The World Health Organization has released updated global guidelines for diagnosing liver fibrosis and cirrhosis in people with chronic hepatitis B.
The update is based on a large systematic review and meta-analysis of noninvasive tests, published in The Lancet Gastroenterology & Hepatology. The analysis included data from 211 studies involving more than 61,000 patients.
Hepatitis B affects more than 250 million people globally and can cause long-term liver damage without symptoms. The revised testing guidelines aim to support earlier diagnosis, timely treatment, and fewer hepatitis-related deaths.
The study evaluated two commonly used noninvasive tests—APRI (aspartate aminotransferase-to-platelet ratio index) and FibroScan (transient elastography)—as alternatives to liver biopsy, which can be invasive, costly, and less accessible, according to the review's authors. These tests help physicians determine when to initiate antiviral treatment.
The updated World Health Organization (WHO) guidelines recommend lower thresholds for APRI and FibroScan to enable earlier detection of liver disease and reduce the risk of complications. Investigators found that an APRI score above 0.5 or a FibroScan reading above 7.0 kilopascals (kPa) identified most adults with significant liver fibrosis; for cirrhosis, an APRI score above 1.0 or a FibroScan reading above 12.5 kPa was determined to be accurate for diagnosis.
In a modeled scenario of 1,000 patients with hepatitis B, using an APRI cutoff of 0.5 would miss about 7% of diagnoses and result in a false-positive rate of 26%; FibroScan, at its threshold, would miss 6% and produce a 16% false-positive rate. According to the authors, these levels are acceptable to minimize missed diagnoses.
“A FibroScan value greater than 7.0 kPa will identify most adults with significant fibrosis (≥F2), and a value greater than 12.5 kPa will identify most with cirrhosis (F4),” wrote first study author Antonio Liguori, MD, of the UCL Institute for Liver and Digestive Health at the Royal Free Hospital and University College London, and colleagues.
The new recommendations reflect improved global access to antiviral therapy—a shift from the 2015 guidelines, which used a higher APRI cutoff of 2.0 to limit unnecessary treatment due to drug cost and availability at the time. That earlier threshold missed more than half of patients with cirrhosis, reported investigators.
WHO plans to apply the study’s findings to train health workers and scale up treatment, particularly in low- and middle-income countries. The updated approach may also guide the use of noninvasive tests for other conditions.
Most of the studies included in the meta-analysis/review were conducted in Asia and Africa, where hepatitis B prevalence is highest. Although many studies were rated at high risk of bias, the results were consistent across test methods and regions.
The study was funded by WHO, which did not participate in data collection or analysis.
The authors reported no competing interests.
