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The Future of HIV Diagnostics:
Market Trends for CD4 and VL Testing
Decade of Diagnostics Satellite
Kuala Lumpur
July 2, 2013
Evaluation:
Timelab
From
Diagnosis
CD4
Staging
ARTneeds;
Initiation
Conventional
diagnostics
doTonot
fully
meetAnd
patient
POC
shows
similarcan
results
in Uganda
diagnostics
accelerate
initiation/switching and reduce LTFU
Uganda1
• Time to ART initiation:
Reduced from 59 to 11
days
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
Mozambique3
• LTFU: 50% reduction in loss to follow-up
from diagnosis to ART initiation
• ART Initiation: 85% increase in ART
initiation
Source: 1MOH Uganda; 2MOH Malawi; 3Jani et al (2011)
PMTCT Initiation in Malawi using
POC CD4 vs. Lab-based tests
17%
54%
34%
23%
Lab-Based CD4
POC CD4
After CD4
Results
Before CD4
Results
LTFU in Mozambique using POC CD4
vs. Lab-based tests
7%
57%
11%
21%
Lab-Based CD4
POC CD4
Before ART
Initiation
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
Project Focus:
CD4, EID and
Viral Load
Market
Preparation,
Shaping
Commodity
Donation &
Scale-up
7 focus countries
in East &
Southern Africa
Through programmatic work, project will partner with Ministries of Health to:
Achieve regulatory
approval for new
products
Develop normative
guidance on POC
Testing
Facilitate uptake
of new products
The project will also work with suppliers to reduce pricing and accelerate
market entry
3
The market shaping goals and public health goals of the project
reinforce each other
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
Market Shaping Goals:
1) Creating healthy market competition
and avoiding monopolies
2) Creating transparent systems for
selecting products
1) Improved patient retention
3) Putting strong product-agnostic
systems in place to allow easier
product adoption
2) Improved access to ART
4) Ensuring long term sustainable prices
3) Improved patient outcomes
5) Planning for a sustainable transition
In addition to improving access to diagnostics in the short term, this project will
leave the market healthy in the long term
4
The project is working in 7 focus countries; each has made significant
progress in POC CD4 implementation
Uganda: Operational study
underway to improve clinic
workflow and identify
supporting interventions for
272 existing sites
Malawi: Site selection and
training plan finalized for 83
scale-up sites in 2013, and
connectivity rollout beginning
Ethiopia: Collaborating with
CDC and other partners on
site selection and training
for 100 scale-up sites in 2013
Kenya: Initial site
selection and training
plan finalized for 150
scale-up sites in 2013
Tanzania: Scale-up reached 445
sites in 2013, focusing on
operational improvement
through training and mentorship
Zimbabwe: Scaling up connectivity
to improve supply levels, quality
assurance, and device maintenance
for 276 existing sites
Mozambique: Phased
regional approach continuing
to scale up from 157 to 207
sites throughout 2013
5
Existing POC CD4 is best suited for certain sites, but other future
products may also be appropriate for different market segments
Site CD4 Test Volume Per Day
Potential Test
Volume
>70
Provincial Hospitals
22%
40-70
District Hospitals
15%
20-40
Large Clinics
20%
10-20
Medium Clinics
19%
5-10
Small Clinics
13%
<5
VCTs, Health Posts, etc.
11%
Higher throughput
devices
Existing POC
products are most
appropriate in
these settings
Low cost devices or
device-free tests that
can be deployed in
very remote settings
New 2013 WHO Guidelines introduce several key changes, and will have
significant impact on the Viral Load and CD4 markets
Viral Load
CD4
• Strong recommendation for
routine VL testing for all
patients on ART, instead of
only targeted use
• All HIV+ adults with CD4
counts ≤500 cells/mm3
should start ART, regardless
of clinical symptoms
• More patients may be
identified as failing treatment
and eligible for 2nd line ARVs,
while others can preserve 1st
line
• 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
7
While new GLs highlight “test and treat” for selected populations, CD4
will remain important to stage millions of patients
34m HIV+ people worldwide
~8m
patients still
not ARTeligible
~9m
patients
ART-eligible
based on
CD4 count
Source: WHO presentation at ASLM Viral Load meeting, Cape Town, April 2013.
8
We see 3 possible scenarios for the long-term CD4/VL need growth
• 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
9
Scenario 1: With new guidelines, VL need will increase significantly;
however, countries may not move to CD4 500 threshold immediately
Tests
(MM)
Global CD4 Need
Global VL Need
80
70
60
50
40
43.8
38.9
33.7
30
20
Assumptions:
• Routine VL for ART
monitoring
• No CD4 for ART
monitoring after 2013
• 2 CD4 and 2 VL tests
per year
26.6
15.9
18.6
21.3
23.9
28.3 26.5
29.8 29.0
31.0 31.2
32.0 33.2
2015
2016
2017
2018
33.5 35.1
35.9 36.8
2019
2020
10
0
2011
2012
2013
2014
New WHO Guidelines go into effect:
Routine VL for ART monitoring
10
Scenario 2: If countries adopt new guidelines for both VL and CD4,
existing CD4 testing volumes will shift to VL more quickly
Tests
(MM)
Global CD4 Need
Global VL Need
80
70
Assumptions:
• Same as Scenario #1
• In addition, CD4
threshold to 500 for ART
initiation
60
50
40
43.8
38.9
33.7
30
20
25.8 25.2
15.9
18.6
26.0
29.5
25.9
40.5
37.1
33.4
25.5
21.3
24.9
46.4
43.6
24.9
25.7
10
0
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
New WHO Guidelines go into effect:
Routine VL for ART monitoring and CD4 500 for ART initiation 11
Scenario 3: WHO ultimately recommends a universal “Test and Treat”
approach, resulting in gradual phase-out of CD4 for staging
Tests
(MM)
Global CD4 Need
Global VL Need
80
70
Assumptions:
• Same as Scenario #2
• In addition, WHO
recommends a universal
“test and treat”
approach in 2016
60
52.5
48.3
50
40
43.8
43.6
38.9
38.5
33.7
33.4
30
20
25.8 25.2
15.9
18.6
26.0
29.5
25.9
21.3
22.5
16.1
9.7
10
3.2
0
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
WHO: “Test and Treat”
New WHO Guidelines go into effect:
Routine VL for ART monitoring and CD4 500 for ART initiation 12
Product agnostic systems for implementation will make transitions to
future POC products and test types easier
Product
Selection
Procurement/
Tendering
Operator
Training
1
2
3
• Objective selection
criteria
• Exclusion criteria to
determine eligibility
Patient
Flow
5
• Referral between
diagnosis and ART
• Immediate
treatment on CD4
• Device rental to ease
switching
• Automatic volume
discounts in tenders
Data Management/
Connectivity
6
• Open data systems to
manage devices
• Data transmitted
remotely by modem
• Standardized
sample collection
• Systems training on
clinic workflow
QA/QC
4
• Sites participate in
global EQA schemes
• Other methods of
QA in development
Data
Analysis
Mentoring/
Supervision
7
8
• Tracking volumes
for forecasting
• Program mgmt with
real time data
• Regular site level
follow up
• Problem solving w/
real-time data
13
Introducing any new technology requires systems changes, but the
coordination required to introduce VL will be even more significant
Funding – Lab
and 2L ARVs
Guideline
& Protocol
Clinician__Changes
& Patient
Sensitization
Training
Health
Workers
S
Systems
Strengthening
POC CD4 experience can be leveraged to implement POC VL. For example:
• Training and mentorship approaches
• Quality assurance mechanism
• Clinic workflow changes
• Connectivity solutions
14
Conclusions
• 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
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