Maraviroc

Pharmacogenomic Information in the Context of the FDA-Approved Drug Label*

The drug labeling for maraviroc is not related to genetic testing of the patient, rather testing of the HIV-1 strain that has infected the patient.

The FDA indicates that HIV tropism testing be carried out before treatment with Maraviroc. This drug is indicated only for CCR5-tropic HIV-1 infection, and due to its mechanism of action, is not effective against CXCR4-tropic and dual-tropic HIV-1. The drug is a CCR5 antagonist, and works by preventing HIV-1 from entering cells via the CCR5 cell surface receptor.

The drug labeling information demonstrates why a sensitive HIV tropism assay should be used to diagnose CCR5-tropic HIV-1, in order to avoid treating individuals with CXCR4- or Dual/ Mixed- tropic virus (discussed in section 14.3). Drug labeling information also includes Maraviroc dosage recommendations if CYP3A inhibitors or CYP3A inducers are taken concomitantly.

Excerpt from the maraviroc drug label:

" SELZENTRY (maraviroc) is a selective, slowly reversible, small molecule antagonist of the interaction between human CCR5 and HIV-1 gp120. Blocking this interaction prevents CCR5-tropic HIV-1 entry into cells."

For the complete drug label text with sections containing pharmacogenetic information highlighted, see the Maraviroc drug label PDF.