Hepatitis B in England 2024

Q: References

1. PHE . ‘Eliminate hepatitis B and C resource summary’. July 2019

Question 1

Foreword

Accepted Answer

This report arrives at a crucial juncture in our national effort to tackle this public health threat. The UK Health Security Agency (UKHSA) continues to prioritise work to achieve WHO targets for hepatitis B and this report provides a critical assessment of our progress towards achieving and demonstrating hepatitis B elimination as a public health problem in England. While there are successes to be celebrated, including achieving WHO certification of elimination of hepatitis B mother to child transmission (otherwise known as vertical transmission or perinatal transmission), there remain significant challenges. This includes a large burden of undiagnosed infections, limited data on treatment initiation and retention, and falling vaccination rates across multiple groups.

We have continued to see the success of the well-established antenatal screening and vaccination programmes for infants. This maintains the UK status of elimination of mother to child transmission, achieved through continued commitment to very high coverage of antenatal screening and targeted birth dose of vaccine and immunoglobulin (where indicated). Notably, antenatal screening coverage has remained high at 99.8%, with birth dose coverage for infants born to women with hepatitis B infection at 98.8%. Coverage of universal infant immunisation also remains high with 91.8% of all infants receiving 3 doses of vaccine by 12 months.

The recent implementation of the bloodborne virus (BBV) opt out testing in emergency departments (EDs) has led to 646 new hepatitis B diagnoses in its first year and is now being expanded to a further 47 sites nationwide. It has however, put a spotlight on the scale of undiagnosed hepatitis B infections in the community and the need to expand access to testing.

Severe outcomes associated with hepatitis B including liver cancers, liver transplants and deaths from hepatitis B remain low but have not declined in over a decade. These outcomes are avoidable with timely prevention, early diagnosis and a clear pathway to treatment and care. This highlights the unmet need and therefore the opportunity to improve the lives of people living with hepatitis B. As hepatitis B is a cancer-causing illness these interventions, including vaccination, are increasingly recognised as being cancer preventing and supporting early diagnosis where cancer does occur, particularly amongst migrant populations.

New analysis by UKHSA has provided data on the number of people diagnosed and receiving treatment. This is essential for monitoring progress towards the WHO targets of 90% or more of people living with hepatitis B being diagnosed, and 80% or more of those eligible for treatment receiving it. This initial data, however, shows that more work is needed to strengthen and develop existing and new surveillance systems if we are to achieve these targets by 2030.

Self-reported vaccine coverage amongst people who inject drugs (PWID) has been steadily declining over recent years and measuring uptake amongst other at-risk populations, including migrant populations, people accessing sexual health services (SHSs), people in prison, and patients with chronic kidney disease, remains challenging. Ongoing engagement with stakeholders, including healthcare providers, communities, health commissioners and policymakers, is vital to strengthen data systems, reporting mechanisms and collaborative networks.

New work is underway to understand how stigma affects people living with hepatitis B and what can be done to reduce the impact of stigma. This work, alongside supporting people with lived experience to share their stories and shape future hepatitis B care pathways, are key to ensuring high quality and accessible services.

This year’s report provides more data on ethnicity and deprivation showing the unequal burden of hepatitis B and its outcomes amongst ethnic minority groups and people living in more deprived areas. UKHSA are committed to working collaboratively with organisations and in partnership with these underserved communities to remove barriers to prevention, diagnosis and treatment so that we reach WHO goals by 2030.

Dr Mary Ramsay CBE
Director of Public Health Programmes, UKHSA
Professor of Vaccine Policy, London School of Hygiene and Tropical Medicine

Question 2

Progress towards the Global Health Sector Strategy on viral hepatitis

Accepted Answer

The WHO Global Health Sector Strategy (GHSS) on viral hepatitis 2016 to 2021 set, for the first time, an ambition of ending the global epidemic of viral hepatitis by 2030. This goal has been continued in the GHSS 2022 to 2030 and the UK government has committed to both of these strategies.

The WHO published updated guidance for country validation of viral hepatitis elimination and path to elimination in 2023. This guidance outlines the targets and indicators required for countries to achieve validation of elimination of viral hepatitis as a public health problem. The data in this report is structured around these indicators to provide an assessment of progress in England towards achieving these goals and identify areas where further work is required if targets are to be met by the 2030 ambition.

UKHSA currently estimates that in 2022 there were around 270,000 people living with hepatitis B which is 0.6% of the population; this increases to 1.5% in London. England has met and exceeded WHO absolute targets on hepatitis B-related mortality, incidence of new infections, elimination of mother to child transmission and universal vaccine coverage among infants. Robust public health programmes and surveillance systems provide a strong platform for these achievements to be maintained and improved, however, declining vaccine coverage demonstrates the need to remain vigilant and ensure these targets continue to be met.

While there are targets that England is either already achieving or on track to achieve there are others that are at risk of not being achieved by 2030 without additional focus and resourcing. Areas that will require increased resourcing to meet the 2030 targets include:

Increasing the proportion of people living with hepatitis B who are unaware of their infection being diagnosed and referred to care. Current estimates suggest that less than half of people living with hepatitis B have been diagnosed. This proportion will need to be doubled by 2030 to meet targets on the proportion of people living with hepatitis B that are diagnosed.
Improving care pathways to increase engagement and retention in care and resources to provide treatment for those eligible for antiviral therapies.
Improving digital solutions for clinical management of people living with hepatitis B, clinical reporting and public health surveillance of people eligible for and receiving treatment to enable effective care pathways and an assessment on progress.

Increasing diagnosis, increasing treatment and tracking of outcomes will require prioritisation of resources to enable England to achieve and to evidence meeting the programmatic targets on diagnoses and treatment required for WHO validation. Assessment of interventions and programmes to achieve these targets is underway in UKHSA in collaboration with partners including the National Institute for Health and Care Research (NIHR) Health Protection Research Units (HPRU). Similar challenges have been faced and addressed for other infectious disease programmes which provide valuable lessons and models which can be used to ensure the 2030 commitment is met.

Question 3

Current and planned work

Accepted Answer

This section outlines current and planned work by UKHSA and partners to improve and sustain progress against WHO targets within existing resourcing and funding commitments.

These actions focus on reducing incidence, increasing testing and linkage into care, reducing mortality and maintaining the elimination of hepatitis B mother to child transmission.

1. Maintaining elimination of mother to child transmission

1.1 Improving uptake of post vaccination serologic testing

Aim

As part of a broader ongoing review of enhanced surveillance of women living with hepatitis B and their infants, undertake quality improvement activities to improve commissioning, implementation and uptake of Post Vaccination Serologic Testing (PVST) for infants at 12 months of age.

Rationale

At present, coverage and reporting of PVST is suboptimal. This hinders the assessment of programme effectiveness and impacts the reliability of estimates for MTCT and hepatitis B incidence. By prioritising efforts to address suboptimal uptake including improving awareness of PVST, supporting primary care practitioners to adopt dried blood spot (DBS) testing, resolving commissioning and reporting gaps and using data linkage to identify untested infants, the quality improvement approach aims to increase the uptake of PVST, support the maintenance of elimination of mother to child transmission and ensure accurate estimates of hepatitis B incidence.

Stakeholders

Led by UKHSA in collaboration with Integrated Screening Outcomes Surveillance Service (ISOSS), part of the NHS Infectious Disease in Pregnancy Screening (IDPS), NHS screening and immunisation teams and NHS primary care services.

1.2 Evidencing seroprevalence of hepatitis B amongst children aged 5 years and under

Aim

Explore availability of additional collections and support the increase of existing collections of paediatric serological samples available for testing to better estimate seroprevalence of hepatitis B among children aged 5 years and under.

Rationale

A recent seroprevalence estimate in children aged 5 years and under showed zero hepatitis B surface antigen (HBsAg) positivity. However, these samples were geographically limited. Expanding the paediatric sample collections ensures a more accurate and representative seroprevalence estimate of hepatitis B for England among children aged 5 years and under. Evidencing seroprevalence of less than 0.1% amongst children aged 5 years and under is a WHO metric and when combined with high PVST coverage provides robust evidence of elimination of hepatitis B mother to child transmission.

Stakeholders

UKHSA.

2. Preventing new infections

2.1 Improving hepatitis B vaccine uptake

Aim

Enhance surveillance systems to improve data on hepatitis B vaccine uptake among key populations such as individuals in prisons, PWID, people accessing SHSs and migrants.

Rationale

Vaccination information where available is often unlinked, provided as aggregate data or poorly recorded. Counts of vaccinations in SHSs are available through the GUMCAD STI Surveillance System, however it is not possible to provide uptake rates due to the data lacking identifiable information. Similarly, for PWID participating in the Unlinked Anonymous Monitoring (UAM) survey, the data is unlinked and self-reported. Additionally, information provided from NHS England (NHSE) Health and Justice are aggregate numbers.

Improving data on hepatitis B vaccine uptake within key populations is crucial for assessing the effectiveness of vaccination programmes and identifying gaps in coverage. By enhancing these systems, we can better understand the barriers to vaccination access and uptake. Ongoing collaboration with NHSE Health and Justice to obtain enhanced information on individuals vaccinated in prison demonstrates progress towards this goal.

Stakeholders

UKHSA in collaboration with NHSE and local authorities.

2.2 Increasing awareness of hepatitis B

Aim

Improve education and awareness of hepatitis B among healthcare professionals by developing and implementing targeted educational resources to raise awareness on hepatitis B transmission routes, the importance of vaccination among high-risk populations and prevention methods.

Rationale

Resources have been created for antenatal screening and for the selective immunisation programmes for healthcare professionals. Additionally, a Royal College of General Practitioners (RCGP) eLearning course on hepatitis B and C has been developed to raise awareness in primary care professionals. Building on and improving existing resources to support professionals working in different settings, through co-design and evaluation, aims to improve professional confidence and competence in having proactive conversations about hepatitis B and to provide non-stigmatising services, which may in turn encourage individuals to take up preventative measures including testing and immunisation.

Stakeholders

UKHSA, British Liver Trust and peer support workers and organisations.

Aim

Define a national target to reduce hepatitis B-related End-Stage Liver Disease (ESLD) and/or hepatocellular carcinoma (HCC) deaths.

Rationale

While hepatitis B-related mortality in England is already lower than the WHO absolute target, hepatitis B-related mortality rates have not declined over the past decade. Defining a new target for reductions in deaths will ensure continued focus on preventing hepatitis B-related deaths, particularly from ESLD and HCC. This proactive approach maintains momentum in achieving the WHO goals for hepatitis B.

Stakeholders

UKHSA in collaboration with a multi-stakeholder group.

3. Prevalence and testing and diagnosis

3.1 Improving estimates of hepatitis B prevalence and the proportion of people living with hepatitis B that are undiagnosed

Aim

Develop robust modelled estimates for hepatitis B prevalence and diagnosed proportion to enhance understanding of disease burden, and the focus and impact of control interventions.

Rationale

Accurate estimates of hepatitis B prevalence are crucial for guiding testing and treatment strategies and assessing progress towards WHO metrics. By conducting modelled estimates, we can obtain a comprehensive picture of the disease burden across demographic groups and geographic regions. This information is essential for identifying priority groups and areas for intervention and monitoring the impact of these interventions over time. Current prevalence estimates use laboratory test data in antenatally screened women, multipliers derived from non-antenatally screened populations within major ethnic groups and England population estimates stratified by age and ethnic group. More complex statistical and mathematical models using Bayesian methods such as multiple parameter evidence synthesis will be developed.

The proportion of people diagnosed with chronic hepatitis B assesses whether current testing coverage is sufficient to identify most people who would benefit from treatment and so is integral to assessment of treatment coverage and the care cascade. Current estimates are crude and not based on mathematical or statistical models. Developing more robust methodology is crucial for understanding the gaps in testing coverage, focusing testing initiatives, and ensuring that individuals living with hepatitis B receive timely diagnosis and care.

Stakeholders

Multi-stakeholder group coordinated by UKHSA and the National Institute for Health and Care Research Health Protection Research Units (HPRUs).

3.2 Evaluating interventions to increase diagnosis and linkage to care

Aim

Continue evaluations for the ongoing NHSE ED bloodborne virus opt-out testing programme to understand its effectiveness, optimise implementation and assess health economics.

