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These highlights do not include all the information needed to use VIREAD safely and effectively. See full prescribing information for VIREAD. GILEAD ACCESS PROGRAM VIREAD™ (tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2001
Medication labelWhy this: Advisory · dailymed-prescription
VIREAD™ 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 VIREAD for the treatment of HIV-1 infection: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™, BIKTARVY™ COMPLERA™, DESCOVY™, GENVOYA™, ODEFSEY™, STRIBILD™, TRUVADA™ or VEMLIDY™ [See Warnings and Precautions (5.4)] . 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 chronic hepatitis B 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 [See Clinical Studies (14.2)]. VIREAD was evaluated in a limited number of subjects with chronic hepatitis B and decompensated liver disease [See Adverse Reactions (6.1), Clinical Studies (14.2)] . The numbers of subjects in clinical trials who had adefovir resistance-associated substitutions at baseline were too small to reach conclusions of efficacy [See Microbiology (12.4), Clinical Studies (14.2)].
- generic_name
- tenofovir disoproxil fumarate
- product_names
- TENOFOVIR DISOPROXIL FUMARATE
- ndc
- 61958-0402, 61958-0402-3, 61958-0402-6
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en