Untoward Effects

Adefovir dipivoxil causes dose-related nephrotoxicity, manifested by azotemia and hypophos-phatemia, acidosis, glycosuria, and proteinuria, which usually are reversible after discontinuation. The lower dose (10 mg/day) used in chronic HBV infection patients has been associated with few adverse events (e.g., headache, abdominal discomfort, diarrhea, and asthenia) and negligible renal toxicity compared with a threefold higher dose. Adverse events lead to drug discontinuation in ~2% of patients. After 2 years of dosing, the risk of a significant rise in serum creatinine is ~2% but is higher in those with preexisting renal insufficiency. Acute, sometimes severe exacerbations of hepatitis can occur in patients stopping adefovir. Close monitoring is needed, and resumption of antiviral therapy may be required.

No clinically important drug interactions are recognized, although drugs that reduce renal function or compete for active tubular secretion could decrease adefovir clearance. An increased risk of lactic acidosis and hepatic steatosis may exist when adefovir is combined with antiretroviral agents.

High doses in animals cause renal tubular dysfunction, hepatotoxicity, and toxicity to lymphoid tissues. Adefovir dipivoxil is not associated with reproductive toxicity (pregnancy category C).

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