Rationale

Evaluation is crucial to determine if interventions meet their objectives and if resources are allocated effectively to support meeting WHO targets in England. The introduction of a 3-year programme of bloodborne virus opt-out testing in EDs commenced in April 2022, with the initial evaluation findings published in November 2023.

Within the first year of the programme’s implementation, in programme-reported data, over 360,000 hepatitis B tests had been conducted across 21 sites. At the 16 sites where surveillance data was available, 646 new hepatitis B diagnoses were made. UKHSA has committed to evaluating the second and final year of this programme, with a final evaluation due in 2025. In addition, planning is underway for an evaluation of the expansion of the EDs testing programme to new sites in areas of high diagnosed HIV prevalence in England from April 2024.

Stakeholders

UKHSA in collaboration with NHSE, the University of Bristol and University College London as part of the NIHR HPRU.

4. Linkage and retention in care

4.1 Developing new models of care including tools for monitoring people in treatment and care

Aim

Explore new models of care pathways for those living with hepatitis B to ensure they can access appropriate care and treatment in a timely manner. New methods for collecting, sharing and reporting data on people in care will be required to support new pathways and to develop treatment surveillance.

Rationale

With increases in people diagnosed via the ED opt-out programme and changes to treatment guidelines, specialist services are coming under increasing strain to provide care and treatment to all eligible patients. Work is currently underway in London to review hepatitis B care pathways and identify new models which will support patient engagement and retention, improve outcomes and increase capacity. Learnings from this review will be shared nationally.

Surveillance of hepatitis B treatment is needed to monitor the effectiveness of changes to care pathways and identify further opportunities for optimisation. It is also required to evidence achievement of WHO targets of at least 80% of people living with hepatitis B and eligible for treatment receiving it. Improved systems for monitoring treatment will also support the transfer of care and re-engaging people who may no longer be in contact with services.

Stakeholders

Multi stakeholder collaboration with NHSE, NHS Trusts, clinicians, academic partners, people with lived experience, primary care, pharmacists, inclusion health teams and UKHSA.

4.2 Piloting a hepatitis B dashboard

Aim

Pilot a hepatitis B dashboard to track and monitor patient outcomes along the care cascade from vaccination to testing and outcomes. This dashboard should also provide local information for clinicians and policymakers allowing them to compare outcomes and interventions with other regions in England.

Rationale

A hepatitis B dashboard is a tool for visualising and assessing patient progress along the care cascade. By integrating data on testing uptake, diagnostic results and vaccination status, a dashboard can provide a comprehensive view of patient care. This will facilitate the identification of gaps, risk groups and opportunities for intervention, ultimately improving patient outcomes. Work on creating a prototype dashboard has begun to be workshopped with stakeholders for further development.

Stakeholders

UKHSA in consultation with relevant stakeholders.

5. Increasing equity

5.1 Improve understanding of disparities associated with hepatitis B access to care and health outcomes

Aim

Enhance surveillance systems to provide descriptions of the care cascade incorporating NHS protected characteristics groups such as age, sex, ethnicity, country of birth and deprivation.

Rationale

Improving surveillance systems to capture and analyse demographic data such as country of birth and deprivation is essential for understanding the disparities in hepatitis B burden and addressing disparities in access to care. By analysing the care cascade stratified by demographics, interventions can be tailored to meet population needs effectively.

Stakeholders

UKHSA alongside data providers including NHS.

Aim

Utilise behavioural science methodologies and analyse the findings of the World Hepatitis Alliance community stigma indicator survey results for England to assess and address stigma associated with hepatitis B. Co-develop and maintain an internal language guide to actively challenge the use of potentially stigmatising language within UKHSA hepatitis-related publications.

Rationale

Addressing stigma associated with hepatitis B is essential in our efforts to eliminate hepatitis B as a public health threat. In 2023, UKHSA held a stigma workshop with academic, public health and community partners. It was agreed that a body of work addressing stigma towards people living with hepatitis is needed. By applying behavioural science techniques, we can gain deeper insights into the underlying attitudes and perceptions surrounding hepatitis B-related stigma among healthcare workers.

Additionally, England took part in the World Hepatitis Alliance’s stigma survey. Analysing survey results will provide valuable insights into the specific challenges and perceptions related to hepatitis B stigma in England. This evidence-based approach will inform the development of tailored strategies and interventions.

Co-developing an internal language guide with community organisations and people with lived experience of viral hepatitis will ensure that the language we use in our hepatitis-related publications helps to challenge and reduce stigma towards viral hepatitis and people living with viral hepatitis.

Stakeholders

UKHSA alongside community organisations, people with lived experience, and healthcare professionals.

Question 4

Introduction

Accepted Answer

Hepatitis B is a bloodborne virus that infects and damages the liver that poses a significant public health threat globally, with millions affected and over 1.1 million lives claimed yearly. Despite significant progress in childhood immunisation, chronic hepatitis B persists, leading to severe liver complications and death. In England, interventions have been implemented to reduce hepatitis B as a public health problem. This report outlines current surveillance data on hepatitis B in England, highlighting both achievements and ongoing challenges in the continued efforts to eliminate viral hepatitis as a public health threat.

Hepatitis B targets the liver, causing acute or chronic infection. While most adults clear acute infections, around 10% develop chronic hepatitis B. Infants who acquire hepatitis B during gestation and/or childbirth have a high risk of chronic infection, putting them at increased susceptibility to future liver complications.

England has made progress with universal immunisation programmes, introducing the hexavalent vaccine (which includes hepatitis B vaccine) in routine infant immunisations in 2017. However, challenges persist, particularly among migrant populations with high prevalence rates. Targeted programmes focussing on outreach and supporting the diagnosis of people living with undiagnosed hepatitis are essential to interrupt transmission in these communities. Additionally, a small percentage of infections are acquired within the UK, requiring tailored education and interventions focussed on people who are at high-risk of exposure to hepatitis B.

Efforts to prevent mother to child transmission, otherwise known as vertical transmission or perinatal transmission) of hepatitis B in England are crucial. Strategies focus on antenatal screening, infant vaccination and treatment for expectant mothers living with hepatitis B. Integration of these efforts with existing maternal and child health services strengthens the effectiveness of these interventions.

Despite the significant burden it places on communities across all global regions, viral hepatitis has historically not received the same attention as other health and development priorities. In May 2016, the UK signed up to the WHO Global Health Sector Strategy on Viral Hepatitis committing to meet targets that include a 90% reduction in incidence of hepatitis B infection and a 65% reduction in mortality from hepatitis B by 2030 from a 2015 baseline.

England remains committed to achieving and evidencing WHO targets on hepatitis B by 2030. These include absolute impact targets for incidence focusing on elimination of mother to child transmission, including a mother to child transmission rate of less than 2%, to 0.1% or less HBsAg prevalence in children 5 years and under), and a combined annual mortality of 6 per 100,000 deaths or fewer attributable to hepatitis B or C.

Question 5

1.  Reducing incidence and prevalence of hepatitis B

Accepted Answer

1.1 Prevalence of hepatitis B

Utilising a method previously published that employs laboratory surveillance data between 2015 to 2021 and population estimates from the 2021 census, UKHSA estimate that the number of people with chronic hepatitis B in England in 2022 was 268,767 with a 95% confidence interval (CI) ranging from 227,896 to 314,004 (Table 1). This corresponds to a prevalence estimate of 0.58% (95% CI 0.50% to 0.68%).

The prevalence estimates were higher in men, those of an ethnic origin other than white British, particularly those of black, black British, Caribbean or African ethnic origin and other ethnic group, and higher for London (1.52%) compared with outside London (0.39%).

Table 1. Estimated HBsAg prevalence and number of people with chronic hepatitis B, England, 2022

Category	Estimated number of individuals with chronic hepatitis B, (95% CI)	Estimated HBsAg prevalence (%), (95% CI)
Female	96,444 (85,086 to 108,782)	0.41 (0.36 to 0.46)
Male	172,323 (142,810 to 205,262)	0.77 (0.64 to 0.92)
16 to 29 years	54,781 (46,886 to 64,492)	0.56 (0.48 to 0.67)
30 to 49 years	128,695 (111,587 to 147,529)	0.86 (0.75 to 0.99)
50 years and over	85,292 (69,423 to 102,023)	0.40 (0.32 to 0.48)
Any other white background	56,076 (49,131 to 63,501)	1.55 (1.36 to 1.76)
Asian or Asian British	50,454 (43,407 to 58,844)	1.22 (1.05 to 1.42)
Black, black British, Caribbean or African	60,649 (54,025 to 67,826)	3.38 (3.01 to 3.78)
Mixed or multiple ethnic groups	11,932 (8,228 to 16,680)	1.27 (0.88 to 1.78)
White British	45,892 (35,542 to 56,275)	0.13 (0.10 to 0.16)
Other ethnic group	43,765 (37,563 to 50,917)	4.60 (3.95 to 5.36)
London	108,216 (83,316 to 140,120)	1.52 (1.17 to 1.97)
Outside London	150,894 (122,726 to 185,155)	0.39 (0.32 to 0.48)
Total	268,767 (227,896 to 314,044)	0.58 (0.50 to 0.68)

The estimate produced this year has increased compared to the estimate presented in the 2023 report due to the use of updated 2021 census data on ethnicity as opposed to a large increased disease prevalence in the population. Since the 2011 census, there has been an increase in the number of Asian and Asian British, and black, black British, Caribbean and African people living in England.

1.2 Monitoring WHO targets for hepatitis B incidence

The WHO targets for reducing incidence prioritise elimination of hepatitis B mother to child transmission, including universal antenatal screening, timely birth dose vaccination and achieving high vaccination coverage with all 3 vaccine doses in the universal infant programme. Additional targets address safe injection practices and blood transfusion safety. Table 2 presents these targets and England’s progress towards meeting them.

Table 2. WHO impact and programmatic targets for reducing incidence of hepatitis B, England, 2021 to 2022

Target type	Target	WHO 2030 target	Most recent data for England 2021 to 2022
Impact	HBsAg prevalence in children aged 5 years or under	0.1% or below	0.0%
Impact	mother to child transmission rate (where countries use a targeted birth dose programme)	2% or below	0.0%
Programme	Coverage of 3 doses of universal hexavalent vaccine which includes hepatitis B vaccine (HepB3)	90% or above	91.8%
Programme	Coverage of those infants at risk with targeted timely hepatitis B birth dose (HepB birth dose)	90% or above	98.8%
Programme	Coverage of maternal antenatal HBsAg testing	90% or above	89.0%
Programme	All eligible pregnant women to receive appropriate antivirals to treat hepatitis B	90% or above	80.2%
Prevention	Safe injections	90%	85%
Prevention	Blood safety	100%	100%

1.3 Elimination of mother to child transmission

England provides a universal antenatal screening offer for hepatitis B, as well as syphilis and HIV. Targeted neonatal birth dose of vaccination and hepatitis B immunoglobulin (HBIG), where indicated, for babies born to women living with hepatitis B are offered as part of the selective neonatal immunisation programme. Additional information is available in Immunisation against Infectious Disease: Green Book Chapter 18: Hepatitis B.

1.3.1 Maternal screening for hepatitis B

Antenatal screening coverage is a key performance indicator, ensuring that pregnant women living with hepatitis B are diagnosed and interventions are implemented to prevent transmission of hepatitis B to their children. In the 2021 to 2022 tax year, the cohort of pregnant women was 634,697 with antenatal screening uptake consistently over 99% from 2017 to 2022 (Figure 1), exceeding the WHO target of 90%.

Figure 1. Maternal screening coverage for hepatitis B in England, 2017 to 2022 tax year

Break shown with symbol in y-axis.

Source: Infectious diseases in pregnancy screening programme standards reports, NHSE.

In the 2021 to 2022 tax year, 2,148 of 633,331 (0.3%) pregnant women received a positive screening test result. Prevalence has remained very low and stable at 0.3% to 0.4% each year, although there is regional variation, with London seeing the highest prevalence (around 0.7%) and the South of England the lowest (around 0.2%) each year. Of women who were HBsAg positive in 2021 to 2022, 7.3% were classified as being at higher risk of passing on hepatitis B: this is as higher infectivity based on presence of hepatitis B e-antigen (HBeAg) , high viral load, or acute hepatitis B in pregnancy. For pregnant women considered to be at high risk, hepatitis B specific immunoglobulin (HBIG) is administered alongside the vaccine to their newborn child, whereas for pregnant women considered to be at low risk only the vaccine is administered.

