The Future of HIV Diagnostics: Market Trends for CD4 and VL Testing

Decade of Diagnostics Satellite Kuala LumpurJuly 2, 2013

Evaluation: Time From Diagnosis To CD4 Staging And ART Initiation shows similar results in Uganda

Conventional lab diagnostics do not fully meet patient needs; POC diagnostics can accelerate initiation/switching and reduce LTFU

Uganda1

• Time to ART initiation: Reduced from 59 to 11 days

Mozambique3

• LTFU: 50% reduction in loss to follow-up from diagnosis to ART initiation

• ART Initiation: 85% increase in ART initiation

Lab-Based CD4 POC CD4

56%

21%

7%

11%

LTFU in Mozambique using POC CD4 vs. Lab-based tests

Before ART Ini-tiation

Before CD4 Results

Malawi2

• PMTCT LTFU: PMTCT initiation during pregnancy increased from 51 to 78%

• Time to CD4 result: Time from CD4 blood draw to result reduced from 11 to 0 days

Source: 1MOH Uganda; 2MOH Malawi; 3Jani et al (2011)

Lab-Based CD4 POC CD4

34% 23%

17% 54%

PMTCT Initiation in Malawi using POC CD4 vs. Lab-based tests

After CD4 Results

Before CD4 Results

2

POC diagnostics project aims to expand access to POC HIV testing and improve patient outcomes: Earlier ART initiation, timely 2L switching

3

CD4, EID and Viral Load

Achieve regulatory approval for new

products

Develop normative guidance on POC

Testing

Facilitate uptake of new products

Project Focus:

Through programmatic work, project will partner with Ministries of Health to:

Market Preparation,

Shaping

Commodity Donation &

Scale-up

7 focus countries in East &

Southern Africa

The project will also work with suppliers to reduce pricing and accelerate market entry

Market Shaping Goals:

1) Creating healthy market competition and avoiding monopolies

2) Creating transparent systems for selecting products

3) Putting strong product-agnostic systems in place to allow easier product adoption

4) Ensuring long term sustainable prices

5) Planning for a sustainable transition

The market shaping goals and public health goals of the project reinforce each other

4

In addition to improving access to diagnostics in the short term, this project will leave the market healthy in the long term

Public Health Goals:

1) Appropriate uptake of POC to achieve improved access to high quality diagnostics

2) Earlier ART initiation, preservation of 1st line ART,

and timely switching to 2nd line

3) Improved patient retention

4) Improved access to ART

5) Improved patient outcomes

The project is working in 7 focus countries; each has made significant progress in POC CD4 implementation

5

Malawi: Site selection and training plan finalized for 83 scale-up sites in 2013, and

connectivity rollout beginning

Kenya: Initial site selection and training plan finalized for 150 scale-up sites in 2013

Zimbabwe: Scaling up connectivity to improve supply levels, quality

assurance, and device maintenance for 276 existing sites

Ethiopia: Collaborating with CDC and other partners on site selection and training

for 100 scale-up sites in 2013

Uganda: Operational study underway to improve clinic

workflow and identify supporting interventions for

272 existing sites

Tanzania: Scale-up reached 445 sites in 2013, focusing on operational improvement

through training and mentorship

Mozambique: Phased regional approach continuing to scale up from 157 to 207

sites throughout 2013

Existing POC CD4 is best suited for certain sites, but other future products may also be appropriate for different market segments

Medium Clinics

Large Clinics

District Hospitals

Provincial Hospitals

Small Clinics

VCTs, Health Posts, etc.

5-10

10-20

20-40

>70

Site

CD

4 Te

st V

olum

e Pe

r Day

Potential Test Volume

22%

15%

20%

19%

13%

11%<5

Low cost devices or device-free tests that

can be deployed in very remote settings

Higher throughput devices

40-70

Existing POC products are most

appropriate in these settings

New 2013 WHO Guidelines introduce several key changes, and will have significant impact on the Viral Load and CD4 markets

7

Viral Load

• Strong recommendation for routine VL testing for all patients on ART, instead of only targeted use

• More patients may be identified as failing treatment and eligible for 2nd line ARVs, while others can preserve 1st line

CD4

• All HIV+ adults with CD4 counts ≤500 cells/mm3 should start ART, regardless of clinical symptoms

• More patients will be identified as eligible for ART

In the long term, both of these changes will result in more demand for VL testing

While new GLs highlight “test and treat” for selected populations, CD4 will remain important to stage millions of patients

8

34m HIV+ people worldwide

Source: WHO presentation at ASLM Viral Load meeting, Cape Town, April 2013.

