FDA Changes Safety Labeling for Hepsera (adefovir) and Viread (tenofovir)

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FDA Changes Safety Labeling for Hepsera (adefovir) and Viread (tenofovir)

The U.S. FDA issued a labeling change on October 13th for Hepsera

(adefovir), an FDA approved antiviral therapy for hepatitis B. According to

the label change, severe acute exacerbation (flare-up) of hepatitis B was

reported in up to 25% of clinical trial patients within 12 weeks after

discontinuing treatment (a total of 492 patients were followed). The label

now includes a warning advising that hepatic function should be monitored

for at least several months after treatment is stopped, and in some cases,

treatment may need to be restarted. Restarting therapy resolved most

exacerbations. Please visit the FDA Medwatch site for full details.

The FDA also approved revisions to safety labeling to advise healthcare

professionals that Viread (tenofovir) is not indicated in the treatment of

chronic hepatitis B, and that tenofovir withdrawal can cause severe

hepatitis B exacerbations in patients coinfected with HIV/HBV. The FDA

advises close monitoring of hepatic function for at least several months in

HIV/HBV co-infected patients who have had acute exarcerbation of hepatitis B

upon stopping tenofovir (with anti-HBV therapy where appropriate).

Currently, tenofovir is indicated in combination with other antiretroviral

agents for the treatment of HIV-1 infection. The FDA recommends that all

patients with HIV be tested for HBV infection before initiating

antiretroviral therapy. For more FDA labeling changes, visit the Medscape

Medical News website.