Transcript Slide 1
Trofile Assay Access Program
Virginia Department of Health
Division of Disease Prevention
AIDS Drug Assistance Program (ADAP)
Revised January 2010
Presentation Overview
Trofile Program Purpose
Client Eligibility Info
Trofile & maraviroc (Selzentry) Exception CriteriaRevised December 2009
Trofile Assay Info
Trofile Assay Access Program Description &
Definition of Duties
Contact & Resource Info
Purpose of Trofile Assay
Access Program
Provides access for all uninsured ADAP clients to
receive tropism testing via the Monogram
Biosciences Trofile assay if the medical provider
deems such testing necessary.
Tropism testing is an allowable expenditure under
Ryan White Part B funding under medical care/lab
services.
What clients are eligible?
Any uninsured ADAP client (treatment
experienced) where the medical provider is
considering use of the CCR5 antagonist
medication maraviroc (Selzentry).
If maraviroc is being considered, client MUST
have a tropism test performed and demonstrate
a positive result (R5 tropism) before being
approved for maraviroc usage.
What about insured clients?
Clients with Medicare, Medicaid, or private
insurance must use that coverage to obtain a
Trofile test.
Trofile Exception Criteria
Clients must exhibit “a viral load greater than 1,000
copies/ml. For maximum accuracy, the viral load
should be drawn within two to four (2-4) weeks of
the Trofile assay draw.”
Trofile Assay Access
Access to designated laboratory collection sites
Began with certain, designated VDH local health
department sites properly equipped & staffed for
collection
Currently have sample collection MOAs with:
Peninsula Health Department (Newport News)-until 4/1/2010
Roanoke City Health Department (Main location)
May utilize any of the 45 LabCorp Patient Service Center
locations (PSCs) after completion of VDH preauthorization phase
Labcorp Option
Monogram Biosciences became a subsidiary
of Labcorp in August 2009
Additional option available for VDH local
health departments to use regarding Trofile
sample collection
LabCorp Access Option
Labcorp Access Option
Two choices for VDH Local Health Departments
once pre-authorization steps completed:
Collect
@ HD if HD has -20C freezer & have Labcorp
retrieve, or
Process all required paperwork & schedule client to
go to Labcorp Patient Service Center (PSC) for Trofile
sample collection.
Reminder: Ensure Labcorp Test Requisition contains
Trofile Test Code 829574 & record “Bill VDH ADAP”
in comments in billing section of form
LabCorp Option (cont’d)
Reminders for Labcorp Option:
Schedule venipunctures with Labcorp PSCs only
on Monday-Wednesday (no Thursday or Friday
draws due to delivery issues to Monogram)
Do not schedule venipunctures during these four
holiday weeks: July 4th, Thanksgiving,
Christmas, or New Year’s
Ensure the client has the fully completed
Monogram Test Request Form, signed client
consent form copy & the Labcorp requisition
form to take to Labcorp
Trofile Assay Access
Collection Sites:
List of currently approved laboratory collection
sites found on ADAP website at:
http://www.vdh.virginia.gov/epidemiology/Diseas
ePrevention/Programs/ADAP/support.htm
List will be updated as new collection sites come
on board.
maraviroc (Selzentry) Info
& How It Works
Maraviroc (Selzentry)-manufactured currently by Pfizer
Entry-inhibitor
CCR5 antagonist only:
Blocks the CCR5 chemokine receptor on the client’s
CD4+ T cell to prevent entry of the R5 tropic HIV-1 virus.
maraviroc not effective if client’s virus is X4 tropic or
Dual/Mixed (D/M) tropic.
maraviroc (Selzentry)
Exception Criteria
“NRTI and NNRTI experienced or contraindicated
and prior experience with 1 or more PIs, or
raltegravir, OR intolerance to current regimen AND
A positive blood test for the CCR5 co-receptor test
(Trofile) within three (3) months.”
ADAP Medication/Lab Exception Form required
only with the initial prescription.
maraviroc Exception
Criteria cont’d:
Note: The exception will be approved for a
treatment experienced client if the client has been
taking a regimen that included this medication prior
to ADAP enrollment, or accessing the medication
through clinical trial or expanded access. This may
be documented on the VDH ADAP Medication/Lab
Exception Form under “Reason for Exception”
section.
