Consensus Guidelines: Best Practices for the Prevention, Detection and Management of Hepatitis B Virus Reactivation in Clinical Trials with Immunosuppressive/Immunomodulatory Therapy

Eric B. Cohen (), Arie Regev, Anju Garg, Adrian M. Bisceglie, James H. Lewis, John M. Vierling, Judith Hey-Hadavi, Klaudia Steplewski, Anna Fettiplace, Chunlin L. Chen, Nonko Pehlivanov, Stuart Kendrick and Mark I. Avigan
Additional contact information
Eric B. Cohen: AbbVie Inc., Pharmacovigilance and Patient Safety
Arie Regev: Eli Lilly and Company, Global Patient Safety
Anju Garg: Sanofi, Patient Safety & Pharmacovigilance
Adrian M. Bisceglie: Saint Louis University
James H. Lewis: Georgetown University
John M. Vierling: Baylor College of Medicine
Judith Hey-Hadavi: Pfizer Inc. Global Medical Affairs
Klaudia Steplewski: GlaxoSmithKline LLC, Clinical Safety and Pharmacovigilance
Anna Fettiplace: AstraZeneca plc, Pharmacovigilance
Chunlin L. Chen: Bayer HealthCare Pharmaceuticals, LLC. Pharmacovigilance
Nonko Pehlivanov: Merck & Co., INC, Clinical Safety Risk Management
Stuart Kendrick: GlaxoSmithKline LLC, Medical Affairs-Hepatology
Mark I. Avigan: Food and Drug Administration, Center for Drug Evaluation and Research

Drug Safety, 2024, vol. 47, issue 4, No 3, 332 pages

Abstract: Abstract Hepatitis B virus reactivation (HBVr) during and after immunosuppressive/immunomodulatory (IS/IM) therapy is associated with significant morbidity and mortality, including hepatic decompensation and acute liver failure. The risk of HBVr with IS/IM has been heterogeneous and often unpredictable. As a result, patients with active or previous HBV infection are often excluded from clinical drug trials of such agents. Thorough screening for HBV infection, antiviral prophylaxis, and careful monitoring for HBVr have proven to be effective in reducing the rate of HBVr and improving its outcome in the context of IS/IM. Therefore, safe enrollment and management of certain HBV-marker–positive patients in clinical trials is possible. There is a great, unmet need for consistent, evidence-based recommendations for best practices pertaining to enrollment, monitoring, and management of HBVr in clinical trial participants receiving IS/IM. The aim of these consensus guidelines is to provide a step-by-step blueprint to safely enroll, monitor and manage the patient with inactive chronic or resolved HBV in IS/IM clinical trials from the time of screening through to the end of post-treatment follow up.

Date: 2024
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DOI: 10.1007/s40264-024-01399-4

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