NHS England Hepatitis C Virus Case Finding in Primary Care Pilot
Research type
Research Study
Full title
NHS England Hepatitis C Virus Case Finding in Primary Care Pilot (HepCAPP)
IRAS ID
281705
Contact name
Matthew Hickman
Contact email
Sponsor organisation
University of Bristol
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Research Summary
There are estimated to be over 100,000 people in the England with chronic Hepatitis C Virus (HCV) infection and over 85% of these infections were acquired through injecting drug use. Due to the recent development of Direct Acting Antivirals (DAAs), chronic HCV can now be cured in over 95% of patients and targeted case-finding using risk markers for HCV has recently shown to be effective and highly cost-effective. However there may be a population group which has been missed which are the people infected with HCV who may have no history of drug injecting recorded on their clinical history. This study aims to invite 100,000 people aged 40-64 years of age registered at selected general practices to have a HCV test using an Oral Fluid swab home testing kit which will be posted to their homes. Patients will be informed of their result and will be followed up accordingly if they have a positive result. Our primary objective is to pilot and establish the acceptability of wide-scale HCV screening of the general public through primary care services to determine whether the intervention should be optimised and rolled out nation wide.
Summary of Results
Background: Birth cohort screening has been implemented in some countries to identify the potentially 'missed population' of undiagnosed chronic Hepatitis C Virus (HCV) in people who may not be found through targeted approaches.
Aim: To determine uptake of HCV antibody testing using an oral swab screening method, overall yield, whether those testing positive had risk markers for HCV in their primary care record, and cost per case detected.
Design and Setting: Pilot screening study set in general practices in the Southwest, South London and Yorkshire and Humber.
Method: Participants consenting were sent an oral swab kit in the post and saliva samples were tested for antibody to HCV.
Results: 16,436/98,396 (16.7%) patients consented and were sent an oral swab kit. 12,216 (12.4%) returned a kit, with 31 participants (yield 0.03%) testing positive for HCV antibody. 45% of those positive had a risk marker for HCV on their primary care record. Two (yield 0.002%) were confirmed RNA positive and referred for treatment, both had HCV risk markers. Cost per case detected was £16,000 per HCV antibody and £247,997 per chronic HCV.
Conclusions: Wide-scale screening could be delivered was acceptable and identified people infected with HCV, however most of these individuals could have been detected through lower-cost targeted screening. Yield and cost per case found were substantially worse than model estimates and targeted screening studies. Birth cohort screening should not be rolled out in primary care in England.Targeted HCV screening in primary care and other settings is highly cost-effective. The NHSE HCV elimination programme has recently shifted to other screening models to identify people who may not be detected through targeted screening. HepCAPP is the first study in the UK to pilot a birth cohort model based in primary care inviting all patients aged 40-64 to have an HCV antibody test using an oral swab kit posted to their homes. Acceptability of testing using this method was above NHS targets, however, the yield was too low and costs too high (compared to theoretical estimates and targeted screening) to recommend implementation.
REC name
Wales REC 6
REC reference
21/WA/0282
Date of REC Opinion
20 Sep 2021
REC opinion
Favourable Opinion