Of the 1,977 samples with completed country of birth data provided by ISOSS for women booked for antenatal screening between April 2021 and March 2022, the majority were from women born in Western Africa and Eastern Europe (Figure 2). Compared to the 2020 to 2021 tax year, there has been an increase in the number of women born in South Asia who were considered at high risk of transmitting hepatitis B to their baby. Previously, a higher proportion of women of Caribbean ethnicity were classified as being at high infectivity risk; this is not seen in the 2020 to 2021 tax year.

Figure 2. Country of birth and risk of passing on hepatitis B to their baby in women living with hepatitis B in England, 2021 to 2022 tax year

Source: antenatal country of birth data is from ISOSS data for 2021 to 2022, geographic region classifications are from the United Nations Statistics Division.

Additional data on testing and positivity is available for tests undertaken in laboratories that report to the Sentinel Surveillance of Blood Borne Viruses (SSBBV). In 2021 to 2022, 119,710 antenatal tests were reported to SSBBV, approximately 19.8% of all antenatal tests conducted. Of those tests reported, almost two thirds (63.4%) were people of white British background, followed by those from any other white background (12.9%) and Asian and Asian British (11.8%) background.

Overall, HBsAg test positivity rates among tests undertaken in antenatal services have decreased for women of all ethnicities between 2015 and 2022, except for women of white British background, the group with the lowest (often zero) rates (Figure 3). The largest decrease was seen among women from black, black British, Caribbean or African background in whom positivity rates halved, from 1.2% in 2015 to 0.6% in 2022.

Figure 3. HBsAg test positivity by year and ethnic group, from antenatal screening in 18 sentinel laboratories, England, 2015 to 2022 tax year

Source: SSBBV (for further details see Appendix 2. Technical note 8 on SSBBV testing).

Among those women with a positive HBsAg result and tested in antenatal services, HBeAg positivity was highest for women of any other ethnic group (16.9%) and for women of Asian or Asian British ethnicity (14.8%).

1.3.2 Coverage of antiviral treatment in pregnant women

Antiviral treatment is recommended for pregnant women living with hepatitis B and with a hepatitis B viral load (DNA level) greater than or equal to 200,000 International Units (IU) per millilitre (ml) to reduce viral load (see the Green Book).

Of the pregnant women screened between 2021 to 2022, 91.8% had viral load information collected and 82 (5%) of these women had a hepatitis B viral load of 200,000 IU per ml or more. Of these women, 73 (89%) had recorded antiviral treatment during pregnancy. The remaining 9 women were listed as not on treatment, and all were of non-white British ethnicity.

1.3.3 Coverage of a timely hepatitis B birth dose vaccine and HBIG in the selective programme

Timely administration of the hepatitis B birth dose vaccine within 24 hours of birth for babies born to women living with hepatitis B is important to prevent these children developing chronic hepatitis B (see hepatitis B Green Book chapter 18) (Figure 4). The proportion of eligible infants who received HBIG within 24 hours is shown in Figure 5. When timely HBIG or vaccine is not given to an eligible infant, there are processes in place to flag and investigate these incidents to improve programme delivery.

Figure 4. Coverage for timely hepatitis B birth dose vaccination, England, 2017 to 2022 tax year

Break shown with symbol in y-axis.

Source: Infectious diseases in pregnancy screening programme standards reports, NHSE.

Figure 5. Coverage for timely HBIG, England, 2017 to 2022 tax year

Break shown with symbol in y-axis.

Source: Infectious diseases in pregnancy screening programme standards reports, NHSE.

1.3.4 Coverage of hepatitis B vaccination in the selective neonatal programme

Figure 6 shows coverage of eligible infants who received all 5 hepatitis B vaccines (birth dose, monovalent dose at 4 weeks, and 3 hexavalent doses as part of the routine immunisation schedule) by 12 months of age and all 6 doses (including a further 12-month monovalent dose) by 24 months of age. This data is aggregated from the quarterly Cover of Vaccination Evaluated Rapidly (COVER) reports.

Figure 6. Coverage of hepatitis B vaccination in the selective neonatal programme, England, 2019 to 2023 tax year [note 1]

Break shown with symbol in y-axis.

Source: Childhood vaccination coverage statistics, NHSE Digital (co-authored with UKHSA).

[note 1] Data prior to 2019 to 2020 is missing some local authorities particularly in London so is not presented.

1.3.5 Post-vaccination serology testing (PVST) in infants born to women living with hepatitis B

PVST of infants born to women living with hepatitis B is undertaken via the national free DBS service provided by UKHSA. It is used to confirm that mother to child transmission has not occurred and ensure timely referral to specialist services for any children who have acquired hepatitis B. Data from these tests are used to calculate the mother to child transmission rate.

Between April 2014 and March 2022, 8,657 infants were tested via the UKHSA DBS service, with a year-on-year increase from 420 in 2014 to 2015 to 1,455 in the 2021 to 2022 tax year. This increase represents more centres using the service rather than increases in the total number of children born to women living with hepatitis B nationally.

By comparing births reported to ISOSS with DBS samples received by UKHSA, in the 2021 to 2022 tax year, it is estimated that 78.2% (1,393 out of 1,781) of eligible children were tested through this service. Testing outside of the DBS service, through hospital phlebotomy and laboratory services, also occurs but is not consistently reported to UKHSA. The sharing of data between ISOSS and UKHSA means that PVST completion can be more accurately reported and infants for whom a PVST result is missing can be followed up. This should improve returns and increase the accuracy of the estimated mother to child transmission rate.

The estimated mother to child transmission rate by year is shown in Figure 7. This has consistently been below the 2% WHO target, having fallen from 0.95% in the 2014 to 2015 tax year to 0.07% in the 2021 to 2022 tax year. Of the 8,657 samples tested up to end of March 2022, 1,947 (22.5%) infants were reported to be born to women considered at high risk of passing hepatitis B to their child, as per the Green Book criteria. Since starting, the service has identified 17 (0.2%) of children living with hepatitis B, all of whom were born to women considered at high risk (where risk status was available).

The number of children confirmed to be living with hepatitis B has decreased from 19 to 17 since the previous hepatitis B report due to a misclassification error in the 2023 report.

Figure 7. Mother to child transmission rate for infants born to women living with hepatitis B, England, 2014 to 2022 tax year

Source: Modular Open Laboratory Information System (MOLIS) data (from DBS testing in blood borne virus unit (BBVU)), UKHSA.

1.4 HBsAg prevalence in children aged 5 years and under

Between September 2017 and December 2020, 2,017 samples collected from children aged 5 years and under, sourced by the UKHSA Seroepidemiology Unit, were tested for HBsAg and all were negative. These sera are residual specimens which have been submitted for diagnostic testing and have been collected from UKHSA and also some NHS laboratories. These samples are anonymised but retain some information, such as age, sex and source laboratory. Among the tested samples, 52.2% were male and 47.6% were female. These findings, in conjunction with the high antenatal screening uptake in section 1.3.1 and PVST results in section 1.3.5 provide confidence that England is below the 0.1% HBsAg seroprevalence target set by WHO in children aged 5 years and under.

It is important to note that the majority of samples originated from the North-West (56.1%) and Yorkshire and Humber (23.2%) regions. Unfortunately, these samples lack additional demographic data, which restricts their comparison with the broader population of young children in England. Efforts are underway to augment the pool of paediatric samples available, aiming to enhance the representativeness and generalisability of samples collected.

1.5 Coverage of hepatitis B 3 doses (HepB3) in the universal programme

UKHSA monitors vaccine coverage for all 3 doses of the universal hexavalent (6 in 1 including hepatitis B) vaccine programme (and other childhood immunisation programmes) through COVER. Details on the COVER programme and methodology are described in COVER reports.

England has consistently maintained over 90% coverage of children receiving the hexavalent vaccine by their first birthday between 2019 to 2020 and 2022 to 2023, exceeding the WHO target. The COVER annual report for 2022 to 2023 reported that 91.8% of children had completed their primary course of 3 doses at 12 months. Coverage in 2021 to 2022 was also 91.8%, showing a general downward trend since the peak of 94.7% reported in 2012 to 2013 (see Figure 8).

Figure 8. Coverage for universal pentavalent and hexavalent vaccine at 12 months of age, England, 2015 to 2016 to 2022 to 2023 tax year

Break shown with symbol in y-axis.

Source: COVER reports, UKHSA.

1.6 Prevention of infection by immunisation in other groups at risk of acquiring hepatitis B

In addition to the infant immunisation programmes, targeted vaccination focussing on people at increased risk of acquiring hepatitis B or its complications is recommended as this is the cornerstone of preventing transmission in the general population. These are outlined in the Green Book and include PWID, gay, bisexual and other men who have sex with men (GBMSM), those in custodial institutions and people with chronic kidney disease.

1.6.1 Vaccine uptake in SHS

British Association for Sexual Health and HIV (BASHH) guidelines recommend that all services commissioned to manage sexually transmitted infections (STIs) should provide appropriate hepatitis B vaccination to non-immune GBMSM.

While vaccination coverage in GBMSM was as high as 95% in 2008, coverage of first dose hepatitis B vaccination in non-immune first-time attendees in 2019 was estimated to be below 20% (ranging from 0% to 67% by clinic) based on data reported by specialist SHSs to UKHSA’s GUMCAD STI Surveillance System (further details in Appendix 2. Technical notes 2 on monitoring vaccination in GBMSM in SHSs).

In 2020, during the first year of the COVID-19 pandemic, the estimated first dose coverage in GBMSM attendees decreased to 4.3% reflecting the reconfiguration of SHSs to increase remote service provision, either online or by telephone. The estimated national vaccination coverage remained below 5% in 2021 for one dose of hepatitis B vaccine in GBMSM. While this may reflect a reduced offer or uptake of vaccination, hepatitis B vaccination coverage is underestimated when using GUMCAD data because of the underreporting of immunity to hepatitis B by SHSs. The latter leads to an overestimate of the denominator of people assumed to be eligible for vaccination, leading to artefactually low estimates of vaccination coverage.

Given this underestimation of vaccine coverage from SHSs, Table 3 presents trends in the administration of hepatitis B vaccine doses in GBMSM within SHSs since 2017. The recording of subsequent vaccine doses may be inconsistent or inaccurate, especially as individuals may receive their second or third doses at different clinics. As SHSs are covered by anonymous access provision in the Health and Social Care Action 2012 and the GUMCAD data they submit to UKHSA are pseudonymised, it is not possible to link records leading to the potential misclassification of subsequent doses as first doses in the new SHS records.

The number of first doses administered increased by 32%, rising from 11,080 in 2017 to 14,645 in 2019. Similar increases were observed for all other doses. However, in 2020 the total number of doses administered nearly halved compared to 2019. Although there was a recovery in 2021 (9,250 doses) and 2022 (10,984 doses), the 2019 peak levels have not been reached again.

Table 3. Hepatitis B vaccination in GBMSM, counts of first, second, third, fourth and booster doses, SHS, England, 2017 to 2022

Hepatitis B vaccination dose	2017	2018	2019	2020 [note 2]	2021 [note 2][note 3]	2022
1st dose	11,080	11,864	14,637	6,801	9,250	10,984
2nd dose	7,659	7,635	11,068	5,082	7,345	8,204
3rd dose	6,053	4,618	7,933	3,952	4,851	5,937
4th dose	857	806	893	451	496	603
Booster	2,702	3,307	4,298	2,191	2,833	3,432

Source: STI diagnoses and services by gender and sexual orientation, UKHSA.

[note 2] The numbers of vaccination doses reported in 2020 and 2021 are lower than reported in previous years due to reduced face to face service provision at SHSs during the periods of COVID-19 lockdown.

[note 3] Due to incomplete reporting of some sexual orientation data in 2021, the number of vaccination doses in GBMSM is under-reported.

