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Global strategies and actions to eliminate hepatitis B virus infection

Clinical and Molecular Hepatology 2025;31(4):1197-1212.
Published online: July 28, 2025

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Corresponding author : Jia-Horng Kao Graduate Institute of Clinical Medicine, National Taiwan University, College of Medicine, 1 Chang-Te St., Taipei 10002, Taiwan Tel: +886-2-23123456 ext. 267307, Fax: +886-2-23825962, E-mail: kaojh@ntu.edu.tw

Editor: Sang Hoon Ahn, Yonsei University, Korea

• Received: May 1, 2025   • Revised: July 6, 2025   • Accepted: July 24, 2025

Copyright © 2025 by The Korean Association for the Study of the Liver

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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  • Through the implementation of hepatitis B vaccination and effective antiviral treatment over the past four decades, the hepatitis B surface antigen (HBsAg) seroprevalence of the vaccinated generation dramatically decline. The incidence of hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) also decreases. However, the elimination of HBV is still a challenge to achieve. Novel HBV biomarkers, including quantitative HBsAg, hepatitis B virus core-related antigen and HBV RNA are promising in predicting clinical phases, risks of disease progression and HBV functional cure. Current antiviral therapies, nucleoside/nucleotide and pegylated alpha-interferon, effectively decrease HCC incidence in chronic hepatitis B (CHB) patients and minimize the recurrence of HCC in patients receiving curative therapy. Novel agents under development to achieve HBV cure include direct-acting antivirals that target various stages of the HBV lifecycle and host targeting agents that enhance HBV-specific immunity. The action plans for eliminating hepatitis B in the future are universal HBV screening, early and simplified treatment as well as precision lifelong management for CHB patients. This narrative review will summarize and discuss global strategies and initiatives aimed at eliminating HBV infection.
Hepatitis B virus (HBV) chronic infection is one of the major global health concerns, with more than 254 million people affected worldwide. It is estimated that approximately 1.1 million people die from HBV-related cirrhosis and liver cancer [1]. Currently, approved antiviral treatments like nucleoside/nucleotide analogues (NA) are highly effective in suppressing viral replication and significantly reduce the risk of cirrhosis and hepatocellular carcinoma (HCC) [2-4]. Previous studies have shown that responders to pegylated interferon alpha (PegIFN-α) and patients with long-term NA treatment have a decreased HCC incidence compared to untreated patients [5,6]. However, fewer than 5–15% of treated patients achieve the loss of hepatitis B surface antigen (HBsAg) or so called “functional cure” [7]. Although NA reduces the risk of death due to liver diseases by 50–70%, NA cannot eliminate intrahepatic covalently closed circular DNA (cccDNA), and thus, viremia recurs in more than 50% of patients after stopping NA treatment [8]. Therefore, it is difficult to successfully achieve the goal of functional cure by using PegIFN-α or NA monotherapy. In 2016, World Health Organization (WHO) called for the elimination of HBV as a major public health goal by 2030, including a reduction in liver-related mortality rates to ≤6 per 100,000 population, reducing new HBV by 95%, reducing HBV-related deaths by 65%, and reducing the HBsAg prevalence rate in ≤5-year-old children to less than 0.1% [9]. According to a modelling study, the estimated global prevalence of HBsAg was 3.29% in 2022, only a slight decrease from 3.61% in 2015 [10]. The liver-related mortality, including HCC and end stage liver disease attributable to viral hepatitis B and C remained at 12.9 per 100,000 population in 2019 [11]. To accelerate the achievement of the WHO 2030 target, realistic strategies should be established according to the prevalence of viral hepatitis, testing rates, and antiviral drug treatment rates in various regions. In addition, measurable indicators should be developed to monitor the status and trends of viral hepatitis. Thus, the achievement of HBV elimination targets in 2030 will be very challenging.
Taiwan is an HBV hyperendemic country; the prevalence of HBsAg in the adult population was approximately 13% [12]. The annual incidence of HCC (mainly HBV related) increased from 15 per 100,000 people in 1980 to 30 per 100,000 people in 2000 [13]. Through the implementation of hepatitis B vaccination of infants and young children over the past 30 years, the HBsAg seroprevalence of the vaccination generation had declined year by year. On the other hand, the expanding antiviral treatment for patients with chronic hepatitis B (CHB) also decreased the incidence of HBV-related HCC [14-16]. A multicenter study including the Asia-Pacific regions and the Western countries also confirmed that NA treatment could reduce the risk of HCC occurrence (adjusted hazard ratio [HR] 0.46, 95% confidence interval [CI] 0.29–0.75) [17].
In this review, the global strategies and actions toward the elimination of HBV will be summarized and discussed.
According to WHO 2024 guideline, the natural history of CHB is divided into HBeAg-positive chronic HBV infection (immune tolerant phase), HBeAg-positive CHB (immune (re)active phase), HBeAg-negative chronic HBV infection (inactive carrier state) and HBeAg-negative CHB (immune-active or HBeAg-negative disease) [1,18]. Patients with perinatal HBV infection are mostly in the HBeAg-positive chronic HBV infection before adolescence. With transition to the HBeAg-positive CHB, patients are characterized by intermittent or persistent elevation of alanine aminotransferase (ALT) levels and high HBV DNA levels. Long-term hepatic necroinflammation results in annual HBeAg seroconversion rate of 5–10% [19], depending on HBV genotypes [20]. During HBeAg-negative chronic HBV infection, the risk of disease progression is usually reduced. However, HBV reactivation may occur in HBeAg-negative patients with suddenly increased hepatitis B viral load. HBV reactivation may occur spontaneously or in immunocompromised individuals [21]. In general, about 30–40% of CHB patients are in persistent chronic inflammation. Without antiviral treatment, about 2% of them deteriorate into cirrhosis each year, and the annual incidence of HCC is about 3–10% [22]. Because of the diversity of clinical manifestations and viral factors, the risk of disease progression and HCC development should be precisely stratified [23].
According to the advancements in molecular virology research, several hepatitis B viral biomarkers have been identified and are clinically used as predictors of disease progression, risk of HCC occurrence, and response to antiviral therapy.
In untreated HBV patients, the viral factors contributing to the risk of HCC include hepatitis B viral load, HBV and host genomic DNA integration, and HBV mutations. Regardless of the HBeAg-positivity or negativity, patients with moderate to high viral load and active hepatic inflammation have a higher risk of HCC [24]. HBV DNA integration leads to genomic instability and insertion mutations in potential HCC-related genes. HBV integrant is associated with the overexpression of cancer driver genes, increase the risk of HCC occurrence [25]. The diversity of HBV genotypes and certain naturally occurring HBV mutations also associate with the risk of liver disease progression. Current evidence reveal that HBV genotypes C, D, F infection, basal core promoter mutation and pre-S deletion mutations are the confirmed risk factors for cirrhosis and HCC development [20].
