[Skip to Content]
[Skip to Content Landing]
Citations 0
From the Food and Drug Administration
November 6, 2002

New Drug for Hepatitis B

Author Affiliations
 

Not Available

Not Available

JAMA. 2002;288(17):2112. doi:10.1001/jama.288.17.2112

The FDA has approved adefovir dipivoxil (Hepsera, Gilead Sciences, Foster City, Calif), a nucleotide analogue, for the treatment of chronic hepatitis B (HB) in adults with evidence of active viral replication and elevations in serum alanine aminotransferase or aspartate aminotransferase, or histologically active liver disease.

Approval was based on the results of two double-blind, randomized, placebo-controlled studies in 507 adults with compensated HB "e" antigen (HBeAg)-positive and HBeAg-negative chronic HB, adequate renal function, detectable HB virus DNA, and alanine aminotransferase levels that were as much as 10 times the upper limit of normal.

First Page Preview View Large
First page PDF preview
First page PDF preview
×