The advent of simple direct-acting antiviral hepatitis C (HCV) therapies with cure rates
>95% is one of the greatest medical advances in decades, having led to a reversal in
liver-related mortality. In Australia, treatment uptake has declined between 2016 (32,000
treated) and 2019/20 (2019: 11,500; 2020: 8,500).1 Progress towards HCV elimination has
been impeded by COVID-19, affecting the delivery of national and state-based HCV
strategies. Improving HCV treatment uptake to reduce disease burden is a key aim of
global, national and state-based HCV strategies.2-4
Scale-up of HCV testing and treatment will be required to achieve elimination by 2030.
Current diagnostic pathways require multiple visits to a practitioner reducing the
proportion who receive a diagnosis. In Australia, 81% of people have had HCV antibody
testing (indicates exposure), but only 47% have been HCV RNA tested (indicates active
infection and the need for HCV treatment).5 Mathematical modelling suggests that HCV RNA
testing needs to increase by at least 50% annually to achieve elimination in Australia by
2030.6
The Kirby Institute is an international leader in research evaluating the Xpert HCV assay
(Grebely Lancet Gastro Hep 2017), having built a large network of Xpert platforms for HCV
testing in needle and syringe programs, prisons, drug treatment clinics, tertiary
hospitals, and Aboriginal Community Controlled Health Service. In Kirby-led research,
point-of-care HCV testing interventions in needle and syringe programs and prisons have
resulted in high HCV treatment uptake (70-90%). The Kirby Institute and Flinders
University also have a strong track record of implementing point-of-care testing for STIs
and COVID-19, providing an ideal foundation to scale-up Xpert HCV testing in Australia.
The Kirby Institute and Flinders University will establish the Australian National HCV
Point-of-care Testing Program for the scale-up of point-of-care HCV RNA testing in
services with high prevalence of HCV infection, including community health centres, drug
treatment clinics, needle and syringe programs, and prisons. This program will include
the development of standard operating procedures, logistics/deployment, initial set-up,
an operator training program, and quality assurance and competency assessment program.
An observational cohort study will be established to evaluate HCV treatment uptake
following scale-up of point-of-care HCV testing among people with a risk factor for
acquisition of HCV infection or people attending a service caring for people with risk
factors for the acquisition of HCV infection.
Participants will be recruited from settings that provide services to people with a risk
factor for the acquisition of HCV infection. All participants who undergo point-of-care
HCV testing at the study site will be included in the data collection. Participants will
not receive treatment as a part of this study. Participants who are HCV RNA positive will
be linked to standard of care for any other clinical assessments and treatment
initiation.