Efficacy and pharmacokinetics of adefovir dipivoxil liquid suspension in patients with chronic hepatitis B and renal impairment

Mitchell L. Shiffman, Stanislas Pol, Lionel Rostaing, Eugene Schiff, Dominique Thabut, Stefan Zeuzem, Jian Zong, David Frederick, Franck Rousseau

Research output: Contribution to journalArticle

8 Scopus citations

Abstract

The study evaluated whether a liquid suspension of adefovir dipivoxil (ADV) is effective and safe when dose adjusted based on varying degrees of renal impairment in patients with chronic hepatitis B. Patients had stable mild, moderate, or severe renal impairment or end-stage renal disease. Twenty-eight patients were enrolled: 10 (mild), 12 (moderate), and 6 severe renal impairment or end-stage renal disease with hemodialysis. Statistical testing demonstrated that daily dosages of ADV liquid suspension at 10 mg and 5 mg in the mild and moderate renal impairment groups, respectively, were clinically similar to ADV 10-mg tablets. However, the antiviral effect observed with the 5-mg/d dose was clearly numerically less than that observed with the 10-mg/d dose. Steady-state adefovir plasma exposures after administration of the ADV liquid suspension were generally within the ranges observed in patients with normal renal function. Treatment with ADV liquid suspension for up to 48 weeks was generally well tolerated. The daily dose-adjustment approach was not clearly safer or more efficacious than the dosing-interval adjustment. Therefore, the results do not support daily ADV dosing using a liquid suspension over the current strategy of adjustment of the ADV dosing interval in patients with impaired renal function.

Original languageEnglish (US)
Pages (from-to)1293-1301
Number of pages9
JournalJournal of Clinical Pharmacology
Volume51
Issue number9
DOIs
StatePublished - Sep 1 2011

Keywords

  • Biostatistics/clinical trials
  • clinical pharmacology
  • clinical research
  • clinical trials
  • infectious diseases

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology

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