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.
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