The first UK clinical trial to increase the identification and treatment of hepatitis C (HCV) patients in primary care has been found to be effective, acceptable to staff and highly cost-effective for the NHS. The University of Bristol-led Hepatitis C Assessment to Treatment Trial (HepCATT), published in the British Medical Journal today [27 February], provides robust evidence of effective action GPs should take to increase HCV testing and treatment.
The National Institute for Health Research funded trial assessed whether a multi-part intervention in GP practices could increase the identification and treatment of HCV -infected patients compared to usual care. It took place in South West England, with 22 practices randomised to intervention and 23 to the control arm.
An electronic algorithm was devised to flag patients with HCV risk markers and invite them for an HCV test by letter, or opportunistically through pop-up messages during consultations. Practice staff received HCV educational training, and HCV posters and leaflets were placed in waiting rooms to increase patient awareness.
Around five percent of all patients were flagged with HCV risk markers. 16 per cent of the flagged patients were tested for HCV in HepCATT intervention practices compared to ten per cent in control practices - a 59 per cent increase after adjusting for the characteristics of different practices. Five times as many patients were assessed for treatment in the HepCATT intervention practices, compared to control.
The intervention was comparatively low cost at an average of £624 per general practice and £3,165 per additional patient assessed at hepatology. The overall benefit - taking into account future reduction in chronic illness - was estimated to be £6,212 per Quality Adjusted Life Year (QALY) gained which is well below the average cost of an intervention in the NHS and the National Institute for Health and Care Excellence (NICE) threshold for recommending interventions of £20,000 per QALY.
Matt Hickman, Professor in Public Health and Epidemiology and co-Director of NIHR Health Protection Research Unit in Evaluation of Interventions at the University of Bristol, who led the study, said:
"We know that scaling up hepatitis C case-finding and treatment alongside interventions that minimise transmission among people who inject drugs is critical for long-term prevention of chronic hepatitis C and hepatitis C-related disease and mortality. The HepCATT intervention had a modest impact but was highly cost-effective. We therefore recommend that it is considered for roll-out across the NHS, with further refinement and improvement before widescale implementation."
Professor Graham Foster from Queen Mary's University London and Clinical Lead for Hepatology at Barts Health, said: "Chronic hepatitis C infection is a major cause of liver disease and cancer. We are working to ensure that England is among the first countries in the world to eliminate the infection. Our primary care colleagues are key partners in the campaign and HepCATT provides the essential evidence base to allow us to expand testing into primary care in an affordable, cost-effective manner."
Dr Sema Mandal, Medical Consultant Epidemiologist lead for Hepatitis at Public Health England, said: "With nearly 100,000 people living with hepatitis C without a diagnosis it's vital that we optimise and implement new ways to enhance case finding in primary care. This new approach not only increases testing but ensures more people access life-saving treatments. Public Health England is working with NHS England and partners across academia to eliminate hepatitis C as a major public health threat and this new approach will help accelerate these efforts."
A qualitative evaluation of the study published in the British Journal of General Practice found that GPs valued the electronic algorithm, which provided them with a list of patients with HCV infection risk factors that GPs may not already know about to target for testing. GPs also appreciated the opportunity to discuss testing with patients, especially those who may not have been aware of their HCV risk. The training enhanced GPs' HCV awareness and knowledge of risk factors, which itself acted as a prompt for opportunistic testing.
GPs suggested refining the algorithm to weight risk factors, fully integrating the pop-up software with electronic patient record systems, and additional resources to screen lists and conduct tests.
Dr Jeremy Horwood, Associate Professor of Social Sciences and Health at the Centre for Academic Primary Care at the University of Bristol and ARC West, who led the qualitative evaluation, said: "With adequate resources and technology, primary care can play an important role in identifying patients with hepatitis C infection who have the potential to benefit from treatment. The cost-effective HepCATT intervention provides primary care with a range of tools to improve identification and care for HCV-infected patients and prevent HCV-related illness. This could help the UK reach the World Health Organization's target of 90 per cent of infected people knowing their status by 2030, and help stem the HCV epidemic."
Around 143,000 people in the UK have chronic HCV infection, 85 per cent of whom have a history of injecting drugs. As symptoms do not appear for several years, less than half of people infected are aware of they have HCV and many more are not receiving treatment, increasing the risk of liver damage and passing the virus to others.
The National Institute for Health and Care Excellence (NICE) in England recommends that GPs should increase testing and treatment, especially among people who inject drugs. However, robust evidence of effective interventions is lacking and testing and treatment rates in many sites are low.
'Cost effectiveness of an intervention to increase uptake of hepatitis C virus testing and treatment (HepCATT): cluster randomised controlled trial in primary care' by Roberts, K. Macleod, J. Metcalfe, C. Hollingworth, W. Williams, J. Muir, P. Vickerman, P. Clement, C. Gordon, F. Irving, W. Waldron, C. North, P. Moore, P. Simmons, R. Miners, A. Horwood, J. Hickman, M. in BMJ
'Increasing uptake of Hepatitis C virus infection case-finding, testing and treatment in primary care: HepCATT (Hepatitis C Assessment Through to Treatment Trial) qualitative evaluation' by Horwood, J. Clement, C. Roberts, K. Waldron, C. A. Irving, W. Macleod, J. & Hickman, M. in British Journal of General Practice