Highlighted Data on SELZENTRY

Several retrospective analyses in both treatment experienced and naive patients were presented evaluating additional approaches for determining tropism and virologic response to maraviroc, including the following:  

A genotypic analysis of 704 pre-treatment samples from patients in the MERIT study who received maraviroc and had a known virologic outcome using population-based sequencing of the V3 loop, which identified 11R residue as a marker of CXCR4 use. An analysis of data from the MERIT study using population-based sequencing of the V3 loop, in which approximately 8 percent of patients screened as R5 by the original Trofile?„? assay were classified as X4 by V3 sequencing and 193/283 (68 percent) classified as R5 by both the enhanced sensitivity Trofile and population-based V3 sequencing had week 48 virologic response (<50 copies/mL) on maraviroc. An analysis of data from MERIT, MOTIVATE-1, MOTIVATE-2 and A4001029 studies using "deep" gp120 V3-loop sequencing, in which deep sequence discriminated between responders and non-responders regardless of treatment experience and excluded fewer treatment-naive patients in MERIT as non-R5 than the enhanced sensitivity Trofile assay (ESTA) while maintaining comparable performance (223/312 (71 percent)) for deep sequencing compared to 216/299 (72 percent) for ESTA.An analysis of data from 31 patients with persistent viremia <50 copies/mL for greater than or equal to 1 year after first line antiretroviral treatment initiation (without a CCR5 antagonist) comparing the ability of different tropism assays to detect X4 viruses, which showed close agreement between V3 quantitative deep sequencing and the enhanced sensitivity Trofile assay.  

Collectively, these data suggest population-based genotyping may be a viable alternative to available phenotypic tests in identifying tropism and predicting response to maraviroc.  

SELZENTRY?® (maraviroc) is a first-in-class oral CCR5 entry inhibitor approved in the U.S. for both treatment-naive and treatment-experienced adult patients with CCR5-tropic HIV-1 virus in combination with other anti-HIV medicines.  SELZENTRY is known as Celsentri?® outside of the U.S. where it is indicated for appropriate treatment-experienced patients.  Use of SELZENTRY in patients with dual/mixed or CXCR4-tropic HIV-1 is not recommended.  SELZENTRY will not cure HIV infection.  

SOURCE ViiV Healthcare