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Entecavir for Chronic Hepatitis B

Entecavir is a promising treatment for patients with chronic hepatitis B.

Entecavir (Baraclude), an inhibitor of hepatitis B virus DNA polymerase, is the latest approved antiviral agent for chronic hepatitis B. Researchers examined the efficacy of entecavir in two industry-sponsored, double-blind, randomized international trials — one with 709 hepatitis B e-antigen (HBeAg)-positive patients, and one with 648 HBeAg-negative patients. Both studies involved patients with compensated liver function, serum alanine aminotransferase (ALT) levels 1.3 to 10 times the upper limit of normal, and biopsy-proven chronic hepatitis. Patients received daily oral doses of either entecavir or lamivudine.

In the HBeAg-positive study, the proportion of patients with histologic improvement at 48 weeks was significantly higher in the entecavir group than in the lamivudine group (72% vs. 62%). Blood HBV DNA levels became undetectable in 67% and 36% of patients in the two groups, respectively. No entecavir resistance occurred, and only one entecavir recipient withdrew because of side effects.

In the HBeAg-negative study, the proportion of patients with histologic improvement at 48 weeks was significantly higher in the entecavir group than in the lamivudine group (70% vs. 61%). Blood HBV DNA levels became undetectable in 90% and 72% of patients in the two groups, respectively. No entecavir resistance occurred, and only six entecavir recipients withdrew because of side effects.

Comment: These two studies demonstrate that entecavir is a promising treatment for chronic hepatitis B. The absence of resistance to entecavir at 1 year is noteworthy, especially because resistance to lamivudine occurs in about 20% of patients yearly. Although longer-term follow-up data are needed, an editorialist notes that entecavir therapy probably should be continued indefinitely in many cases.

— Allan S. Brett, MD

Published in Journal Watch General Medicine March 17, 2006

Citation(s):

Chang T-T et al. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med 2006 Mar 9; 354:1001-10.

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Lai C-L et al. Entecavir versus lamivudine for patients with HBeAg-negative chronic hepatitis B. N Engl J Med 2006 Mar 9; 354:1011-20.

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Hoofnagle JH. Hepatitis B — Preventable and now treatable. N Engl J Med 2006 Mar 9; 354:1074-6.

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