Barriers to Hepatitis B Treatment: A Multicentre Cross‐Sectional Registry and Survey Study by the Canadian Hepatitis B Network

ABSTRACT

Background & Aims

Chronic hepatitis B (CHB) remains a leading cause of cirrhosis and hepatocellular carcinoma (HCC) worldwide, yet treatment uptake is suboptimal even in high‐resource settings. This pan‐Canadian study aimed to quantify treatment gaps within the Canadian Hepatitis B Network (CanHepB) Registry, compare characteristics of treatment‐eligible but untreated patients to those receiving therapy, and assess patient and specialist perspectives on barriers to treatment.

Methods

A cross‐sectional, retrospective analysis of 1983 adults with CHB followed in 18 Canadian hepatitis B specialty clinics between January 2018 and November 2024. Treatment eligibility was determined using the 2018 Canadian Association for the Study of the Liver guidelines. An anonymous survey captured patient‐reported barriers and perspectives (n = 191), while a separate survey evaluated specialist perceptions (n = 54).

Results

Among 881 untreated patients, 46.4% (n = 409) were treatment eligible. Compared with the treatment group (n = 1087), the treatment‐eligible but untreated patients were younger (median 47.3 vs. 54.5 years), more frequently female (54.2% vs. 39.7%), and more likely to be of Black/African/Caribbean origin (18.2% vs. 9.7%). They had a lower prevalence of cirrhosis (2.4% vs. 20.3%), HCC (0.7% vs. 9.3%), and hypertension (17.1% vs. 22.9%), but a higher prevalence of steatotic liver disease (36.4% vs. 24.6%) and dyslipidemia (14.7% vs. 10.8%). Among untreated respondents, concerns included side effects, the need for long‐term therapy, and lack of curative options. Conversely, specialists identified cost as the primary barrier and side effects as the least concerning.

Conclusion

This nationwide study reveals a significant treatment gap in CHB care, driven by demographic disparities and a mismatch between patient concerns and clinician perceptions.

Lay Summary

Nearly half of people in this study who were eligible for hepatitis B treatment were not receiving it, despite effective therapies being available. The findings highlight a disconnect between patient concerns, such as side effects and long‐term treatment, and what healthcare providers perceive as the main barriers. Addressing this gap through better communication and patient‐centred care may improve treatment uptake and help prevent serious liver complications.

Abbreviations

ALT

alanine aminotransferase

AMMI

association of medical microbiology and infectious disease Canada

CanHepB

Canadian hepatitis B network

CAP

controlled attenuation parameter

CASL

Canadian association for the study of the liver

CHB

chronic hepatitis B

DSM‐5

diagnostic and statistical manual of mental disorders, fifth edition

HBeAg

hepatitis B E antigen

HBsAg

hepatitis B surface antigen

HBV

hepatitis B virus

HCC

hepatocellular carcinoma

HCV

hepatitis C virus

HDV

hepatitis D virus

HIV

human immunodeficiency virus

IQR

interquartile range

LSM

liver stiffness measurement

PROMs

patient‐reported outcome measures

qHBsAg

quantitative hepatitis B surface antigen

SLD

steatotic liver disease

WHO

World Health Organization

1. Introduction

Chronic hepatitis B (CHB) is a major global health problem and is the leading cause of cirrhosis and hepatocellular carcinoma (HCC) [1]. According to the World Health Organization (WHO) Global Hepatitis Report, about 240 million people are living with CHB, causing approximately 1.1 million deaths annually [2]. There are effective, well‐tolerated oral therapies (e.g., tenofovir and entecavir) that can suppress viral replication, prevent liver fibrosis progression, and reduce the incidence of HCC. The WHO estimates that only 10% of people living with CHB have been identified, and among those, only 5% receive treatment [3]. Canada has signed onto the WHO goals to achieve viral hepatitis elimination by 2030, which includes targets of > 80% of those eligible on hepatitis B virus (HBV) antiviral therapy and > 65% reduction in deaths from hepatitis B [2]. Many HBV endemic countries have developed programs to reduce the burden of HBV by scaling up both childhood vaccination and access to lifesaving treatment. Regions that are not on track to meet the WHO targets often lack strong health care infrastructure and/or policies to drive linkage to care. Canada has a publicly funded health care system in which the federal, provincial and territorial governments share responsibility for health care. The federal government sets the conditions that jurisdictions must meet to receive funding through the Canada health transfer, supporting access to medically necessary hospital and physician services. The Canada Health Act does not define medical necessity. Provinces and territories are responsible for health care delivery, including prescription drugs coverage, resulting in substantial variation in publicly funded drug programs across Canada and potential for health care disparities [4, 5]. Furthermore, there are differences in management and prescription for hepatitis B treatment by primary care physicians among different provinces. For example, in some provinces, prescriptions for anti‐HBV antivirals are restricted to specialists (i.e., infectious disease, gastroenterology and hepatology). In other provinces, practitioners with experience in hepatitis B management can apply to become designated prescribers [4].