Except for HBV viral load, several quantifiable viral markers have been identified to predict the outcomes of CHB, including quantitative HBsAg, HBV core-related antigen (HBcrAg) and HBV RNA. These biomarkers summarized in Table 1 will help develop personalized risk stratification management for HBV patients [26].
Identifying clinical phases of CHB
Quantitative HBsAg in combination with HBV DNA could more accurately identify the clinical phases of CHB [27]. Several studies indicated that low serum HBsAg levels predict spontaneous or treatment-induced HBsAg loss in HBeAg-negative patients [28-30].
HBcrAg consists of three components: hepatitis B core antigen, HBeAg, and precore protein. HBcrAg is positively correlated with HBV DNA. Both of them are high concentration in the active phase of hepatitis and low levels in the inactive phase [31]. In a retrospective study with untreated CHB patients, low HBcrAg was associated with HBsAg seroclearance during follow-up [32]. Similarly, in a multicenter study of patients treated with PegIFN-α, low HBcrAg levels at the end of treatment were positively correlated with HBsAg seroclearance and seroconversion [33]. In HBeAg-negative patients with NA treatment achieving viral response, both of low quantitative HBsAg and undetectable HBcrAg at the time of NA withdrawal was significantly correlated with HBsAg seroclearance [34]. Taken together, quantitative HBsAg and HBcrAg may predict functional cure of HBV over time.
HBV RNA, a template for reverse transcription, was also correlated with replicative activity of covalently closed circular HBV DNA. Serum HBV RNA levels are parallel to HBV DNA and quantitative HBsAg levels. Low HBV RNA level may discriminate the inactive and active phases of chronic HBV infection with an AUROC of 0.833 (P<0.001) [35]. However, there is no commercially available HBV RNA assay in our clinical practice.
Both traditional and novel biomarkers are crucial for the personalized management of CHB [36]. Based on the existing evidence, the algorithm integrating both traditional and novel biomarkers for the personalized management of CHB has been proposed (Fig. 1). Traditional markers, such as HBeAg, serum ALT level and HBV DNA, are used to identify the clinical phase of patients. Quantitative HBsAg, HBcrAg and HBV RNA for assessing HCC risk, the need for antiviral treatment, the risk of relapse after discontinuation of treatment and finally the probability of functional cure.
Predicting HCC risk
In a hospital cohort study involving 2,688 untreated patients without cirrhosis over a mean follow-up period of 14.7 years, both HBV DNA and quantitative HBsAg levels showed a positive correlation with the incidence of HCC. Notably, in HBeAg-negative patients with low HBV DNA levels, a high quantitative HBsAg level was also significantly associated with the risk of HCC occurrence [37]. In the latest study, Tseng et al. [38] found that HBeAg-positive patients in immune tolerance phase with high levels of quantitative HBsAg had a higher risk of delayed HCC development compared to those with low levels of quantitative HBsAg.
Recent studies highlighted the value of HBcrAg in predicting the risk of HCC development. Several long-term follow up studies of untreated CHB patients showed that those with high serum levels of HBcrAg had a significantly increased risk of HCC compared to those with low HBcrAg levels [39]. This association also persisted in untreated, noncirrhotic, HBeAg-negative CHB patients with intermediate HBV DNA levels and normal serum ALT levels [40]. Another large-scale retrospective study enrolled 1,268 NA-treated CHB patients with a median follow-up of 8.9 years; patients with high on-treatment HBcrAg levels had a greater risk of HCC compared to those with low levels. For HBeAg-positive and -negative patients, the HR was 6.15 (95% CI 1.89–20.0) and 2.54 (95% CI 1.40–4.60), respectively [41].
Regarding the association between HBV RNA and HCC, in a prospective cohort study with 2974 patients who received NA treatment, the patients with detectable HBV RNA at enrollment had a significantly higher risk of HCC development than patients with undetectable HBV RNA (adjusted HR 2.21, 95% CI 1.27–3.84) [42].
In summary, quantitative HBsAg, HBcrAg and HBV RNA are all valuable to predict the risk of developing HCC in CHB patients.
Lifelong care of CHB
Lifelong care of CHB refers to the ongoing management and monitoring of CHB patients. For the children with perinatal HBV infection, most of them are at the HBeAg-positive immune-tolerance phase. Patients require regular monitoring for liver function and HBV DNA levels. When the disease status changes from immune tolerance phase to immune active phase, antiviral therapy should be considered. According to guidelines before 2024, several factors must be evaluated to determine the treatment initiation: (1) active viral replication with high HBV DNA levels (≥20,000 IU/mL for HBeAg-positive and ≥2,000 IU/mL for HBeAg-negative patients); (2) hepatitis activity with abnormal ALT levels; and (3) advanced liver fibrosis or cirrhosis [2-4]. However, a substantial group of patients is outside the treatment criteria for antiviral therapy and falls into the indeterminate phase or “grey zone”. The necessity of earlier antiviral treatment for these patients is still a subject of debate [43]. In a retrospective study with 1,303 patients in the indeterminate phase, 52.7% of patients remained in the indeterminate phase and 21.7% of them transitioned to the immune active phase during a mean follow-up of 10 years [44]. Another retrospective study from China further indicated that the phase transition rates over 10 years to immune active phase were 55% and 38.2% for HBeAg-positive and -negative patients in the indeterminate phase [45].
Several studies reported that patients in the indeterminate phase have significantly higher incidence of HCC than those in the inactive phase [44,46]. Compared to untreated patients in the indeterminate phase, antiviral therapy significantly decreased the risk of HCC occurrence for those patients [47]. Therefore, patients in the indeterminate phase must be closely followed to determine the optimal timing of treatment initiation.
For the patients with NA therapy, the treatment duration and the criteria for discontinuation of NA or lifelong therapy remain unresolved [48]. Current evidence revealed that the probability of achieving HBsAg seroclearance or seroconversion are very low with long-term NA treatment [49]. On the other hand, the probabilities of HBsAg seroclearance may increase after cessation of NA treatment. In a randomized controlled trial with 166 HBeAg-negative CHB patients receiving more than 4 years of NA treatment, the cumulative HBsAg seroclearance rate was significantly higher in patients stopping NA than those continuing NA treatment [50]. However, the concern is the poor durability of sustained virological response after NA cessation [51]. In a meta-analysis with HBeAg-negative CHB patients receiving NA therapy, the virological relapse rate and ALT flare up after discontinuing NA were as high as 63% and 35% at one year [52]. Furthermore, ALT flare up will progress to hepatic decompensation in a certain proportion of patients, although the incidence is not high [53].
Therefore, regardless of long-term treatment or not, lifelong monitoring is necessary for all CHB patients to minimize the risk of disease progression.
