The Impact of Treatment for Chronic Hepatitis B Virus on Non-clinical Harms

Not yet recruiting

• Conditions: Hepatitis B Virus (HBV)

• Registration Number: NCT07053449
• Lead Sponsor: Nottingham University Hospitals NHS Trust

Brief Summary

The goal of this qualitative study is to explore the impact of antiviral treatment, or none, for chronic hepatitis B virus on the non-clinical (social) harms experienced by migrant populations living in the UK.

Two groups of participants living with hepatitis B virus will be interviewed, those taking the daily treatment, and those not prescribed any treatment.

Detailed Description

1. BACKGROUND Globally, chronic hepatitis B virus infection (HBV) is the most commonly occurring blood borne virus with approximately 300 million people infected. Infection with HBV can lead to the development of cirrhosis, resulting in liver failure or hepatocellular carcinoma (HCC). This is an important cause of preventable deaths, hence the World Health Organisation (WHO) objective to eliminate viral hepatitis as a public health problem by 2030. The WHO reported that globally, yearly deaths from acute and chronic viral hepatitis were approximately 1.4million, with 47% caused by HBV. Chronic HBV related global mortality in 2019 was estimated to be 331,000 attributable to cirrhosis, and 192,000 from hepatocellular cancer, all of which is entirely preventable if sufficient vaccination programmes were implemented for at-risk populations. The prevalence of HBV in England is estimated to be 268,767 (95% CI: 227,896 to 314,004), which equates to a prevalence of 0.58% (95% CI: 0.50% to 0.68%). HBV disproportionally affects people from global majority migrant populations who have relocated from lower income countries where prevalence rates are higher, largely Africa, South and South East Asia, and to a lesser extent Eastern Europe, predominantly due to mother to baby transmission and insufficient access to birth-dose preventative vaccines, iatrogenic transmission, and poor access to healthcare services. In the absence of antiviral treatment, the 5-year cumulative incidence of cirrhosis attributable to chronic HBV is between 8% and 20%. Finally, liver disease attributable to HBV is one cause of the inequalities in health outcomes experienced by ethnic populations that the NHS Race and Health Observatory are seeking to dissolve.

There are a number of challenges when providing care to people with HBV infection. There are no symptoms until any resultant liver disease is advanced, the tests to diagnose and monitor it are complex and confusing to many healthcare professionals as well as patients and carers. Furthermore, HBV is most prevalent in populations at considerable social disadvantage, and it is associated with considerable stigmatization. The current oral treatments are also life-long. Treatment for HBV is currently initiated according to the physical factors that indicate the person is at increased risk of developing cirrhosis or acute liver failure, namely serum levels of HBV deoxyribonucleic acid (DNA), alanine transaminase (ALT), Hepatitis B e antigen (HBeAg) status, and the presence of liver fibrosis or cirrhosis, age, family history of hepatocellular carcinoma, or receiving immunosuppressant medication. There is a caveat in UK and European guidelines explaining that treatment may be offered for extra hepatic manifestations, but these refer to physical disorders such as vasculitis or glomerulonephritis rather than any non-clinical (social, cultural or psychological) manifestations. A report by the World Health Organisation (WHO) recommends an expansion to the criteria for treatment to reduce physical morbidity and mortality, but there is a current absence of data that explains the impact of treatment on the social domains of health.

2. RATIONALE The WHO however define health as being "...a state of complete physical, mental and social well-being and not merely the absence of disease and infirmity". Furthermore, holistic approaches to care view the person as a whole being and consider their social, psychological, and spiritual needs in addition to their physical health needs. The impact of living with chronic HBV infection in countries with a high prevalence has been shown to result in significant social harm, such as difficulty gaining employment, financial distress, and relationship difficulties. The holistic approach is at odds with the current biomedical model approach that focuses on the reduction of liver disease as the criteria for determining if and when to commence antiviral therapy for HBV. Whilst it is clear that the impact of living with HBV is more than the sum of the actual and potential physical ill-health, the specific role that treatments may have on the non-clinical, specifically social, outcomes has not been specifically unpacked. It is not clear for example, if treatment that leads to an undetectable viral load, considered to be a functional cure, reduces patient's experiences of felt or enacted stigma, social exclusion or relationship rejection.

A new HBV patient and public involvement and engagement group (PPIE) to identify research questions and advise on elements of study design has been created as part of an NIHR funded liver partnership, of which the chief investigator of this planned study is a member. An in-person meeting was held on 29.01.24 where individuals living with HBV and the British Liver Trust charity representatives remarked that patient-centred and holistic care had lost its meaning, and that most clinicians focused too heavily on the physical aspects of health. The PPIE group members agreed that a qualitative study to understand the role of antiviral therapy in mitigating against the social harms experienced by this population was a research priority.

Against this background, the aim of this qualitative study is to explore the impact of antiviral treatment, or none, for chronic HBV on the non-clinical (social) harms experienced by migrant populations living in the UK. Data will be obtained via semi-structured one to one interviews.

Study Timeline

• Study First Submitted: 2025-04-15
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-26
• Study First Posted: 2025-07-08
• Last Update Submitted: 2025-07-11
• Last Update Posted: 2025-07-16
• Study Start: 2025-08-01
• Primary Completion: 2025-12
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Chronic HBsAg
• Able to give informed consent in English
• Able to converse in English
• Any migrant population member (non-UK) including if born overseas or in the UK
• Aged 18 years and over
• Has never taken antiviral treatment for HBV (12-15 participants)
• Prescribed and taking any oral treatment for HBV for a minimum of 12 months (12-15 participants)

Exclusion Criteria

• Emotionally distressed due to HBV diagnosis
• Current episode of decompensated cirrhosis
• Current diagnosis of hepatocellular carcinoma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The qualitative Interview Topic Guide Questionnaire will thematically measure patients' experience of treatment, or not having treatment, for chronic hepatitis B virus infection.	The outcome measure will be assessed and data collected for reporting on day 1	A qualitative interview topic guide questionnaire on patient's experience of treatment, or no treatment, for hepatitis B virus infection. The coding scheme will be inductively derived by the study team and overarching themes that characterise patients' experiences will be determined.