~9m patients

ART-eligible based on

CD4 count

~8m patients still

not ART-eligible

We see 3 possible scenarios for the long-term CD4/VL need growth

9

• Scenario 1: Shift from CD4 to VL for ART monitoring following guidelines change

• Scenario 2: VL for monitoring, CD4 to 500 for ART initiation drives significant shift from pre-ART patients to ART

• Scenario 3: “Test and Treat”, gradual phase out of CD4 for initiation

Scenario 1: With new guidelines, VL need will increase significantly; however, countries may not move to CD4 500 threshold immediately

10

2011 2012 2013 2014 2015 2016 2017 2018 2019 20200

10000000

20000000

30000000

40000000

50000000

60000000

70000000

80000000

33692294.938891155.7

43780395.9

26552656.428329612.929818099.431027851.931959483.333542539.235915201.4

15,907,698.218,643,533.8

21,315,831.123,942,138.9

26,547,294.628,958,470.8

31,188,124.533,239,172.635,107,844.436,795,944.4

Global CD4 Need Global VL NeedTests(MM)

Assumptions:• Routine VL for ART

monitoring• No CD4 for ART

monitoring after 2013• 2 CD4 and 2 VL tests

per year

New WHO Guidelines go into effect: Routine VL for ART monitoring

Scenario 2: If countries adopt new guidelines for both VL and CD4, existing CD4 testing volumes will shift to VL more quickly

11

2011 2012 2013 2014 2015 2016 2017 2018 2019 20200

10000000

20000000

30000000

40000000

50000000

60000000

70000000

80000000

33692294.938891155.7

43780395.9

25760553.425959209.525877518.125522492.624894426.024921561.325741953.1

15,907,698.218,643,533.8

21,315,831.125,169,513.3

29,468,020.333,446,460.9

37,125,389.640,509,619.0

43,592,927.446,378,292.3

Global CD4 Need Global VL NeedTests(MM)

New WHO Guidelines go into effect: Routine VL for ART monitoring and CD4 500 for ART initiation

Assumptions:• Same as Scenario #1• In addition, CD4

threshold to 500 for ART initiation

Scenario 3: WHO ultimately recommends a universal “Test and Treat” approach, resulting in gradual phase-out of CD4 for staging

12

2011 2012 2013 2014 2015 2016 2017 2018 2019 20200

10000000

20000000

30000000

40000000

50000000

60000000

70000000

80000000

33692294.938891155.7

43780395.9

25760553.425959209.525877518.122547349.4

16105249.6

9663149.7

3221049.9

15,907,698.218,643,533.8

21,315,831.125,169,513.3

29,468,020.333,446,460.9

38,465,954.243,593,574.4

48,265,253.852,485,503.7

Global CD4 Need Global VL NeedTests(MM)

WHO: “Test and Treat”New WHO Guidelines go into effect: Routine VL for ART monitoring and CD4 500 for ART initiation

Assumptions:• Same as Scenario #2• In addition, WHO

recommends a universal “test and treat” approach in 2016

Product agnostic systems for implementation will make transitions to future POC products and test types easier

1

Product Selection

2

Procurement/ Tendering

3

Operator Training

4

QA/QC

5

Patient Flow

6

Data Management/Connectivity

7

Data Analysis

8

Mentoring/Supervision

• Objective selection criteria

• Exclusion criteria to determine eligibility

• Device rental to ease switching

• Automatic volume discounts in tenders

• Standardized sample collection

• Systems training on clinic workflow

• Sites participate in global EQA schemes

• Other methods of QA in development

• Referral between diagnosis and ART

• Immediate treatment on CD4

• Open data systems to manage devices

• Data transmitted remotely by modem

• Tracking volumes for forecasting

• Program mgmt with real time data

• Regular site level follow up

• Problem solving w/ real-time data

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Introducing any new technology requires systems changes, but the coordination required to introduce VL will be even more significant

14

Guideline& Protocol __Changes

S

Systems Strengthening

Training Health Workers

Funding – Lab and 2L ARVs

Clinician & Patient

Sensitization

POC CD4 experience can be leveraged to implement POC VL. For example:• Training and mentorship approaches• Quality assurance mechanism• Clinic workflow changes• Connectivity solutions

Conclusions

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• Early progress in POC CD4 has begun

• The 2013 WHO guidelines will have a significant impact on the CD4 and VL markets

• CD4 staging will remain instrumental in reaching the “15 by 15” target and beyond

• Routine VL will increasingly be used for ART monitoring instead of CD4, but the shift will be gradual

• POC VL implementation will build on the foundation of POC CD4, but there will be many additional challenges