Research using unlinked anonymised testing of residual serum samples from GBMSM who attended SHSs (mainly in London) for syphilis and HIV testing in 2017 to 2018 found that immunity to hepatitis B was 77.1%.

Another study from the NIHR HPRU in Blood Borne and Sexually Transmitted Infections at UCL found that among adults who used a HIV home self-testing service in 2016, evidence of hepatitis B immunity was lower at 29.9% of GBMSM and 17.4% of heterosexuals. Vaccine uptake among GBMSM completing an online community-based survey via social media and data apps was 72%, and of these 75% completed the full course. Behaviour considered at higher risk of acquiring hepatitis B, a prior diagnosis of HIV, visiting a SHS, having a STI test in the past year or receipt of Pre-Exposure Prophylaxis (PrEP) for HIV were all associated with increased vaccine uptake.

Vaccination for females engaged in sex work is recommended in the Green Book. Research among female sex workers (FSWs) attending SHSs between 2015 to 2019 found a low uptake (30%) and coverage (37%) of hepatitis B vaccination; further research is needed to understand how to remove barriers to vaccination for this group.

1.6.2 Vaccine uptake in PWID

PWID are at increased risk of acquiring hepatitis B and vaccination is recommended for them and their close contacts. Vaccination recommendations for individuals engaged in, or potentially transitioning to, injecting drug use have been in place since the 1980s. Immunisation efforts for PWID have historically played a pivotal role in reducing acute hepatitis B infections, as highlighted in the Green Book.

Data from the UAM survey of PWID for England indicates that self-reported uptake of at least one dose of hepatitis B vaccine has decreased from 74.6% in 2015 to 60.7% in 2022. Prior to 2019, uptake remained relatively stable between 71.3% and 74.6% (Figure 9).

Figure 9. Proportion of PWID self-reporting at least one hepatitis B vaccination, England, 2013 to 2022, calendar year [note 4][note 5][note 6]

Source: UAM survey of HIV and viral hepatitis among PWID, 2023 report, UKHSA.

[note 4] Recent initiates are defined as people who first injected drugs during the preceding 3 years.

[note 5] UAM survey data is provided for combined years due to limited recruitment due to the COVID-19 pandemic.

[note 6] During 2020 and 2021, recruitment to the UAM survey was impacted by the COVID-19 pandemic. As a result, there were changes in the geographic and demographic profile of those taking part. This should be considered when interpreting data for these years. For more information, please see the UAM annual data tables report.

In 2022, hepatitis B vaccination uptake was particularly low among those aged 25 years and under as well as recent initiates to injecting drug use (those who first injected during the preceding 3 years), where vaccine uptake was 23.9% and 38.4%, respectively. However, the number of people participating in the UAM who are in the 25 years and underage group and/or who recently started injecting is small (and declining) and these results should be interpreted cautiously. UAM survey data indicates that these people report recent contact with other services, such as general practice, prison health and drug treatment services, highlighting missed opportunities for hepatitis B vaccination.

Data from the National Drug Treatment Monitoring System (NDTMS) in England also shows a similar trajectory in the proportion of those at risk who are offered and accept a hepatitis B vaccine, declining from 58% in 2011 to 48% in 2019, and, using a new methodology, from 42% in 2020 to 38% in 2022 (Figure 10).

Figure 10. Hepatitis B vaccine acceptance amongst PWID from the NDTMS, England, 2011 to 2023 tax year [note 7][note 8]

Source: NDTMS, Office for Health Improvement and Disparities (OHID).

[note 7] Excludes those previously vaccinated, with acquired immunity, deferred due to clinical reasons or assessed as inappropriate to offer. Includes those with ‘missing’ data.

[note 8] NDTMS data on the proportion offered and accepting an hepatitis B vaccine for the 2020 to 2021 tax year is not comparable to previous years. Data for the 2020 to 2021 tax year represent people newly presenting for drug treatment, instead of all PWID presenting for drug treatment.

1.6.3 Vaccine uptake in prisons and detained settings

Due to multiple factors, people in prison and other detained settings can be at a higher risk of bloodborne viruses than the general population and so immunisation against hepatitis B is recommended for everyone residing within a prescribed place of detention.

Currently the Health and Justice Strategic Reporting Unit (H&J SRU) provides information on vaccine coverage in these settings. During 2022 to 23, 48% of people in prisons were identified as having had at least one dose of hepatitis B vaccine. However, it is not possible to ascertain from the way data is collected if individuals were vaccinated in prison or elsewhere. These data can be subject to data quality issues and may result in an under-estimate; work is ongoing to increase data linkage between health and justice data systems to improve reporting of vaccine uptake amongst prisoners.

1.7 Prevention of infection by ensuring safe blood supplies

Blood donors are a cohort with a lower risk of bloodborne virus infection because people with a history of associated risk factors are asked not to give blood. All donations are individually screened for HBsAg, plus hepatitis B nucleic acid testing is performed in pools of 24. All repeat reactive donations and donors undergo confirmatory testing. Donors with a confirmed positive donation test result are referred for follow up and notified to the local Health Protection Team.

Screening for antibodies to hepatitis B core antigen (anti-HBc) was rolled out in 2022 to mitigate the potential risk of occult hepatitis B infection (OBI) to the blood supply. This followed recommendations from the Advisory Committee on the Safety of Blood, Tissues and Organs OBI working group to screen all donors at least once. A person with OBI is defined as having undetectable levels of HBsAg in the blood but with low and variable levels of hepatitis B DNA which may not be detected by pooled screening, and with detectable levels of anti-HBc.

There were approximately 800,000 donors in England in 2022 giving around 1,500,000 donations, of which approximately 115,000 (8%) donations were given by new donors. The rate of hepatitis B in new donors in 2022 was 55.9 per 100,000 donations, which was the second highest rate since surveillance began in 1996 (Figure 11). Prior to 2021 the average rate for 1996 to 2020 was 34.7 per 100,000 donations.

The number and rate of hepatitis B in repeat NHSBT donors is low (compared to new donors) ranging from 0.1 per 100,000 donations to 0.6 per 100,000 donations. In 2022, the rate in repeat donors was 0.4 per 100,000 donations.

Figure 11. Rate of hepatitis B among donations from new and repeat blood donors, England, 1996 to 2022 calendar year

Source: NHS Blood and Transplant (NHSBT), UKHSA Epidemiology Unit.

In 2022, 70 blood donors in England were confirmed to be living with hepatitis B, 64 of whom were new donors. Five donors had acute hepatitis B, 3 of whom were repeat male donors reporting sex with women. Sixty donors had chronic hepatitis B with 56 born abroad. The increase in rate of hepatitis B amongst new donors in the last few years mainly reflects increased diversity in donors: the proportion of individuals of black, black British, African, and Caribbean and Asian and Asian British ethnicity has increased to meet clinical need, and previously undiagnosed hepatitis B infections are being detected. The remaining 5 donors had occult hepatitis B, of whom 4 were born abroad. A further 1,578 of 487,763 (0.3%) donations testing positive for anti-HBc were likely to be from donors with past hepatitis B (not shown).

Overall, from 2009 to the end of 2022, 37 donors with an OBI were identified, including 2 identified by anti-HBc testing. Country of birth was known for 34 of these donors, of whom 8 (23.5%) were born in the UK. Possible exposure was identified in 26 donors (70.3%) with 21 associated with travel to an endemic area.

Screening of donations does not completely prevent hepatitis B transfusion transmitted infection (TTI) due to the long window period of hepatitis B virus where assays will not detect very recently acquired infections, or occult infections, with low levels of DNA which may be below the level of detection of current tests. With a low hepatitis B incidence in the general and donor populations, it is estimated that there is a less than one in a million chance of not detecting a potentially infectious window period donation. This equates to up to one donation per year which may lead to a new acquisition of hepatitis B if an infectious dose is transfused to a susceptible patient. Prior to anti-HBc screening, modelling work estimated that at least 13 potentially infectious donations from donors living with OBI remained undetected annually. Since 1996, there have been 11 reported confirmed hepatitis B TTI incidents with 15 recipients, plus 4 further probable incidents due to OBI.

Further data on donors living with hepatitis B is also available from the NHSBT and UKHSA Epidemiology Unit annual review.

The recent Infected Blood Inquiry has highlighted the risk of transmission of BBVs through blood transfusions and some blood products before screening of donations and viral inactivation processes were implemented. Screening for hepatitis B virus in blood donations was in place from the 1970s, therefore very few of the transmission incidents during the inquiry period were related to hepatitis B infection. The publication of the report may, however, lead to increased awareness of BBVs and particularly hepatitis C testing for those who received transfusions prior to hepatitis C screening of donations.

1.8 Prevention of infection by ensuring safe injections in healthcare

The UK adheres to the EU Directive for the prevention of sharps injuries in the healthcare setting, by using safety engineered devices. The WHO programmatic target requires 90% of healthcare injection devices procured to be safety-engineered. In 2022, 85% of all sharps purchased by NHS procurement had been safety engineered, increasing from 58% in 2015 (Figure 12). Sharps have been defined as per the NHS Supply Chain framework for Syringes, Needles and Associated Products. Non-safety engineered sharps may be purchased for several reasons, including unavailability of safety engineered devices (for example, spinal, epidural, and biopsy sharps), supply chain disruptions (for example, COVID-19), lower cost, and clinical preference or need.

Figures 12a and 12b. The number and proportion of safety engineered sharps purchased by year, England, 2015 to 2022 calendar year [note 9][note 10]

Figure 12a

Figure 12b

Source: NHS Supply Chain [note 10].

[note 9] A ‘safety engineered sharp’ is defined as all products purchased that has a safety device which meets the 2010/32/EU directive. Safety-engineered injection devices are those with a sharps injury protection feature or the use of injection devices with a reuse prevention feature.

[note 10] Data from NHS Supply Chain, which has over 90% market share of purchasing syringes, needles and associated products, intravenous cannulas and associated products and blood collection systems.

1.9 Trends in incidence of acute hepatitis B

Acute infectious hepatitis is a notifiable condition. Data on incidence of reported acute hepatitis B infection is available from 1980, based on laboratory reports and reconciliation with clinician reporting of acute viral hepatitis. The number of laboratory-reported acute hepatitis B diagnosis can be used as an indicator of national trends.

Acute hepatitis B infection is when a person has test results positive for HBsAg and anti-HBc immunoglobulin M (IgM), and also has abnormal liver function tests with a clinical pattern consistent with acute viral hepatitis. As part of enhanced molecular surveillance of acute hepatitis B, diagnostic laboratories are requested to submit samples from people living with acute hepatitis B to UKHSA BBVU for confirmation and sequencing.

Figure 13 shows the number of acute hepatitis B diagnoses in England since 1980. Between 2015 and 2022 an average of 342 acute hepatitis B diagnosis were reported annually to UKHSA (range from 175 to 457). Despite a continuous decline in the number of people living with acute hepatitis B in England since 2015, 239 individuals were reported in 2022 which indicates that reporting is returning to pre-pandemic levels. For the year 2022, where sex was reported, 60% (139 out of 231) of those diagnosed with acute hepatitis B were male. The median age of those living with acute hepatitis B was 45 years (interquartile range (IQR) 30 to 56); 48 years for those who reported their gender as male (IQR 31 to 61) and 40 years (IQR 26 to 52) for those who reported their gender as female.

Figure 13. Number of diagnosed with acute hepatitis B, England, 1980 to 2022 calendar year [note 11]

Source: Second Generation Surveillance System (SGSS), MOLIS and HPZone

[note 11] Data from 2004 to 2008 not available due to change in reporting and surveillance system. Laboratory and clinical reporting systems were reinstated in 2008.

Where ethnicity was known 48% (93 out of 194) were of white British ethnicity, followed by people of black, black British, Caribbean or African ethnicity (19%; 36 out of 194). Where region was reported, the highest proportion of cases were from London (22%; 46 out of 208) followed by the West Midlands (14%; 30 out of 208).