Tropism Defined
What is Tropism?
Tropism refers to the “affinity” of a virus, or the preferred
pathway a virus uses to enter a certain cell type.
Specifically for the HIV-1 virus, the type of tropism refers to
which co-receptor the client’s virus uses to enter the CD4+
T cell (aka the “helper cell.”)
Tropism cont’d
HIV-1 viruses currently exhibit one of four tropism
classifications:
R5: Uses CCR5 co-receptor only
X4: Uses CXCR4 co-receptor only
Dual-tropic (D): Uses either the CCR5 or CXCR4 coreceptor
Mixed-tropic (M): HIV-1 virus may be mosaic, wild-type,
etc., that may contain combinations of R5, X4, and/or
dual tropic viruses; uses either R5 or X4 co-receptor or
both co-receptors.
What is the Trofile Assay?
What is the Trofile Assay?
Currently, sole provider for assay: Monogram Biosciences,
Inc. (South San Francisco, California), a subsidiary of
LabCorp as of August 2009
Currently the only CLIA-validated tropism assay available
for use to determine client’s tropism before approving for
maraviroc usage
MUST be performed if clinician is considering use of
maraviroc (or in the future, any R5 antagonist) in client’s
HAART/ART
Trofile Assay description
Client’s sample containing at least 1000 copies/ml or more
of the HIV-1 virus is amplified (via PCR) to generate
sufficient copies of the gp160 coding region of the client’s
envelope protein contained in the client’s HIV-1 virus.
The amplified copies are introduced into a CCR5
“expressing” cell line, and into a CXCR4 “expressing” cell
line, resulting in two “infected” cell lines.
After “incubation” to allow the viral particles to infect the cell
lines, a single round of viral replication occurs.
Trofile Assay description
cont’d:
The “infected” cell lines post viral replication are tested in
the presence and absence of an antagonist (maraviroc).
A reporter gene then expresses its light-emitting indicator
gene (luciferase), which emits a visible signal
(fluorescence), that identifies which tropism the virus
exhibits.
Trofile assay description
cont’d:
Results are visualized/expressed as follows:
R5 Trophotype (tropism)
Fluoresces only with the CCR5 cell line in the
absence of the antagonist drug (maraviroc)
X4 Trophotype (tropism)
Fluoresces only with the CXCR4 cell in the absence
of the antagonist
D/M (dual/mixed) Trophotype (tropism)
Fluoresces in both the CCR5 and CXCR4 cell lines in
the absence of the antagonist
Trofile Assay Access Program
Description
Trofile Assay Access Program
Description
Provider determination of need for maraviroc usage
VDH review process & approval/denial for Trofile draw
Scheduling of venipuncture
Laboratory collection & initial processing
Courier retrieval of frozen sample
Result reporting & approval/denial for maraviroc usage
Filling of ADAP prescription
Reimbursement to collection sites (for sites with an MOA
with VDH); or processing of Monogram invoice if direct
billed from Monogram
Special Considerations
Involved
Specialized laboratory test collection procedures involved
Sample must be collected in PPT tubes
Sample must be centrifuged and frozen at -20C
within two (2) hours of collection
Collection sites must be properly staffed and equipped to
handle specimen collection
Viral load integrity must be maintained, and must be
greater than or equal to 1000 copies/ml
Most recent viral load must have been measured within
2-4 weeks before Trofile venipuncture collection date.
Medical Provider
Responsibilities
Medical Provider Responsibilities:
Medical Provider:
Determines if client appears to meet maraviroc
exception criteria
Either contacts VDH Lab Liaison at (804) 864-8000 or
downloads the following from the ADAP website:
ADAP Medication/Lab Exception Form
Client Consent Form
List of VDH contracted lab/collection sites
Completes ADAP Medication/Lab Exception Form &
signed consent form & faxes both to VDH Lab Liaison at
(804) 864-8050
Medical Provider Responsibilities cont’d
Medical Provider upon receipt of approval from VDH Lab
Liaison:
Contacts Laboratory collection site to set up client’s
venipuncture appointment
Will complete all sections of Monogram Biosciences
Trofile test request form except for date/time collected &
date/time separated.
