Guidance

Protocol for the enhanced surveillance of childhood cases of hepatitis B and C in England

Updated 6 March 2025

Applies to England

This protocol is for the Hepatitis Infection Paediatric Surveillance Network (HIPSNet), a collaboration between clinical paediatric infectious disease and hepatology specialists and the Immunisation and Vaccine preventable diseases division and Virus reference department (VRD) of the UK Health Security Agency (UKHSA).

With the introduction of a hexavalent vaccine containing hepatitis B into the primary immunisations as part of the routine (universal) infant programme in England in mid-2017 and the availability of direct acting antivirals for treatment of hepatitis C in children, requirements for the surveillance of hepatitis B and C cases have changed. In order to monitor the performance of the vaccination programme more detailed information is required on childhood cases of hepatitis B diagnosed following the programmes’ introduction. There is also a need to monitor treatment and outcome of chronic cases of hepatitis B and C to ensure equitable access to treatment and care.

Aims and objectives

The aim of the enhanced surveillance of childhood cases of hepatitis B and C is to collect more detailed information on confirmed cases of hepatitis B in children aged 18 years and under in order to monitor:

• the effectiveness and impact of the routine childhood vaccine programme
• risks and trends in children diagnosed with hepatitis B and C
• the uptake and outcome of testing and treatment interventions and care quality and equity

The objectives of the enhanced surveillance of childhood cases of hepatitis are to:

• describe the epidemiology including demographic, risks, sources of infection and clinical features of childhood cases
• determine the hepatitis B virus genotype and undertake molecular characterisation of viruses found in childhood cases
• determine vaccination status to identify if cases represent vaccine failures or missed opportunity for testing and vaccination
• identify potential barriers to testing, vaccination and treatment
• evaluate infant testing and vaccination and new entrant screening and vaccination
• ensure children with hepatitis B and C are referred to specialist care and monitor equitable access to services
• monitor and review outcomes of care and treatment to identify best clinical practice to share information between units and regions
• monitor demand on paediatric infectious disease services and facilitate healthcare planning to reduce future burden
• reduce inequalities in care due to the diverse needs of different populations and the wide range of specialists involved in treatment pathways
• feedback findings to clinicians to improve standards for testing, vaccination and treatment

Methods

Case reporting to UKHSA

There are 4 routine sources of case reports of hepatitis B and C to the hepatitis team at UKHSA Colindale:

1. Second Generation Surveillance System (SGSS) data is from the UKHSA laboratory reporting surveillance system SGSS. The SGSS is a national surveillance system that obtains records of all positive microbiological and virological test results from NHS diagnostic laboratories, and some private laboratories, and contains all laboratory confirmed cases of diagnosed hepatitis B and C.

2. HPZone is the case management system used by health protection teams (HPTs) in UKHSA. This is mostly a source of acute hepatitis B cases as these are prioritised for public health action.

3. Enhanced surveillance of infants born to hepatitis B positive mothers, which is fed into by the Integrated Screening Outcomes Surveillance System (ISOSS). The enhanced surveillance system monitors the hepatitis B antenatal screening and selective neonatal immunisation pathway in partnership with IDPS (Infectious Diseases in Pregnancy Screening), where any mother-to-child transmission events identified in this pathway will be reported.

4. Notifications directly from clinicians managing paediatric hepatitis B and C infections.

Online survey forms are available and distributed to clinicians known to be directly managing paediatric hepatitis B and C infections so cases can be reported directly.

Co-ordination of surveillance activities

Co-ordination of the enhanced surveillance, including analysis and outputs, will be undertaken by the hepatitis team of the Immunisation and vaccine preventable diseases division and the VRD at UKHSA.

Case definition

To be included in the surveillance system, a case must meet the following eligibility criteria:

• laboratory confirmed hepatitis B or C infection (acute or chronic)
• aged 18 years and under upon first notification
• resident in England
• reported to UKHSA Colindale through the SGSS laboratory surveillance system, HPZone, ISOSS, or directly from a treating clinician

Data collection

Case identification

Cases are extracted from all UKHSA sources on a monthly basis and fed into a central database. Case notifications are received from:

• SGSS: UKHSA’s national laboratory surveillance database
• ISOSS: mother-to-child transmission events
• HPzone: UKHSA’s public health case and outbreak management system
• snap survey: case reports directly from specialist paediatric clinicians
• the National Reference Laboratory at Colindale

Cases from the national laboratory surveillance database are extracted on the following criteria for hepatitis B and C.