The impact of steatotic liver disease on CHB
Metabolic dysfunction-associated steatotic liver disease (MASLD) has emerged as a prevalent health concern worldwide; the estimated global prevalence in adult population is up to 38% [54]. A meta-analysis of 98 studies with 48,472 patients demonstrated a global prevalence of hepatic steatosis in patients with CHB of 34.9% [55]. The impact of concurrent MASLD on natural course of CHB deserves further clarification. A previous study revealed that steatotic liver disease (SLD) was negatively correlated with the hepatitis B viral load [56]. Two large cohort studies demonstrated that SLD was significantly associated with HBsAg seroclearance and facilitated the functional cure [57,58]. In hospital cohort studies with more than ten-thousand CHB patients in Taiwan, SLD was associated with a 58% reduced risk of HCC. However, SLD with cardiometabolic risk factors increased the risk of HCC (adjusted HR 1.40 per cardiometabolic risk factor increase, 95% CI 1.19–1.66) [59]. Huang et al. [60] further found that CHB patients with MASLD had a higher risk of all-cause mortality compared with those without MASLD (adjusted HR 1.79, 95% CI 1.24–2.58). In addition, the more cardiometabolic risk factors, the higher the risk of all-cause mortality, in a dose-dependent relationship [60]. In a recent multi-national study including 7 countries/regions, Huang et al. [61] investigated more than 4,500 CHB patients receiving long-term NA therapy with sustained viral suppression. Patients with diabetes mellitus (DM) had significantly higher risks of cirrhosis, HCC, liver related and all-cause mortality than those without DM [61].
Therefore, in addition to effective antiviral therapy, CHB management requires integrated care for comorbidities, such as MASLD and DM.
Before achieving the goal of eliminating HBV, the most important issue is the prevention of HBV-related HCC. The preventive strategies are divided into primary, secondary, and tertiary prevention. The aim of primary prevention is protecting total population from acquiring HBV infection. Secondary prevention focuses on delivering effective treatment to decrease HCC incidence and provide HCC surveillance for early diagnosis and treatment of HBV-related HCC. Tertiary prevention aims to improve liver reserve and minimize the recurrence of HCC in patients receiving curative therapy [62].
The impact of immunization on HBV epidemiology
Perinatal transmission and horizontal transmission in infancy and childhood are major routes of HBV transmission [63]. Therefore, hepatitis B vaccination is the most cost-effective prevention strategy. The WHO recommended incorporating hepatitis B vaccine for infant into routine immunization programs in 1997, and now 190 countries have adopted it [64]. It is estimated that 40% of HBV carriers are maternal transmission in Taiwan. Following the successful implementation of a nationwide hepatitis B vaccination program in 1984, all children from newborns to first grade of elementary school have been vaccinated against hepatitis B. The vaccination coverage rate for complete three doses reached 97% in 2004 [65]. The seropositive rate of HBsAg and anti-HBc dramatically decreased from 10% and 28% in children who were born before the universal infant vaccination program in 1984 to 0.9% and 7% in children who were born after the program in 2009 [66]. Similarly, hepatitis B vaccination program was launched in the early 1980s in Korea. The prevalence of HBsAg in children decreased from 4–5% in the early 1980s to 0.2% in 2006 [67].
The hepatitis B vaccination program in 1984 also led to a decrease in HCC incidence from 0.92 per 100,000 in unvaccinated children to 0.23 per 100,000 in vaccinated children in Taiwan [66]. A national cancer registry indicated a 16.6% decrease in childhood primary liver cancer incidence from 2003 to 2011, with the incidence dropping to zero since 2011 [68]. Similar benefits have been observed in other countries, like China and Korea. Compared to unvaccinated population, the risk of HCC incidence decreases 84% in vaccinated cohort in China [69]. The HCC related mortality in Korean adolescents decreased 70% [67]. Chien et al. [70] conducted a 20-year cohort study to observe the HBV-related outcomes in 3.8 million vaccinated neonates through the National Registry Systems in Taiwan. Compared to vaccinated infants with HBsAg-negative mothers, the infants with HBsAg-positive mothers had significantly higher risk of HCC (HR 3.90, 95% CI 1.68–9.04). While infants whose mothers were both HBsAg-positive and HBeAg-positive had a much higher risk of HCC than infants whose mothers were HBsAg-negative (HR 17.58, 95% CI 9.41–32.84). For those with HBsAg-positive mothers, the HR of HCC risk was 2.41 with completed vaccines and 10.33 with incomplete vaccines. Among vaccinated infants whose mothers were seropositive for HBsAg and HBeAg, the infants with and without hepatitis B immunoglobulin (HBIG) had much higher risk of HCC (HR 13.03, 95% CI 6.30–26.92 and HR 29.95, 95% CI 13.99–64.12) than vaccinated infants with HBsAg-negative mothers. Accordingly, the risk of HCC increased with maternal HBeAg status and incomplete immunization [70].
Overall, neonatal hepatitis B vaccination is recognized as a significant measure in primary prevention of HBV-related HCC. Many challenges remain in hepatitis B immunization programs. First, despite HBV vaccination effectively reducing the prevalence of HBV infection among children, mother-to-child transmission of HBV in HBeAg-positive mothers remains a concern. A study involving 303 mother-infant pairs showed that 3.3% of infants developed chronic HBV infection, all were born to HBeAg-positive mothers with high viral loads [71]. To prevent mother-to-child transmission of HBV, NA therapy for HBsAg-positive mothers is recommended. Previous prospective studies in Taiwan and China revealed that tenofovir disoproxil fumarate (TDF) prophylaxis during the third trimester for HBeAg-positive pregnant women significantly decreased the transmission rate of HBV compared to those without prophylaxis [72-74]. Large-scale real-world data further confirmed these results [75,76]. Consequently, international liver societies now recommend antiviral prophylaxis in the third trimester for HBsAg-positive mothers with high viral loads [2,4]. Second is the timing of HBIG administration. Several studies with HBeAg-positive mothers showed that the earlier HBIG and birth-dose of hepatitis B vaccine are administered to infants after birth, the lower HBV infection incidence in infant [77,78]. Third is the incomplete vaccination on schedule. In 2023, the global coverage rate of the hepatitis B vaccination among infants reached only about 83%. The highest coverage rate was in the European Region at 92%, followed by the Western Pacific region at 91%, the South-East Asia Region at 90%, the region of the Americas at 85%, the Eastern Mediterranean Region at 79% and Africa at just 74%. WHO reported that 2.0% of countries did not include the HBV vaccine in their national infant vaccination programs; only 45% of countries provided the first dose of HBV vaccine within 24 hours [79]. The administration of HBV vaccine on schedule, especially the birth dose within 24 hours, is effective in preventing neonatal HBV infection [80].
Antiviral therapy and unmet needs
The optimal goals of antiviral therapy for patients with chronic HBV infection are not only to achieve complete viral elimination but also to prevent or reverse the progression of liver fibrosis.

