Tenofovir disoproxil

Tenofovir disoproxil 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 is also indicated for the treatment of HIV-1 infected paediatric patients and adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to <18 years.

The choice of tenofovir disoproxil to treat antiretroviral-experienced patients with HIV-1 infection should be based on individual viral resistance testing and/or treatment history of patients.

Tenofovir disoproxil 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.
• evidence of lamivudine-resistant hepatitis B virus.
• decompensated liver disease.

Tenofovir disoproxil is indicated for the treatment of chronic hepatitis B in paediatric patients aged 6 to <12 years who weigh from 17 kg to less than 35 kg, and 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.