As part of the national enhanced surveillance programme for acute hepatitis B, samples from people diagnosed with acute hepatitis B are requested for avidity testing and molecular characterisation. This testing aims to confirm the acute hepatitis B diagnosis with additional genotyping and phylogenetic analysis informing on the diversity of circulating viruses and identifying emerging clusters. In 2022, the BBVU at UKHSA received only 45% (107 out of 239) of samples for avidity testing and molecular characterisation, while 88% (208 out of 239) were notified to Health Protection Teams and recorded on HPZone. The remaining 12% (29 out of 239) were identified through laboratory reporting only.

Avidity testing indicated that approximately 20% of samples from individuals diagnosed with acute hepatitis B were mis-classified and were instead likely to be associated with a chronic hepatitis B infection. Molecular characterisation showed the 5 major globally dominant hepatitis B genotypes to be present with genotype A to be the most common virus (39.3%), followed by genotype D (28%), genotype E (16.8%), genotype C (13.1%) and genotype B (2.8%). This genotype distribution trend is similar to what has been observed in samples from acute hepatitis B cases over a 5-year period with a possible increase in genotype E cases noted in 2022.

Risk factor information was available for 66% of the individuals where a sample was sequenced. At 81%, sexual contact was the dominant risk factor with 59% and 20% of individuals stating heterosexual contact and GBMSM respectively to be linked to their diagnosis; sexual contact was not specified in the remaining 2% of individuals.

Figure 14 shows phylogenetic analysis across the HBsAg region on 368 sequences generated from acute hepatitis B cases between 2018 and 2022, indicating a dominant cluster within the genotype A2 viruses. Approximately 34% of the generated sequences grouped within this cluster, and these sequences, were commonly seen across all 5 years. Another notable cluster of 20 sequences was observed within genotype C1. A male dominance was noted in both clusters and mapping of available information indicated GBMSM and heterosexual contact to be the dominant risk factors in the A2 and C1 clusters respectively.

Figure 14. Phylogenetic analysis of acute hepatitis B diagnoses, England, 2018 to 2022 calendar year [note 12] [note 13]

Source: UKHSA acute hepatitis B surveillance programme.

[note 12] Filled circles indicate samples received in 2022.

[note 13] Phylogenetic tree based on 678 nucleotides of the HBsAg region from 368 sequences. All sequences were generated from cases of acute hepatitis B identified between 2018 and 2022. Hepatitis B genotypes are indicated by the letter and colours in the outer circle.

Question 6

2.  Reducing hepatitis B-related mortality by increasing diagnosis and treatment

Accepted Answer

Targets related to reducing mortality include an absolute combined target of 6 or fewer hepatitis B and C-related deaths per 100,000 population annually. Previous targets separated hepatitis B and hepatitis C mortality at 4 per 100,000 and 2 per 100,000 persons respectively but these have now been combined to reflect the overall goal of eliminating viral hepatitis. Data to monitor trends in viral hepatitis-related mortality is available from the Office of National Statistics (ONS) (for further details, see Appendix 2).

As England is a low prevalence country for hepatitis B the absolute targets for mortality have been achieved for several years; the current mortality rate is 0.15 per 100,000 population. However, it is still important to monitor trends in hepatitis B mortality to ensure that progress continues to be made in addressing avoidable morbidity and mortality.

WHO programmatic targets relate to diagnosis of people living with hepatitis B and ensuring that those eligible for treatment are receiving it. Data on people diagnosed is derived from national surveillance systems and includes a number of interventions to proactively identify people living with undiagnosed hepatitis described in the subsections below. Treatment data continues to be an area of development with significant collaborative work underway between UKHSA, NHSE, NHS trusts and academic partners (Table 4).

Table 4. WHO impact and programmatic targets for reducing mortality from hepatitis B, England, 2022

Target type	Target	WHO 2030 target	Most recent data for England 2021 to 2022
Impact	Hepatitis B mortality	4 per 100,000 or less	0.15
Programme	Proportion of people living with hepatitis B diagnosed	90% or more	Estimated range 31.0 to 46.8% [note 14]
Programme	Proportion of people diagnosed with hepatitis B and eligible, receiving treatment	80% or more	Data not available

[note 14] This new estimate is based on experimental data.

Death registrations from hepatitis B-related ESLD and/or HCC have remained below 0.2 per 100,000 population since 2005. The annual hepatitis B-related ESLD and/or HCC mortality rate in 2022 was 0.15 per 100,000 population (Figure 15), and this rate has remained stable between 0.13 and 0.19 since 2005. The number of deaths peaked in 2011 with 100 death registrations, which has declined to 84 in 2022 (Figure 16).

Figure 15. Death registrations for hepatitis B-related ESLD [note 15] and/or HCC, England, 2005 to 2022 calendar year [note 16][note 17]

Source: ONS.

[note 15] Defined by codes or text entries for ascites, bleeding oesophageal varices, hepato-renal syndrome, hepatic encephalopathy, or hepatic failure.

[note 16] Excluding deaths registered in England when the deceased’s usual residence is outside England or postcode is missing.

[note 17] For further information on methodology see Appendix 2. Technical note 4 on monitoring hepatitis B-related mortality.

While hepatitis B-related mortality is below the WHO absolute target there has been no overall reduction in deaths since 2005 with a slight increase in hepatitis B-related HCC deaths over time from 48 in 2005 to 60 in 2022 (Figure 16).

Figure 16. Number of death registrations [note 18] for hepatitis B-related ESLD [note 19] and/or HCC registrations, England, 2005 to 2022 calendar year

Source: ONS.

[note 18] Excluding deaths registered in England when the deceased’s usual residence is outside England, or the postcode is missing.

[note 19] Defined by codes or text entries for ascites, bleeding oesophageal varices, hepato-renal syndrome, hepatic encephalopathy, or hepatic failure.

The proportion of death registrations for hepatitis B-related ESLD and/or HCC also differs by socioeconomic deprivation. Deprivation is measured using the Index of Multiple Deprivation (IMD). The first quintile (Q1) represents the most deprived 20% of lower super output areas (LSOAs) in England and the fifth quintile (Q5) the least deprived 20% of LSOAs.

Almost two-thirds (63.5%) of hepatitis B-related ESLD and/or HCC deaths occurred among people living in the most deprived areas (36.7% in Q1 and 26.8% in second quintile (Q2)). In contrast, 19.9% of such deaths were seen in those living in the least deprived areas (11.6% in fourth quintile (Q4), 8.3% in Q5) (Table 5) To reduce hepatitis B-related mortality and these associated inequalities, considerable effort is required to ensure early diagnosis, linkage to and retention in care and availability of treatment for everyone living with hepatitis B.

Table 5: Number of death registrations for hepatitis B-related ESLD and/or HCC by IMD, England, 2005 to 2022

IMD quintile	Number of death registrations	%
Q1 (Most deprived)	566	36.7
Q2	413	26.8
Q3	257	16.7
Q4	179	11.6
Q5 (Least deprived)	128	8.3
Total	1,543	Not applicable

Source: ONS.

Hepatitis B-related morbidity can be estimated by monitoring the incidence of hepatitis B-related ESLD and/or HCC in England using Hospital Episode Statistics (HES) (for further details see Appendix 2. Technical note 5 on monitoring hepatitis B-related morbidity associated with ESLD and/or HCC).

In 2022, HES analysis identified 570 people with first presentations to hospital with hepatitis B-related ESLD and/or HCC: 102 people had first presentations with hepatitis B-related HCC, 382 people had first presentations with hepatitis B-related ESLD, and 86 people had first presentations with both hepatitis B-related ESLD and HCC. The number represents a 30.1% reduction from 815 people with first presentations in 2019 to 570 in 2022 (Figure 17).

Figure 17. Incidence of hepatitis B-related ESLD [note 20] and/or HCC in England, 2010 to 2022 calendar year [note 21][note 22][note 23]

[note 20] Defined by codes or text entries for ascites, bleeding oesophageal varices, hepato-renal syndrome, hepatic encephalopathy, or hepatic failure.

[note 21] Estimates of incidence of hepatitis B-related ESLD [note 20] and/or HCC are not available for 2017 and 2018. This is due to an interruption in the supply of identifiers by NHS Trusts in tax year April 2017 to March 2018.

[note 22] Data based on HES as of January 2024.

[note 23] For further information on methodology see Appendix 2. Technical note 5 on monitoring hepatitis B-related morbidity associated with ESLD and/or HCC.

When looking at ethnicity of people with a first episode of hepatitis B-related ESLD and/or HCC (Table 6), just over half (54.8%) were white. A higher proportion of cases were among people from Asian or Asian British (19.3%) and black, black British, Caribbean or African (16.8%) origin than would be expected based on the general population.

Table 6. Ethnicity breakdown of people with a first episode of hepatitis B-related ESLD [note 24] and/or HCC, England, 2010 to 2022 [note 25][note 26]

Ethnic group	Number	%
Asian or Asian British	1,259	19.3
Black, black British, Caribbean or African	1,091	16.8
Mixed or multiple ethnic groups	142	2.2
White	3,571	54.8
Other ethnic group	448	6.9
Total	6,511	100

[note 24] Defined by codes or text entries for ascites, bleeding oesophageal varices, hepato-renal syndrome, hepatic encephalopathy, or hepatic failure.

[note 25] Estimates of incidence of hepatitis B-related ESLD and/or HCC are not available for 2017 and 2018. This is due to an interruption in the supply of identifiers by NHS Trusts in tax year April 2017 to March 2018.

[note 26] Data based on HES as of January 2024.

A similar association between hepatitis B-related ESLD and/or HCC, and deprivation is seen as with mortality; between 2010 and 2022 the IMD distribution among people newly diagnosed with hepatitis B-related ESLD and/or HCC has remained relatively stable with over half drawn from the most deprived 40% of areas (Q1 and/or Q2) and only 20% from the least deprived 40% of areas (Q4 and/or Q5) (Figure 18).

Figure 18. IMD breakdown of people newly diagnosed with hepatitis B-related ESLD [note 27] and/or HCC in England by calendar year, 2010 to 2022 [note 28][note 29]

[note 27] Defined by codes or text entries for ascites, bleeding oesophageal varices, hepato-renal syndrome, hepatic encephalopathy, or hepatic failure.

[note 28] Estimates of incidence of hepatitis B-related ESLD and/or HCC are not available for 2017 and 2018. This is due to an interruption in the supply of identifiers by NHS Trusts in tax year April 2017 to March 2018.

[note 29] Data based on HES as of January 2024.

Between 2009 and 2022, first registrations for a liver transplant fluctuated between 18 and 40 per year. Over this period, 399 patients had post-hepatitis B cirrhosis or acute hepatitis B reported as either the primary, secondary, or tertiary indication for a transplant (Figure 19). Over the same period, first liver transplants fluctuated between 13 and 33 per year with a total of 285 patients receiving a first liver transplant where post-hepatitis B cirrhosis and/or acute hepatitis B or hepatitis B-related HCC were reported as primary, secondary or tertiary indication at registration or transplant.

Figures 19a and 19b. Number of hepatitis B-related liver transplant registrations and transplants, England, 2009 to 2022 calendar year [note 30]

Figure 19a

Figure 19b

Source: NHSBT UK Transplant Registry. These figures are based on registry data as of January 2024 and include both elective and urgent registrations.

[note 30] Hepatitis B status was ascertained by interpreting results for the following hepatitis B virus markers hepatitis B DNA, HbsAg and HbeAg.

[note 31] Number of first registrations for a liver transplant where post-hepatitis B cirrhosis or acute hepatitis B were given as either primary, secondary or tertiary indications for transplant.

[note 32] First liver transplants undertaken where post-hepatitis B cirrhosis and/or acute hepatitis B or hepatitis B-related HCC were given as primary, secondary, or tertiary indication for transplant at registration and transplant.

[note 33] First liver transplants undertaken where post-hepatitis B cirrhosis or acute hepatitis B or hepatitis B-related HCC were given as primary, secondary, or tertiary indication for transplant at registration and transplant as a percentage of all liver transplants.

Table 7 shows that a much higher proportion of hepatitis B-related liver transplants are among ethnic minority groups compared to overall liver transplants. Between 2009 to 2022, 62.1% of hepatitis B-related transplants were among people of Asian or Asian British, black, black British, Caribbean or African, and other ethnic groups, compared to only 16.9% of all liver transplants during the same period. This likely reflects the high prevalence of hepatitis B in regions such as sub-Saharan Africa and Asia.

