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(adefovir dipivoxil, Gilead Sciences)
An antiviral for treating chronic hepatitis B in adults with evidence of active viral replication plus persistent elevations in serum alanine aminotransferase or aspartate aminotransferase, or histologically active disease. The third approved treatment for hepatitis B; others are interferon alfa 2b and Epivir (lamivudine).
* Recommended Dosage: 10 mg by mouth once daily if renal function is adequate. Labeling includes a formula for adjusting dose in those at risk for kidney injury.
* Special Considerations: Nephrotoxicity, reported in patients who had or were at risk of kidney dysfunction, is generally not a concern if renal function is normal. Many patients will use Hepsera indefinitely, so kidney function should be monitored, said Dr. Eugene Schiff, director, Center for Liver Diseases, University of Miami. Severe, acute hepatitis B exacerbations after discontinuing Hepsera have been reported.
* Comment: Approval was based on studies of over 800 patients with chronic hepatitis B, who were negative for HIV and hepatitis C, and had ...