For hepatitis B

The extract is restricted to confirmed cases only based on the following case definitions:

• acute: hepatitis B surface antigen (HBsAg) positive and antibodies to hepatitis B core antigen immunoglobulin M (anti-HBc IgM) positive
• chronic: HBsAg positive twice at least 6 months apart or HBsAg positive and anti-HBc IgM negative and hepatitis B core antigen (anti-HBc) positive

Based on the laboratory markers therefore a provisional ‘acute’ or ‘chronic’ diagnosis should be available for all confirmed cases, however incomplete data can mean that this diagnosis is often uncertain. Uncertain diagnoses will be followed up for confirmation with relevant specialists.

For hepatitis C

The extract is restricted to hepatitis C PCR (polymerase chain reaction) positive cases only.

Clinical and epidemiological data collection

Upon notification, confirmed childhood hepatitis cases will be run through the Personal Demographics Service to obtain the patient’s full contact details and the details of their GP. The patient will also be cross-checked against other linked data sets to import information already known about the case.

For cases not directly reported by specialist clinicians, letters will be sent to the patient’s GP first asking them to confirm the infection status if possible and to notify the UKHSA of the specialist managing the child’s infection (Appendix 2). In addition, for cases of hepatitis B, GPs will be asked to complete a baseline enhanced surveillance of childhood hepatitis B cases questionnaire (Appendix 1). This questionnaire includes questions on the case’s hepatitis B vaccination history, clinical symptoms, laboratory results, demographic information, and information on potential source of infection.

A follow-up telephone call will be made to non-responding GP practices.

For both hepatitis B and C cases, the named clinician managing the hepatitis infection will be contacted informing them of the childhood surveillance programme and asking for completion of a baseline clinical data form (Appendix 1). If it is identified that a child’s infection is not being monitored or managed, the UKHSA will provide patient information to the HIPSNet regional clinical lead who will liaise with the GP to try to ensure access to care. Neither the UKHSA or the corresponding member of HIPSNet assume clinical responsibility for the children identified through this surveillance.

Annual follow up questionnaires will be sent to the named lead consultant responsible for managing the child’s hepatitis, usually the paediatric infectious diseases or gastroenterology hepatology specialist. These will be sent out until a child moves into adult care, their infection resolves, or they are lost to follow-up (that is, moves out of England). Follow-up questionnaire data will be entered via a web portal (snap survey).

Where information on household contact and child vaccination status is not available from the GP, these will be requested from the specialist managing the child’s infection through a supplementary form at first follow-up.

Molecular characterisation of new hepatitis B cases

Where hepatitis B cases are notified through laboratory surveillance, residual blood samples will be requested to be sent from the laboratory of diagnosis to the VRD at UKHSA Colindale (if not already requested via the existing enhanced surveillance for acute hepatitis B) (Appendix 2).

Residual samples will only be requested for those aged 10 years and under, as the primary aim of their collection is in evaluating the UKHSA’s infant vaccination programmes. Samples received at the reference laboratory will undergo molecular characterisation investigations to confirm the diagnosis and conduct additional genotyping and phylogenetic analysis. Genotyping and phylogenetic analysis provide information on the diversity of the viruses affecting children with additional molecular characterisation informing on the presence of variants.

Information governance

The UKHSA has legal permission, provided by Regulation 3 of The Health Service (Control of Patient Information) Regulations 2002, to process patient confidential information for national surveillance of communicable diseases. This includes the UKHSA’s responsibility to monitor the safety and effectiveness of vaccines, identify risks and trends in diseases and outcomes, and as such, individual patient consent is not required.

The UKHSA Colindale information governance leads have approved the inclusion of this surveillance system under the above-mentioned legal framework.

Patient identifiable information may be shared with members of HIPSNet clinicians only if it is identified that the child is not currently in direct care for their hepatitis infection. Aggregated national surveillance data will be shared with the paediatric infectious diseases or hepatology consultant responsible for managing the child’s hepatitis infection.

The Privacy notice for the enhanced surveillance of childhood cases of hepatitis B and C in England gives further details on information governance and some frequently asked questions on data collection.

System level security policy (SLSP)

A SLSP has been drafted for the additional enhanced surveillance system and has been reviewed and approved by the UKHSA information governance leads.

Dissemination of information and outputs

If the surveillance programme identifies any cases where a health protection incident is considered to have been the most likely source of infection, for example during healthcare procedures in the UK, this will be reported promptly to the local HPT. The HPT will be responsible for any incident investigation and follow-up.

