Document Type
Article
Original Publication Date
2003
Journal/Book/Conference Title
The New England Journal of Medicine
Volume
348
Issue
9
First Page
808
Last Page
816
DOI of Original Publication
10.1056/NEJMoa020681
Date of Submission
January 2015
Abstract
BACKGROUND
In preclinical and phase 2 studies, adefovir dipivoxil demonstrated potent activity against hepatitis B virus (HBV), including lamivudine-resistant strains.
METHODS
We randomly assigned 515 patients with chronic hepatitis B who were positive for hepatitis B e antigen (HBeAg) to receive 10 mg of adefovir dipivoxil (172 patients), 30 mg of adefovir dipivoxil (173), or placebo (170) daily for 48 weeks. The primary end point was histologic improvement in the 10-mg group as compared with the placebo group.
RESULTS
After 48 weeks of treatment, significantly more patients who received 10 mg or 30 mg of adefovir dipivoxil per day than who received placebo had histologic improvement (53 percent [P
CONCLUSIONS
In patients with HBeAg-positive chronic hepatitis B, 48 weeks of 10 mg or 30 mg of adefovir dipivoxil per day resulted in histologic liver improvement, reduced serum HBV DNA and alanine aminotransferase levels, and increased the rates of HBeAg seroconversion. The 10-mg dose has a favorable risk–benefit profile for long-term treatment. No adefovir-associated resistance mutations were identified in the HBV DNA polymerase gene.
Rights
From the New England Journal of Medicine, Marcellin, P., Chang, T-T., Lim, S.G., et al., Adefovir Dipivoxil for the Treatment of Hepatitis B e Antigen–Positive Chronic Hepatitis B, Vol. 348, Page 808, Copyright © 2003 Massachusetts Medical Society. Reprinted with permission.
Is Part Of
VCU Internal Medicine Publications
Comments
Originally published at http://dx.doi.org/10.1056/NEJMoa020681
This article was updated on March 20, 2003, at NEJM.org. The correction was published as follows:
Adefovir Dipivoxil for the Treatment of Hepatitis B e Antigen–Negative Chronic Hepatitis B (Original Article, N Engl J Med 2003:348;800 807) and Adefovir Dipivoxil for the Treatment of Hepatitis B e Antigen–Positive Chronic Hepatitis B (Original Article, N Engl J Med 2003:348;808 816) . On page 801, in line 10 of the right-hand column, and on page 809, in the first line of the second paragraph, the trade name for adefovir dipivoxil should be “Hepsera” rather than “Preveon.” We regret the error. The Web versions of the articles have been corrected.