There are limited studies on treatment rates among CHB patients in Canada and other resource‐rich regions. In Italy, a regional study found that 84% of treatment‐eligible CHB patients did not receive therapy [6]. A meta‐analysis of 13 studies including 31,342 individuals revealed that only 41% of treatment‐eligible patients received treatment [7].

Most Canadians living with CHB were born in endemic regions and likely acquired infection at birth or in early childhood from close contact with HBV‐affected family members. A prior study by the Canadian hepatitis B network (CanHepB) reported that a significant proportion of HBV patients had advanced fibrosis [8]. Published data indicate there are health care disparities for hepatitis C care in Canada, but there is limited data for hepatitis B [9]. Potential factors impacting treatment access include lack of familiarity with the health care system, language barriers and financial difficulty [10, 11]. Furthermore, both patients' and providers' understanding and treatment preferences may influence treatment rates.

The aims of this descriptive study were to (1) quantify the proportion of patients in the CanHepB Network Registry who met 2018 Canadian Association for the Study of the Liver (CASL)/Association of Medical Microbiology and Infectious Disease Canada (AMMI) treatment criteria but were not receiving nucleos(t)ide analogue therapy at the index visit, (2) compare the demographics of this group to those who are on treatment (defined as ongoing nucleoside/nucleotide analogue therapy), (3) describe self‐reported survey‐based patient barriers, experiences and perspectives on treatment and living with hepatitis B more broadly, and (4) assess how these measures compare to the perspectives of specialists (physicians and health care providers).

2. Methods

2.1. CanHepB Registry Retrospective Review

The CanHepB Network (https://canadianhbvnetwork.ca) is a collaborative organization of healthcare providers and researchers across Canada with an interest in advancing hepatitis B patient care. Within the Network is a registry of de‐identified patient chart data. The data are entered locally by research sites and housed centrally at the University of Calgary, Canada within the web‐based REDCap platform.

This was a cross‐sectional, retrospective study of patients followed in 18 hepatology or infectious disease clinics in seven provinces across Canada involved in the CanHepB Network. Adult participants with confirmed CHB infection (i.e., hepatitis B surface antigen (HBsAg) positive for greater than 6 months) were included if they were seen by a physician affiliated with the CanHepB Network at least once between January 2018 and November 2024, and had blood work that included HBV DNA, alanine aminotransferase (ALT) and/or a liver stiffness measurement (LSM) [FibroScan; EchoSens, Paris]. If the patients had more than one clinic visit that met this criterion, the most recent visit was used. 2018 was chosen to align with the release of the updated CASL Hepatitis B guidelines [12].

Patients were excluded if they had a history of alcohol use disorder (as defined by the diagnostic and statistical manual of mental disorders (DSM‐5)), coinfection with hepatitis C (HCV), hepatitis D (HDV), or human immunodeficiency virus (HIV), had a liver transplant, and/or if their treatment history was unknown. Treatment eligibility was defined using the 2018 guidelines, i.e., treatment is recommended when HBV DNA > 2000 IU/mL and ALT > 25 U/L in females and ALT > 35 U/L in males, and for those with LSM > Stage 1 fibrosis (> 7 kPa), even if HBV DNA < 2000 IU/mL or ALT is normal [12].

On treatment and treatment‐eligible groups were compared with respect to age, sex, self‐declared ethnicity, province of residence, history of HCC, non‐liver related comorbidities, smoking and intravenous drug use, family history of CHB, cirrhosis (defined as LSM > 12 kPa or via ultrasound or MRI diagnosis) and HCC, and standard laboratory measurements. Steatotic liver disease (SLD) was defined by controlled attenuation parameter (CAP) > 248 db/m [13] or if explicitly mentioned in the patient's medical record. Standard laboratory tests included ALT, HBV DNA, hepatitis B E‐antigen (HBeAg) status and, if available, quantitative (q) HBsAg.

