Routine screening for HBV should be standard practice, experts say
In the light of an FDA boxed warning for reactivation of hepatitis B virus with two drugs, researchers reviewed studies and suggested the problem is larger than those two drugs or their classes of immunosuppressant or chemotherapy medications. They recommended routine screening for HBV in patients set to receive any medications in question.
“While the FDA urged clinicians to screen patients for HBV prior to starting treatments with ofatumumab and rituximab to prevent the reoccurrence of the virus, this may be just the tip of the iceberg,” Adrian Di Bisceglie, MD, from Saint Louis University School of Medicine, said in a press release. “Our research suggests that the issue of HBV reactivation may be an under-appreciated clinical challenge that extends well beyond the use of just two anti-CD20 medications.”
In September 2013, the FDA issued a boxed warning for Arzerra (oftatumumab, GlaxoSmithKline) and Rituxan (rituximab, Genentech). The warning encouraged screening for HBV in all patients prior to beginning these specific therapies.
“Reactivation of HBV is known to occur with a wide variety of immune-suppressive therapies and may occur in the context of cancer treatment, immunosuppressive therapy for autoimmune disease, and transplantation. It is a potentially lethal condition and yet is preventable,” they wrote.
The researchers in this review found 504 studies through 2012 that related to reactivation of HBV. They outlined scenarios in which reactivation occurred: chemotherapy, organ and tissue transplantation, treatment of autoimmune diseases with biological agents and the use of high-dose corticosteroids.
“The present authors and the American Association for the Study of Liver Disease strongly recommend that all patients undergoing chemotherapy, immunosuppressive therapy, HSCT, or solid organ transplantation be screened for active or prior HBV infection by testing for HBsAg and anti-HBc in serum. … In addition, it is recommended that screening of patients with inflammatory bowel disease or other benign medical conditions necessitating long-term immunosuppressive therapy for hepatitis B be incorporated into their routine care,” they wrote. “While further study will be necessary to completely define the risks, benefits, and costs of universal screening, we feel that the evidence as it stands now is sufficiently compelling to make routine screening for hepatitis B a standard practice.”
Disclosure: Di Bisceglie has financial relationships with Gilead and Bristol-Meyers Squibb. See study for full list of authors and financial relationships.