Annual reports on aggregated national data from the treatment and outcome questionnaires will be disseminated to reporting paediatric infectious diseases and hepatology consultants.

Appendices

Appendix 1. Enhanced surveillance questionnaires

Form A1a. Questionnaire for GPs

The following questionnaire is emailed by the UKHSA to GPs to complete on behalf of their patient:

• National epidemiological surveillance for childhood hepatitis B questionnaire

Form A1b. Enhanced surveillance questionnaires for paediatric specialists

The following are enhanced surveillance questionnaires from HIPSNet:

• notification form
• clinical baseline form

To complete clinical baseline forms, paediatric specialists are given unique HIPSNet usernames to access the survey portal. To request a username, please contact phe.childhoodhepatitis@nhs.net

Appendix 2. Letters and communications

Letter A2a. Letter to GP to request baseline questionnaire

This letter is sent from the UKHSA to a child’s GP to request the completion and return of an enhanced surveillance questionnaire:

• Letter to GP to request baseline questionnaire

Letter A2b. Letter to laboratory of diagnosis to request residual blood samples

This letter is sent from UKHSA to laboratory of diagnosis to request blood samples when notification is received from a specialist clinician or national laboratory (SGSS):

• Letter to laboratory of diagnosis to request residual blood samples

Letter A2c. Letter to hepatitis specialist informing of diagnosis

This letter is sent from the UKHSA to a clinical specialist informing the clinician of the child’s diagnosis and inviting them to join HIPSNet to complete baseline questionnaires. Specialists are named by GPs in the enhanced surveillance questionnaires:

• Letter to hepatitis specialist informing of diagnosis

Letter A2d. Letter to member of the HIPSNet informing of a child not in specialist care

This letter is sent from the UKHSA to the most geographically suitable member of HIPSNet following notification of a child with no known specialist. The clinician is requested to devise a strategy with the child’s GP to ensure the child is under specialist care:

• Letter to member of the HIPSNet informing of a child not in specialist care

Appendix 3. Protocol flowcharts

Accessible text equivalent of flowchart A3a

There are 3 pathways:

• specialist clinician
• the UKHSA reference laboratory
• SGSS (national laboratory)

For all pathways, firstly cases are imported into a central database and deduplicated.

If the child is aged 10 years and under and the notification is from a specialist clinician or SGSS, a letter will then be send to the local laboratory requesting they refer a sample to the UKHSA.

In all 3 pathways, a letter will be sent to the GP asking for completion of a surveillance questionnaire and to notify the UKHSA of the specialist details (if not notified directly by the specialist already).

For notifications only from the UKHSA reference laboratory and SGSS, a letter will then be sent to the specialist.

Following this, in all 3 pathways, a baseline questionnaire link will be sent to the specialist by email, followed by a vaccination and household contact questionnaire dependant on the response from the GP.

An annual follow-up will then occur in all 3 pathways until the child is 18 years old and/or transitioned into adult care.

Flowchart A3a. Communications and questionnaires sent by the notification source for hepatitis C

Accessible text description of flowchart A3b

There are 3 pathways:

• specialist clinician
• the UKHSA reference laboratory
• SGSS (national laboratory)

For each pathway, firstly cases are imported into a central database and deduplicated.

For any new cases from the UKHSA reference laboratory or SGSS pathways, letters are sent to the GP requesting details of the specialist. Letters will then be sent to the specialist followed by a baseline questionnaire link sent by email.

Cases notified by the specialist clinicians will be sent the baseline questionnaire straight away.

For all pathways, annual follow-up will occur until the child is 18 years old and/or transitioned into adult care.

Flowchart A3b. Communications and questionnaires sent by the notification source for hepatitis B

Accessible text equivalent of flowchart A3c

The UKHSA identifies a hepatitis case with no specialist identified by the GP practice.

The UKHSA sends a notification to the most geographically suitable member of HIPSNet identified from the network contact list. The HIPSNet member does not take on responsibility for clinical care. The HIPSNET clinician contacts the GP to identify possible barriers and develop a strategy to access specialist care.

The child is referred to specialist care. Contact details of the specialist is passed to the UKHSA to continue surveillance.

The child is unable to access care. The UKHSA is notified to cease follow-up and provided reasons that access to care was not possible.

Protocol A3c. Hepatitis B or C cases not currently under specialist care

Appendix 4. Privacy notice

Details on how we protect, store and how long we keep your information, along with your rights and the UKHSA’s legal basis to use your this information can be found in Privacy notice for the enhanced surveillance of childhood cases of hepatitis B and C in England.