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First UK clinical trial to identify, assess and treat hepatitis C patients found to be effective

A University of Bristol-led clinical trial to increase the identification and treatment of hepatitis C (HCV) patients in primary care has found to be effective, acceptable to staff and highly cost-effective for the NHS.

Publishing their findings from the study in the British Medical Journal, researchers working on the Hepatitis C Assessment to Treatment Trial (HepCATT) provided robus evidence of effective action GPs should take to increase HCV testing and treatment.

The National Institute for Health Research (NIHR)-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. The clinical trial took place in south west England, with 22 practices randomised to intervention and 23 to the control arm.

Flagging patients with HCV risk markers through a newly-devised electronic algorithm, they were then invited in 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 awareness among patients.

As part of the new algorithm, around 5% of all patients were flagged with HCV risk markers, and of the flagged patients tested for HCV there was a 59% increase in testing at HepCATT intervention practices compared with the control practices. Five times as many patients were assessed for treatment in HepCATT intervention practices.

Intervention of this nature was comparatively low cost at an average of £624 per general practice and £3,165 per additional patient assessed at hepatology. Extrapolating the full cost, taking into account future reduction in chronic illness, saw the overall benefit estimated to be £6,212 per Quality Adjusted Life Year (QALY), 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.”

Dr Sema Mandal, Medical Consultant Epidemiologist Lead for Hepatitis at Public Health England, added: “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.”

Across the UK, around 143,000 people have chronic HCV infection, with 85% of those having a history of injecting drugs.

As symptoms do not present themselves for several years, less than half of people infected are aware they have HCV and many more do not receive 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 at present and testing and treatment rates in many sites are low.