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JAMA. 2002;288:2112.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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.

At week 48, the benefit of Hepsera treatment over placebo was statistically significant with respect to the primary efficacy end point, which was defined as a reduction from baseline of two points or more in the Knodell necroinflammatory score, with no concurrent worsening of the Knodell fibrosis score. In one of the studies, 67% of patients receiving . . . [Full Text of this Article]

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