Hepatitis B elimination in the United States: which gaps need to be closed?

Hepatitis B virus (HBV) infection remains an important yet under-addressed public health issue in the US. The prevalence of chronic HBV in the US ranges between 0.5 – 2.5 million people (0.5 – 0.7% of the US population), and many people with HBV are undiagnosed or uncaptured through conventional surveillance.¹ People with untreated HBV are at risk of developing chronic liver disease, cirrhosis, liver cancer, and liver failure. Left untreated, approximately 25% of people with HBV go on to develop severe liver complications. HBV-related complications result in an estimated 1,800–2,000 deaths annually in the US.

To address HBV globally, the World Health Organization outlined targets for country-level elimination of viral hepatitis “as a public health threat” with a 90% reduction in new infections and 65% reduction in HBV-related mortality by 2030, both compared with a 2015 baseline. The Department of Health and Human Services (DHHS) followed suit with a Viral Hepatitis National Strategic Plan for the elimination of viral hepatitis in the US.² This Strategic Plan adapts the WHO goals to the US context and specifically emphasizes prevention of new infections, treatment with antiviral therapy to prevent complications, and addressing inequities in viral hepatitis screening, treatment, and outcomes.²

A new study by Wong, et al., provides unique insights into some of the gaps in treatment that need to be closed to achieve HBV elimination in the US.³ Using the TriNetX dataset, they identified individuals with positive HBV DNA testing and determined the proportion who met criteria for antiviral treatment. To define treatment eligibility, the investigators compared available laboratory and diagnosis fields in the dataset to HBV treatment guidelines from the American Association for the Study of Liver Diseases (AASLD). They found that three quarters of patients were not prescribed antiviral therapy, which leaves out many patients for whom treatment would be beneficial: just over 40% of did not have evidence of treatment within 6 months of presumably qualifying.

Most concerningly, the treatment gaps included patients with diagnosed cirrhosis or liver decompensation: while this group of patients was more likely to be prescribed antiviral therapy in general, approximately 40% of patients with diagnosis codes related to cirrhosis or liver decompensation still had no evidence of treatment. The analysis also uncovered disparities in race and ethnicity, finding lower odds of HBV treatment in people of non-Asian race relative to Asian race. The researchers performed a dedicated analysis on women of childbearing potential, given the importance of achieving an undetectable HBV DNA level during pregnancy to minimize the risk of mother-to-child HBV transmission. Only 17% of all women aged 18 – 44 years-old (regardless of pregnancy) received treatment, with persistent racial disparities.

Important limitations in the study design should be noted. First, the study only included individuals with elevated HBV DNA levels, meaning that people who had HBV with undetectable HBV DNA levels because of consistent treatment were not included in this denominator. Second, this study evaluated patients in cross-section, but HBV treatment eligibility is more often assessed after longitudinal monitoring of laboratory markers over time. Given that many patients with chronic HBV are monitored before referral to a specialist or initiation of antiviral therapy, it is not known whether some of the patients in this cross-sectional study went on to start treatment later in time. For these reasons, the proportion of all people with chronic HBV who are on treatment is likely higher than what is reported here. Furthermore, the finding that specific demographic groups of patients were less likely to be on treatment does not necessarily mean that those groups were more likely to have a gap between treatment eligibility and treatment initiation. The analysis of race-based disparities warrants more investigation about whether the gap in care lies in testing, monitoring, treatment initiation, or retention in care.

It should also be noted that while treatment initiation is low in women of reproductive age, the risk of perinatal HBV transmission in the US is exceedingly low in the general population, largely owing to perinatal screening with availability of HBV immunoglobullin and a long-standing policy of HBV birth-dose vaccination.⁴ There is cause for concern that this policy may change, as newly appointed members of the Advisory Committee on Immunization Practices (ACIP) in 2025 debate removing the recommendation for birth-dose HBV vaccination in the US. Removing the recommendation for universal birth-dose vaccination would be a major step backwards for elimination of HBV and would be potentially in direct contradiction to the DHHS Viral Hepatitis National Strategic Plan for the US.

How should clinicians and policy makers respond to this study? There is clearly more work to do in simplifying and consistently applying HBV treatment initiation criteria. Special attention should be paid to those with fibrosis, cirrhosis, and evidence of past liver decompensation as those people may be at highest risk of developing liver-related complications, leading to morbidity and mortality. Finally, the medical community should redouble efforts to engage with populations at risk of acquiring and living with HBV, such as immigrant groups, people who use drugs, and sexual minority persons.¹ The need to minimize stigma and improve access to care will only increase in urgency as changing federal policies limit access to Medicaid and threaten public confidence in scientific research, vaccines, and treatment.