A drug safety evaluation of rituximab and risk of hepatitis B

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Abstract
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. 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. 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.

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