2.2. Patient‐Reported Outcome Measures and Health Care Provider Surveys

Patient‐reported outcome measures (PROMs) were collected using an anonymous English language survey from three large clinics within the CanHepB Network (Pacific Gastroenterology Associates, Vancouver, BC; University of Calgary Liver Unit, Calgary, AB and The Ottawa Hospital Viral Hepatitis Program, Ottawa, ON) between May 2022 and January 2023. All three clinics contribute to the CanHepB Network Registry; therefore, survey respondents were recruited from clinical populations that overlap substantially with the Registry population. However, the survey was completed anonymously; thus, direct individual‐level linkage was not possible.

An anonymous online survey about HBV practices and perceived treatment barriers was conducted by physicians and health care providers within the CanHepB Network, as well as two national specialist health care organizations: CASL and the AMMI.

Both surveys were templated from a prior study conducted by the Hepatitis B Foundation (with permission to use, personal communication CSC) and revised based on literature review [14, 15, 16] and expert feedback from CanHepB, CASL and AMMI members. All survey responses were optional; the number of responses for a given question is indicated in the figure caption. Patients were offered a small honorarium to participate ($20 CAD), and no reimbursement was offered to physicians.

2.3. Ethics Statement

The study was conducted in accordance with the principles of the Declaration of Helsinki. For the registry component, ethics approval was obtained from the University of Calgary (REB16‐0041, REB21‐0224) and participating sites. Some sites obtained written informed consent from participants, while others were granted a waiver of consent for the use of de‐identified data, in accordance with local ethics approvals. For the survey component, separate institutional review board approvals for patient participation were obtained for participating clinics in Vancouver (Pro00067797), Calgary (REB21‐0224), and Ottawa (20210556‐01H). All patients provided signed informed consent to participate. The physician survey was included as part of the Calgary ethics approval. A research ethics board‐approved implied consent statement was provided at the beginning of the survey, and completion of the questionnaire by healthcare providers was taken to indicate consent to participate.

2.4. Statistical Analysis

Demographic and clinical characteristics were summarized as median and interquartile range (IQR) and compared using Wilcoxon rank‐sum tests due to non‐normal distributions. Categorical variables were compared using chi‐square or Fisher's exact tests, as appropriate. All tests were two‐sided, and a p < 0.05 was considered statistically significant. Given the descriptive nature of the study and multiple comparisons, p‐values were interpreted as exploratory. Statistical analyses were conducted using SPSS version 31.

3. Results

3.1. Proportion of Treatment‐Eligible but Untreated Patients

Overall, there were 3258 patients in the CanHepB Registry who had at least one clinic date between January 1, 2018 and November 1, 2024. Individuals were excluded if they had one or more of the following: coinfections, current or past alcohol misuse and/or liver transplant, which resulted in 2376 remaining patients. Of those, 393 patients had missing treatment status details and were excluded, leaving 1983 individuals. 45.2% (n = 896) were not on treatment, while 54.8% (n = 1087) were on treatment. Of those untreated, fifteen patients had missing lab and LSM data and were excluded because treatment eligibility status could not be assessed. Of the remaining 881 individuals, 46.4% (n = 409) were treatment‐eligible, while 53.6% (n = 472) did not require treatment based on 2018 guidelines12 (Figure 1).

FIGURE 1.

Flowchart illustrating inclusion criteria and treatment status of eligible patients with chronic hepatitis B in the Canadian Hepatitis B Network retrospective registry. *Categories are not mutually exclusive; individuals may meet more than one exclusion criterion.