Table 7. Number of liver transplant registrations and transplants by hepatitis B status and ethnicity, England, 2009 to 2022 [note 34][note 35]

Ethnicity	All liver transplant registrations (%)	All liver transplants (%)	Hepatitis B-related liver transplant registrations [note 36] (%)	Hepatitis B-related liver transplants [note 37] (%)
Asian or Asian British	1,425 (11.3)	1,086 (11.3)	143 (36.4)	105 (37.5)
Black, black British, Caribbean or African	494 (3.9)	361 (3.8)	77 (19.6)	55 (19.6)
Mixed or multiple ethnic groups	41 (0.3)	27 (0.3)	0	0
White	10,490 (82.8)	7,946 (82.9)	151 (38.4)	106 (37.9)
Other ethnic group	215 (1.7)	170 (1.8)	22 (5.6)	14 (5.0)
Total	12,665	9,590	393	280

Source: NHSBT UK Transplant Registry.

[note 34] These figures are based on registry data as of January 2024 and includes both elective and urgent registrations.

[note 35] Hepatitis B status was ascertained by interpreting results for the following hepatitis B virus markers: hepatitis B DNA, HbsAg and HbeAg.

[note 36] First registrations for a liver transplant where post-hepatitis B cirrhosis or acute hepatitis B were given as either primary, secondary or tertiary indications for transplant.

[note 37] First liver transplants undertaken where post-hepatitis B cirrhosis and/or acute hepatitis B or hepatitis B-related HCC were given as primary, secondary, or tertiary indication for transplant at registration and transplant.

2.4 Proportion of people with chronic hepatitis B diagnosed and aware of their infection

The WHO service coverage target aims to achieve a diagnosis rate of 90% or higher among people living with hepatitis B. This target serves a dual purpose. Firstly, by ensuring timely diagnosis and intervention, the spread of hepatitis B is mitigated. Secondly, by facilitating early detection and management, it reduces the burden of morbidity and mortality associated with hepatitis B-related liver disease. SGSS and SSBBV are used to monitor testing and diagnosis in the general population and risk groups (see Appendix 2) for further information).

Experimental data to estimate the proportion of people with chronic hepatitis B diagnosed in England uses laboratory-confirmed reports of all hepatitis B diagnoses (HbsAg) reported to UKHSA via NHS or private laboratories in England, and data linkage to established healthcare datasets. Laboratory-confirmed reports of hepatitis B diagnoses, excluding reported acute infections, were linked to the ONS death registrations to remove people who are known in England to have died. Remaining records were linked to the NHS Personal Demographic Service (PDS) to map an individual’s current region of residence, and HES to identify those who have engaged with secondary care for any reason within the past 3 years as a proxy for still residing in England.

Between 1998 and 2023, 163,363 individuals had a diagnosis of hepatitis B (HbsAg) in England reported to UKHSA. After linking to ONS death registrations, records of acute infections and the NHS PDS, individuals with a reported death in the UK, an acute infection, and/or resident outside of England were excluded. After exclusions, 102,502 individuals were estimated to be living with diagnosed hepatitis B in England, representing 38.1% of the 268,767 people estimated (using the methodology described above) to be living with chronic hepatitis B; 36.2% for London and 39.9% outside London.

Since some individuals diagnosed with hepatitis B may have left the country but still be registered with a general practitioner (GP), engagement with secondary care services for any reason in the past 3 years was used as an additional proxy for still being resident in England. This resulted in a lower estimate of 31.0% living with diagnosed hepatitis B in England: 30.5% for London and 33.2% for outside London (Figure 20). An upper estimate of people with diagnosed hepatitis B was calculated by applying the same regional distribution for those without identifiers for linking, resulting in estimates of 46.8% for England, 47.8% for London and 49.1% for outside London.

Figure 20. Estimated proportion of individuals living with diagnosed chronic hepatitis B, England, 1998 to 2023 [note 38]

Source: SGSS, HES, prevalence estimates using SSBBV testing.

[note 38] Excluding those reported to have died in the UK, an acute infection, and/or resident outside of England.

2.5 New laboratory-confirmed diagnoses of hepatitis B in England

England’s laboratory-confirmed reports of hepatitis B diagnoses received through SGSS have steadily climbed over 20 years, driven by factors like enhanced awareness, improved diagnostics, targeted testing, and improved, including mandatory, reporting. There was a more than 6-fold increase between 1999 and 2016, peaking at over 11,454 new diagnoses in 2016, followed by a 25% decrease to 8,346 reports in 2019 (Figure 21). Reports of new diagnoses decreased further through the COVID-19 pandemic years (2020 to 2021), however new diagnoses have increased in 2022 with 9,614 new diagnoses; greater than pre-pandemic levels in 2018 and 2019.

Figure 21. Number of laboratory reports of hepatitis B, England, 1999 to 2022 calendar year

Source: SGSS.

2.5.1 Age and sex distribution of hepatitis B diagnoses

Between 1999 and 2022, hepatitis B diagnoses in England displayed distinct trends in sex and age. While males consistently comprised on average 56.0% (range 51.1% to 62.5%) of people diagnosed, there has been an upward shift in age at diagnosis, resulting in an aging cohort. In 1999, 58.8% of diagnoses occurred in individuals 35 years and under, but this steadily decreased to 32.1% by 2022. Conversely, the number of new diagnoses that were among people in the 35 to 64 age group surpassed that among those 34 years and under in 2014 and continued to climb, reaching 58.9% in 2022 compared to 35.5% in 1999. Diagnoses among people aged 65 years and over also saw a slight increase, rising from 5.2% to 7.6%. This trend has continued in 2022, with two thirds of new diagnoses occurring in people aged 35 and above, compared to just 40.6% in 1999.

Historically, females were younger at diagnosis with a much higher proportion of diagnoses amongst females in those aged 35 years and under compared with other age groups. Among females, the proportion of new diagnoses that were among people 34 years and under decreased from 71.1% in 1999 to 37.0% in 2022, with the proportion of males dropping from 52.5% to 30.8% over the same period.

2.5.2 Ethnicity distribution of hepatitis B diagnoses

An estimated 95% of new chronic hepatitis B diagnoses in the UK are in migrants, who acquired their infection overseas in endemic countries, most often perinatally. Data on ethnicity was available for 61.6% of laboratory reports of new diagnoses. Most people for whom ethnic origin was unknown were tested in sexual health and drug and alcohol services where only minimal demographic data is available.

Figure 22 shows that, between 1999 and 2022, of all laboratory reports where ethnicity was available, 28.0% of diagnoses were in people of Asian or Asian British ethnicity, followed by 27.6% of diagnoses among people of black, black British, Caribbean or African ethnicity. Over time the ethnicity breakdown has changed with the proportion of laboratory reports among people of white British ethnicity reducing significantly as diagnoses among other black, Asian and other white ethnic groups has increased.

Figure 22. Trends in the ethnicity distribution of those newly diagnosed with hepatitis B from laboratory reports, England, 1999 to 2022 calendar year

Source: SGSS.

2.5.3 Socioeconomic distribution of hepatitis B diagnoses

Figure 23 presents the IMD distribution of people newly diagnosed with hepatitis B in England between 2018 and 2022. The completeness of IMD has greatly improved over this time, with the proportion of diagnoses with linked IMD data increasing from 9.8% in 2018 to 70.7% in 2022.

Approximately 60% of new hepatitis B diagnoses over the 5-year period are in people residing in IMD Q1 and Q2, the 2 most deprived IMD quintiles. This underscores the association between hepatitis B infection and socioeconomic deprivation, highlighting the disproportionate burden of the disease on socioeconomically disadvantaged communities.

Figure 23. IMD distribution of new hepatitis B diagnoses, England, 2018 to 2022 calendar year

Source: SGSS.

2.6 Hepatitis B testing

Analysis of data from 23 sentinel laboratories, available since January 2015, provides information on trends in testing activity. Overall, the number of individuals tested for HBsAg demonstrated a steady increase of 60% between 2015 and 2019, followed by a 30% decrease in 2020, associated with the COVID-19 pandemic. Since the COVID-19 pandemic, testing rates have exhibited partial recovery in both 2021 and 2022 but have not yet surpassed the 2019 peak. This increase in testing between 2015 and 2019 is observed across all settings, as is the drop in testing in 2020 during the COVID-19 pandemic. However, while testing in GP and drug services have seen a partial recovery, and renal services have recovered fully in the number of individuals tested during 2021 and 2022, this recovery has not been observed in sexual health and prisons services where testing is 37.7% and 43.1% lower, respectively, in 2022 than in 2019.

Test positivity remained stable throughout this period, ranging from 0.8% in 2020 to 1% in 2015. This suggests a consistent testing focus on people at increased risk of exposure to hepatitis B, despite overall volume fluctuations. This was similar across all services.

Throughout this period, people aged 35 to 64 years consistently comprised the largest proportion of tests conducted ranging from 40.1% to 46.6% each year. Higher positivity rates were also identified in this age group, ranging between 1.0% and 1.1%. Some of the highest positivity rates were in 2020 in drug services (2.0%) indicating that while testing was limited, those at high risk of acquiring hepatitis B continued to be tested. Positivity is lowest in renal settings, averaging under 0.5%. Individuals tested in SHS were younger with the majority of tests conducted among those aged 15 to 34 years ranging from 58.5% to 64.6%, as were those tested in prison. Whilst males were more likely to test in SHS, drugs services, renal services and prisons compared to women, a higher proportion of women tested through GPs.

Regardless of testing service, people of white British ethnicity contributed to the highest percentage of HBsAg tests. However, overall, positivity rates were highest for those of black, black British, Caribbean or African ethnicity; this pattern was seen in those testing in GP, drug services and prisons whereas among those testing in SHS, positivity was highest in those of Asian or Asian British ethnicity. Those of white British ethnicity had the lowest positivity across all settings.

2.7 Hepatitis D testing and diagnosis

Hepatitis D is caused by the hepatitis D virus (HDV), and only occurs in people who are also living with hepatitis B. Living dually diagnosed with both hepatitis D and B can cause the most severe form of chronic viral hepatitis due to more rapid progression towards cirrhosis, HCC and liver-related death. NICE guidelines state that a test for hepatitis D viral antibodies should be arranged following a HBsAg positive result.

Data collected from the 8 laboratories in England that undertake testing for hepatitis D, antibody and/or RNA, suggests that between 2011 and 2021, fewer than half of people newly diagnosed with hepatitis B have a subsequent hepatitis D test: this has remained stable over time. During this 11-year period, hepatitis D viralHDV antibody test positivity was 4.9%, and among those tested for hepatitis D RNA (regardless of an antibody test) RNA test positivity was 16.2%. Among people who had a hepatitis D antibody positive result, 55.6% had a subsequent hepatitis D RNA test, of which 45.7% were RNA positive. The median time between antibody and RNA tests was 0 days (IQR: 0 to 111 days), indicative of reflex testing for RNA on the same sample.

Where disease stage was available, 17.2% of people with an antibody and/or RNA positive result had evidence of disease progression. Among those , and 35% of those who were RNA positive, 35% exhibited disease progression. Disease progression ranged from cirrhosis to HCC (see Figure 24).

Figures 24a and b. Number of hepatitis D viral antibody tests and positivity in England, 2015 to 2021 calendar year

Figure 24a

Figure 24b

2.8 Monitoring access to hepatitis B treatment

Entecavir and tenofovir disoproxil are the primary recommended options for people in whom antiviral treatment is indicated. Surveillance of antiviral treatment coverage of individuals living with diagnosed chronic hepatitis B is required to monitor equity in access and outcome from treatments. The main aim of current treatment strategies is to prevent chronic liver disease progression through endpoints of long-term suppression of hepatitis B virus replication, with HBsAg loss being the optimal endpoint.

As treatment eligibility has historically been complex and can change over a person’s life, with many people attending regular check-ups but not started on treatment for years, attrition in retention in care can occur. Simplified treatment guidelines may improve patient engagement, require less specialist follow up, and expedite achievement of public health programme goals. WHO have recently simplified guidance on treatment eligibility to:

those with significant fibrosis or cirrhosis, or
hepatitis B DNA more than 2,000 IU/ml and elevated alanine aminotransferase, or
living concomitantly with another infection (for example HIV, HDV, HCV), family history of cancer or cirrhosis, immune suppression, comorbidities, or extrahepatic manifestations, or
persistently abnormal alanine aminotransferase if hepatitis B DNA testing is not available

Additionally, all patients should be regularly assessed for disease progression and HCC.

