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    HBV reactivation with direct acting antivirals for HCV is highly manageable

    Direct-acting antiviral agents (DAAs) are a safe and highly effective treatment for hepatitis C virus (HCV) infection and, with proper screening, monitoring and treatment, reactivation of hepatitis B virus (HBV) is a manageable adverse event, according to a new study.

    Recent reports have noted HBV reactivation in patients with HBV–HCV co-infection. The Food and Drug Administration (FDA) has asked the manufacturers of DAAs to update their labeling to indicate the potential for HBV reactivation with treatment. In September 2016, updated guidance from the American Association for the Study of Liver Diseases and the Infectious Disease Society of America reviewed new information about the risk of HBV infection reactivation in patients who are co-infected and who clear HCV with DAAs. The mechanism for HBV reactivation with DAA therapy remains unknown.

    The researchers published their results on April 25, 2017 in Annals of Internal Medicine.

    HBV reactivation, defined as an abrupt increase in HBV replication in patients with inactive or resolved HBV infection, may result in clinically significant hepatitis, stated researchers led by Susan Bersoff-Matcha, MD, a medical officer with the FDA, located in Silver Spring, Maryland.

    “DAAs remain a safe and highly effective treatment for the management of HCV infection, and are a well-tolerated class of medications that may be administered by more primary care physicians and physician extenders in the future,” Bersoff-Matcha told Medical Economics.

    “The goal of our paper was to make sure all physicians are aware of the possibility of the HBV reactivation risk in patients co-infected with HBV-HCV who are initiating HCV DAAs,” she said. “In patients with serologic evidence of HBV infection, FDA recommends that physicians should monitor for clinical and laboratory signs of hepatitis flare or HBV reactivation during DAA therapy and during post-treatment follow up. Antiviral therapy for HBV infection should be given if criteria for HBV treatment are met.” 

     

    Next: Study details

    Mark L. Fuerst
    Staff Correspondent

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