INTELENCE, 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, who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents.
This indication 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 following points should be considered when initiating therapy with INTELENCE: Treatment history and, when available, resistance testing, should guide the use of INTELENCE.
The use of other active antiretroviral agents with INTELENCE is associated with an increased likelihood of treatment response.
In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE in combination with only N[t]RTIs [see Pharmacology: Pharmacodynamics: Clinical Studies: Treatment-Experienced Subjects under Actions].
The safety and efficacy of INTELENCE have not been established in pediatric patients or in treatment-naïve adult patients.