Chronic Hepatitis B Virus Infection
Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferase (ALT or AST) or histologically active disease.
This indication is based on efficacy and safety data in nucleoside-treatment-naive and lamivudine-refractory Adults patients with HBeAg-positive or HbeAg-negative chronic HBV infection with compensated liver disease and on more limited data in adult patients with HIV/HBV co-infection who have received prior lamivudine therapy.
Entecavir 0,5 mg
0 to 16 Years Old
Safety and effectiveness of entecavir in pediatric patients below the age of 16 years have not been established.
16 Years Old and Above
Patients with chronic hepatitis B virus infection:
0.5 mg once daily.
Patients with a history of hepatitis B viremia while receiving lamivudine or with known lamivudine resistance mutations:
1 mg daily.
Entecavir is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Entecavir should be used on an empty stomach (at least 2 hours after food and at least 2 hours before the next meal).
Patients with Renal Impairment
In patients with renal impairment, the apparent oral clearance of entecavir decreased as creatinine clearance decreased. Dosage adjustment is recommended for patients with creatinine clearance <50 ml/minute, including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
Patients with Hepatic Impairment
No dosage adjustment is necessary for patients with hepatic impairment.