Adefovir licensed for HBV in US

Michael Carter
Estimated reading time 1 minutes
This article is more than 22 years old.

Adefovir has been approved by the US Food and Drug Administration (FDA) for the treatment of chronic hepatitis B.

Tradenamed Hepsera, adefovir is a nucleotide analogue and slows the progression of chronic hepatitis B by inhibiting viral replication. FDA approval is based upon two double-blind placebo-controlled trials. At week 48, 53% of patients receiving adefovir in one study and 63% in the other showed significant improvement in the liver inflammation caused by hepatitis B compared to 25% and 35% of patients receiving the placebo. An improvement in fibrosis (liver scarring) was also observed in people receiving adefovir which also showed itself to be effective against strains of hepatitis B resistant to 3TC.

Side effects of adefovir include kidney toxicities and a short-term worsening of hepatitis B infection.

Glossary

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

placebo

A pill or liquid which looks and tastes exactly like a real drug, but contains no active substance.

fibrosis

Thickening and scarring of connective tissue. Often refers to fibrosis of the liver, which can be caused by an inflammatory reaction to long-term hepatitis infection. See also ‘cirrhosis’, which is more severe scarring.

strain

A variant characterised by a specific genotype.

 

replication

The process of viral multiplication or reproduction. Viruses cannot replicate without the machinery and metabolism of cells (human cells, in the case of HIV), which is why viruses infect cells.

Originally developed as an anti-HIV drug, adefovir was investigated for treatment of chronic hepatitis B after it was found that the doses used to treat HIV caused severe kidney toxicities. The 10mg dose of adefovir used to treat hepatitis B has been shown to be much less likely to cause kidney problems.

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