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Tenofovir indications and usage

Introduction

Tenofovir
Viread® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Clinical Studies
Dosage and Administration
How Supplied
Labels and Packages
Indications and Usage

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

References

Adapted from the FDA Package Insert.

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]