Lancet Gastroenterology and Hepatology published a key new WHO-led study on January 24, 2023, in collaboration with the University of Bristol showing the benefit of using a quick, clinic-based diagnostic test for hepatitis C virus (HCV) infection over a standard laboratory-based test.
Chronic HCV infection is a major global public health problem and a cause of liver disease, with the highest 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 goal of ending the epidemics of viral hepatitis B and C by 2030.
Good progress was made as more than 10 million persons with chronic HCV infection were cured using a 12-week short course direct-acting antiviral treatment. However, as of 2019, there were still 58 million people with chronic HCV, resulting in 399,000 deaths. Only 20 percent of those infected worldwide had been diagnosed and 13 percent treated.
Patient care pathways and diagnostic approaches must be simplified to close this gap and achieve WHO targets. The standard approach to diagnosing chronic HCV infection includes an initial screening with an HCV antibody test followed by a laboratory-based molecular HCV viral load (VL) test that confirms the presence of an active virus and the need for treatment. But since access to laboratory-based viral load tests is limited in many LMICs, most chronic HCV patients are never linked to care and treatment.
HCV VL assays performed on point-of-care (POC) devices outside of the laboratory and in clinics close to where patients receive care are being increasingly used as an alternative to laboratory-based diagnosis. WHO already recommends the use of these POC assays to diagnose and monitor other infectious diseases, including tuberculosis, COVID-19, and HIV-AIDS. Until recently, there was limited data on how the assays improved access and uptake of HCV testing and treatment.
This new study pooled results from 45 studies (around 50 percent were from LMICs) and compared POC HCV viral load assays with centralized, laboratory-based standard approaches. It showed that POC HCV viral load assays reduced the time it took from initial HCV antibody screening to starting the treatment (19 days compared to 67 days).
Overall uptake of treatment was higher with POC assays at the clinic site (77 percent) and when delivered in mobile units (81 percent), compared to standard laboratory-based assays (53 percent). The best results were seen when the POC assays were placed at a site where both testing and treatment were offered, ensuring the treatment started on the same day as diagnosis.
These findings led to recent WHO recommendations for the adoption of POC HCV viral load testing as an alternate approach to laboratory-based platforms for rapid diagnosis and treatment of HCV infection. This complements other recent WHO recommendations in the same updated guidance for HCV diagnosis and treatment that promotes simplification of service delivery and task-sharing of testing and treatment among nurses and nonspecialist doctors.
POC assays are targeted to reach marginalized populations, persons addicted to drugs, and/or those experiencing homelessness. The POC assay can be offered in harm-reduction clinics, primary care clinics, prisons, mobile units, or even in community clinics, and presents the possibility of a one-stop, same-day diagnosis and treatment of HCV infection.
WHO is encouraging affected countries to consider including the use of POC assays in their national policies on hepatitis C. The COVID-19 pandemic prompted a major expansion of these POC diagnostic assays in many LMICs, providing an opportunity to share their use for HCV VL testing and cut down on costs. Many countries including Australia, Cambodia, Malaysia, and Myanmar have added the POC assays to their national programs. WHO is now undertaking a similar evaluation of POC viral load assays for hepatitis B in its planned 2023 updated guidance.
- This press release was originally published on the World Health Organization website