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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
A drug safety evaluation of rituximab and risk of hepatitis B
Peter Riedell1, Kenneth R Carson
1Washington University School of Medicine, Division of Oncology, Department of Medicine , 660 S. Euclid Ave, Campus Box 8056, St. Louis, MO 63110 , USA +1 314 362 0492 ; +1 314 747 5123 ; kcarson@dom.wustl.edu.
Introduction:
Rituximab is a widely prescribed anti-CD20 mAb for the treatment of CD20(+) B-cell non-Hodgkin Lymphoma and many other immune mediated conditions. There is a well-described association between rituximab containing chemo-immunotherapy treatment and reactivation of the hepatitis B virus (HBV). This review summarizes the current literature surrounding rituximab-associated HBV reactivation.
Areas Covered:
Herein, we review the literature detailing the risk of HBV reactivation in inactive carriers and those with resolved hepatitis. The clinical presentation and management of HBV reactivation are also discussed along with a summary of clinical trials evaluating antiviral prophylaxis. Finally, clinical recommendations are detailed. Data from clinical trials, observational studies, reviews, and meta-analyses available in the Medline database were included in this narrative review.
Expert Opinion:
Screening should be performed in all patients prior to the administration of any type of anti-CD20 mAb therapy. Among those with positive screening serology, testing for hepatitis B e antigen or viral load by polymerase chain reaction is appropriate. In those patients with detectable HBV DNA, the decision regarding the use of antiviral prophylaxis or observation should be individualized.
