Emerging Trends and Future Directions in the Development of Novel Drugs for Chronic Hepatitis B: A Horizon Scanning Review
Author(s)
Jie Kai Yao, Master degree candidate.
Shanghai Jiao Tong University, Shanghai, China.
Shanghai Jiao Tong University, Shanghai, China.
OBJECTIVES: Chronic hepatitis B (CHB) remains a major global public health issue, with current treatments such as nucleos(t)ide analogues and interferons only capable of suppressing the virus, not curing it. There is an urgent need for novel drugs that can achieve a functional cure.
METHODS: Utilizing a horizon scanning methodology, this study compiled and analyzed data on emerging drug therapies from various clinical trial stages. This involved extensive database searches and examination of drug categories, target mechanisms, and clinical trial phases.
RESULTS: Our study captures the evolving landscape of drug development for CHB, tracing advancements from the early 2000s to the present. Our analysis covers the trajectory of drugs through clinical trial phases, noting significant attrition due to stringent safety and efficacy standards. Recent trends show a shift from traditional treatments towards novel therapeutic approaches, including entry inhibitors and gene editing, targeting critical aspects of the virus’s life cycle and the host’s immune response. Notably, emerging targets such as cccDNA are becoming focal points due to their potential to fundamentally alter treatment paradigms through gene editing technologies, signaling a shift towards potentially curative strategies.
CONCLUSIONS: The evolving drug development landscape for CHB indicates a shift towards treatments that not only manage disease but also aim to eradicate the virus. This transition is critical for achieving the global health goals of reducing hepatitis B incidence and mortality by 2030. Continued innovation and strategic resource allocation are imperative to accelerate the introduction of these new therapies into clinical practice, offering hope for a paradigm shift in CHB management.
METHODS: Utilizing a horizon scanning methodology, this study compiled and analyzed data on emerging drug therapies from various clinical trial stages. This involved extensive database searches and examination of drug categories, target mechanisms, and clinical trial phases.
RESULTS: Our study captures the evolving landscape of drug development for CHB, tracing advancements from the early 2000s to the present. Our analysis covers the trajectory of drugs through clinical trial phases, noting significant attrition due to stringent safety and efficacy standards. Recent trends show a shift from traditional treatments towards novel therapeutic approaches, including entry inhibitors and gene editing, targeting critical aspects of the virus’s life cycle and the host’s immune response. Notably, emerging targets such as cccDNA are becoming focal points due to their potential to fundamentally alter treatment paradigms through gene editing technologies, signaling a shift towards potentially curative strategies.
CONCLUSIONS: The evolving drug development landscape for CHB indicates a shift towards treatments that not only manage disease but also aim to eradicate the virus. This transition is critical for achieving the global health goals of reducing hepatitis B incidence and mortality by 2030. Continued innovation and strategic resource allocation are imperative to accelerate the introduction of these new therapies into clinical practice, offering hope for a paradigm shift in CHB management.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EPH71
Topic
Epidemiology & Public Health
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
Infectious Disease (non-vaccine), No Additional Disease & Conditions/Specialized Treatment Areas