HIV-1 infection: Tenofovir Disoproxil Fumarate Teva 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 fumarate 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 fumarate 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).
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 Teva 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; evidence of lamivudine-resistant hepatitis B virus (see Adverse Reactions); decompensated liver disease (see Precautions and Adverse Reactions).