3.2. Comparison of Patients Receiving Treatment to Those Treatment‐Eligible but Untreated

Patient characteristics are summarized in Table 1. The treatment‐eligible group had a higher proportion of females (54.2% vs. 39.7%, p < 0.001) and was significantly younger (median: 47.3y vs. 54.5y, p < 0.001) than the on‐treatment group. The treatment‐eligible group had a lower percentage of Asian/Southeast Asian individuals (71.4% vs. 82.9%, p < 0.001), but a higher percentage of Black/African/Caribbean individuals (18.2% vs. 9.7%, p < 0.001) than the on‐treatment group. The treatment‐eligible group had significantly less cirrhosis (2.4% vs. 20.3%, p < 0.001), HCC (0.7% vs. 9.3%, p < 0.001), and hypertension (17.1% vs. 22.9%, p = 0.015), but higher prevalence of SLD (36.4% vs. 24.6%, p < 0.001) and dyslipidemia (14.7% vs. 10.8%, p = 0.037) compared to the on‐treatment group. The treatment‐eligible group also had lower family history of end‐stage liver disease (8.0% vs. 13.3%, p = 0.020) and were less likely to be HBeAg positive (13.1% vs. 28.0%, p < 0.001). This group also had higher median qHBsAg (1484 IU/mL vs. 365.5 IU/mL, p = 0.008) and ALT (33 U/L vs. 25 U/L, p < 0.001) compared to the on‐treatment group. There were differences among provinces, with British Columbia and Saskatchewan both having significantly higher percentages of treatment‐eligible individuals (28.1% vs. 17.1% and 9.3% vs. 3.2%, p < 0.001), while Alberta had a significantly lower percentage of treatment‐eligible patients (21.3% vs. 36.8%, p < 0.001) compared to the on‐treatment group.

TABLE 1.

Comparison of demographic and clinical characteristics of patients with chronic hepatitis B enrolled in the Canadian Hepatitis B Network retrospective registry who received treatment compared to those who were treatment‐eligible based on 2018 CASL/AMMI HBV Guidelines12 but remained untreated. Grey cells indicate statistical significances between groups.

		On treatment (N = 1087)	Treatment‐eligible but untreated (N = 409)	p
Demographics	Female sex, N (%)	428/1079 (39.7%); 8 UNK	220/406 (54.2%); 3 UNK	p < 0.001
	Age (clinic visit), yrs., Median (IQR)	54.5 (43.5–64.7); 3 UNK	47.3 (38.4–57.4); 1 UNK	p < 0.001
	Ethnicity	120 UNK	35 UNK
	Asian or Southeast Asian, N (%)	803/969 (82.9%)	267/374 (71.4%)	p < 0.001
	Black/African or Caribbean, N (%)	94/969 (9.7%)	68/374 (18.2%)	p < 0.001
	White/Caucasian, N (%)	41/969 (4.2%)	17/374 (4.5%)	p = 0.731
	Other, N (%)	31/969 (3.2%)	22/374 (5.9%)	p = 0.018
	Canadian born, N (%)	43/826 (5.2%); 261 UNK	10/318 (3.1%); 91 UNK	p = 0.159
Medical History	Cirrhosis, N (%)	221 (20.3%)	10 (2.4%)	p < 0.001
	HCC, N (%)	100 (9.3%)	3 (0.7%)	p < 0.001
	SLD, N (%)	267 (24.6%)	149 (36.4%)	p < 0.001
	Diabetes mellitus, N (%)	135 (12.4%)	48 (11.7%)	p = 0.719
	Cardiovascular disease, N (%)	40 (3.7%)	11 (2.7%)	p = 0.347
	Hypertension, N (%)	249 (22.9%)	70 (17.1%)	p = 0.015
	Chronic kidney disease, N (%)	41 (3.8%)	8 (2.0%)	p = 0.079
	Dyslipidemia, N (%)	117 (10.8%)	60 (14.7%)	p = 0.037
	Osteoporosis, N (%)	32 (2.9%)	6 (1.5%)	p = 0.106
	Psychiatric disorders, N (%)	48 (4.4%)	15 (3.7%)	p = 0.521
Social History	Smoking (current and/or past), N (%)	99 (9.1%)	29 (7.1%)	p = 0.214
	IV Drug Use (current and/or past), N (%)	2 (0.2%)	1 (0.2%)	p = 0.816
Family history	Hepatitis B, N (%)	370/728 (50.8%); 359 UNK	153/338 (45.3%); 71 UNK	p = 0.091
	Cirrhosis, N (%)	78/586 (13.3%); 501 UNK	23/289 (8.0%); 120 UNK	p = 0.020
	HCC, N (%)	94/610 (15.4%); 477 UNK	30/297 (10.1%); 112 UNK	p = 0.030
Laboratory and Imaging	ALT, U/L, Median (Q1–Q3)	25 (19–36); 112 UNK	33 (24–48); 9 UNK	p < 0.001
	Hepatitis B e Antigen‐positive, N (%)	134/479 (28.0%); 608 UNK	28/214 (13.1%); 195 UNK	p < 0.001
	HBV DNA, IU/mL, Median (Q1–Q3)	11 (0–626.5); 556 UNK	3315 (456–17 150); 65 UNK	p < 0.001
	qHBsAg, IU/mL, Median (Q1–Q3)	365.5 (36.41–2399.25); 805 UNK	1484 (66.31–7571.05); 346 UNK	p = 0.008
	LSM kPa, Median (Q1–Q3)	5.5 (4.5–7.8); 649 UNK	5.3 (4.3–6.9); 153 UNK	p = 0.020
Clinic Province	British Columbia, N (%)	186 (17.1%)	115 (28.1%)	p < 0.001
	Alberta, N (%)	400 (36.8%)	87 (21.3%)	p < 0.001
	Saskatchewan, N (%)	35 (3.2%)	38 (9.3%)	p < 0.001
	Manitoba, N (%)	5 (0.5%)	4 (1.0%)	p = 0.248
	Ontario, N (%)	447 (41.1%)	158 (38.6%)	p = 0.381
	Quebec, N (%)	9 (0.8%)	4 (1.0%)	p = 0.759
	Nova Scotia, N (%)	5 (0.5%)	3 (0.7%)	p = 0.458