HBsAg loss reduces lifetime HCC risk

In a long-term follow-up study for 2,946 untreated CHB patients in Taiwan, the HBeAg-negative patient who had detectable serum HBV DNA at the enrollment had a much higher lifetime cumulative incidence of HCC, up to 80% for patients with persistent detectable HBV DNA. On the contrary, it was only 4.0% for those who achieved seroclearance of both HBV DNA and HBsAg, 6.6% for those with seroclearance of HBV DNA only, and 14.2% for those with no seroclearance of both HBV DNA and HBsAg [81]. In a meta-analysis including 28 studies (17 studies on Asian populations and 11 studies on Caucasian populations) and 34,952 HBV carriers, the patients with HBsAg seroclearance had significantly lower HCC incidence than those with persistent positivity of HBsAg (relative risk 0.34, 95% CI 0.20–0.56) [82]. Therefore, the elimination of HBsAg can significantly reduce the incidence of HCC. However, the annual incidence of spontaneous clearance of HBsAg is very low, only 1.3% [83]. Current antiviral therapies, including PegIFN-α and NA, may increase the probability of HBsAg seroclearance. After finite therapy of PegIFN-α treatment, the 3–5-year cumulative HBsAg seroclearance will be achieved in 8–14% of patients with sustained virologic response [84-86]. NA is more effective than PegIFN-α in sustained suppression of HBV DNA. The 10-year cumulative rate of HBsAg seroclearance is 2–5%, which is also higher than spontaneous HBsAg seroclearance in untreated patients [7]. In addition, HBeAg-negative patients who discontinued NA after persistently undetectable HBV DNA have higher HBsAg seroclearance rates compared to those who continued treatment [86]. A large scale study (the RETRACT-B study) included 1,552 HBeAg-negative patients from different countries, who stopped NA after achieving long-term viral suppression. The results showed the 1- and 2-year cumulative rates of HBsAg seroclearance were 3.2% and 13.0% after cessation of therapy [87]. These findings were subsequently confirmed in a multicenter, randomized-controlled trial including NA-treated HBeAg-negative patients with viral suppression for more than 4 years. The patients randomized to stop NA had significantly higher 2 year cumulative rate of HBsAg seroclearance than those randomized to continue NA therapy (10.1% vs. 0%) [50].
Similar to spontaneous seroclearance of HBsAg, the incidence of HCC will also reduce after antiviral therapy-induced HBsAg seroclearance. In a case-control study, the long-term outcomes, including HCC incidence, overall mortality and complication of cirrhosis were comparable between patients with spontaneous and NA induced HBsAg seroclearance [88]. A territory-wide database study with 7,124 patients also revealed that the incidence of HCC occurrence was quite low in patients with spontaneous or NA induced HBsAg seroclearance [89].

