HBV Treatment Eligibility Greater in New WHO Guidelines Than Other International Guidelines

New research is providing clinicians and policymakers with an overview of the differences in treatment eligibility rates among various international hepatitis B guidelines.¹

Compared with the Asian Pacific Association for the Study of the Liver (APASL) 2015 guidelines, the American Association for the Study of Liver Diseases (AASLD) 2018 guidelines, and the European Association for the Study of the Liver (EASL) 2017 guidelines, the World Health Organization (WHO) 2024 guidelines had the highest treatment-eligible rate.¹

“Recently, the World Health Organization (WHO) updated HBV guidelines, with expanded treatment eligibility being a key priority area,” Rui Huang, MD, PhD, associate chief physician in the department of infectious diseases at Nanjing Drum Tower Hospital and an associate professor of internal medicine at Nanjing Medical University, and colleagues wrote.¹ “However, there is limited information on the differences in treatment eligibility rates among international hepatitis B guidelines.”

On March 29, 2024, the WHO announced the publication of new guidelines on the prevention, diagnosis, and treatment of chronic hepatitis B infection, seeking to provide a substantial simplification and expansion of eligibility for treatment to overcome barriers to access to HBV testing and treatment. Specifically, the guidelines prioritized simplified treatment criteria for adults and adolescents as well as expanded eligibility for antiviral prophylaxis for pregnant women to prevent mother-to-child transmission.²

To assess differences in treatment eligibility rates among international hepatitis B guidelines, investigators conducted a retrospective cross-sectional study of 12,217 treatment-naive patients with chronic HBV from 2015 to 2023 across 3 medical centers. Specifically, they compared treatment-eligible rates across APASL 2015, AASLD 2018, EASL 2017, and WHO 2024 HBV guidelines.¹

Investigators excluded 2175 patients due to insufficient clinical data, leaving 10,042 patients who were included in the final analysis. Among the cohort, the mean age was 37 (interquartile range [IQR], 30-48) years and 61.5% of patients were male. Investigators noted median levels of alanine aminotransferase and HBV DNA were 32.1 (IQR, 20.3-64.5) U/L and 3.2 (IQR, 2.7-6.2) log10IU/mL, respectively, and 30.1% of patients were hepatitis B e antigen (HBeAg) positive.¹

A total of 2318 (23.1%) patients were treatment-eligible according to APASL 2015 guidelines; 2773 (27.6%) were eligible according to AASLD 2018 guidelines, and 2841 (28.3%) were eligible according to EASL 2017 guidelines. Of note, 6338 patients (63.1%) met the treatment criteria of WHO 2024 guidelines, which was significantly higher than for the other guidelines (P <.001).¹

Investigators pointed out more patients who were HBeAg positive than negative were eligible for treatment in different guidelines, with rates as high as 88.7% for WHO 2024, followed by 65.1% for EASL 2017, 48.0% for AASLD 2018, and 46.9% for APASL 2015 guidelines among those who were HBeAg positive (P <.001). For patients who were HBeAg negative, rates were 52.1%, 12.5%, 17.1%, and 12.9%, respectively (P <.001).¹

By sex, investigators pointed out the proportion of treatment-eligible patients for WHO 2024 guidelines was 67.0% in males, which was significantly higher than that for EASL 2017 (31.1%), AASLD 2018 (29.8%), and APASL 2015 (26.4%) guidelines (P <.001). They observed a similar trend in females and additionally noted a higher treatment-eligible rate among older patients.¹

Investigators acknowledged the need for further prospective studies involving racially and ethnically diverse populations and broader regions of the general HBV-infected population to validate these findings, as the present study involved patients who were retrospectively enrolled from liver centers or hospitals in China.¹

“In this cross-sectional study, we found that the WHO 2024 guidelines had the highest treatment-eligible rate compared with other international guidelines,” investigators concluded.¹ “Although the treatment-eligible rate increased significantly according to the WHO 2024 guidelines, efforts to increase treatment uptake and linkage to care are equally important.”

References

1. ^{Wang J, Zhang S, Zhu C, et al. WHO 2024 Hepatitis B Guidelines and Treatment-Eligible Rate Among Treatment-Naive Patients. JAMA Netw Open. doi:10.1001/jamanetworkopen.2024.35777}
2. ^{World Health Organization. WHO publishes new guidelines on hepatitis B. March 29, 2024. Accessed October 1, 2024. https://www.who.int/news/item/29-03-2024-who-publishes-updated-guidelines-on-hepatitis-b}