Etravirine indications and usage: Difference between revisions
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In treatment-experienced adult and pediatric patients, the following points should be considered when initiating therapy with INTELENCE®: | In treatment-experienced adult and pediatric patients, the following points should be considered when initiating therapy with INTELENCE®: | ||
Treatment history and resistance testing should guide the use of INTELENCE® due to concerns for potential cross-resistance | Treatment history and resistance testing should guide the use of INTELENCE® due to concerns for potential cross-resistance. | ||
In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE® in combination with only N[t]RTIs [seeClinical Studies (14)]. | In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE® in combination with only N[t]RTIs [seeClinical Studies (14)]. | ||
The use of other active antiretroviral agents with INTELENCE® is associated with an increased likelihood of treatment response. | The use of other active antiretroviral agents with INTELENCE® is associated with an increased likelihood of treatment response. | ||
The safety and efficacy of INTELENCE® have not been established in pediatric patients less than 6 years of age or in treatment-naïve adult or pediatric patients.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = INTELENCE (ETRAVIRINE) TABLET [JANSSEN PRODUCTS LP] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6a9cbc29-9f15-4b24-8d86-206b82887f3d | publisher = | date = | accessdate = }}</ref> | The safety and efficacy of INTELENCE® have not been established in pediatric patients less than 6 years of age or in treatment-naïve adult or pediatric patients.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = INTELENCE (ETRAVIRINE) TABLET [JANSSEN PRODUCTS LP] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6a9cbc29-9f15-4b24-8d86-206b82887f3d | publisher = | date = | accessdate = }}</ref> | ||
==References== | ==References== | ||
{{Reflist}} | {{Reflist}} | ||
Revision as of 16:55, 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
INTELENCE®1, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced patients ages 6 years and older, who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents.
The indication for adult use is based on Week 48 analyses from 2 randomized, double-blind, placebo-controlled trials of INTELENCE®. Both studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced adults. The indication for pediatric use is based on 24-week analyses of a single-arm, Phase 2 trial in antiretroviral treatment-experienced pediatric subjects 6 years to less than 18 years of age [seeUse in Specific Populations (8.4)].
In treatment-experienced adult and pediatric patients, the following points should be considered when initiating therapy with INTELENCE®:
Treatment history and resistance testing should guide the use of INTELENCE® due to concerns for potential cross-resistance.
In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE® in combination with only N[t]RTIs [seeClinical Studies (14)]. The use of other active antiretroviral agents with INTELENCE® is associated with an increased likelihood of treatment response. The safety and efficacy of INTELENCE® have not been established in pediatric patients less than 6 years of age or in treatment-naïve adult or pediatric patients.[1]
References
Adapted from the FDA Package Insert.