Entecavir (entecavir): Reviews and patient testimonials

Entecavir 0.5mg Film-coated Tablets

Entecavir is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:

- compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.

- decompensated liver disease

For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naïve patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B, see sections 4.2, 4.4 and 5.1.

Entecavir is also indicated for the treatment of chronic HBV infection in nucleoside naïve 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. With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, and 5.1.

Entecavir 1mg Film-coated Tablets

Entecavir is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:

- compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.

- decompensated liver disease

For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naïve patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B, see sections 4.2, 4.4 and 5.1.

Entecavir is also indicated for the treatment of chronic HBV infection in nucleoside naïve 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. With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, and 5.1.

Entecavir Accord 0.5/1 mg film-coated tablets

Entecavir Accord is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:

▪ compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.

▪ decompensated liver disease

For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B, see sections 4.2, 4.4 and 5.1.

Entecavir Accord 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. With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, and 5.1.

Entecavir Zentiva 0.5 mg Film-coated tablets

Adults:

Treatment of chronic hepatitis B virus (HBV) infection in adults with:

• compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.

• decompensated liver disease.

For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B, see sections 4.2, 4.4 and 5.1.

Paediatric population:

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. With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, and 5.1.

Entecavir Zentiva 1.0 mg film-coated tablets

Adults:

Treatment of chronic hepatitis B virus (HBV) infection in adults with:

• compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.

• decompensated liver disease.

For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B, see sections 4.2, 4.4 and 5.1.

Paediatric population:

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. With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, and 5.1.