Tenofovir indications and usage: Difference between revisions
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<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=33fd6418-fbdc-42ca-a50d-ce2a476a5418 | publisher = |date = | accessdate = }}</ref> | ==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.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=33fd6418-fbdc-42ca-a50d-ce2a476a5418 | publisher = |date = | accessdate = }}</ref> | |||
==References== | ==References== | ||
{{Reflist}} | {{Reflist}} | ||
Latest revision as of 20:09, 2 January 2014
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.