Abbreviations: ALT, alanine aminotransferase; HCC, hepatocellular carcinoma; LSM, liver stiffness measurement; qHBsAg, quantitative hepatitis B surface antigen; SLD, steatotic liver disease; UNK, unknown.

3.3. Patient Reported Outcome Measures (PROMs)

PROMs were collected from 191 patients with CHB. Most (61.3%; 117/191) were 40–59 years old and half (50.3%; 92/183) were male. Three quarters (76.7%; 145/189) were employed and about one third (36.1%; 69/191) did not have extended drug coverage. When asked, 57.1% (109/191) indicated that they were not currently on treatment, but because the survey was anonymous, it was not possible to confirm whether the untreated individuals were eligible or not. Untreated individuals were asked how likely they would be to accept their physician's recommendation to start treatment and acceptance rate ranged from 36.7% ‘definitely’, 24.8% ‘probably’, 27.5% ‘might’, 8.3% ‘probably not’, and 2.7% ‘definitely not’. Participants were asked what would increase their comfort with treatment, and 37.6% preferred trying diet or natural remedies first, 28.4% wanted clarity on when treatment could stop, and 25.7% preferred longer monitoring. Untreated individuals were also asked about their level of concern for factors related to taking medication (Figure 2). Medication side effects, requirement for long‐term therapy, non‐curative nature of therapy, and high medication costs were reported as very concerning (4 or 5 on 5‐point scale) by 64.4% (67/104), 57.1% (60/105), 53.3% (56/105), and 37.1% (39/105) of patients, respectively.

FIGURE 2.

Distribution of patient concern regarding factors related to initiating anti‐HBV treatment. Green represents the lowest level of concern and red the highest. N = 104–105 respondents per question.

All participants were asked about challenges they may face as a person living with CHB (Figure 3). The most challenging categories (‘extremely’, ‘very’ or ‘somewhat’) were staying current on the latest hepatitis B research (36.2%; 67/185), the cost of hepatitis B medication (35.3%; 65/184), and maintaining a healthy diet (34.1%; 63/185). Despite being assessed and followed by specialists at tertiary centres, more than 25% of patients (28.9%; 54/187) still had some to significant concerns about finding a doctor who knows how to manage CHB. The stigma of living with CHB remains somewhat to extremely challenging in 26.2% of participants (49/187).

FIGURE 3.

Percentage distribution of patient‐reported concern levels across various hepatitis B‐related health challenges (N = 183–187).

Individuals were asked about their modes of transportation and whether this was a barrier to seeing a medical specialist. 84.3% (161/191) reported that transportation did not prevent them from attending medical appointments in the past year. Most respondents drive (75.9%, 145/191), while 14.7% (28/191) travel as passengers, 12.6% (24/191) use public transportation, and less than 5% reported using a taxi, accessible transit, cycling, or walking as transportation.

Participants were asked about factors that may have limited their access to care (Figure 4), with the most common barriers being long wait times for appointments, difficulty getting to appointments, and extended waits in the doctor's office.

FIGURE 4.

Patient‐identified barriers to accessing care (N = 191).

