trofile

Trofile®

Trofile® is a phenotypic viral RNA assay that is the only commercially available tropism assay that has been clinically validated through use in Phase 2 and Phase 3 clinical studies to identify CCR5 antagonist candidates.1-3 One such drug, maraviroc (Selzentry®), is available for clinical use. Trofile is a clinically validated assay for the selection of clinically appropriate patients for maraviroc.


The Trofile Coreceptor Tropism Assay:

  • Is 100% sensitive at detecting 0.3% CXCR4-using minor variant.4
  • Uses the complete gp160 coding region of the HIV-1 envelope protein to ensure that all determinants of tropism are tested.
  • Can successfully amplify and reliably report results with viral loads ≥1,000 copies/mL.

Trofile has been shown to be accurate, precise, sensitive, reproducible, and robust in the measurement of HIV-1 co-receptor tropism. More than 100,000 samples have been tested using this assay.

References

  1. Hardy WD, Gulick R, Mayer H, et al. Efficacy and safety of maraviroc in treatment-experienced (TE) patients infected with R5 HIV-1: 96-week combined analysis of the MOTIVATE 1 and 2 studies. Poster presented at: Ninth International Congress on Drug Therapy in HIV Infection; November 9-13, 2008; Glasgow, UK. Poster O425.
  2. Saag M, Heera J, Goodrich J, et al. Reanalysis of the MERIT study with the enhanced Trofile® assay (MERIT-ES). Program and abstracts of the 48th Annual ICAAC/IDSA 46th Annual Meeting; October 25-28, 2008; Washington, DC. Abstract H1232a.
  3. Cooper DA, Heera J, Goodrich J et al. Maraviroc versus efavirenz, both in combination with zidovudine-lamivudine, for the treatment of antiretroviral-naive subjects with CCR5-tropic HIV-1 infection. J Infect Dis. 2010;201:803-813. 
  4. Trinh L, Han D, Huang W, et al. Technical validation of an enhanced sensitivity Trofile HIV coreceptor tropism assay for selecting patients for therapy with entry inhibitors targeting CCR5. Antivir Ther. 2008; 13(Suppl. 3):A128 (abstract no. 118)