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Expert Opin Drug Saf. 2011 Sep;10(5):809-18. doi: 10.1517/14740338.2011.593507. Epub 2011 Jun 15.

Drug safety evaluation of adefovir in HBV infection.

Author information

  • 1A. M. and A. Migliavacca Center for Liver Disease, 1st Gastroenterology Unit, Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico, Università di Milano, Via F. Sforza 35, 20122 Milan, Italy.

Abstract

INTRODUCTION:

Several nucleos(t)ide analogs (NUC) are available for the management of patients with chronic hepatitis B (CHB). In most patients, NUC need to be administered on a long-term basis, thus increasing the risk of adverse effects. Adefovir dipivoxil (ADV), the first nucloeotide analog developed to treat CHB, may indeed cause nephrotoxicity.

AREAS COVERED:

The pharmacokinetic mechanism of action, potential mechanism of renal damage and long-term safety profile of ADV in CHB patients have been reported. The current monitoring modalities, together with dosage adjustments, treatment of patients with ADV-related kidney impairment and the therapeutic algorithm in place at the authors' Liver Center are also summarized. Although, in short-term clinical trials, a daily dose of 10 mg of ADV was safe owing to a low rate of negligible nephrotoxic effects, the same dose may be associated with a usually reversible, proximal renal tubular toxicity as reflected by hypophosphatemia and elevated creatinine levels. Occasionally, Fanconi syndrome occurred in ADV-treated patients.

EXPERT OPINION:

Renal function at baseline and during treatment should be carefully assessed in all patients receiving ADV to adjust the dose according to creatinine clearance, aimed to prevent or minimize nephrotoxicity.

[PubMed - indexed for MEDLINE]
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