The Food and Drug Administration (FDA) has approved adefovir dipivoxil tablets (Hepsera™, Gilead Sciences) for patients with chronic hepatitis B, a serious infection that can cause cirrhosis, liver cancer, liver failure, and death. HepseraTM slows the progression of the infection by interfering with viral replication and causing deoxyribonucleic acid (DNA) chain termination after its incorporation into viral DNA.
The FDA’s approval is based on two randomized, double-blind, placebo-controlled studies. At week 48, 53% of patients in one study and 64% in the other study showed significant improvement in liver inflammation caused by the hepatitis B virus (HBV), compared with 25% and 35% of patients receiving placebo. Patients taking HepseraTM also showed statistically significant improvement in the degree of liver fibrosis. HepseraTM has also been shown to be effective in treating patients with clinical evidence of HBV that is resistant to lamivudine, an antiviral agent.
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The major adverse events included severe, acute exacerbation of hepatitis B after the drug regimen was discontinued; this result has also been seen with other hepatitis treatments.
Patients who stop taking HepseraTM should be monitored for hepatic function at regular intervals over a period of time. Kidney toxicity was reported in patients who were at risk for or who had underlying kidney dysfunction. The FDA has noted a theoretical concern that resistance to HIV might emerge in patients who have chronic hepatitis B with unrecognized or untreated HIV infection.