The Medical Letter on Drugs and Therapeutics
Entecavir (Baraclude) for Chronic Hepatitis B
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Entecavir (Baraclude – Bristol-Myers Squibb), a nucleoside analog, has been approved by the FDA for treatment of adults with active chronic hepatitis B virus (HBV) infection.

DRUGS FOR HEPATITIS B — Chronic HBV infection is currently treated with interferon alfa, lamivudine or adefovir.1 Lamivudine is much better tolerated than interferon and much less expensive, but resistance to the drug occurs in about 15%-30% of patients after one year and in about 50% after 3 years.2 Resistance has been less of a problem with adefovir, which is active against lamivudine-resistant strains, but can cause nephrotoxicity.3

CLINICAL STUDIES — FDA approval was based on 3 unpublished randomized, double-blind trials (described in the package insert) comparing treatment with entecavir to lamivudine in adults with chronic HBV. Some ... more      

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Title: Entecavir (Baraclude) for Chronic Hepatitis B
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