Post on 23-Feb-2016
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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
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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
CD4
Test
Vol
ume
Per D
ay
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
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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
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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
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• 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
26,547,294.628,958,470.831,188,124.533,239,172.635,107,844.436,795,944.4
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
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Data Analysis
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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
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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