Hepatitis B Virus (HBV) treatment eligibility in the UK: retrospective longitudinal cohort data to explore the impact of changes in clinical guidelines

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ABSTRACT Objective Nucleos/tide analogue (NA) drugs are used for the long-term treatment of chronic hepatitis B virus (HBV) infection. In a landscape of changing clinical recommendations, we set out to quantify the prescription of NA drugs to date, and to determine the impact of relaxing treatment eligibility criteria in a unique large real-world dataset. Design We assimilated longitudinal data from adults with chronic HBV infection from six centres in England through the UK National Institute for Health Research (NIHR) Health Informatics Collaborative (HIC) viral hepatitis framework. We describe factors currently associated with receipt of NA treatment, and determine the proportion of the population who would become treatment eligible as thresholds change. Results We reviewed data for 7558 adults, with mean follow up of 4.0 years (SD 3.9 years). NA treatment was prescribed in 2014/7558 (26.6%), and in line with existing guidelines was associated with HBeAg positivity and ALT above the upper limit of normal (ULN). Treatment was significantly more likely in males, older adults, in Asian and Other ethnicities (as compared to White), and significantly less likely in socioeconomically deprived individuals. The proportion of individuals who were treatment eligible was 32.3% based on 2 records of ALT>ULN over 6-12 months; 41.7% based on ALT>ULN and VL > 2000 IU/ml; and 95.1% based on detectable VL and either ALT>ULN or age>30 years. Conclusion We quantify the proportion of the population living with HBV who may become treatment eligible as guidelines change, providing insights to support the implementation of clinical services. KEY MESSAGES (3-5 sentences required by Gut ) • What is already known on this topic To date, only a minority of adults living with chronic hepatitis B (CHB) infection have been eligible for treatment with nucleos/tide analogue (NA) therapy. However, worldwide guidelines are changing, with recommendations for treatment of an increasing proportion of the population. There is a need for evidence to inform the design of services to meet the needs of people living with CHB as more of the population becomes treatment eligible. • What this study adds We have determined the proportion of the UK population of people living with HBV infection who are currently treated, and determined the increasing proportion who would become eligible as treatment criteria change, with this proportion reaching 95% based on the least stringent treatment thresholds. • How this study might affect research, practice or policy Our study provides crucial real-world evidence that can inform planning of service delivery and resource allocation for people living with HBV, in a landscape of changing clinical guidelines.

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