3.4. Health Care Provider Perspectives

Fifty‐four healthcare providers responded to the survey (30/54 male). Age distribution was 31–40 (n = 15), 41–50 (n = 24), 51–60 (n = 11), and > 60 (n = 4). Years in practice were < 5 (n = 8), 6–10 (n = 18), 11–14 (n = 10), and > 15 (n = 18). Primary specialties included gastroenterology (n = 17), hepatology (n = 16), infectious disease (n = 17), and other (n = 4). The estimated number of HBV patients seen annually was < 50 (n = 18), 51–100 (n = 8), 101–199 (n = 8), 200–299 (n = 6), 300–500 (n = 4), and > 500 (n = 10).

Specialists were surveyed on their perceptions of patient concerns regarding medication side effects, the need for long‐term therapy, the non‐curative nature of treatment, and medication costs (Figure 5). Compared with patient responses, a greater proportion of specialists rated cost as a high concern (4 or 5 on a 5‐point scale; 61.1%, 33/54), while fewer rated side effects as a high concern (9.3%, 5/54).

FIGURE 5.

Level of concern that specialist report patients feel regarding HBV treatment. Green indicates lowest level of concern and red indicates highest level of concern (N = 54).

Based on 2018 CASL/AMMI guidelines, the majority of health care providers believed treatment criteria should be broadened, with considerations of family history of HCC (51.4%; 19/37), age over 40 years (16.2%; 6/37) and presence of SLD (16.2%; 6/37).

Most specialists (86.8%, 46/54) estimated that fewer than 20% of their patients remain untreated despite a recommendation for therapy. However, 75.9% (41/54) indicated that some patients (also less than 20%) remain untreated due to inability to afford extended health benefits.

4. Discussion

This study identifies a substantial treatment gap in chronic hepatitis B (CHB) care across Canada based on 2018 CASL/AMMI guidelines and highlights demographic and clinical disparities among untreated yet eligible patients. Importantly, this study reveals important mismatches between patient and provider perspectives on treatment barriers.

The first aim of this study was to quantify the proportion of patients in the Canadian Hepatitis B Network Registry who were treatment‐eligible but not receiving therapy. Among 881 untreated patients, 46.4% met treatment eligibility criteria according to the 2018 CASL/AMMI guidelines, while 53.6% did not. This finding underscores a significant treatment gap, with nearly half of eligible patients remaining untreated. Multiple factors may contribute to this undertreatment, including patient‐level barriers, provider hesitation in borderline cases, and variation in provincial medication reimbursement policies [4]. These findings are particularly relevant in the context of the 2025 CASL/AMMI guidelines, which advocate for expanded treatment eligibility, simplified diagnostic pathways, and earlier intervention [17]. These updates may help reduce the treatment gap moving forward.

The second aim of this study was to compare the characteristics of treatment‐eligible but untreated patients (n = 409) with those receiving treatment (n = 1087). Compared with treated individuals, the untreated cohort was younger, included a higher proportion of females, and had greater representation of Black/African/Caribbean individuals. These findings are consistent with prior literature identifying barriers such as younger age, lower income, immigrant status, language barriers, limited awareness of CHB risks, mistrust of healthcare systems, and social stigma [14]. Possible explanations include perceptions among both clinicians and patients that younger individuals have less advanced disease, concerns among women regarding treatment during childbearing years, and structural or cultural barriers affecting immigrant populations. Together, these findings highlight important health disparities in CHB care in Canada.

Patients who were treatment‐eligible but untreated had significantly lower rates of cirrhosis, HCC, hypertension, and family history of end‐stage liver disease, indicating less advanced disease at presentation. Notably, the untreated cohort had higher rates of SLD and dyslipidemia, factors associated with fibrosis progression in CHB [18, 19]. This may reflect under‐recognition of metabolic comorbidities in treatment decision‐making and suggests an opportunity to better integrate metabolic risk into CHB management strategies.

Despite meeting treatment criteria, clinicians may perceive these individuals as relatively stable and opt for monitoring rather than immediate therapy. This reflects the nuances of real‐world clinical care and individualized decision making. Guidelines provide a framework for clinicians, acknowledging that not all untreated Hepatitis B patients progress to significant liver disease. In such instances, close monitoring is often more appropriate than initiating immediate treatment.

Geographic variation was also observed, with higher proportions of untreated eligible patients in British Columbia and Saskatchewan, and higher treatment rates in Alberta. Although these differences likely reflect variations in drug coverage policies and prescribing practices across provinces, the data were also limited by lower registry data input from some regions.

