Chronic hepatitis B

Active Ingredient: Adefovir dipivoxil

Indication for Adefovir dipivoxil

Population group: only adults (18 - 65 years old)

Adefovir dipivoxil is indicated for the treatment of chronic hepatitis B in adults with:

compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and fibrosis. Initiation of adefovir dipivoxil treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate.
decompensated liver disease in combination with a second agent without cross-resistance to adefovir dipivoxil.

For this indication, competent medicine agencies globally authorize below treatments:

10 mg once daily

Route of admnistration

Oral

Defined daily dose

10 - 10 mg

Dosage regimen

From 10 To 10 mg once every day

Detailed description

The recommended dose of adefovir dipivoxil is 10 mg once daily taken orally with or without food.

Higher doses must not be administered.

The optimum duration of treatment is unknown. The relationship between treatment response and long-term outcomes such as hepatocellular carcinoma or decompensated cirrhosis is not known.

In patients with decompensated liver disease, adefovir should always be used in combination with a second agent, without cross-resistance to adefovir, to reduce the risk of resistance and to achieve rapid viral suppression.

Patients should be monitored every six months for hepatitis B biochemical, virological and serological markers.

Treatment discontinuation may be considered as follows:

In HBeAg positive patients without cirrhosis, treatment should be administered for at least 6-12 months after HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection) is confirmed or until HBs seroconversion or there is loss of efficacy. Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation to detect any late virological relapse.
In HBeAg negative patients without cirrhosis, treatment should be administered at least until HBs seroconversion or there is evidence of loss of efficacy. With prolonged treatment for more than 2 years, regular reassessment is recommended to confirm that continuing the selected therapy remains appropriate for the patient.

In patients with decompensated liver disease or cirrhosis, treatment cessation is not recommended.

Dosage considerations

It should be taken once daily, orally with or without food.

Active ingredient

Adefovir dipivoxil
Adefovir dipivoxil is an oral prodrug of adefovir, an acyclic nucleotide phosphonate analogue of adenosine monophosphate, which is actively transported into mammalian cells where it is converted by host enzymes to adefovir diphosphate. Adefovir diphosphate inhibits viral polymerases by competing for direct binding with the natural substrate (deoxyadenosine triphosphate) and, after incorporation into viral DNA, causes DNA chain termination. Read more about Adefovir dipivoxil

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