Unmet needs of current antiviral therapy

Although effective antiviral therapy reduces the risk of HCC development in patients with chronic HBV infection, several challenges exist. The first is the presence of persistent intrahepatic cccDNA, which contributes to the viral relapse after the discontinuation of antiviral therapy. In Taiwan, a large hospital-based cohort study included HBeAg-negative CHB patients who stopped NAs after meeting the discontinuation criteria set by the Asia-Pacific Association for the Study of the Liver. The 2-year cumulative rate of hepatitis flare with serum ALT levels ≥5 times upper limit of normal was 58% in patients treated with TDF and 38% in those treated with entecavir (ETV), respectively. Furthermore, 3% of them experienced hepatic decompensation [90]. In a meta-analysis including 15 studies with 4,525 NA-treated patients who stopped NA after viral suppression, severe hepatitis flares occurred in 1.21% of patients and hepatitis flare-related death or liver transplantation occurred in 0.37% of patients [91]. Currently, several biomarkers were used to predict the outcomes of NA discontinuation. In an international, multiethnic study involving 1,552 HBeAg-negative Asian and Caucasian patients treated with NA who achieved virologic response (the RETRACT B study), low quantitative HBsAg levels at the time of NA discontinuation were associated with a high probability of HBsAg loss after NA cessation. Additionally, the probability of HBsAg loss was higher in Caucasian patients compared to Asian population (HR 6.8; 95% CI 2.7–16.8) [87]. A global retrospective study revealed that the factors significantly associated with HBsAg seroclearance after NA discontinuation were non-Asian ethnicity, the combination of lower HBsAg and undetectable HBcrAg levels at the time of stopping NA and HBV genotypes A and D [34]. In a prospective trial with HBeAg-positive patients who stopped NA after achieving HBeAg seroconversion, patients with undetectable HBV RNA at the time of stopping NA had a significantly lower relapse rate and higher rate of HBsAg seroclearance than those with positive HBV RNA [92]. Therefore, the outcomes of NA discontinuation are influenced by several factors. The benefits and harms of NA discontinuation need to be cautiously evaluated. The patients who are most likely to clear HBsAg after discontinuation should be selected to avoid hepatitis flare caused by viral rebound after NA discontinuation [93].
The second unresolved issue warranting further investigation is the effectiveness of long-term NA therapy in preventing or delaying HCC in cirrhotic patients. Several studies have shown that the HCC risk in patients receiving NA therapy remains persistent. In the CTEAM (Cirrhosis Taiwanese Entecavir Multicenter) study, Su et al. [94] examined the long-term effects of ETV therapy in CHB patients with cirrhosis. Compared to historical untreated cirrhotic patients, the risk of cirrhotic complications, HCC and mortality all decreased in patients with NA therapy. In particular, the HCC risk decreased by 60% after four years of NA therapy [94]. Although the age-adjusted lifetime cumulative incidence of HCC significantly declined, the risk shifted to old age, indicating a delay in HCC occurrence rather than complete elimination of HCC risk [95]. A Korean study also found this phenomenon. Based on the analysis of 127,426 patients with newly diagnosed HCC in Korea from 2008 to 2018, Chon et al. [96] found that the age-standardized incidence rate of HCC decreased from 21.9 per 100,000 person-years in 2008 to 14.3 per 100,000 person-years in 2018. However, the age-standardized incidence rate in patients aged older than 80 years significantly increased from 70.0 to 160.2 per 100,000 person-years from 2008 to 2018 and is estimated to reach 387.6 per 100,000 person-years in 2028 [96]. These results indicate that the risk factors of HCC in NA-treated patients are diverse, including the persistent cccDNA, the integrated HBV genome and the degree of liver fibrosis. Even those who are treated effectively still have a significant risk of HCC, highlighting the need for continuous monitoring as well as identifying predictors of HCC development in these patients [95].
Novel agents to achieve possible HBV functional cure
Novel agents under development for achievement of HBV functional cure include direct-acting antivirals that target various stages of the HBV lifecycle and host targeting agents that enhance HBV-specific immunity (Table 2) [97,98].
Direct-acting antivirals
Direct-acting antivirals target various stages of HBV replication. The modes of action of emerging antiviral agents targeting HBV are summarized in Figure 2. The first is “entry inhibitor”. Bulevirtide, a synthetic lipopeptide, prevents HBV from entering hepatocytes by blocking the sodium taurocholate co-transporting polypeptide receptor. The clinical trial and real-world data showed effectiveness on HBsAg decline in chronic HBV and hepatitis D virus coinfections [99,100]. However, the efficacy in chronic HBV monoinfection remains uncertain. The second is “inhibitors of HBsAg release”. Nucleic acid polymers can block the release of HBsAg. In a phase 2 randomized study, HBsAg loss was reached in 35% post-treatment at 6 months in patients receiving nucleic acid polymers (REP-2139 or REP-2165) with PegIFN-α and TDF combination therapy [101]. The third is “Capsid Inhibitors”. Vebicorvir, the oral small molecule, decreases pregenomic RNA encapsidation and disrupts capsid formation. In a phase 2 clinical trial combining capsid inhibitor with NA demonstrated additive effects in reducing HBV DNA and pregenomic RNA levels compared to NA monotherapy [102]. The fourth is “Post-transcription inhibitors”. Small interfering RNAs and antisense oligonucleotides both inhibit HBV RNA, and suppress viral replication and protein production. In a phase 2 clinical trial, a small interfering RNA molecule (xalnesiran) combined with PegIFN-α indicated HBsAg loss in 23% of patients under NA therapy with viral suppression [103]. Another phase 2 study revealed that small interfering RNA agent, VIR-2218 (elebsiran), in combination with or without PegIFN-α reached HBsAg seroclearance in 13% of patients [104]. In a phase 2b clinical trial with 130 HBeAg-negative patients receiving NA therapy, the combination therapy with small interfering RNA agent (JNJ-3989) and the capsid assembly modulator (JNJ-6379; bersacapavir) resulted in a significant on-treatment HBsAg reduction. By week 48, 81.5% of patients with combination therapy had reductions of >1 log10 IU/mL, compared to 12.5% in the patients with NA alone treatment [105]. Bepirovirsen is an unconjugated antisense oligonucleotide. In a phase 2b clinical trial, 15% of patients under NA therapy with viral suppression reached HBsAg loss after sequential therapy with bepirovirsen followed by PegIFN-α [106].