Will send two part test request form & signed client
consent form with client to take to lab collection site
Will retain a photocopy of both the test request form &
the signed client consent form for office records
VDH Lab Liaison Responsibilities:
Conducts VDH ADAP Trofile Review Process to determine
if client meets Trofile assay eligibility criteria
Lab Liaison will:
Review completed ADAP Medication/Lab Exception
Form; contact medical provider for any missing info
Verify ADAP enrollment; if not enrolled or eligibility redetermination due, will contact medical provider to send
client to local health department to complete enrollment
or re-determine eligibility
VDH Lab Liaison Responsibilities cont’d:
Contact medical provider for identity of provider-selected
laboratory collection site
Complete applicable sections of VDH Test Authorization
Form & forward to Assistant Director of HIV Care
Services for approval.
VDH Lab Liaison Responsibilities cont’d:
Fax completed/approved Test Authorization Form to
Monogram Biosciences
Confirm mailing address/contact info for Monogram to
send test request form to medical provider if needed
Confirm shipping address/contact info for Monogram to
send PPT tubes to lab collection site if local health
department or independent lab collection site to be used
& site does not already have PPT tubes on hand. If
using Labcorp PSC, Labcorp already has tubes on hand.
Monogram Biosciences
Responsibilities
Monogram’s Responsibilities:
Monogram Biosciences:
Upon receipt of approved test authorization, sends test
request form to medical provider and two PPT tubes to
lab collection site (if needed)
Will dispatch courier service to retrieve & package
client’s frozen sample tubes post venipuncture when
notified by lab collection site
Provides test result report to VDH ADAP program and to
medical provider within 14 days of sample receipt
Bills VDH ADAP program for completed Trofile test that
yields an actual tropism result
Laboratory/Collection Site
Responsibilities
Laboratory/Collection Site Responsibilities
Laboratory/Collection Site will:
Document scheduled venipuncture appointment
Perform venipuncture & initial processing services to
include checking form completeness, sample collection,
centrifugation, freezing, and storage of back copy of test
request form and client consent form
Will contact Monogram Biosciences for courier service to
be dispatched to retrieve frozen sample
Lab/Collection Site Responsibilities cont’d
If Peninsula or Roanoke City HD, will complete ATV
form if local health department site or submit
purchase order (for other sites) on monthly basis &
submit to VDH Lab Liaison for processing for
reimbursement of specimen collection/processing
fee
Will fax copy of airbill & client consent form to VDH
Lab Liaison
Will assist courier with initial packaging of frozen
samples & ensure compliance with IATA shipping
guidelines
Test Result Reporting & Final
Processing
Test Result Reporting & Final
processing cont’d:
Upon receipt of final test report:
Lab Liaison will:
Document on ADAP Medication/Lab Exception Form
approval/denial of maraviroc use
Will notify local health department ADAP Coordinator
by phone and fax of approval/denial of maraviroc use
via Medication Exception Form
Will notify medical provider of approval of maraviroc
use & to issue prescription request
Test Result Reporting & Final
Processing cont’d:
Medical Provider will:
Issue prescription for maraviroc (Selzentry)
Local Health Dept. ADAP Coordinator will:
Process approval & proceed with locality’s usual
procedure for filling ADAP prescriptions if patient
approved for maraviroc usage
VDH ADAP Trofile Website
Info
VDH ADAP Website:
http://www.vdh.virginia.gov/epidemiology/DiseasePr
evention/Programs/ADAP/support.htm
Contains the following info:
VDH ADAP Medication/Lab Exception Form
VDH/Monogram Biosciences Client Consent & Release of
Information Form
List of VDH contracted laboratory/collection sites
Frequently Asked Questions Info
Links to additional resource information
Copy of this Power Point presentation
Contact Info for VDH ADAP
Trofile Program
VDH Laboratory Liaison
Phyllis Morris, (804) 864-8000
[email protected]
VDH ADAP Coordinator
Rachel Rees, (804) 864-7919
[email protected]
Additional Resource Info
Trofile Assay Info:
http://www.trofileassay.com
maraviroc(Selzentry) Info:
http://www.fda.gov/bbs/topics/news/2007/new01677.html
Questions?
Please contact Phyllis Morris, VDH Lab Liaison, at (804)
864-8000 or via [email protected]
Thank you for your time in reviewing this presentation, and
please feel free to contact us with suggested
improvements.