Although a national comprehensive treatment monitoring system has not yet been established, healthcare company IQVIA collects data on antiviral prescriptions dispensed in secondary care pharmacies in England and shares that data with UKHSA for public health analysis. Volume data (number of packs) were extracted from IQVIA for entecavir (0.5 milligram (mg) or 1mg once daily) and for tenofovir disoproxil (245mg once daily) between 2019 and 2022. With 30 doses per pack, we estimated the number of daily doses per year and divided that by 365 (days per year) to estimate the number of individuals treated. Tenofovir, in combination with other antiretroviral drugs, is also a treatment for HIV and is recorded as a combination treatment in IQVIA. We identified any single use of tenofovir disoproxil as indicating hepatitis B treatment.

The average number of prescriptions (which equates to packs) per year between 2019 and 2022 was 60,363 units for entecavir and 115,817 units for tenofovir disoproxil. Numbers of prescriptions increased between 2019 and 2022 from 50,621 to 73,708 units for entecavir and from 114,769 to 120,469 units for tenofovir disoproxil. Between 2019 and 2022, an estimated annual average of 14,480 were treated for chronic hepatitis B: 4,961 people (Figure 25) were treated with entecavir and 9,519 people treated with tenofovir disoproxil (Figure 26). Between 2019 and 2022, the estimated number of people treated increased from 13,594 to 15,960, with treatment with entecavir increasing from 4,161 to 6,058 and treatment with tenofovir disoproxil increasing from 9,433 to 9,902. For London, an estimated annual average of 2,370 people were treated with entecavir and 4,200 with tenofovir disoproxil; outside London the estimated numbers were 2,591 and 5,319 people, respectively.

Figure 25. Estimated number of people treated for hepatitis B with entecavir, England, 2019 to 2022 calendar year

Source: secondary care usage within NHS hospitals, IQVIA Hospital Pharmacy Audit (HPA) May 2024

Figure 26. Estimated number of people treated for hepatitis B with tenofovir disoproxil, England, 2019 to 2022 calendar year

Source: secondary care usage within NHS hospitals, IQVIA Hospital Pharmacy Audit (HPA) May 2024

Question 7

3.  Raising awareness, supporting the diagnosis of people living with undiagnosed hepatitis and reducing barriers to treatment

Accepted Answer

NICE guidelines highlight the importance of up-to-date information being available and accessible to communities and professionals on hepatitis B and its consequences, vaccination, benefits of early diagnosis, and treatment.

As hepatitis B is usually asymptomatic in the early years, many people remain unaware of their infection. As a result, raising both professional and public awareness remains critical to reduce the undiagnosed burden of hepatitis B and to encourage those diagnosed to engage with specialist care and adhere to treatment to reduce long term complications of cirrhosis and cancer. Engagement in care is undermined by stigma, noting that underserved communities, already experiencing intersectional inequalities, are disproportionately affected by hepatitis B.

3.1 Raising awareness among healthcare professionals

Local audits have shown that there is variation in primary care management of people with new hepatitis B diagnoses and their close household contacts, with some people not being referred to specialist care and family or household contacts not being offered testing and immunisation. Effective interventions have been developed to support primary care in identifying and managing cases and contacts but need to be more widely implemented and may also require additional optimisation and promotion as part of their implementation. These include nurse-led enhanced management of cases and contacts, electronic flagging or risk-based search tools on GP systems, and remote or home-based sampling with non-invasive test kits. Other tools include the following:

National Institute for Health and Care Excellence (NICE) published its public health guidance ‘Hepatitis B and C testing: people at risk of infection‘ in 2012.
Resources for the antenatal screening and selective neonatal immunisation programmes are available for health professionals online.
A drugs commissioning support pack for adults is available which outlines principles that local areas might consider when developing plans for integrated alcohol and drugs prevention, treatment and recovery systems.
Public Health England (PHE) produced COVID-19 guidance for commissioners and providers of services for people who use drugs or alcohol as the availability and accessibility of services, including needle and syringe programme reduced in England during the COVID-19 pandemic.
Local authorities continue to play a central role in testing for viral hepatitis in people accessing community drug treatment services with hepatitis B testing recommended for those with a history, risks (including current or past injecting), symptoms, or findings from physical examinations that signify testing is indicated.
A RCGP eLearning course Hepatitis B and C is available to help raise awareness in primary care and among other professionals working with groups at high risk of viral hepatitis infection. By 31 December 2023, 679 individuals had completed the eLearning module.
PHE in partnership with NHSE and HM Prison and Probation Service oversaw the rollout of opt-out blood-borne virus testing in adult prisons, primarily at reception since 2013.

3.2 Raising awareness among communities at risk of acquiring viral hepatitis

A suite of resources is available in ‘Eliminate hepatitis B and C resource summary’ (1) to help encourage people at risk of acquiring hepatitis B to seek a hepatitis B test. These include posters, videos and banners for social media in multiple languages, co-branded by the World Hepatitis Alliance and the British Liver Trust.

An evidence review conducted by Liverpool John Moores University entitled ‘A practice survey of activities and interventions that aim to raise awareness among, and/or engage with, groups who are at an increased risk of hepatitis B and C infection’ describes services and interventions implemented to raise awareness in the UK among those at increased risk of acquiring hepatitis B and C. Commonly reported interventions for raising awareness were providing advice and information through leaflets and posters. For South Asian migrant populations, regional specific interventions included outreach in mosques, providing information to South Asian men, and ‘on the spot testing’.

NHSE have funded community vans to support safe community working across operational delivery networks, clinical networks established by NHSE, which are responsible for delivering hepatitis C treatment in England. These and other independently funded mobile vans focus on areas of high health inequality and offer hepatitis C testing (and treatment) to people from various backgrounds such as those who sleep rough, asylum seekers, sex workers, GBMSM and PWID. Providers operating the mobile vans also engage with other local professionals to include addiction service workers, needle exchange and access to testing for other conditions as a part of van delivery, including hepatitis B, HIV, STIs and occasionally tuberculosis.

3.3 Bloodborne virus opt-out testing in EDs

A 3-year NHSE funded programme of ED opt-out testing for HIV, hepatitis B and hepatitis C was launched in April 2022 in sites in London, Brighton, Manchester and Blackpool that were selected due to being in areas of very high diagnosed HIV prevalence. London adopted a city-wide implementation approach and included all Type 1 EDs (major EDs that provide a consultant-led 24-hour service with full facilities for resuscitating patients). Among the 3 bloodborne viruses tested for in the programme, the highest number and proportion of new diagnoses were for hepatitis B, reflective of the higher prevalence of people living with undiagnosed hepatitis B compared to HIV and hepatitis C. Across 16 sites where SSBBV data was available, there were 646 new hepatitis B diagnoses between April 2022 and March 2023. At 5 London sites selected for a deep dive analysis, hepatitis B positivity was 1.1%, with new diagnoses higher among people aged 35 to 64 and those of black African ethnicity.

UKHSA is co-leading on a new research project, commissioned through NIHR, which will evaluate an expansion of the ED opt-out testing programme to an additional 47 sites in areas of high diagnosed HIV prevalence starting from April 2024.

3.4 Stigma

There is a need to better understand and address stigma and discrimination experienced by people living with hepatitis B in England to improve the overall health and wellbeing of people living with hepatitis B and thereby aid England’s achievement of WHO goals. UKHSA is currently collaborating with national and international partners to undertake a body of work to understand and minimise the impacts of stigma among people living with hepatitis B in England. This includes the rollout of an international community stigma index tailored for people living with either hepatitis B or hepatitis C in 2024, which is in collaboration with The World Hepatitis Alliance and the Hepatitis C Trust. This survey was piloted in February and March 2024 in several European countries including England with findings due to be published in the coming months.

Stigma is a process in which an individual or group is linked to a negative stereotype or misconception, often resulting in adverse experiences, loss of social status, and limited opportunities. Stigma can be holding negative feelings towards oneself, anticipating stigma in certain situations, or experiencing stigma and discrimination. Stigma relating to hepatitis B can impact uptake of prevention methods (for example vaccination, testing and diagnosis, and treatment). Additionally, people living with hepatitis B in England may experience stigma and discrimination relating to gender, ethnicity, migration status or behaviours associated with sexual transmission of hepatitis B. Therefore, there is a need to understand not only how stigma relating to hepatitis B may affect prevention, diagnosis and treatment, but also how wider social factors may impact these and how the impact of these factors can be mitigated.

Question 8

Appendix 1. Hepatitis B markers

Accepted Answer

Table 8. Hepatitis B markers

Hepatitis B marker	Abbreviation	Description
Hepatitis B surface antigen	HBsAg	Marker of hepatitis B infection. Can be detected in both acute and chronic hepatitis B.
Hepatitis B e antigen	HBeAg	Marker detected in the early phases of an acute infection and some chronic infections. Its presence is usually associated with high levels of virus replication.
Antibody to hepatitis B e antigen	Anti-HBe	Marker appears following HBeAg seroconversion and is detected in late acute and in chronic hepatitis B infections. Its presence usually indicates lower levels of virus replication.
IgM antibody to hepatitis B core antigen	Anti-HBc IgM	Marker indicates recent hepatitis B virus infection and can be used to differentiate between an acute and chronic infection. It may also be present during flares in chronic hepatitis B.
Total antibody to hepatitis B core antigen	Total anti-HBc	Marker indicates current or past hepatitis B infection
Antibody to hepatitis B surface antigen	Anti-HBs	Marker indicates recovery and immunity to hepatitis B . It is also detectable in those who have been immunised.
Hepatitis B virus DNA	Hepatitis B DNA	Marker measures viral load and indicates level of virus replication. Used to guide treatment decisions and to monitor response to antivirals.

Question 9

Appendix 2. Technical notes

Accepted Answer

1. Monitoring elimination of mother to child transmission

1.1 Monitoring screening coverage in antenatal population

For IDPS HBsAg coverage, eligible women are the total number of pregnant females booked for antenatal care during the reporting period, or presenting in labour without previously having booked for antenatal care, excluding women who:

miscarry between booking and testing
opt for termination between booking and testing
transfer out between booking and testing (do not have a result)
transfer in who have a result from a screening test performed elsewhere in the NHS in this pregnancy

2. Monitoring vaccination in GBMSM in SHSs

Current data on hepatitis B vaccination coverage in GBMSM is collected through the GUMCAD STI Surveillance System which collects pseudonymised patient level data on all STI diagnoses and services provided by all SHSs in England.

3. Monitoring vaccination in detained settings

The Health and Justice Indicators of Performance released on 1 April 2014 include an hepatitis B vaccine indicator, where the hepatitis B vaccine coverage for completed course (3 doses) for all eligible patients should be installed into the establishment within 4 weeks of reception. From 2019, H&J SRU Health and Justice Information System reported on uptake. This data captured which prisoners have been vaccinated for hepatitis B, but do not show whether this was in prison or in another setting. These do not specify a fully vaccinated individual and will include those with a full course or who have only received one dose.

4. Monitoring hepatitis B-related mortality

ESLD is defined by codes or text entries for ascites, bleeding oesophageal varices, hepato-renal syndrome, hepatic encephalopathy, or hepatic failure. Deaths registered in England when the deceased’s usual residence is outside England are excluded.

4.1 ICD10 codes used for HCC and/or ESLD

A full list of ICD10 codes used by UKHSA and WHO and European Centre for Disease Prevention and Control for monitoring annual hepatitis B-related mortality rates and death registrations for hepatitis B and hepatitis B-related ESLD and/or HCC are found in previous hepatitis B reports.

5. Monitoring hepatitis B-related morbidity associated with ESLD and/or HCC

ESLD is defined by codes or text entries for ascites, bleeding oesophageal varices, hepato-renal syndrome, hepatic encephalopathy or hepatic failure.