Overall, these DAAs showed promise in HBV treatment, but further research is needed to establish their long-term efficacy and safety.
Host targeting agents
Toll-like receptor (TLR) 7 and TLR8 agonists trigger the innate immune response that can be applied to HBV treatment. Ruzolotolimod, a TLR7 agonist, combined with a small interfering RNA molecule (xalnesiran) and NA resulted in a 12% HBsAg loss 24 weeks after the end of treatment, compared to none with NA alone. However, this response was less effective than 23% of patients with xalnesiran combined with PegIFN-α [103].
Inducing an effective HBV-specific T cell response by therapeutic vaccination has been considered a promising strategy to achieve HBV functional cure. For example, a lentiviral-vectored therapeutic vaccine, encoding the core, preS1, or large HBsAg proteins can improve HBV-specific T cell function. In the HBV-infected mice model, 60% of mice achieved HBsAg loss after lentiviral-vectored therapeutic vaccine therapy [107].
HBsAg-specific monoclonal antibody can neutralize HBsAg. In an animal study, the monoclonal antibody VIR-3434 neutralized and decreased circulating HBsAg in human liver-chimeric mice [108]. This novel antibody may combine with other anti-HBV drugs to achieve HBV functional cure in the future.
Lastly, immune checkpoint inhibitors have shown promise in restoring immune control of HBV. Envafolimab (ASC22) is a programmed cell death ligand 1 antibody. A phase 2b study with envafolimab showed HBsAg loss in 30% of patients with baseline HBsAg levels ≤100 IU/mL after 24 weeks of treatment [109].
According to the goals of 2030 set by the WHO for the elimination of chronic viral hepatitis, there should be a 90% reduction in the total incidence of new infection and a 65% reduction in mortality rate. In terms of prevention, the hepatitis B vaccine coverage should reach 90%, with a 90% prevention rate for mother-to-child transmission and 100% screening of blood products. Regarding treatment, 90% of patients with CHB should be diagnosed, and 80% of them should receive treatment [110]. However, the majority of countries or regions cannot meet the WHO targets, and are not even on track for achieving the goals. According to the assessment of the Coalition for Global Hepatitis Elimination for the progress made by 33 countries/regions toward eliminating hepatitis B, 24 of them (73%) have achieved the WHO’s 2025 target of HBsAg prevalence less than 0.5% among children under five years old. However, the hepatitis B testing and treatment remain unsatisfactory. Seven countries/regions have reached the WHO’s target of 60% diagnostic coverage by 2025. No country or region has yet achieved the treatment target set by the WHO for at least 50% of patients to receive treatment by 2025 [111]. The HBV progress towards elimination target is far below the WHO 2030 target of 90% diagnosis rate and 80% eligible treatment rate. To achieve the elimination of hepatitis B by WHO, more effective strategies and initiatives must be adopted.
Two levels, 4 steps strategies
The strategies include two levels: establishing the national public health care policy and implementing individualized precision management. The national public health care policy should promote HBV screening, early and expanded treatment eligibility, simplified treatment criteria, and improved access to affordable care (Fig. 3). The first step is nationwide HBV screening. The Health Promotion Administration of Taiwan has provided a lifetime HBsAg screening for adults aged 45 to 79 since 2011. As of 2024, 6.12 million people had been screened for HBsAg. The average positive rate of HBsAg was 11%, with a declining trend year by year since 2015 (Fig. 4).
The second step is early treatment for patients tested HBsAg-positive and expanded treatment eligibility. The indications of treatment initiation in the current international guidelines are mainly based on the clinical phase, liver function, viral load and severity of hepatic fibrosis [2-4]. However, a certain proportion of patients categorized as the indeterminate phase or grey zone do not meet the existing treatment criteria. Therefore, they are not receiving antiviral treatment [43]. The latest European Association for the Study of the Liver guideline expanded the treatment indication for those patients in the indeterminate phase. For example, patients with persistent low viremia (<2,000 IU/mL) and abnormal ALT levels and patients who have a high risk of HCC should receive antiviral therapy [4]. In addition, a recent randomized controlled trial (the ATTENTION study) revealed that early antiviral therapy reduced the risk of HBV related complication in non-cirrhotic patients with moderate to high viremia and normal or mildly elevated ALT levels [112].
The third step is to simplify treatment criteria. The 2024 WHO guideline recommends expanding treatment to all adults (including pregnant women) and adolescents over 12 years of age, which includes the following criteria: 1) patients with significant fibrosis (stage ≥F2) should receive treatment, regardless of HBV DNA and ALT levels; 2) HBV DNA is greater than 2,000 IU/mL and ALT exceeds the upper limit of normal; 3) co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus, family history of HCC or cirrhosis; immunosuppression; and HBV-associated extrahepatic manifestation or comorbidities; 4) in the region with insufficient medical resources to test HBV DNA, treatment may be considered for patients with persistent ALT abnormalities [1].
The final step is “developing individualized precision management with regular tracking”. HBV patients have unique personal characteristics, including viral properties, host factors and the severity of hepatic fibrosis. Treatment strategies will be personalized based on these traits. In addition to early treatment with antiviral drugs, several HBV biomarkers and artificial intelligence models will be applied in disease stratification, antiviral response monitoring, and HCC prediction [113]. The development of precision medicine can provide personalized reminders, and health literacy education, and enhance patients’ compliance with management plans.
With the expanding global coverage of hepatitis B vaccination, the prevalence of HBsAg among children has declined significantly. Currently approved antiviral therapies, such as PegIFN-α and NA, effectively reduce disease progression and the risk of HCC. Lifelong monitoring remains essential for all patients with CHB to enable timely initiation of antiviral therapy and to minimize disease progression. Recently, several novel agents targeting cccDNA have been developed in pursuit of a functional cure for HBV. Although most are still in phase 2 clinical trials, preliminary results are promising and warrant attention. Looking ahead, the combination of rapid advancements in antiviral therapy, improved diagnostic rates, and expanded access to treatment for CHB patients brings the global goal of HBV elimination within reach.

