HCV infection should be managed in specialist centres

It has been estimated that between 200 000 and 400 000 people in England and Wales have hepatitis C virus (HCV) infection, with subgroup prevalences of 0.04% in healthy blood donors, 0.4% in antenatal clinic attendees (in London), 1% in genitourinary clinic attendees, and up to 50% in intravenous drug users.¹ The population in England and Wales is close to 50 million,² implying that approximately 0.5% are viraemic as 85% of acute infections lead to chronic disease.³ A district general hospital serving a population of 350 000 people may therefore have 1750 viraemic individuals in its catchment area. Although the fraction of this hypothetical iceberg that is visible to secondary care is currently small and varies according to local demographics, it is already of the order of 15% in rural Gloucestershire (personal data).

Comprehensive consensus guidelines for the management of HCV infection have been published by both the NIH⁴ and EASL,⁵ and one of the major factors in delay of implementation in the UK has been lack of resources in terms of clinicians’ time, nursing supervision, counsellors, and the drug budget. Nevertheless, in order to help British clinicians meet the ever increasing demand for the management of HCV, the Royal College of Physicians (RCP) of London and the British Society of Gastroenterology (BSG) have recently compiled Clinical guidelines on the management of hepatitis C⁶ in order “to improve the patient’s management from first diagnosis to completion of a course of antiviral therapy and during follow-up” (section 1.2.3). These national guidelines were drawn up by specialists and the editorial board of this journal, at the request of the BSG, took the progressive view that they should be available on the Gut website before appearing in print. It would appear therefore that the BSG and RCP have already concluded that hepatitis C is unlikely to be managed exclusively in centres of tertiary referral (which only exist to provide foci of expertise and resource for rare conditions or complex treatments) as there would be no requirement to take such unprecedented action unless they were intended for gastroenterologists working in general hospitals. Indeed, the first author of the document, which provides “a framework for local groups to develop according to local needs” (section 1.2.4) is a consultant working in a district general hospital. The summary states, “Patients infected with HCV should be referred to a clinician with a particular interest in the infection. Patients must have access to adequate counselling from a health carer with knowledge and experience of chronic HCV infection. All patients must have access to the appropriate diagnostic and therapeutic options available in the management of HCV infection”. Is this achievable in a district general hospital?

The answer is “yes” if there is a clinician with an interest and a counsellor with knowledge that is keen to gain experience. The British Liver Trust⁷ has a national support group network and can provide high quality patient information leaflets, as do the major suppliers of antiviral therapies. Industry is only too keen to assist in the training of counsellors, as they are usually nurse practitioners with concurrent responsibility for the supervision of antiviral therapy. Although the current recommendations for duration of treatment are related to viral load and genotype^8,9 there is no “in house” requirement for these advanced molecular virological techniques as cost and quality assurance considerations dictate centralisation within the PHLS.

The guidelines state “All liver biopsies should be examined by a histopathologist with experience in liver pathology and who can apply the recently reformed grading and staging scores” (section 4.6) but there is no evidence that such a sophisticated scoring system¹⁰ is required in clinical practice. The section concludes “In patients with mild, slowly progressive disease it may be best to withhold treatment until more efficacious treatments are available. Others would regard this as the best time to treat, perhaps resulting in higher numbers of responders, and others would argue that the virus rather than the disease process needs to be treated and so all infected patients need to be considered for treatment”. This would suggest that simple reproducible schemes for the interpretation of liver biopsies¹¹ by general pathologists are just as good for the stratification of patients for treatment¹² as this still remains a matter of opinion (category of evidence—level C).

One of the major difficulties in establishing a local service for patients with HCV infection is meeting the cost. Although the National Institute of Clinical Excellence (NICE) guidelines¹ give advice on clinical audit and implementation, it is the Commission for Health Improvement (CHI) that will eventually monitor adherence in NHS trusts and primary care. The cost of drugs, molecular virological tests, and nursing salaries remain beyond our control and there are insufficient gastroenterologists nationally to satisfy all the other requirements of the service. Nevertheless, there is such a local abundance of patients that most interested clinicians would accumulate a case load sufficient to consolidate expertise, and NHS trusts would do well to nurture such individuals before CHI impose a less palatable implementation.

Reasons for managing HCV in non-specialist centres.

• 0.5% of the population in England and Wales are viraemic with HCV.

• Clinical guidelines have been distributed to all gastroenterologists.

• Viral genotyping and quantification is available nationally through the PHLS.

• Complex scoring of liver biopsies is unnecessary for treatment planning.

• The British Liver Trust provides a national patient support group network.

• Industry provides nursing support and education.

At first sight, section 3.2 of the national guidelines appears to be inconsistent with the philosophy of developing a local management framework—“Following a positive antibody test, patients should be referred to the nearest specialist service for further clinical assessment. Specialist clinicians will be responsible for the care of these patients and will ensure some uniformity of approach, whilst facilitating data collection, audit and research”—unless it is envisaged that successful implementation creates specialist clinicians within a specialist service. Those gastroenterologists who are not selected to work in a specialist centre for HCV should take heart. They are probably already working in a specialist centre for inflammatory bowel disease or peptic ulceration.