موافقات الدواء

HIV-1 infection
Tenofovir Disoproxil Fumarate 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 tri-therapy) 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 Fumarate 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 Fumarate 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 Fumarate 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 amino transferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.
• evidence of lamivudine-resistant hepatitis B virus.
• decompensated liver disease.
Tenofovir Disoproxil Fumarate 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,