Drug safety evaluation of adefovir in HBV infection.

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.

• Authors: Mauro Viganò, Pietro Lampertico, Massimo Colombo
• Journal: Expert opinion on drug safety (Expert Opin Drug Saf) Vol. 10 Issue 5 Pg. 809-18 (Sep 2011) ISSN: 1744-764X [Electronic] England
• PMID: 21671843 (Publication Type: Journal Article, Review)

Chemical References

• Antiviral Agents
• Organophosphonates
• Adenine
• adefovir dipivoxil

Topics

• Adenine (administration & dosage, adverse effects, analogs & derivatives)
• Antiviral Agents (administration & dosage, adverse effects)
• Clinical Trials, Phase III as Topic
• Hepatitis B, Chronic (drug therapy)
• Humans
• Organophosphonates (administration & dosage, adverse effects)
• Randomized Controlled Trials as Topic