Tenofovir indications and usage
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]
Indications and Usage
HIV-1 Infection
VIREAD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older.
The following points should be considered when initiating therapy with VIREAD for the treatment of HIV-1 infection:
VIREAD should not be used in combination with ATRIPLA®, COMPLERA®, STRIBILD®, or TRUVADA®.
Chronic Hepatitis B
VIREAD is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older.
The following points should be considered when initiating therapy with VIREAD for the treatment of HBV infection:
The 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 . VIREAD was evaluated in a limited number of subjects with chronic hepatitis B and decompensated liver disease. The numbers of subjects in clinical trials who had adefovir resistance-associated substitutions at baseline were too small to reach conclusions of efficacy.[1]
References
Adapted from the FDA Package Insert.