The final aim explored patient‐reported barriers and perspectives through survey data. Among untreated respondents, over one‐third (36.7%) indicated they would ‘definitely accept’ treatment if recommended, and an additional 24.8% would ‘probably accept’, suggesting strong trust in specialist recommendations and willingness to initiate therapy. Patients identified medication side effects, long‐term therapy, and the lack of a cure as their primary concerns, while cost was rated as least concerning. In contrast, specialists perceived cost as the primary patient concern and side effects as least important. This mismatch may reflect patients' reluctance to disclose financial concerns or clinicians' underestimation of patient apprehension regarding treatment burden and safety. These findings emphasize the importance of incorporating patient‐reported perspectives into clinical decision‐making.

The survey data also highlighted findings from the perspective of informing clinical care quality improvement strategies. Despite being followed at specialist clinics, more than a quarter of the patients expressed concerns about finding a doctor who knows how to manage their CHB. Possible explanations for these findings include patients' ongoing anxiety about their care, worry about loss to follow up, and language barriers. Additionally, patients reported challenges in staying informed about hepatitis B and maintaining a healthy lifestyle, suggesting a potential role for peer support programs and patient education initiatives.

Although medication cost was rated as a lower concern by individual respondents, it remained one of the most frequently cited systemic barriers across the broader cohort, likely reflecting the difference between perceived and experienced burden. Generic HBV antivirals are available in Canada, but costs remain relatively high compared with other Group of 7 (G7) countries, at approximately $4‐5CAD per day for generic TDF or ETV [20, 21]. The pricing of originator drugs are determined based on negotiations between the pan‐Canadian pharmaceutical alliance and individual manufacturers as well as provincial and territorial governments [22]. Pricing of generic drugs is based on a tiered pricing scale of the originator's list price based on the number of generics on the market [23]. This disparity has led to advocacy efforts in Canada to highlight drug pricing and reimbursement as key structural barriers.

These findings are relevant to Canada's progress toward WHO hepatitis B elimination targets [24]. Approximately 260 000 individuals are estimated to be living with HBV in Canada with estimated 40% unaware of their infection [25]. The prevalence of CHB among Canadian immigrants is significantly higher than the general population (4.03% among immigrants vs. 0.68% nationally) [26]. Immigrants often face amplified barriers: lack of routine pre‐ or post‐arrival hepatitis B screening, language and cultural issues, navigation challenges and stigma, which all potentially lead to delay in diagnosis and further widen the treatment gap [27]. However, once engaged in care and established in Canada, available data show that immigrants are more likely to have a regular health care provider and receive treatment and monitoring compared to recent immigrants [28]. Addressing these gaps will require targeted public health strategies, including universal screening for hepatitis B, community outreach, culturally tailored education, and simplified treatment pathways to improve diagnosis and linkage to care.

A key strength of this study is that it represents a large national analysis of CHB care gaps in Canada, incorporating a diverse patient population across multiple centres. Importantly, the direct comparison of patient and provider perspectives provides actionable insights to inform policy and practice.

This study has several limitations. As a cross‐sectional registry analysis, it represents a single time point, and we could not determine whether clinicians appropriately deferred treatment based on follow‐up testing or evolving clinical context. Conversely, some patients may have initiated treatment after data collection. Treatment decisions involve important clinical nuances, which may not be fully captured. Although we applied the Canadian Association for the Study of the Liver criteria, including LSM > 7.0 kPa, or elevated ALT with HBV DNA > 2000 IU/mL, clinicians may not strictly apply these recommendations in all cases, particularly when other comorbid liver diseases or competing clinical factors are present. Furthermore, because the registry outcomes were retrospective and not directly linked to patient or provider perspectives, the factors associated with not initiating antiviral therapy may differ from the survey data. The cohort was limited to individuals under specialist care, which may introduce selection bias toward those with better healthcare access. Registry representation from Quebec was limited despite its large HBV population, which may affect the national generalizability of these findings. Findings may not be generalizable to regions with different healthcare systems or treatment criteria. Survey data have inherent limitations, including the potential that patients under‐reported financial concerns related to medication, either due to social desirability bias or to hypothetical bias. Another limitation is non‐response bias. Survey non‐response bias due to individuals who choose not to participate and differ systematically from those who do can skew the results of our study. The study investigators tried to mitigate non‐response bias through use of incentives (i.e., nominal gift cards), ensuring confidentiality, relatively short survey design and convenient timing (i.e., while in clinic waiting room). Finally, treatment eligibility was determined using the 2018 CASL guidelines, and the registry reflects practice patterns based on these older criteria.

