Author information
1AbbVie Inc., Pharmacovigilance and Patient Safety, North Chicago, IL, USA. eric.cohen@abbvie.com.
2Eli Lilly and Company, Global Patient Safety, Indianapolis, IN, USA.
3Sanofi, Patient Safety & Pharmacovigilance, Bridgewater, NJ, USA.
4Department of Internal Medicine, Saint Louis University, St. Louis, MO, USA.
5Division of Gastroenterology, Georgetown University, Washington, DC, USA.
6Section of Gastroenterology and Hepatology and Division of Abdominal Transplantation, Baylor College of Medicine, Houston, TX, USA.
7Pfizer Inc. Global Medical Affairs, New York, NY, USA.
8GlaxoSmithKline LLC, Clinical Safety and Pharmacovigilance, Collegeville, PA, USA.
9AstraZeneca plc, Pharmacovigilance, Cambridge, UK.
10Bayer HealthCare Pharmaceuticals, LLC. Pharmacovigilance, Berlin, Germany.
11Merck & Co., INC, Clinical Safety Risk Management, Rahway, NJ, USA.
12GlaxoSmithKline LLC, Medical Affairs-Hepatology, Stevenage, UK.
13Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, USA.
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.