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CD4 for monitoring HIV Progression. 31 st Annual National Conference of Indian Association of Preventive & Social Medicine, 27 th – 29 th Feb 2004 PGIMER, Chandigarh Dr. Arvinder Singh BD Biosciences. China -CDC -MOH -BDB. BD Bio-IS - Value Proposition

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cd4 for monitoring hiv progression

CD4 for monitoring HIV Progression

31st Annual National Conference of

Indian Association of Preventive & Social Medicine,

27th – 29th Feb 2004

PGIMER, Chandigarh

Dr. Arvinder Singh

BD Biosciences

bd activities

China

-CDC

-MOH

-BDB

BD Bio-IS

-Value Proposition

-Education and training

-QC/QA protocols

-Application protocols

-Reference range studies

India

-ICMR

-NACO

-Hospitals / Path labs

-BDB

Africa

-WHO -Countries

-DOD -NGOs

-BDB

Thailand

-MOH

-COE

-BDB

Other Countries

-WHO

-NGOs

-BDB

GOVT

-NIH -WHO

-HRF -UNAID

-DOD -USAID

NGOs

-AAACP -MSF

-IAVI -WJCF

-HVTN -AMFAR

-JHU -GMHC

BD Activities

Brazil

-COOPEX

-MOH

-BDB

flow cytometry clinical applications
Flow Cytometry Clinical Applications
  • HIV immunophenotyping (CD4 absolute counts)
  • Cytokine analysis
  • Leukemia and lymphoma diagnosis - minimum residual disease detection
  • Cell cycle and DNA ploidy analysis
  • Stem Cell Analysis
  • HLA – B 27 Typing
  • Residual white blood cell detection
  • Reticulocyte enumeration
  • Flow crossmatching (organ transplantation)
what is flow cytometry
What Is Flow Cytometry?

A technology that simultaneously measures multiple characteristics of single cells at a rapid rate

lysed whole blood

1000

800

600

400

200

0

0

200

400

600

800

1000

Lysed Whole Blood

Neutrophils

Side Scatter

Monocytes

Lymphocytes

Forward Light Scatter

two color cell analysis
Two-Color Cell Analysis

104

10 3

CD8 PE

10 2

101

10 0

100

101

102

103

10 4

CD4 FITC

slide14

Fourcolor analysis

CD8 PE

SSC Height

CD45 PerCP

CD3 FITC

CD8 PE

CD4 Cy5

CD3 FITC

CD4 Cy5

india current situation hiv
India – Current Situation HIV
  • HIV prevalence rate is 0.7%
  • India has had a sharp increase in the estimated number of HIV infections, from a few thousand in the early 1990s to a working estimate of about 3.8 million children and adults living with HIV/AIDS in 2001
  • Estimates range from 8 - 15 million HIV infected adults and children living with HIV in 2010
  • Given India's large population, a mere 0.1 percent increase in the prevalence rate would increase the number of adults living with HIV/AIDS by over half a million people
india current situation hiv17
India – Current Situation HIV
  • About 90% of the total reported AIDS cases occur in the sexually active and economically productive 15 to 44 age group
  • Men account for 79% of HIV infections in India
  • The predominant mode of HIV transmission is through heterosexual contact
  • In 2001, the HIV infection rate went above one per cent in six states
    • Maharashtra, Tamil Nadu and Manipur - account for 75% of estimated HIV cases
    • the burden of AIDS cases is beginning to be felt in states affected early - Mumbai and Manipur have recorded 20 to 49 per cent bed occupancy by HIV positive people in certain hospitals
hiv aids pandemic
HIV/AIDS Pandemic

Disease Management

Vaccines, Drugs, Education

  • Antiretroviral Therapy (ART)

Controls disease progression

Increasing drug resistance patterns

Expensive (Big Pharma – western countries)

Trend to affordable (generic) drugs in developing world

  • CD4 T-Lymphocyte Count

Flow cytometry is gold standard

Alternate technologies – currently inadequate

FacsCount is considered system of choice

CD4 count is the single most important objective criteria to guide clinical decision-making on when to use ART

hiv testing paradigm
HIV Testing paradigm

Screen

Confirm*

CD4

Viral load

Est. annual tests

15-20M

4-6M

5-8M

1-2M

*(includes genotyping)

pcr viral load
PCR Viral load

It is a technique that imitates a cell’s ability to replicate DNA by generating multiple copies of specific sequences of DNA through amplification. In clinical diagnostics, a specimen of genetic material can be repeatedly copied by PCR to provide sufficient material to detect the presence or absence of a virus as well as to quantitate its levels in the blood. It’s used for:

  • The development of new drugs
  • To establish a patient’s disease status and the likelihood of disease progression
  • To determine when to start treatment
  • To help the physician decide which drugs to use in a treatment regimen
  • To assess whether a treatment regimen is working
hiv aids pandemic22
HIV/AIDS Pandemic

