Study Highlights Global Disparities in HBV Evaluation, Treatment

Mindie Nguyen, MD

Credit: Stanford Health Care

Findings from a recent study are sounding the alarm on significant sex and ethnic disparities in hepatitis B virus (HBV) evaluation and treatment.¹

Results of the multinational, real-world study were published in Journal of Hepatology and showed female treatment-eligible patients were about 50% less likely to receive antiviral treatment and Asian patients from Western regions were also about 50% less likely to receive adequate evaluation or treatment compared to Asians from the East.¹

"It is vitally important to understand what the continual barriers are to treatment for patients with HBV,” Mindie Nguyen, MD, professor of medicine at Standford University, said in a press release.²

In 2016, the World Health Organization set a goal to eliminate viral hepatitis as a public health problem by 2030 through a 90% reduction in incidence and a 65% reduction in mortality by 2030. An estimated 254 million people were living with chronic HBV in 2022, with 1.2 million new infections each year. Although it is preventable with a vaccine, linkage to care with oral antiviral therapy is necessary to suppress HBV replication and reduce hepatic inflammation, fibrosis, decompensation, and hepatocellular carcinoma (HCC) development.³

To determine the proportion of patients with chronic HBV who received adequate treatment evaluation, were eligible for treatment according to American Association for the Study of Liver Diseases (AASLD) criteria, and initiated treatment with nucleos(t)ide analogs, investigators conducted a cross-sectional study within the Real-world Effectiveness from the global Alliance for HBV (REAL-B) registry, a retrospective multinational clinical consortium. Study data included treatment-naïve patients with chronic HBV from 25 REAL-B centers from 2000 - 2021.¹

For inclusion, patients were required to be ≥ 18 years of age, have a positive HBV DNA or hepatitis B surface antigen test for ≥6 months, and be treatment-naïve at the initial presentation. Patients with HCC, decompensated cirrhosis, organ transplant or other immunosuppression, or co-infection with hepatitis C or D, or HIV were excluded. Patients were followed until loss to follow-up, death, or the end of the study period, whichever came first.¹

Investigators categorized patients by sex, ethnicity, and geographic location. Of note, patients were considered to be from the East if their study center was located in Hong Kong, Japan, Korea, Singapore, or Taiwan, whereas patients from the West were from study centers in Argentina, Romania, Spain, and the US.¹

In total, 12,566 treatment-naïve adults with CHB met the study criteria and were included in the analysis. Overall, the cohort had a mean age of 47.1 (Standard deviation, 13.8) years and the majority of patients were male (58.3%) and of Asian ethnicity (96.1%). By geographic region, similar proportions of patients resided in the East (50.7%) and West (49.3%), although investigators noted a significantly greater proportion of non-Asian patients were located in the West (99.4%) compared to the East (0.6%) and the East contained almost entirely Asian patients (>99.9% vs 92.2%; P <.001).¹

Overall, 73.3% of the cohort received an adequate HBV evaluation. Investigators pointed out that compared to patients without an adequate evaluation, those who had an adequate evaluation were older (47.6 vs 45.7; P <.001), more likely to be of non-Asian ethnicity (4.1% vs 3.2%; P = .02) and located in the East (53.5% vs 42.8%; P <.001), and more likely to have cirrhosis (11.2% vs 2.0%; P <.001).¹

After adjusting for age, sex, cirrhosis, and ethnicity plus region, female sex was associated with adequate evaluation (adjusted odds ratio [aOR], 1.13; P = .004). Compared to Asian patients from the East, Asian patients from Western regions were 40% less likely to receive an adequate evaluation (aOR, 0.60; 95% CI, 0.55-0.65; P <.001), while there was no significant difference with non-Asian patients from Western regions (aOR, 0.95; 95% CI, 0.76-1.19; P = .64).¹

By AASLD criteria, 32.6% of the patients who underwent adequate evaluation were treatment-eligible, 83.3% of whom initiated treatment with nucleos(t)ide analogs. Compared to untreated patients, treated patients were older (48.6 vs 44.7; P <.001), more likely to be male (66.6% vs 52.1%; P <.001), more likely to be from the East (69.2% vs 52.3%; P <.001), and more likely to have cirrhosis (26.5% vs 15.1%; P <.001).¹

Further analysis revealed female patients were about 50% less likely to be treated compared to their male counterparts (aOR, 0.54; 95% CI, 0.44-0.66; P <.001). Additionally, compared to Asian patients from Eastern regions, Asian patients from Western regions were also about 50% less likely to receive nucleos(t)ide analogs (aOR, 0.54; 95%, CI 0.44-0.66; P <.001), while there was no significant difference for non-Asian patients from Western regions (aOR, 0.83; 95% CI, 0.46-1.47; P = .51).¹

Investigators outlined several potential limitations to these findings, including potentially inflated rates of adequate evaluation and treatment initiation in specialized clinics compared to the community setting, lack of generalizability to regions not included in the study, overrepresentation of Asian patients, and the retrospective nature of the study.¹

“Our multinational real-world study of patients with chronic HBV revealed that rates of treatment evaluation and initiation remain below optimal levels, even among patients with cirrhosis and patients from referral practices,” Nguyen concluded.²

References:

1. ^{Kudaravalli S, Huang DQ, Yeh ML, et al. Sex and ethnic disparities in hepatitis B evaluation and treatment across the world. Journal of Hepatology. https://doi.org/10.1016/j.jhep.2024.02.033}
2. ^{Elsevier. Hepatitis B is globally underassessed and undertreated, especially among women and Asian minorities in the West. EurekAlert! May 1, 2024. Accessed May 9, 2024. https://www.eurekalert.org/news-releases/1042952}
3. ^{World Health Organization. Hepatitis B. Newsroom. April 9, 2024. Accessed May 9, 2024. https://www.who.int/news-room/fact-sheets/detail/hepatitis-b}