This document addresses the use of phenotypic co-receptor tropism assay tests in the management of individuals with human immunodeficiency virus type-1 (HIV-1) infection. Phenotypic co-receptor tropism testing with the Trofile® assay (Trofile or Trofile DNA, Monogram Biosciences, Inc., South San Francisco, CA) is performed to identify HIV viral tropism (that is, chemokine receptor 5 [CCR5], chemokine receptor 4 [CXCR4], or dual/mixed-tropic) to assist in the selection of individuals for a CCR5 antagonist.

Clinical Indications

Medically Necessary:

HIV tropism testing with a phenotypic co-receptor tropism assay is considered medically necessary in an HIV-1 infected individual for either of the following indications:

• Prior to initiating a combination antiretroviral drug regimen with a co-receptor antagonist (CCR5 inhibitor, that is, maraviroc); or
• In an individual who has experienced virologic failure while receiving therapy that contains a CCR5 inhibitor.

Not Medically Necessary:

HIV tropism testing with a phenotypic co-receptor tropism assay is considered not medically necessary for all other indications, including, but not limited to the following:

• When using other co-receptor (genotypic) assay techniques; or
• Repeat HIV tropism testing during co-receptor antagonist treatment or after failure with a co-receptor antagonist; or
• To predict disease progression, irrespective of co-receptor antagonist treatment.