increased infectivity. [NICE clinical guideline 165]
Recommended intervals for monitoring
Monitoring intervals for people who do not meet the criteria for antiviral treatment are outlined in NICE clinical guideline 165. These vary with infection status and age, and include:
  • Adults with HBeAg-positive disease in the immune-tolerant and immune-clearance phases (recommendations 1.6.1 and 1.6.2).
  • Adults with inactive chronic hepatitis B (immune-control phase) (recommendation 1.6.3).
  • Children and young people (recommendations 1.6.4, 1.6.5 and 1.6.6).
  • Children, young people and adults with HBeAg or HBsAg seroconversion after antiviral treatment (recommendations 1.6.7 and 1.6.8).
Monitoring people with chronic hepatitis B infection who meet the criteria for antiviral treatment
Monitoring intervals for people who meet the criteria for antiviral treatment are outlined in NICE clinical guideline 165. These vary with infection status, age and clinical status. [NICE clinical guideline 165, recommendations 1.5.1 to 1.5.53]

Equality and diversity considerations

The information on monitoring people (including children, young people and adults) with chronic hepatitis B infection who do not meet the criteria for antiviral treatment should be accessible to people with additional needs such as physical, sensory or learning disabilities, and to people who do not speak or read English. Adults receiving information should have access to an interpreter or advocate if needed. The information should be tailored to the age of the person.

Six-monthly surveillance testing for hepatocellular carcinoma in adults with chronic hepatitis B infection who have significant liver fibrosis or cirrhosis

This quality statement is taken from the hepatitis B quality standard. The quality standard defines clinical best practice in hepatitis B care and should be read in full.

Quality statement

Adults with chronic hepatitis B infection who have significant liver fibrosis or cirrhosis are offered 6 monthly surveillance testing for hepatocellular carcinoma.

Rationale

Significant liver fibrosis or cirrhosis is a substantial risk factor for hepatocellular carcinoma, and people with chronic hepatitis B infection who develop liver damage are at increased risk. This form of cancer develops quickly and may be asymptomatic until it is advanced. Regular surveillance testing at 6-month intervals helps to ensure that hepatocellular carcinoma is detected early, which can lead to earlier treatment and may improve the person’s chances of survival.

Quality measures

Structure
Evidence of local arrangements to ensure that adults with chronic hepatitis B infection with significant liver fibrosis or cirrhosis are offered 6 monthly surveillance testing for hepatocellular carcinoma.
Data source: Local data collection.
Process
Proportion of adults with chronic hepatitis B infection with significant liver fibrosis or cirrhosis who receive 6 monthly surveillance testing for hepatocellular carcinoma.
Numerator – the number in the denominator who received their most recent hepatocellular carcinoma surveillance testing within 6 months of their previous test or within 6 months of having significant liver fibrosis or cirrhosis identified.
Denominator – the number of adults with chronic hepatitis B infection with significant liver fibrosis or cirrhosis.
Data source: Local data collection.
Outcome
Stage of hepatocellular carcinoma at diagnosis for adults with chronic hepatitis B infection.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (hospital-based specialist care providers) ensure that competent healthcare professionals are in place to meet the commissioned levels of activity through outpatient clinics and may demonstrate outcomes to commissioners by monitoring the stage of hepatocellular carcinoma at diagnosis for adults with chronic hepatitis B infection.
Healthcare professionals offer adults with chronic hepatitis B infection and significant liver fibrosis or cirrhosis 6-monthly surveillance testing for hepatocellular carcinoma.
Commissioners (clinical commissioning groups) ensure that hospital-based specialist care providers have systems and facilities in place to provide 6 monthly surveillance testing for hepatocellular carcinoma for adults with chronic hepatitis B and significant liver fibrosis or cirrhosis. For more information on surveillance testing see Hepatitis B (chronic): diagnosis and management of chronic hepatitis B in children, young people and adults (NICE clinical guideline 165) section 1.7.

What the quality statement means for patients, service users and carers

Adults with chronic hepatitis B infection (infection that has lasted for 6 months or more) and severe scarring of the liver (called fibrosis or cirrhosis) are offered an ultrasound scan and a blood test every 6 months to check for liver cancer.

Source guidance

Definitions of terms used in this quality statement

Chronic hepatitis B
Chronic hepatitis B infection is defined as persistence of hepatitis B surface antigen (HBsAg) for 6 months or more after acute infection with hepatitis B virus. Chronic hepatitis B infection can be divided into e antigen (HBeAg)-positive or HBeAg-negative disease based on the presence or absence of e antigen. The presence of HBeAg is typically associated with higher rates of viral replication and therefore increased infectivity. [NICE clinical guideline 165]
Significant liver fibrosis or cirrhosis
Fibrosis is a progressive form of liver disease that can be caused by hepatitis B infection. Damage to liver cells results in scarring that prevents the liver from working normally. Significant fibrosis is determined by histological assessment and semi-quantitative scoring systems (METAVIR and Ishak score). Significant fibrosis is METAVIR stage F2 or higher, or Ishak stage 3 or higher.
Cirrhosis occurs when liver inflammation and fibrosis spread to disrupt the shape and function of the liver. Even with no signs or symptoms of liver disease, the working capacity of liver cells has been badly impaired and they are unable to repair the liver. This is permanent cell damage and can lead to liver failure or liver cancer. [Adapted from Hepatitis B (chronic) (full guideline)]
Hepatocellular carcinoma
People with cirrhosis of the liver are at a small but significantly increased risk of developing a type of liver cancer called hepatocellular carcinoma.
[NHS choices, accessed June 2014]
Surveillance testing
The 6 monthly surveillance testing for hepatocellular carcinoma is carried out by hepatic ultrasound and alpha-fetoprotein testing. [NICE clinical guideline 165, recommendation 1.7.1]

Effective interventions library

Effective interventions library

Successful effective interventions library details

Implementation

These resources include support for commissioners to plan for costs and savings of guidance implementation and meeting quality standards where they apply.
These resources will help to inform discussions with providers about the development of services and may include measurement and action planning tools.
These resources provide help with planning ahead for NICE guidance, understanding where you are now, and conducting improvement initiatives.
NICE produces resources for individual practitioners, teams and those with a role in education to help improve and assess users' knowledge of relevant NICE guidance and its application in practice.