Authors’ contributions

All authors contributed to the intellectual content, literature search, preparation, editing, and critical review of the manuscript. Chih-Lin Lin prepared the manuscript and did the final editing. Jia-Horng Kao provided critical revision of the manuscript and approved the final manuscript.

Acknowledgements

This work was supported by grants from the National Taiwan University Hospital, the Ministry of Health and Welfare, and the National Science and Technology Council, Executive Yuan, Taiwan.

Conflicts of Interest

The authors have no conflicts to disclose.

Figure 1.
The proposed algorithm integrates both traditional and novel biomarkers for the personalized management of chronic hepatitis B. ALT, alanine aminotransferase; HBeAg, hepatitis B e antigen; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; HCC, hepatocellular carcinoma. Modified from the article of Tseng et al.36 (Clin Liver Dis (Hoboken) 2024;23:e0155) with original copyright holder’s permission.
cmh-2025-0492f1.jpg
Figure 2.
The modes of action of emerging antiviral agents targeting HBV. cccDNA, covalently closed circular DNA; HBcrAg, hepatitis B virus core-related antigen; HBeAg, hepatitis B e antigen; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; NTCP, sodium taurocholate cotransporting polypeptide.
cmh-2025-0492f2.jpg
Figure 3.
Two levels, 4 steps strategies and action plans to achieve the elimination of hepatitis B. HBsAg, hepatitis B surface antigen.
cmh-2025-0492f3.jpg
Figure 4.
A lifetime HBV screening for adults aged 45 years and above in Taiwan since 2011. As of 2024, 6.12 million people have been screened for HBsAg. The average positive rate of HBsAg is 11%, demonstrating a declining trend year by year since 2015. HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus.
cmh-2025-0492f4.jpg
Table 1.
Serum HBV biomarkers for predicting the outcomes of CHB
Table 1.
Identifying clinical phases Quantitative HBsAg, HBcrAg, HBV RNA, viral diversity
Predicting response to antiviral treatment Quantitative HBsAg, HBcrAg, HBV RNA, viral diversity
Predicting relapse after NA discontinuation Quantitative HBsAg, HBcrAg, HBV RNA, viral diversity
Predicting HCC development Quantitative HBsAg, HBcrAg, HBV RNA
Predicting functional cure Quantitative HBsAg, HBcrAg, HBV RNA

CHB, chronic hepatitis B; HBcrAg, hepatitis B core-related antigen; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; HCC, hepatocellular carcinoma; NA, nucleoside/nucleotide analogues.

Table 2.
Novel agents for HBV functional cure in clinical trials
Table 2.
Compound Mode of action Number of patients HBeAg status Treatment history HBsAg loss rate Clinical trial (reference no.)
Direct-acting antivirals
Bulevirtide Entry inhibitor 150 Positive 10%/negative 90% NA-treated - Phase 3 [99]
Nucleic acid polymers Inhibitors of HB-sAg release 40 Negative Treatment-naïve 35% at 48 weeks after the end of treatment Phase 2 [101]
Vebicorvir Capsid inhibitors 25 Positive Treatment-naïve - Phase 2a [102]
Small interfering RNA (xalnesiran) Post-transcription inhibitors 159 Positive 29.5%/negative 70.5% NA-treated 23% at 24 weeks after the end of treatment (combined with pegIFN-α) Phase 2 [103]
Small interfering RNA (VIR-2218, elebsiran) Post-transcription inhibitors 84 Positive 31%/negative 69% NA-treated 13% at the end of treatment (combined with pegIFN-α) Phase 2 [104]
Antisense oligonucleotide (bepirovirsen) Post-transcription inhibitors 108 Positive 26%/negative 74% NA-treated 15% at 24 weeks after the end of treatment Phase 2b [106]
Host targeting agents
Ruzolotolimod Toll-like receptor 7 agonist 159 Positive 29.5%/negative 70.5% NA-treated 12% at 24 weeks after the end of treatment (combined with xalnesiran) Phase 2 [103]
Envafolimab Immune checkpoint inhibitor (PD-L1 antibody) 149 Negative NA-treated 30% of patients with baseline HBsAg levels ≤100 IU/mL at 24 weeks after the end of treatment Phase 2b [109]

HBsAg, hepatitis B surface antigen; NA, nucleoside/nucleotide analogues; PD-L1, programmed cell death ligand 1; PegIFN-α, pegylated interferon alpha.

