Hepsera

Adefovir dipivoxil, previously called bis-POM PMEA, with trade names Preveon® and Hepsera®, is an orally-administered nucleotide analog reverse transcriptase inhibitor (NRTI) used for treatment of Hepatitis B. It is a failed treatment for HIV. more...

History

Adefovir was originally developed by Gilead Sciences for HIV with the brand name Preveon. However, in November 1999, an expert panel advised the U.S. Food and Drug Administration (FDA) not to approve the drug due to concerns about the severity and frequency of kidney toxicity when dosed at 60 or 120mg. The FDA followed that advice, refusing to approve adefovir as a treatment for HIV.

Gilead Sciences discontinued its development for HIV treatment in December 1999 but continued to develop the drug for Hepatitis B (HBV), where it is effective with a much lower dose. FDA approval for use in the treatment of Hepatitis B was granted on September 20, 2002, and adefovir is sold for this indication under the brand name Hepsera.

Adefovir became an approved treatment for HBV in the United States in September 2002 and in the European Union in March 2003. The main benefit of Adefovir over Lamivudine (the first NRTI approved for the treatment of Hepatitis B) is that it takes a much longer period of time before the virus develops resistance to it.

Mechanism of action

Adefovir works by blocking reverse transcriptase, an enzyme that is crucial for the hepatitis B virus (HBV) to reproduce in the body.

It is approved for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (primarily ALT) or histologically active disease.

Adefovir is a failed treatment for HIV due to the severity and frequency of kidney toxicity when dosed at 60 or 120mg. However, trials have found the 10mg dose of adefovir to be an effective and safe treatment for HBV. The main benefit of Adefovir over lamivudine is that it takes a much longer period of time before the virus develops resistance to it.

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