Point-of-care hepatitis C testing: From pilot to national scale-up

What started as a small seed grant by SPHERE’s Infectious Disease, Immunity and Inflammation (Triple I) Clinical Academic Group for a Pilot project has grown to become a national initiative receiving over $17 million in grant funding and bringing together partnerships across all Local Health Districts (LHDs), UNSW, consumer organisations and industry.

The need for a new approach for hepatitis C testing

Hepatitis C infection poses a significant public threat in Australia and globally. The good news is that new hepatitis C therapies can cure infection in >95% of people, leading to declines in liver-related deaths. Progress towards hepatitis C elimination in Australia is impeded by low testing and treatment.

“Among the estimated 124,000 people with hepatitis C in Australia, 47% don’t know they have the virus, or have not received treatment due to testing and treatment barriers,” explains Lead investigator, Professor Jason Grebely from the Kirby Institute, UNSW.

These barriers have led to declines in annual treatment from 32,000 in 2016 to 6,500 in 2021, with the most marginalised populations of people who inject drugs and those in prisons yet to receive treatment.

A major barrier to improving testing and treatment is that the current diagnostic pathway requires multiple visits (HCV antibody to confirm exposure, HCV RNA to confirm active infection, and one or more assessments to start treatment) leading to frequent loss to follow-up. This is amplified in populations with high hepatitis C burden, such as people who inject drugs and those in prison.

“New point-of-care hepatitis C testing technologies capable of detecting current hepatitis C infection in one hour are a game-changer. These new tests enable diagnoses and treatment in a single visit, overcoming the barrier of multiple visits that frequently leads to loss to follow-up,” says Professor Grebely.

The TEMPO Pilot study

Initially funded as a seed grant by SPHERE’s Infectious Disease, Immunity and Inflammation (Triple I) Clinical Academic Group, the TEMPO Pilot study partnered with the Kirketon Road Centre, South Eastern Sydney Local Health District (SESLHD) and the New South Wales Users and AIDS Association (NUAA) to evaluate an intervention integrating point-of-care hepatitis C testing, nursing care, and consumer-based support to facilitate same-day testing and treatment.

Overall, 101 participants were tested, 27% were found to have current hepatitis C infection, and 81% initiated treatment. Key to the success of the project was strong partnerships with the SESLHD and NUAA.

From pilot project to national program

The TEMPO Pilot study provided critical evidence and catalysed the implementation of the National Australian Point-of-Care Testing Program, which is scaling up pointof-care hepatitis C testing at 90 sites nationally, including community health services and prisons.

The initial TEMPO Pilot funding ($75K) has leveraged for a further $17 million in funding ($13M cash, $4M in-kind) from the Australian Government and Industry including the NHMRC (two Partnership Project Grants), MRFF (Clinical Trials Activity Grant) and Gilead Sciences, Cepheid, and AbbVie.

Since 2022, 10,035 tests have been performed with 1,248 people testing positive. Of these, 77% have initiated treatment.

Using Implementation Science for further scale-up

But Prof Grebely’s team are determined not to stop there. Their next goal is to scale-up the program even further.

“The next pressing challenge is to deliver point-of-care hepatitis C testing at scale to facilitate increased HCV testing and treatment and achieve HCV elimination. This requires an understanding of the barriers and facilitators for implementing pointof-care testing and treatment and how to address them using specific implementation strategies to embed changes into practice and bring them to scale.”

To that end, the next stage of the project will bring together experts in implementation science, epidemiology, social sciences, diagnostic testing, mathematical modelling, health economics and consumer-led research to understand what works to enhance implementation of point-ofcare testing and why. The project will develop clinical trial capacity (research training across more than 360 health services nationally), many of whom have not previously been involved in research.

“Impact will be achieved by increasing hepatitis C testing and treatment to improve the health of people with hepatitis C in Australia and address national hepatitis C elimination targets which includes an 80% incidence reduction and 65% reduction in mortality.”

A perfect example of partnerships

To date, over 150 national stakeholders, including consumers and health services, national and state/ territory viral hepatitis and drug user consumer organisations have helped co-design the program. The program also has extensive involvement of academic, industry (Cepheid, Gilead Sciences, AbbVie) and all state/ territory governments.

“Critical to the success of our program has been the involvement of consumer, government, health service, and academic partners nationally,” says Prof Grebely.

From seed to growth

From a small seed grant, the TEMPO Pilot study has grown into a national initiative that could see Australia reach the World Health Organisation’s target to eliminate hepatitis C by 2030.

“I truly believe that the initial seed funding from SPHERE’s Triple I Clinical Academic Group to pursue this project provided a catalyst and the initial data to facilitate national funding. We’ve made significant gains in improving our testing rates and are closer to achieving hepatitis C elimination and improving the quality of care for patients in Australia,” says Prof Grebely.