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News From the Food and Drug Administration
November 6, 2002

New Drug for Hepatitis B

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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.