In England, new diagnoses of hepatitis B-related ESLD and/or HCC are monitored using HES. This analysis enables the production of preliminary estimates of new diagnoses (incidence) of hepatitis B-related ESLD and/or HCC. However, it is important to recognise the limitations of these estimates; hepatitis B may be unreported in HES, and patient episodes can only successfully be linked when identifiers exist in HES to allow this. New diagnoses are identified by first linking all episodes of ESLD or HCC for an individual using their unique patient identifier and then linking these to hospital records with a diagnosis of hepatitis B since 2004. Once these are linked, a diagnosis of hepatitis B-related ESLD or HCC is classified as ‘new’ if no previous episodes of ESLD or HCC for that individual are found in at least the previous 5 years (less than 1% of HCC/ESLD episodes are estimated to have had a previous episode more than 5 years earlier).

The loss of identifiers in HES data for 2017 meant that it was not possible to distinguish repeat hospital episodes for the same person and thus determine the number of incident or prevalent diagnoses of hepatitis B-related ESLD and/or HCC in 2017. This had a further effect on 2018, as although the issue was rectified, attendees may appear as incident cases in 2018 due to a failure to link to previous records in 2017, thus over-counting incident cases. To rectify this, NHS Digital facilitated a resubmission of around 54% of HES data for 2017.

The scaling factor used was the historic proportion of hepatitis B-related ESLD and/or HCC from resubmitting providers of the national total. However, exploration of more recent data suggests that this proportion may not be constant over time, which would lead to bias in estimates scaled up from the subset of resubmitted provider data. Further, it has been suggested that resubmitted data is not guaranteed to be complete for all providers. In this report, data for 2017 and 2018 is therefore omitted. By 2019, however, the residual impact of the loss of identifiers in 2017 is small. Misclassification of an incident case would require a first attendance in 2017, no attendance in 2018, then attendance in 2019.

Analysis of pre-2017 HES data shows that the proportion of people living with hepatitis B-related ESLD and/or HCC with such an attendance pattern is less than 5%, and for a 2-year gap (2020) less than 3%, indicating that observed incidence in 2019, and certainly 2020, are unlikely to overcount incidence by more than a small degree. This is also supported by further comparisons of corrected and uncorrected data sets for these years. It is unfortunate that there is now a gap in the time trend, which is likely to remain.

A total of 399 first registrations in England between 2009 and 2022 had either post-hepatitis B cirrhosis or acute hepatitis B given as the primary, secondary or tertiary indication for a liver transplant. These cases may have also had other indications for a liver transplant including:

primary biliary cirrhosis
alcoholic cirrhosis
post hepatitis C cirrhosis
HCC non-cirrhotic
HCC carcinoma cirrhotic
autoimmune cirrhosis
non-alcoholic fatty liver disease
haemochromatosis
primary liver sarcoma
other

Hepatitis B virus test markers were not available for registrations.

There was a total of 129 first liver transplants in England between 2009 and 2022 that had a code for post-hepatitis B cirrhosis and acute hepatitis B given as the primary, secondary, or tertiary indication at registration and/or transplant. These had no other indicators for a transplant. A number of these people also had a positive result for hepatitis B.

In addition, there were a total of 156 first liver transplants that had codes for HCC non-cirrhotic or HCC cirrhotic. These also had a positive result for hepatitis B and/or post-hepatitis B cirrhosis or acute hepatitis B as a transplant indicator. A small number of these people had additional indicators for transplant, which included:

autoimmune cirrhosis
secondary biliary cirrhosis
alcoholic cirrhosis
post hepatitis C cirrhosis
non-alcoholic fatty liver disease
other indicator not described

A positive hepatitis B result was described as a positive result for HBsAg and/or hepatitis B DNA and/or hepatitis B virus E-antigen.

Of the people who had post-hepatitis C cirrhosis, all had a negative or unknown result for hepatitis C RNA. NHSBT transplant indicator codes are listed in previous hepatitis B reports.

6. Monitoring proportion of people with chronic hepatitis B diagnosed and aware of their infection

It is important to note that this data is experimental and should be treated with caution and is subject to change. Some people will have been diagnosed in England prior to comprehensive laboratory surveillance so are not included in diagnosed figures. Furthermore, those who fall into the undiagnosed fraction include a proportion of people who may have been diagnosed before residing in England and therefore may be aware of their status but have not been engaged in care for their chronic hepatitis B, resulting in a HBsAg test not being conducted and reported to UKHSA.

7. Testing and diagnosis: SGSS

Laboratory reports of new diagnoses of hepatitis B include positive test results for HBsAg, and these are submitted to UKHSA or predecessor organisations via SGSS. Mandatory reporting by laboratories of notifiable organisms started in 2010. 2021 data is provisional and figures for previous years are subject to change due to late reporting and the associated de-duplication procedure. Patient identifiable data submitted by NHS laboratories is variable, particularly from sexual health and drug and alcohol services, which limits the ability to deduplicate. Results for children under one year of age are excluded to rule out detecting maternal antibody.

8. Testing and diagnosis: SSBBV testing

Sentinel surveillance data is from 19 laboratories and is based on complete and consistent reporting for a 5-year period. This means that the numbers of laboratories included for trend data may change each year depending on their reporting history. Sentinel surveillance covers approximately 45% of all testing in the GP registered population. As sentinel surveillance includes the 2 laboratories processing DBS tests for the major drug services in England, it is likely that sentinel surveillance covers most tests coming from drug services, where DBS is the main method of testing.

Sentinel surveillance excludes samples collected outside routine testing such as look back studies, reference testing, and children aged 1 year and under. Patient identifiable data submitted by laboratories is variable, particularly from sexual health and drug and alcohol services, which limits the ability to de-duplicate. Data is de-duplicated subject to availability of date of birth, Soundex, NHS number and first initial. The proportion positive is calculated using number of individuals tested.

For antenatal testing, only women aged 12 to 49 years old are included. Test request location and free text clinical field accompanying the test request are used to identify antenatal testing, not all women will have been correctly classified. Ethnicity is identified through linking to HES and is dependent on an individual having their NHS number reported as part of the test request.

Trend data does not reflect cumulative data as only locations that have consistently reported during the 5 years presented are included in trend data to remove any artificial changes in testing. The positive result is the first reported by participating laboratories and may not reflect an individual’s first diagnosis.

9. Monitoring hepatitis B treatment

Treatment data is subject to limitations which may over or underestimate true numbers of people on treatment. The data is anonymised and aggregated so we cannot deduplicate records and cannot account for individuals who commence, cease or switch treatments midway through a year. Furthermore, IQVIA data does not capture treatment eligibility so we can only estimate the numbers receiving treatment, not the proportion of those eligible, which is required for monitoring progress towards WHO targets.

Question 10

References

Accepted Answer

1. PHE. ‘Eliminate hepatitis B and C resource summary’. July 2019

Question 11

Acknowledgements

Accepted Answer

Authors: David Leeman (report editor), Sarah Arnold, Eleanor Clarke, Annastella Costella, Sameera Lyons, Sema Mandal, Holly Mitchell, Simon Packer, Rajani Raghu, Ruth Simmons.

Our thanks also go to Chelsea Allen, Maulik Ankolia, Simon Burton, Jamie Crummy, Katy Davidson, Monica Desai, Bennet Dugbazah, Chantal Edge, Matthew Hibbert, Rachel Roche, Stephanie Migchelsen, Hamish Mohammed, Debbie Mou, Sarah Murdoch, Peter Ottaway, Claire Reynolds, Claire Sharp, Rhiannon Taylor, Steve Taylor, Angelique Whitfield, Jin-Min Yuan.

We would also like to thank the clinicians, microbiologists, scientists, data analysts, public health practitioners, academics, commissioners, third sector organisations and other colleagues who have contributed insights and/or data to the surveillance and monitoring systems presented in this report, in particular:

National Strategic Group for Viral Hepatitis
NIHR HPRU in Blood Borne and Sexually Transmitted Infections at University College London
NIHR HPRU in Behavioural Science and Evaluation at University of Bristol
NHS community, primary and secondary care services
NHS Screening and Immunisation Teams
community drug service staff and service users who support and participate in, the UAM survey of PWID
NHSBT
ONS carried out the original collection and collation of the data but bears no responsibility for their future analysis or interpretation.
OHID
National Drugs Treatment Monitoring System team
staff who work in the laboratories and contribute to the laboratory surveillance of new diagnoses of hepatitis B (SGSS) and SSBBV
NHS Infectious Diseases in Pregnancy Screening Programme team (part of NHS Antenatal and Newborn Screening Programmes)
ISOSS
IDPS
NHSE H&JRU
NHSE Public Health Commissioning
RCGP
WHO global HIV, hepatitis and STI programmes

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Foreword

Progress towards the Global Health Sector Strategy on viral hepatitis

Current and planned work

1. Maintaining elimination of mother to child transmission

1.1 Improving uptake of post vaccination serologic testing

Aim

Rationale

Stakeholders

1.2 Evidencing seroprevalence of hepatitis B amongst children aged 5 years and under

Aim

Rationale

Stakeholders

2. Preventing new infections

2.1 Improving hepatitis B vaccine uptake

Aim

Rationale

Stakeholders

2.2 Increasing awareness of hepatitis B

Aim

Rationale

Stakeholders

2.3 Reducing hepatitis B-related deaths

Aim

Rationale

Stakeholders

3. Prevalence and testing and diagnosis

3.1 Improving estimates of hepatitis B prevalence and the proportion of people living with hepatitis B that are undiagnosed

Aim

Rationale

Stakeholders

3.2 Evaluating interventions to increase diagnosis and linkage to care

Aim

Rationale

Stakeholders

4. Linkage and retention in care

4.1 Developing new models of care including tools for monitoring people in treatment and care

Aim

Rationale

Stakeholders

4.2 Piloting a hepatitis B dashboard

Aim

Rationale

Stakeholders

5. Increasing equity

5.1 Improve understanding of disparities associated with hepatitis B access to care and health outcomes

Aim

Rationale

Stakeholders

5.2 Reduce hepatitis B-related stigma

Aim

Rationale

Stakeholders

Introduction

1. Reducing incidence and prevalence of hepatitis B

1.1 Prevalence of hepatitis B

Table 1. Estimated HBsAg prevalence and number of people with chronic hepatitis B, England, 2022

1.2 Monitoring WHO targets for hepatitis B incidence

Table 2. WHO impact and programmatic targets for reducing incidence of hepatitis B, England, 2021 to 2022

1.3 Elimination of mother to child transmission

1.3.1 Maternal screening for hepatitis B

Figure 1. Maternal screening coverage for hepatitis B in England, 2017 to 2022 tax year

Figure 2. Country of birth and risk of passing on hepatitis B to their baby in women living with hepatitis B in England, 2021 to 2022 tax year

Figure 3. HBsAg test positivity by year and ethnic group, from antenatal screening in 18 sentinel laboratories, England, 2015 to 2022 tax year

1.3.2 Coverage of antiviral treatment in pregnant women

1.3.3 Coverage of a timely hepatitis B birth dose vaccine and HBIG in the selective programme

Figure 4. Coverage for timely hepatitis B birth dose vaccination, England, 2017 to 2022 tax year

Figure 5. Coverage for timely HBIG, England, 2017 to 2022 tax year

1.3.4 Coverage of hepatitis B vaccination in the selective neonatal programme

Figure 6. Coverage of hepatitis B vaccination in the selective neonatal programme, England, 2019 to 2023 tax year [note 1]

1.3.5 Post-vaccination serology testing (PVST) in infants born to women living with hepatitis B

Figure 7. Mother to child transmission rate for infants born to women living with hepatitis B, England, 2014 to 2022 tax year

1.4 HBsAg prevalence in children aged 5 years and under

1.5 Coverage of hepatitis B 3 doses (HepB3) in the universal programme

Figure 8. Coverage for universal pentavalent and hexavalent vaccine at 12 months of age, England, 2015 to 2016 to 2022 to 2023 tax year

1.6 Prevention of infection by immunisation in other groups at risk of acquiring hepatitis B

1.6.1 Vaccine uptake in SHS

Table 3. Hepatitis B vaccination in GBMSM, counts of first, second, third, fourth and booster doses, SHS, England, 2017 to 2022

1.6.2 Vaccine uptake in PWID