ALT

alanine aminotransferase

cccDNA

covalently closed circular DNA

CHB

chronic hepatitis B

CI

confidence interval

DM

diabetes mellitus

HR

hazard ratio

HBcrAg

hepatitis B virus core-related antigen

HBeAg

hepatitis B e antigen

HBIG

hepatitis B immunoglobulin

HBsAg

hepatitis B surface antigen

HBV

hepatitis B virus

HCC

hepatocellular carcinoma

MASLD

metabolic dysfunction-associated steatotic liver disease

NA

nucleoside/nucleotide analogues

PegIFN-α

pegylated interferon alpha

SLD

steatotic liver disease

TDF

tenofovir disoproxil fumarate

TLR

toll-like receptor

WHO

World Health Organization
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Global strategies and actions to eliminate hepatitis B virus infection
Clin Mol Hepatol. 2025;31(4):1197-1212.   Published online July 28, 2025
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Clin Mol Hepatol. 2025;31(4):1197-1212.   Published online July 28, 2025
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Global strategies and actions to eliminate hepatitis B virus infection
Image Image Image Image
Figure 1. The proposed algorithm integrates both traditional and novel biomarkers for the personalized management of chronic hepatitis B. ALT, alanine aminotransferase; HBeAg, hepatitis B e antigen; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; HCC, hepatocellular carcinoma. Modified from the article of Tseng et al.36 (Clin Liver Dis (Hoboken) 2024;23:e0155) with original copyright holder’s permission.
Figure 2. The modes of action of emerging antiviral agents targeting HBV. cccDNA, covalently closed circular DNA; HBcrAg, hepatitis B virus core-related antigen; HBeAg, hepatitis B e antigen; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; NTCP, sodium taurocholate cotransporting polypeptide.
Figure 3. Two levels, 4 steps strategies and action plans to achieve the elimination of hepatitis B. HBsAg, hepatitis B surface antigen.
Figure 4. A lifetime HBV screening for adults aged 45 years and above in Taiwan since 2011. As of 2024, 6.12 million people have been screened for HBsAg. The average positive rate of HBsAg is 11%, demonstrating a declining trend year by year since 2015. HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus.
Global strategies and actions to eliminate hepatitis B virus infection
Identifying clinical phases Quantitative HBsAg, HBcrAg, HBV RNA, viral diversity
Predicting response to antiviral treatment Quantitative HBsAg, HBcrAg, HBV RNA, viral diversity
Predicting relapse after NA discontinuation Quantitative HBsAg, HBcrAg, HBV RNA, viral diversity
Predicting HCC development Quantitative HBsAg, HBcrAg, HBV RNA
Predicting functional cure Quantitative HBsAg, HBcrAg, HBV RNA
Compound Mode of action Number of patients HBeAg status Treatment history HBsAg loss rate Clinical trial (reference no.)
Direct-acting antivirals
Bulevirtide Entry inhibitor 150 Positive 10%/negative 90% NA-treated - Phase 3 [99]
Nucleic acid polymers Inhibitors of HB-sAg release 40 Negative Treatment-naïve 35% at 48 weeks after the end of treatment Phase 2 [101]
Vebicorvir Capsid inhibitors 25 Positive Treatment-naïve - Phase 2a [102]
Small interfering RNA (xalnesiran) Post-transcription inhibitors 159 Positive 29.5%/negative 70.5% NA-treated 23% at 24 weeks after the end of treatment (combined with pegIFN-α) Phase 2 [103]
Small interfering RNA (VIR-2218, elebsiran) Post-transcription inhibitors 84 Positive 31%/negative 69% NA-treated 13% at the end of treatment (combined with pegIFN-α) Phase 2 [104]
Antisense oligonucleotide (bepirovirsen) Post-transcription inhibitors 108 Positive 26%/negative 74% NA-treated 15% at 24 weeks after the end of treatment Phase 2b [106]
Host targeting agents
Ruzolotolimod Toll-like receptor 7 agonist 159 Positive 29.5%/negative 70.5% NA-treated 12% at 24 weeks after the end of treatment (combined with xalnesiran) Phase 2 [103]
Envafolimab Immune checkpoint inhibitor (PD-L1 antibody) 149 Negative NA-treated 30% of patients with baseline HBsAg levels ≤100 IU/mL at 24 weeks after the end of treatment Phase 2b [109]
Table 1. Serum HBV biomarkers for predicting the outcomes of CHB

CHB, chronic hepatitis B; HBcrAg, hepatitis B core-related antigen; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; HCC, hepatocellular carcinoma; NA, nucleoside/nucleotide analogues.

Table 2. Novel agents for HBV functional cure in clinical trials

HBsAg, hepatitis B surface antigen; NA, nucleoside/nucleotide analogues; PD-L1, programmed cell death ligand 1; PegIFN-α, pegylated interferon alpha.