Information for the public

NICE produces information for the public that summarises, in plain English, the recommendations that NICE makes to healthcare and other professionals.
NICE has written information for the public explaining its guidance on each of the following topics.

Pathway information

Your responsibility

Guidelines

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients or service users. The application of the recommendations in this interactive flowchart is not mandatory and does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Local commissioners and/or providers have a responsibility to enable the interactive flowchart to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this interactive flowchart should be interpreted in a way that would be inconsistent with compliance with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Technology appraisals

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this interactive flowchart is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Commissioners and/or providers have a responsibility to provide the funding required to enable the recommendations to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Medical technologies guidance, diagnostics guidance and interventional procedures guidance

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take these recommendations fully into account. However, the interactive flowchart does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Commissioners and/or providers have a responsibility to implement the recommendations, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this interactive flowchart should be interpreted in a way that would be inconsistent with compliance with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Person-centred care

People have the right to be involved in discussions and make informed decisions about their care, as described in your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Supporting information

Offer antiviral treatment to adults aged 30 years and older who have HBV DNA greater than 2000 IU/ml and abnormal ALT (greater than or equal to 30 IU/ml in males and greater than or equal to 19 IU/ml in females) on 2 consecutive tests conducted 3 months apart.
Offer antiviral treatment to adults younger than 30 years who have HBV DNA greater than 2000 IU/ml and abnormal ALT (greater than or equal to 30 IU/L in males and greater than or equal to 19 IU/L in females) on 2 consecutive tests conducted 3 months apart if there is evidence of necroinflammation or fibrosis on liver biopsy or a transient elastography score greater than 6 kPa.
Offer antiviral treatment to adults who have HBV DNA greater than 20,000 IU/ml and abnormal ALT (greater than or equal to 30 IU/L in males and greater than or equal to 19 IU/L in females) on 2 consecutive tests conducted 3 months apart regardless of age or the extent of liver disease.
Offer antiviral treatment to adults with cirrhosis and detectable HBV DNA, regardless of HBeAg status, HBV DNA and ALT levels.
Consider antiviral treatment in adults with HBV DNA greater than 2000 IU/ml and evidence of necroinflammation or fibrosis on liver biopsy.
NICE medical technologies guidance addresses specific technologies notified to NICE by companies. The 'case for adoption' is based on the claimed advantages of introducing the specific technology compared with current management of the condition. This case is reviewed against the evidence submitted and expert advice. If the case for adopting the technology is supported, then the technology has been found to offer advantages to patients and the NHS. The specific recommendations on individual technologies are not intended to limit use of other relevant technologies which may offer similar advantages.

Virtual Touch Quantification

The following recommendations are from NICE medical technologies guidance on Virtual Touch Quantification to diagnose and monitor liver fibrosis in chronic hepatitis B and C.
The case for adopting Virtual Touch Quantification (VTq) software to diagnose and monitor liver fibrosis is supported by the evidence. VTq is as accurate as transient elastography in diagnosing and staging liver fibrosis, and may offer other benefits in terms of imaging the liver and sampling selected areas to assess fibrosis and identify associated pathologies. By avoiding liver biopsies, it may also benefit people whose liver fibrosis needs monitoring. Cost savings through adopting VTq will be greater in hospitals in which liver biopsy is the primary method for diagnosing and monitoring liver fibrosis.
VTq should be considered as an option for people with chronic hepatitis B or C who need assessment of liver fibrosis.
Cost modelling suggests that using VTq is cost saving compared with transient elastography and liver biopsy, whether or not a compatible Siemens ultrasound machine needs to be purchased. Compared with transient elastography, the estimated overall cost saving for VTq is around £53 per person. This saving assumes that 10% of the ultrasound machine capacity would be used for VTq measurements, leaving 90% to be applied to other uses. Compared with liver biopsy, the corresponding saving is around £434 per person.

Glossary

Alanine aminotransferase, an enzyme found in the liver that is released into the bloodstream when the liver is damaged.
Chronic hepatitis B is defined as persistence of hepatitis B surface antigen (HBsAg) for 6 months or more after acute infection with hepatitis B virus (HBV).
Hepatitis B virus (HBV) DNA level, or 'viral load', is an indicator of viral replication.
Hepatitis B surface antigen (HBsAg) is a viral protein detectable in the blood in acute and chronic hepatitis B infection.
The development of antibodies against HBsAg is known as HBsAg seroconversion. It signifies clearance of HBsAg and resolution of the chronic infection.
Hepatitis B e antigen (HBeAg) is an indicator of viral replication, although some variant forms of the virus do not express HBeAg. Active infection can be described as HBeAg-positive or HBeAg-negative according to whether HBeAg is secreted.
HBeAg-negative hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. People can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in people initially infected with the HBeAg-positive form of the virus.
HBeAg seroconversion occurs when people infected with the HBeAg-positive form of the virus develop antibodies against the 'e' antigen.

Paths in this pathway

Pathway created: June 2013 Last updated: December 2015

© NICE 2017

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