Annotation of FDA Label for maraviroc and CCR5

Summary

The drug labeling for maraviroc (SELZENTRY) is not related to genetic testing of the patient, rather testing of the HIV-1 strain that has infected the patient. The FDA-approved label states 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.

Annotation

Maraviroc (SELZENTRY) 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).

Excerpt from the maraviroc (SELZENTRY) drug label:

SELZENTRY, in combination with other antiretroviral agents, is indicated for adult patients infected with only CCR5-tropic HIV-1.

The following points should be considered when initiating therapy with SELZENTRY: Adult patients infected with only CCR5-tropic HIV-1 should use SELZENTRY...Tropism testing must be conducted with a highly sensitive tropism assay that has demonstrated the ability to identify patients appropriate for use of SELZENTRY. 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 SELZENTRY

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

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Former FDA Biomarker

This label used to be included on the FDA biomarker list(opens in new window) and has since been removed. The PharmGKB curation staff monitors the FDA biomarker list on a regular basis and notes removals. There is no official list of removals supplied by the FDA.

Evidence for Clinical Annotations

This annotation has been used as evidence for the following clinical annotations.

    History

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