Situational Analysis

Unmet Needs

  • Affordable drugs/ART
  •   Affordable CD4
flow cytometry

Flow Cytometry

GOLD STANDARD FOR CD4/CD8

Monitoring in HIV/AIDS Patients

Conceptually established by BD Worldwide

facscount complete system
FACSCount - Complete System

Premeasured Reagents

facscount complete system26
FACSCount - Complete System

FACSCount Reagents and Controls

FACSCount Workstation

facscount
FACSCount

Measuring Absolute

CD4, CD8 and CD3 Counts

In Three Easy Steps

facscount clinical need
FACSCount - Clinical Need
  • Safety
  • Minimal Sample Preparation
  • Fixed Samples
  • Absolute Counts
  • Limited Handling of
  • Biohazardous Samples
facscount clinical need29
FACSCount - Clinical Need
  • Easy to use
  • Absolute Counts
  • Unit Dose Reagents
  • Minimal Hands-On Time
  • No Formal Training Required
facscounts in india
FACSCounts in India
  • 35 Placements
  • 23 Instruments through NACO
  • 12 Instruments in Private Path Laboratories
reference range of lymphocytes subsets in healthy individuals india
MALES

CD3+ 617 – 2485

CD19+ 125 – 701

CD4+ 337 – 1090

CD8+ 174 – 1240

Ratio 0.61 – 2.68

HIV Patients-Low CD4

FEMALES

CD3+ 898 – 2786

CD19+ 119 – 721

CD4+ 424 – 1050

CD8+ 255 – 1353

Ratio 0.95 – 2.40

Reference Range of Lymphocytes Subsets In Healthy Individuals (India)
facscount analysis
FACSCount - Analysis
  • A hard copy results
  • The control
  • Patient sample
hiv monitoring
HIV Monitoring

BD provides a gold standard system of reliable products and support services for CD4+ T-cell testing at affordable pricing.

  • Appropriate Technology
    • Flow Cytometry
  • Capacity Building
    • Training, Support, Service
  • Reliable Laboratory Systems
    • GMP/GLP (IVDP)/GCP
pharmas taking action
Pharmas taking action
  • Abbott Laboratories
  • Bristol-Meyers Squibb
  • GlaxoSmithKline
  • Hoffmann La-Roche Ltd
  • Boehringer Ingelheim
  • Merck & Co., Inc
  • Pfizer
  • Cipla
  • Ranbaxy
  • Matrix
slide36
General concensus is that flow cytometry based CD4 count is the most accepted technique to HIV monitoring
    • Quantitative – more cells counted, more reliable result
    • Specific – mAb, identify CD4 T-lymphocytes most precisely
    • QA/QC – internal and external - necessary for accreditation
    • Throughput – manual operation is acceptable as technician costs are not significant and does not limit test demand
  • Existing flow cytometry systems (FACSCalibur or similar) are adequate/accepted for Central Reference facilities – usually at the sites of principal government services
    • Perform broad clinical testing plus Research studies associated with international partners
  • Affordable lower cost platform required at Provincial and Local clinic sites – dedicated clinical test platform
    • Capability to perform CD4 count ( - ideal with broader test menu )
    • Current FACSCount system should be viewed as maximal technology complexity – sample preparation potential issue – reagent cost limitation
    • Challenge from Partec / Guava like technology or alternative assays
slide38

Affordable Testing for HIV/AIDS in the Developing WorldFebruary 5, 2004

On January 14, 2004, the William J. Clinton Presidential Foundation announced that BD, through BD Biosciences, had entered into an agreement with the Foundation to provide affordable CD4 testing, both reagents and instruments, to the poorest and most severely HIV/AIDS afflicted areas in the developing world.

The CD4 immunocytometry test has been used to establish decision points for antiretroviral (ARV) therapy, to monitor efficacy of various treatments, as a prognostic indicator, and as one criterion for initiating prophylaxis for opportunistic infections. The viral load test helps measure how effective ARV therapies are in suppressing the virus and can alert clinicians about the need to adjust dosages or change regimens.

bd biosciences accomplishing our mission hiv aids
BD BiosciencesAccomplishing our Mission – HIV/AIDS

BD Biosciences is Helping With the Global AIDS Crisis by:

  • Supporting the Brazilian AIDS prevention program
    • Example program for reducing mortality and new infections in the developing world
    • Our flow instruments and reagents are used as the gold standard to monitor disease progression in HIV-infected individuals
  • Collaborating with the International AIDS Vaccine Initiative (IAVI)
    • Speed the development and distribution of preventive AIDS vaccines
    • Our flow instruments and reagents are used to detect immune response to the vaccine
hiv aids
HIV/AIDS

PANDEMIC

2010

80+ million PLWHA

India (15+ million) China (15+ million)

Negative growth rates in most of Africa due to AIDS mortality

WW economic impact

2002

Brazil

Achieves 50% reduction in AIDS deaths over last 10 years

Accessible drugs and health care

$500,000 million savings on AIDS impact