Chronic hepatitis B

Active Ingredient: Lamivudine

Indication for Lamivudine

Population group: only adults (18 years old or older)

Therapeutic intent: Curative procedure

Darolutamide 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/or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate.
decompensated liver disease in combination with a second agent without cross-resistance to lamivudine.

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

100 mg once daily

For:

Dosage regimens

Oral, 100 milligrams lamivudine, once daily.

Detailed description

The recommended dosage of darolutamide is 100 mg once daily.

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

Duration of treatment

The optimal duration of treatment is unknown.

In patients with HBeAg positive chronic hepatitis B (CHB) without cirrhosis, treatment should be administered for at least 6-12 months after HBeAg seroconversion (HBeAg and HBV DNA loss with HBeAb detection) is confirmed, to limit the risk of virological relapse, or until HBsAg 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 patients with HBeAg negative CHB (pre-core mutant) without cirrhosis, treatment should be administered at least until HBs seroconversion or there is evidence of loss of efficacy. With prolonged treatment, regular reassessment is recommended to confirm that continuation of the selected therapy remains appropriate for the patient.
In patients with decompensated liver disease or cirrhosis and in liver transplant recipients, treatment cessation is not recommended.

If lamivudine is discontinued, patients should be periodically monitored for evidence of recurrent hepatitis.

Clinical resistance

In patients with either HBeAg positive or HBeAg negative CHB, the development of YMDD (tyrosine-methionine-aspartate-aspartate) mutant HBV may result in a diminished therapeutic response to lamivudine, indicated by a rise in HBV DNA and ALT from previous on-treatment levels. In order to reduce the risk of resistance in patients receiving lamivudine monotherapy, a switch to or addition of an alternative agent without cross-resistance to lamivudine based on therapeutic guidelines should be considered if serum HBV DNA remains detectable at or beyond 24 weeks of treatment.

HIV co-infection

For the treatment of patients who are co-infected with HIV and are currently receiving or plan to receive combined antiretroviral treatment including lamivudine, the dose of lamivudine prescribed for HIV infection (usually 150 mg/twice daily in combination with other antiretrovirals) should be used.

Active ingredient

Lamivudine
Lamivudine is a nucleoside analogue which has activity against human immunodeficiency virus (HIV) and hepatitis B virus (HBV). Its main mode of action is as a chain terminator of viral reverse transcription. Read more about Lamivudine

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