Gilead Sciences Inc (GILD)

[DewDiligence]

HIV patients are suited for a CCR5 agent only if they test positive on a CCR5 assay. The need to obtain such an assay reduces the commercial prospects.

From the FDA label for Selzentry (http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208984_022128s017lbl.pdf )

INDICATIONS AND USAGE

SELZENTRY is a CCR5 co-receptor antagonist indicated in combination with other antiretroviral agents for the treatment of only CCR5-tropic HIV-1 infection in patients 2 years of age and older weighing at least 10 kg.

Limitations of Use:
• Not recommended in patients with dual/mixed- or CXCR4-tropic HIV-1.

DOSAGE AND ADMINISTRATION

Prior to initiation of SELZENTRY, test all patients for CCR5 tropism using a highly sensitive tropism assay.