Tea Kakabadze, MD, PhD, Associate Medical Director, Novotech
Dr. Kakabadze is an experienced medical professional with over 25 years in clinical research, infectious diseases, and academic medicine. As Associate Medical Director at Novotech, she leads medical oversight and investigator engagement to ensure clinical trial excellence. Prior to Novotech, Tea held senior roles at ARENSIA Exploratory Medicine and MSD, and served as an Associate Professor at David Tvildiani Medical University. She brings deep therapeutic and operational expertise supporting high-quality, patient-centered research.
As an attendee at the International Hepatitis B Meeting in Berlin (September 8–11, 2025), I had the opportunity to hear directly from leading scientists, clinicians, industry experts and patient advocates driving progress toward HBV and HDV management and better outcomes. Across four days, the meeting delivered latest advances in HBV and HDV research and development and provided the novel HBV cure strategies.
For biotech and pharmaceutical teams, the core message was clear: progress is accelerating, but success still depends on smart study design, fit-for-purpose endpoints, and operational execution, especially as programs move toward combination regimens and functional cure strategies.
Day 1: Epidemiology, Guidelines, and Patient-Centered Care
The opening sessions set a helpful baseline for sponsors shaping global and Asia-Pacific clinical trials. Speakers outlined trends in Germany such as rising case identification due to broader screening and migration from endemic regions, alongside persistent gaps in diagnosis among high-risk groups. The alignment of German practice with EASL 2025 guidance broadens treatment eligibility and supports simplified, scalable models of care.
Equally important, the patient perspective took center stage. Discussions emphasized quality-of-life outcomes, real-world access, and culturally informed care pathways, considerations that should inform endpoint selection, PROs, and recruitment strategies in multinational trials.
Day 2: Pathogenesis, Immunity, and Drug Targets
Day 2 went deeper into HBV and HDV biology. Viral entry, innate and adaptive immunity, and mechanisms of persistence were all subjects of discussion. Several themes stood out for clinical developers:
- Biomarker nuance matters. Patterns of HBsAg distribution carry clinical context that may refine patient stratification and response assessment.
- HDV remains a priority. New data on HDV replication mechanisms can inform target selection and combination approaches.
- Entry and immune targets are maturing. Examples included interest in CDC42-related pathways for HBV entry and monoclonal strategies designed to restore HBV-specific T-cell responses.
For sponsors, these findings reinforce the value of adaptive designs that enable signal detection across immune and virologic readouts, along with banked samples for translational analyses.
Day 3: Mechanisms of Clearance and the Therapeutic Pipeline
The spotlight shifted to HBsAg loss and functional cure. Strong CD4+ T-cell responses, B-cell recovery, and insights into the gut–liver axis all point to immune-reconstitution strategies that could complement direct antivirals. The pipeline overview tracked roughly 67 preclinical HBV programs, and showed breadth across viral entry inhibitors, RNA interference agents, capsid assembly modulators, therapeutic vaccines, and rational combinations.
One data point that caught attention: an interferon-class candidate (IB-001) with signals of improved tolerability and antiviral activity compared with traditional interferons. While early, it illustrates how next-generation modalities may expand the risk–benefit profile and patient eligibility.
Day 4: Host–Virus Dynamics and Emerging Interventions
The final sessions connected host–virus interplay with practical intervention strategies:
- Oral HDV inhibitors may broaden access and adherence versus injectable options.
- Capsid assembly modulators continued to show compelling effects on replication and potential impact on cccDNA dynamics.
- Therapeutic vaccination including approaches that combine siRNA and immunization. This aims to re-engage HBV-specific immunity, a likely requirement for durable HBsAg loss.
The takeaway for clinical planning: multi-modal regimens are coming. Designing studies to evaluate sequence, timing, and pharmacodynamic complementarity will be critical as programs enter proof-of-concept and pivotal stages.
What Sponsors Should Do Now
If you are advancing HBV or HDV assets, consider the following actions to increase the probability of technical and regulatory success:
- Align early with evolving guidance. Map EASL-aligned criteria and local standards to your inclusion/exclusion logic, particularly in countries with active screening initiatives.
- Build for combination. Power your study to detect additive or synergistic effects and include interim decision points to optimize sequencing.
- Elevate immune and virologic endpoints. Incorporate HBsAg kinetics, quantitative HBsAg, HBV DNA, HBcrAg, and immune markers where appropriate, paired with patient-reported outcomes.
- Plan for HDV complexity. Where relevant, stratify and analyze HDV coinfection to capture differential effects and safety signals.
- Design for global recruitment. Leverage experienced sites across Asia-Pacific, North America, and Europe to reach high-prevalence populations and accelerate enrollment.
- Invest in translational sampling. Banked specimens enable biomarker discovery that can de-risk later-stage studies and support regulatory dialogue.
How Novotech Supports HBV and HDV Development
As a global clinical research organization with deep infectious disease expertise, Novotech helps sponsors execute hepatitis B clinical trials efficiently and responsibly:
- End-to-end support from feasibility and regulatory strategy through site activation, monitoring, and submission.
- Global site networks across Asia-Pacific, North America, and Europe, enabling targeted recruitment in high-prevalence settings and efficient multicountry execution.
- Therapeutic specialists experienced in HBV/HDV endpoints, virologic and immune assays, and combination study logistics.
- Operational rigor to keep timelines on track, ensure data integrity, and support inspection-ready documentation.
Final Thoughts
The International Hepatitis B Meeting in Berlin highlighted a field moving decisively toward functional cure, with meaningful advances in immunology, biomarkers, and combination strategies. For developers, the opportunity is significant, but so is the need for precise clinical design and proven execution across geographies.
If you are planning or optimizing HBV/HDV studies, our team would value a discussion about your objectives and timelines. Talk to an expert: https://novotech-cro.com/talk-to-an-expert