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Published on: February 1, 2017
Emerging Trends and Future Directions in the Development of Anti-hepatitis B Therapies: A Horizon Scanning Review
Kaijie Yao1, Hao Feng2, Ying Chen1
1Department of Pharmacy, Shanghai Chest Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Background And Objectives:
Chronic hepatitis B virus infection remains a Major global public health challenge, affecting over 254 million individuals and causing substantial mortality owing to the limited curative potential of current therapies. This horizon scanning review aims to comprehensively analyze emerging trends and future directions in novel anti-hepatitis B virus therapeutic development, evaluating their progress and potential to achieve functional or complete cures.
Methods:
We conducted a systematic horizon scanning review from January 2020 to June 2025, searching databases (PubMed, Embase, the Cochrane Library, China National Knowledge Infrastructure [CNKI], and WanFang), clinical trial registries (ClinicalTrials.gov, EU Clinical Trials Register, World Health Organization International Clinical Trials Registry, Chinese Clinical Trial Registry, and chinadrugtrials.org), hepatology conference abstracts (American Association for the Study of Liver Diseases, European Association for the Study of the Liver), and pharmaceutical company websites. Inclusion criteria focused on studies detailing novel anti-hepatitis B virus treatments, with data extracted on category, target, clinical phase, and discontinuation reasons.
Results:
Our analysis identified 161 unique anti-hepatitis B virus treatments: 75 in clinical trials, 34 in preclinical development, and 52 discontinued post-clinical trials because of safety or insufficient efficacy. The pipeline reveals a diversification of targets, with capsid assembly modulators, therapeutic vaccines, and monoclonal antibodies being most prevalent. Three therapies representing novel mechanisms have reached phase III-bepirovirsen (an antisense oligonucleotide), canocapavir (a capsid assembly modulator), and εPA-44 (a therapeutic vaccine), illustrating diversification of late-stage pipelines; however, 6-month off-treatment endpoints should be interpreted cautiously across modalities until durability is established.
Conclusions:
The robust and diverse pipeline of novel anti-hepatitis B virus treatments offers promise for improving functional cure rates, but definitive conclusions await longer off-treatment follow-up and durability data. Continued research, rational combination strategies, and global collaboration are crucial to overcome challenges and ensure equitable access to these transformative therapies worldwide.
Insights
Novel hepatitis B virus (HBV) therapies show promise for functional cures, with a diverse pipeline including vaccines and novel targets. Further research and data on long-term durability are needed to confirm efficacy and ensure global access.
Area of Science:
- Hepatology
- Virology
- Drug Development
Background:
- Chronic hepatitis B virus (HBV) infection affects over 254 million globally, posing a significant public health challenge.
- Current therapies have limited curative potential, necessitating the development of novel treatments.
Purpose of the Study:
- To conduct a horizon scanning review of emerging trends and future directions in novel anti-HBV therapeutic development.
- To evaluate the progress and potential of these therapies to achieve functional or complete cures for HBV infection.
Main Methods:
- A systematic horizon scanning review was conducted from January 2020 to June 2025.
- Searched multiple databases, clinical trial registries, conference abstracts, and company websites for novel anti-HBV treatments.
- Included studies detailing treatment category, target, clinical phase, and discontinuation reasons.
Main Results:
- Identified 161 unique anti-HBV treatments, with 75 in clinical trials and 34 in preclinical development.
- The pipeline shows diversification in targets, with capsid assembly modulators, therapeutic vaccines, and monoclonal antibodies being most prevalent.
- Three novel mechanism therapies (bepirovirsen, canocapavir, εPA-44) reached Phase III, but off-treatment endpoints require cautious interpretation pending durability data.
Conclusions:
- A robust and diverse pipeline of novel anti-HBV treatments offers hope for improved functional cure rates.
- Longer off-treatment follow-up and durability data are essential for definitive conclusions.
- Continued research, combination strategies, and global collaboration are crucial for overcoming challenges and ensuring equitable access.
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