Tenofovir disoproxil Zentiva 245 mg film-coated tablets
HIV-1 infection Tenofovir disoproxil Zentiva is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults. In adults, the demonstration of the benefit of tenofovir disoproxil in HIV-1 infection is based on results of one study in treatment-naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which tenofovir disoproxil was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml). Tenofovir disoproxil Zentiva is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years. The choice of Tenofovir disoproxil Zentiva to treat antiretroviral-experienced patients with HIV-1 infection should be based on individual viral resistance testing and/or treatment history of patients. Hepatitis B infection Tenofovir disoproxil Zentiva 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 inflammation and/or fibrosis (see section 5.1). - evidence of lamivudine-resistant hepatitis B virus (see sections 4.8 and 5.1). - decompensated liver disease (see sections 4.4, 4.8 and 5.1). Tenofovir disoproxil Zentiva is indicated for the treatment of chronic hepatitis B in adolescents 12 to < 18 years of age with: - compensated liver disease and evidence of immune active disease, i.e. 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, 4.8 and 5.1.