Celsentri Indications/Uses

CELSENTRI is indicated in combination with other antiretroviral agents for the treatment of only CCR5-tropic human immunodeficiency virus type 1 (HIV-1) infection in adult patients.
Limitations of Use: CELSENTRI is not recommended in patients with dual/mixed- or CXCR4-tropic HIV-1 [see Microbiology under Actions].
This indication is based on analyses of plasma HIV-1 RNA levels in 2 controlled trials of CELSENTRI in treatment-experienced subjects and one trial in treatment-naive subjects. Both trials in treatment-experienced subjects were conducted in clinically advanced, 3-class antiretroviral-experienced (nucleoside reverse transcriptase inhibitor [NRTI], non-nucleoside reverse transcriptase inhibitor [NNRTI], protease inhibitor [PI], or enfuvirtide) adults with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
The following points should be considered when initiating therapy with CELSENTRI: Adult patients infected with only CCR5-tropic HIV-1 should use CELSENTRI.
Tropism testing must be conducted on a current sample with a highly sensitive tropism assay that has demonstrated the ability to identify patients appropriate for use of CELSENTRI. Outgrowth of pre-existing low-level CXCR4- or dual/mixed-tropic HIV-1 not detected by tropism testing at screening has been associated with virologic failure on CELSENTRI [see Microbiology and Pharmacology: Pharmacodynamics: Clinical Studies under Actions].
Use of CELSENTRI is not recommended in subjects with dual/mixed- or CXCR4-tropic HIV-1 as efficacy was not demonstrated in a Phase 2 trial of this patient group.
The safety and efficacy of CELSENTRI have not been established in pediatric patients.
In treatment-naive subjects, more subjects treated with CELSENTRI experienced virologic failure and developed lamivudine resistance compared with efavirenz [see Microbiology and Pharmacology: Pharmacodynamics: Clinical Studies under Actions].