HIV-1 Infection: Tenofovir disoproxil fumarate tablet is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.
The following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablet for the treatment of HIV-1 infection: Tenofovir disoproxil fumarate should not be used in combination with DESCOVY, GENVOYA, STRIBILD, TRUVADA or other products containing tenofovir disoproxil fumarate (DF) or tenofovir alafenamide (See Precautions).
Chronic Hepatitis B: Tenofovir disoproxil fumarate tablet is indicated for the treatment of chronic hepatitis B in adults.
The following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablet for the treatment of HBV infection: This indication in adults is based on safety and efficacy data from treatment of subjects who were nucleoside-treatment naïve and subjects who were treatment-experienced with documented resistance to lamivudine. Subjects were adults with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease (see Pharmacology: Clinical Studies under Actions).
Tenofovir disoproxil fumarate tablet was evaluated in a limited number of subjects with chronic hepatitis B and decompensated liver disease. (See Adverse Reactions, Pharmacology: Clinical Studies under Actions.)
The numbers of subjects in clinical trials who had adefovir resistance-associated substitutions at baseline were too small to reach conclusions of efficacy (see Pharmacology: Clinical Studies and Microbiology under Actions).