Tenofovir disoproxil 245 mg film-coated tablets.
HIV-1 infection Tenofovir disoproxil tablets 245 mg film-coated tablets are 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 tablets 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 tablets 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 245 mg film-coated tablets are 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 tablets 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 245 mg film-coated tablets are 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 245 mg film-coated tablets are 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, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis (see sections 4.4, 4.8 and 5.1).