Current WHO guidelines for chronic hepatitis B failed to detect half of the patients in need of treatment in Ethiopia and more than half of those who met eligibility criteria had developed decompensated cirrhosis.
In a study published in Journal of Hepatology, Hanna Aberra from St. Paul’s Hospital Millennium Medical College in Ethiopia, and colleagues wrote that these results imply the need for a revision of the WHO treatment criteria.
“In 2015, the World Health Organization (WHO) published guidelines for the prevention, care and treatment for persons with [chronic HBV], with an emphasis on resource-limited settings,” they wrote. “However, most of the evidence used to develop the WHO guidelines was based on studies from Asia, North America and Western Europe, and little is known about the accuracy and applicability of the WHO treatment criteria in sub-Saharan Africa.”
To evaluate the diagnostic performance of the guidelines, Aberra and colleagues enrolled 1,190 of 1,303 adult patients with chronic HBV who presented at the St. Paul’s Hospital between February 9 and December 14, 2015. The researchers defined chronic HBV as carriage of HBV surface antigen for more than 6 months.
Results showed that 25.2% were eligible for treatment based on EASL 2017 criteria and 15.3% were eligible based on WHO 2015 criteria. While 51.6% of those with decompensated cirrhosis met WHO eligibility, the percentage of eligible patients among those with compensated cirrhosis was much lower at 35.7%.
Of the 153 patients eligible for treatment based on EASL 2017 criteria but excluded from treatment by WHO 2015 guidelines, 48.4% had cirrhosis and 68.6% had significant fibrosis based on transient elastography measurements.
“The challenge in resource-limited settings, where liver biopsies are generally unrealistic and transient elastography too costly, is to find simple and reliable tools to accurately predict significant liver fibrosis,” the researchers wrote. “An ideal tool should be simple, affordable and easy-to-use, and should have a high sensitivity and specificity to detect patients with advanced liver fibrosis.”
When the researchers analyzed aspartate aminotransferase-to-platelet ratio index results, they found that the APRI threshold of 2.0 recommended by WHO failed to identify most patients in need of treatment, with a sensitivity of 8.5% and specificity of 99.3% compared with EASL guidelines.
However, lowering the APRI threshold improved sensitivity without a substantial decrease in specificity. An APRI lower than 1.5 had a sensitivity of 12% and specificity of 98.5%, while APRI lower than 0.5 had a sensitivity of 46.6% and specificity of 94.8%.
“Results from our own cohort suggest that APRI might still be of use, provided that the decision threshold is set lower than the cut-off at 2.0 currently recommended by the WHO,” Aberra and colleagues concluded. “Our results suggest that the WHO guidelines might be unsuitable in an African setting, and that a future revision should take into account local data from real-life CHB cohorts in sub-Saharan Africa.” – by Talitha Bennett
Disclosure: The authors report no relevant financial disclosures.