Discover the latest advancements in Hepatitis B through Novotech CRO's in-depth disease analysis. Gain valuable insights into novel therapies, ongoing clinical trials, and future innovations shaping the treatment of Hepatitis B.
Hepatitis B is a highly infectious liver disease caused by the Hepatitis B virus (HBV) and is primarily transmitted through infected blood, bodily fluids, or childbirth. Although many cases are acute and asymptomatic, Hepatitis B can become chronic, posing a serious risk of cirrhosis and liver cancer. It remains a major global health concern, accounting for 65% of the worldwide hepatitis burden, with significant disparities in prevalence and clinical outcomes across regions and ethnicities. The WHO 2024 report estimates over 250 million people living with chronic Hepatitis B (CHB) globally, with 1.2 million new infections occurring annually. The disease burden varies significantly by region, with the Western Pacific and African regions carrying the highest prevalence. In the Asia-Pacific region, China and India have the highest affected populations, while Europe and the Americas maintain lower but steady infection rates. Racial and ethnic disparities affect Hepatitis B outcomes, with Asian populations having the highest chronic infection rates. Variations in HBV mutations influence disease progression and treatment, highlighting the need for preventive measures, early detection, and targeted therapies that address regional needs.
The treatment landscape for Hepatitis B focuses on antiviral therapies to suppress viral replication and reduce liver damage. Guidelines established by organizations like the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) provide personalized treatment options, recommending nucleos(t)ide analogs like tenofovir and entecavir for managing chronic Hepatitis B. While these treatments do not cure the infection, they slow disease progression, reduce the risk of complications like cirrhosis and liver cancer, and improve long-term outcomes. Ongoing research aims to develop next-generation therapies targeting HBV replication and enhancing immune control.
Building on these established treatment strategies, the global Hepatitis B clinical trial landscape is expanding, with the Asia-Pacific leading 65% of trials. Research focuses on achieving a functional cure through RNA-based treatments, monoclonal antibodies, and gene therapies. Most trials are in the early and mid-stages, with over 55% in Phase II. Emerging therapies, including capsid assembly modulators, translation inhibitors, and cccDNA-targeting treatments, aim to improve viral control and immune response. Immunotherapy options like checkpoint inhibitors and therapeutic vaccines are also being explored, with combination approaches showing the most promise for a long-term cure.
Advancements in Hepatitis B research have led to a better understanding of clinical features influencing disease progression, particularly through emerging biomarkers like HBV RNA and HBcrAg. These biomarkers provide deeper insights into viral activity, immune response, and liver health, improving disease monitoring and treatment strategies. While traditional biomarkers such as HBsAg and HBV DNA are essential for staging and monitoring, they have limitations in predicting treatment outcomes. The latest Hepatitis B treatment data highlights advancements in antiviral therapies, with emerging biomarkers improving the refinement of treatment endpoints. As research continues, these new diagnostic tools are expected to enhance personalized treatment approaches and improve long-term patient outcomes.
With growing efforts to develop a functional cure for Hepatitis B, investment in clinical trials has surged, driven by public funding and venture capital. Between 2020 and 2024, the U.S. and China led investments, while the UK, Singapore, and France contributed moderate amounts. Building on this momentum, key players leading Hepatitis B cure trials include Bluejay Therapeutics, Precision Biosciences, and Tune Therapeutics. These advancements, backed by strong financial support, highlight a growing commitment to achieving a functional cure.
Novotech, a global clinical CRO, has conducted 5,000+ clinical studies, including 600+ infectious disease projects. Novotech is the global leader in hepatitis B research, having supported 90 Hepatitis B trials and counting, initiating 340+ sites and enrolling 5,000+ participants across all trial phases, including 65 Phase I and 25 Phase II studies. Its expertise spans small molecules, RNAi, monoclonal antibodies, vaccines, and peptides. Recognized for industry leadership, Novotech has earned multiple awards, including the Frost & Sullivan 2024 Global Biotech CRO Award and the 2024 Employer of Choice.
Discover more about Hepatitis B by downloading our comprehensive disease report.