Active Ingredient: Entecavir
ฮntecavir is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to <18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
0.5 - 0.5 mg
From 0.5 To 0.5 mg once every day
For appropriate dosing in the paediatric population, entecavir oral solution or entecavir 0.5 mg film-coated tablets are available.
The decision to treat paediatric patients should be based on careful consideration of individual patient needs and with reference to current paediatric treatment guidelines including the value of baseline histological information. The benefits of long-term virologic suppression with continued therapy must be weighed against the risk of prolonged treatment, including the emergence of resistant hepatitis B virus.
Serum ALT should be persistently elevated for at least 6 months prior to treatment of paediatric patients with compensated liver disease due to HBeAg positive chronic hepatitis B; and for at least 12 months in patients with HBeAg negative disease.
Paediatric patients with body weight of at least 32.6 kg, should be administered a daily dose of one 0.5 mg tablet or 10 ml (0.5 mg) of the oral solution, with or without food. The oral solution should be used for patients with body weight less than 32.6 kg.
The optimal duration of treatment is unknown. In accordance with current paediatric practice guidelines, treatment discontinuation may be considered as follows:
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