4.1 Therapeutic indications
Lamivudine Accord 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 (see section 5.1).
▪ decompensated liver disease in combination with a second agent without cross-resistance to lamivudine (see section 4.2).
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Drug Licencing
Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).