New WHO study: Making diagnosis of hepatitis C more accessible and closer to the community using point-of-care HCV viral load assays

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Lancet Gastroenterology and Hepatology, in collaboration with the University of Bristol, today published a major new WHO-led study exploring the benefits of
using a rapid clinical diagnostic test for hepatitis C virus (HCV) infection instead of a standard laboratory test.

Chronic infection with the hepatitis C virus (HCV) is a major global public health problem and a cause of liver disease, with the greatest burden in low and middle income countries (LMICs). In 2016, WHO launched the Global Health Sector Strategy for Viral Hepatitis, which was renewed in 2022, with the aim of ending the epidemics of viral hepatitis
B and C by 2030. Good progress has been made: more than 10 million people with chronic HCV infection have been cured with a 12-week short-term direct-acting antiviral treatment. However, in 2019, there were still 58 million people with chronic HCV,
resulting in 399 000 deaths. Only 20% of those infected worldwide had been diagnosed and 13% treated. Closing this gap and achieving WHO’s goals for eliminating HCV requires simplifying patient care pathways, including diagnostic approaches. The standard
approach to the diagnosis of chronic HCV infection is an initial screening with an HCV antibody test, followed by a laboratory-based molecular HCV viral load (VL) test, to confirm the presence of an active virus and the need for treatment. Access to
laboratory-based viral load testing remains limited in many LMICs. As a result, many of those with chronic HCV are never linked to care and treatment.

HCV VL assays performed on point-of-care (POC) devices outside the laboratory and in a clinic close to where patients are cared for are increasingly being used as an alternative approach to laboratory-based diagnosis. The WHO recommends the
use of these POC assays for diagnosis and monitoring of other infectious diseases, including tuberculosis, COVID-19 and HIV. Until recently, there was limited data on its use to improve access to and use of HCV tests and treatments.

This new study pooled the results of 45 studies (approximately 50% were from LMICs) and compared POC HCV viral load assays to centralized, laboratory-based standard approaches. It showed that using POC HCV viral load assays led to faster times from initial HCV
antibody screening until starting treatment (19 days instead of 67 days). Overall treatment acceptance was higher with POC assays at the clinic site (77%) or delivered in mobile units (81%) compared to standard lab-based assays (53%). The
the best results were seen when the POC assays were placed in a location where both testing and treatment were offered in the same location, allowing treatment to start on the same day as diagnosis.

The findings of this study led to recent WHO recommendations for using POC HCV viral load testing as an alternative approach to lab-based platforms for diagnosing HCV infection and accelerating initiation of curative treatment. This recommendation
complements other recent WHO recommendations in the same updated guidance on HCV diagnosis and treatment that promotes simplification of testing and treatment services and division of labor for nurses and non-specialist physicians.

The optimal populations and settings for POC assays are hard-to-reach or marginalized populations at high risk of loss to follow-up, such as those who inject drugs or those who are homeless. The POC assay can be placed primarily in harm reduction clinics
care clinics, prisons, in mobile units or even community clinics, providing the option of one-stop, same-day diagnosis and treatment of HCV infection.

The WHO encourages affected countries to consider incorporating the use of POC assays into their national hepatitis C policies. The COVID-19 pandemic led to a major expansion of these POC diagnostic assays in many LMICs, presenting an opportunity offers to
their use for HCV VL testing and thus save costs. Many countries, including Australia, Cambodia, Malaysia and Myanmar, have incorporated these POC assays into their national programs. The WHO is now conducting a similar evaluation of POC viral
load assays for hepatitis B in the planned 2023 updated guidelines.

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