Clinical Context

Estimated US prevalence of chronic hepatitis B (CHB) is 2.4 million. CHB disproportionately affects persons of Asian or African descent. Compared with White people with CHB, Asian American and African American or Black people also have higher hepatocellular carcinoma (HCC) incidence and develop HCC at an earlier age.

Earlier Hepatitis B Research Network analyses found significant differences in presumed mode of infection, hepatitis B virus (HBV) genotype, hepatitis B e antigen status, HBV DNA levels, and alanine aminotransferase (ALT) levels across racial groups and among African American and Black people, including significant differences between those born in the US, East Africa, and West Africa.

Study Synopsis and Perspective

Researchers studying differences in treatment initiation for CHB among a large, multiracial cohort in North America did not find evidence of disparities by race or socioeconomic status.

Instead, they observed a similar gap across races between the number of people eligible for treatment and those receiving it.

That gap suggests that treatment guidelines need to be simplified and that efforts to increase HBV awareness and train more clinicians are needed to achieve the World Health Organization’s goal of eliminating HBV by 2030, the researchers write.

The Hepatitis B Research Network study was published online April 10 in JAMA Network Open.^[1]

The prevalence of CHB in the United States is estimated at 2.4 million. It disproportionately affects persons of Asian or African descent, the investigators note. Their study examined whether treatment initiation and outcomes differ between African American or Black, Asian, and White participants, as well as between African American and Black participants born in North America and East or West Africa.

The research involved 1550 adult patients: 1157 Asian American, 193 African American or Black (39 born in the United States, 90 in East Africa, 53 in West Africa, and 11 elsewhere), 157 White, and 43 who identified as being of “other races.” All had CHB but were not receiving antiviral treatment at enrollment.

Participants came from 20 centers in the United States and 1 in Canada. They underwent clinical and laboratory assessments and could receive anti-HBV treatment after they enrolled. Enrollment was from January 14, 2011, to January 28, 2018. Participants were followed at 12 and 24 weeks, and every 24 weeks thereafter, in the longitudinal cohort study by Mandana Khalili, MD, Division of Gastroenterology and Hepatology, University of California, San Francisco, and colleagues.

Information on patients’ country of birth, duration of US or Canadian residency, educational level, employment, insurance, prior antiviral treatment, family history of HBV or HCC, and mode of transmission were collected by research coordinators.

Treatment Initiation

During the study period, slightly fewer than one third (32.5%) of the participants initiated treatment. The incidences were 4.8 per 100 person-years in African American or Black participants, 9.9 per 100 person-years in Asian participants, 6.6 per 100 person-years in White participants, and 7.9 per 100 person-years in those of other races (P<.001).

A lower percentage of African American and Black participants (14%) met the American Association for the Study of Liver Diseases treatment criteria compared with Asian (22%) and White (27%) participants (P=.01).

When the researchers compared cumulative probability of initiating treatment by race for those who met criteria for treatment, they found no significant differences by race.

At 72 weeks, initiation probability was 0.45 for African American and Black patients and 0.51 for Asian and White patients (P=.68). Similarly, among African American and Black participants who met treatment criteria, there were no significant differences in cumulative probability of treatment by region of birth.

The cumulative percentage of treatment initiation for those who met guideline-based criteria was 62%.

“Among participants with a treatment indication, treatment rates did not differ significantly by race, despite marked differences in educational level, income, and type of health care insurance across the racial groups,” the researchers write. “Moreover, race was not an independent estimator of treatment initiation when adjusting for known factors associated with a higher risk of adverse clinical outcomes, namely, HBV DNA, disease severity, sex, and age.”

Adverse liver outcomes (hepatic decompensation, HCC, liver transplant, and death) were rare and did not vary significantly by race, the researchers write.

One study limitation is that participants were linked to specialty liver clinics, so the findings may not be generalizable to patients who receive care in other settings, the authors note.

The results are “reassuring,” said senior author Anna S. Lok, MD, Division of Gastroenterology and Hepatology at University of Michigan in Ann Arbor. However, she noted, study participants had already overcome barriers to receiving care at major academic centers.

Many factors drive the decision to undergo treatment, including the physician’s opinion as to need and the patient’s desire to receive treatment, she said.

The study participants who were more likely to get treated were those with higher-level disease who had a stronger indication for treatment, Dr Lok said.

Finding the Disparities

Centers for Disease Control and Prevention statistics show that Black people are 3.9 times more likely to have CHB and 2.5 times more likely to die from it than White people, notes H. Nina Kim, MD, from the Department of Medicine, University of Washington, Seattle, in an accompanying invited commentary.^[2]

“The fact that we have not observed racial disparities in treatment initiation does not mean none exist; it means we have to look harder to find them,” she writes.

“We need to examine whether our guidelines for HBV treatment are so complex that it becomes the purview of specialists, thereby restricting access and deepening inequities,” Dr Kim adds. “We should look closely at retention in care, the step that precedes treatment, and stratify this outcome by race and ethnicity.”

Primary care clinicians in some regions might find it difficult to manage patients who have hepatitis B because they see so few of them, Dr Lok noted.

Dr Khalili has received grants and consulting fees from Gilead Sciences Inc and grants from Intercept Pharmaceuticals outside the submitted work. Dr Lok has received grants from Target and consultant fees from Abbott, Ambys, Arbutus, Chroma, Clear B, Enanta, Enochian, GNI, GlaxoSmithKline, Eli Lilly, and Virion outside the submitted work. Coauthors have received grants, consulting fees, or personal fees from Bayer, Boston Scientific, Exact Sciences, Fujifilm Medical Sciences, Gilead Sciences Inc, Glycotest Inc, Redhill Biopharma, Target RWE, MedEd Design LLC, Pontifax, Global Life, the Lynx Group, AstraZeneca, Eisai, Novartis Venture Fund, Grail Inc, QED Therapeutics, Genentech, Hepion Pharmaceuticals, Roche, Abbott, AbbVie, and Pfizer. Editorialist Dr Kim has received grants from Gilead Sciences (paid to her institution) outside the submitted work.

JAMA Network Open. Published online April 10, 2023.

Clinical Implications

• Racial disparity was not identified in rates of treatment initiation among patients with CHB meeting treatment criteria.
• Failure to observe racial disparities in treatment initiation does not prove their absence.
• Implications for the Health Care Team: Increased HBV awareness and training of clinicians, and simplifying treatment guidelines, are needed to achieve World Health Organization goals of HBV elimination by 2030.

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