Studies 437 and 438 Integrated 0-96 WeeksAdefovir Dipivoxil 10 mg Safety Summary

• Safety and tolerability of ADV 10 mg similar to placebo through 48 weeks

  • Increases in ALT and AST more frequent on placebo

• Safety appears similar with extended dosing

• Incidence of increases in serum creatinine is low

  • One patient discontinued

• No hypophosphatemia

• Increases in serum ALT after stopping treatment

  • Liver function should be closely monitored for at least 12 weeks after discontinuation of therapy

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