Development of Entecavir: Superior Therapy for the Management of Chronic Hepatitis B Viral Infection
Current therapies for chronic hepatitis B virus (HBV) infection are limited by factors such as poor tolerability and viral resistance. The novel and selective HBV antiviral entecavir (Bristol-Myers Squibb Company; Wallingford, CT) has demonstrated potent activity against HBV and is in phase III clinical development. Oral entecavir has high bioavailability, shows linear pharmacokinetic properties in several ethnic populations, and is well tolerated. At doses of 0.5 mg to 1.0 mg daily, entecavir has significantly greater antiviral activity in nucleoside-naïve patients, assessed by reduction in HBV viral load, than the currently available therapy lamivudine. Entecavir also shows superior efficacy compared with lamivudine in reducing viremia and normalizing alanine aminotransferase levels in lamivudine-resistant patients. In addition, entecavir has demonstrated utility in the setting of HBV reinfection occurring in liver transplant recipients. Based on results of phase I and II dose-ranging, safety, and efficacy trials, several multinational phase III trials are currently ongoing. These studies are evaluating the optimal duration of therapy with entecavir, as well as the durability of response to this novel treatment for chronic HBV infection.
KeywordsLamivudine Therapy Woodchuck Hepatitis Virus Entecavir Treatment Entecavir Therapy Oral Entecavir
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