Studies 437 and 438Primary Endpoint

• Improvement in liver histology at week 48, relative to baseline (ADV 10 mg vs. placebo)

  • Defined as ? 2 point reduction in the Knodell necroinflammatory score with no worsening in fibrosis
  • Missing/unevaluable week 48 biopsy = no improvement

• Histology assessed

  • One histopathologist blinded to treatment assignment and sequence (baseline or week 48)
  • Knodell and Ishak scoring systems

• Evaluable paired biopsies

  • 86% HBeAg+
  • 91% HBeAg–

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