In conclusion, this study highlights significant treatment gaps and health disparities in CHB care across Canada. Addressing these challenges will require improved alignment between patient and provider perspectives, enhanced access to therapy through equitable reimbursement policies, and targeted education and support initiatives to promote timely treatment uptake.

Author Contributions

Substantial contributions to study conception and design: Hin Hin Ko, Jordyn Vienneau, Curtis L. Cooper, Pam Crotty, Stephen E. Congly, Mayur Brahmania, Alnoor Ramji, Erin Kelly, Angela M. Crawley, Karen Doucette, Vanessa Meier‐Stephenson, Mang Ma, Scott K. Fung, David K. Wong, Nabiha Faisal, Kelly Kaita, Carla Osiowy, Edward Tam, Alexander Wong, Robert Bailey, Giada Sebastiani, Tianyan Chen, Brian Conway, David Truong, Abdel‐Aziz Shaheen, and Carla S. Coffin; substantial contributions to analysis and interpretation of the data: Hin Hin Ko, Jordyn Vienneau, Curtis L. Cooper, Pam Crotty, Stephen E. Congly, Mayur Brahmania, Alnoor Ramji, Erin Kelly, Angela M. Crawley, Karen Doucette, Vanessa Meier‐Stephenson, Mang Ma, Scott K. Fung, David K. Wong, Nabiha Faisal, Kelly Kaita, Carla Osiowy, Edward Tam, Alexander Wong, Robert Bailey, Giada Sebastiani, Tianyan Chen, Brian Conway, David Truong, Abdel‐Aziz Shaheen, and Carla S. Coffin; drafting the article or revising it critically for important intellectual content: Hin Hin Ko, Jordyn Vienneau, Curtis L. Cooper, Pam Crotty, Stephen E. Congly, Mayur Brahmania, Alnoor Ramji, Erin Kelly, Angela M. Crawley, Karen Doucette, Vanessa Meier‐Stephenson, Mang Ma, Scott K. Fung, David K. Wong, Nabiha Faisal, Kelly Kaita, Carla Osiowy, Edward Tam, Alexander Wong, Robert Bailey, Giada Sebastiani, Tianyan Chen, Brian Conway, David Truong, Abdel‐Aziz Shaheen, and Carla S. Coffin; final approval of the version of the article to be published: Hin Hin Ko, Jordyn Vienneau, Curtis L. Cooper, Pam Crotty, Stephen E. Congly, Mayur Brahmania, Alnoor Ramji, Erin Kelly, Angela M. Crawley, Karen Doucette, Vanessa Meier‐Stephenson, Mang Ma, Scott K. Fung, David K. Wong, Nabiha Faisal, Kelly Kaita, Carla Osiowy, Edward Tam, Alexander Wong, Robert Bailey, Giada Sebastiani, Tianyan Chen, Brian Conway, David Truong, Abdel‐Aziz Shaheen, and Carla S. Coffin.

Funding

This work was supported by Gilead Sciences, IN‐CA‐320‐6073.

Conflicts of Interest

Hin Hin Ko is a speaker and advisor for Gilead and GSK. Giada Sebastiani has acted as a speaker for Pfizer, Merck, Novo Nordisk, Gilead, AbbVie, Biron, Boehringer Ingelheim, Lupin, and Eli Lilly, served as an advisory board member for Merck, Gilead, GSK, and Novo Nordisk, and has received research funding from Novo Nordisk. Carla S. Coffin has received research funding or consulting fees from Gilead Sciences, GSK, Ausperbio, Vir, and Janssen Pharmaceuticals, paid to the University of Calgary. Curtis L. Cooper is a speaker for Gilead and an advisor for Gilead and GSK. Stephen E. Congly reports research funding from Merck, Ipsen, Bausch Health, Oncoustics, Boehringer Ingelheim, GSK, and Gilead Sciences Canada, as well as personal fees from GSK, Boehringer Ingelheim, and Gilead Sciences Canada outside of the submitted work. All other authors have nothing to disclose.

Ko H. H., Vienneau J., Cooper C. L., et al., “Barriers to Hepatitis B Treatment: A Multicentre Cross‐Sectional Registry and Survey Study by the Canadian Hepatitis B Network,” Liver International 46, no. 9 (2026): e70835, 10.1111/liv.70835.

Data Availability Statement

The data that support the findings of this study are available from the corresponding author upon reasonable request.