Accelerating access to innovative point of care HIV diagnosticsDecade of Diagnostics Satellite SessionWashington, DCJuly 22, 2012

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Agenda

Introduction

Goals and activities of the project

Expected impact

Alignment with other initiatives

Current diagnostic tools are unable to fully meet the need of the continuum of care

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1

HIV Diagnosis

2

Enrollment in HIV care

3

Blood draw

4

Test performed

Continuum of Care

5

Result received

6

Clinical consultation

7

ART initiation

8

Monitoring

Existing systems contribute to: 1. Late ART initiation among adults2. Late ART initiation among infants due to limited access to HIV diagnosis3. Late identification of first-line treatment failure due to limited access to viral load

testing

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2nd line (when necessary

High Loss

High Loss

High Loss

Few Services

Estimates of wastage with conventional diagnostics are significant

Based on weighted average of data from 3 countries1, 46% of CD4 test results were NOT

received by the patient2

(n=12 million tests in 2010)

45.736%

54.264%

Results not receivedResults received

Sources: 1Mozambique: LTFU estimated based on Jani et al (2011); Malawi; MOH Malawi; South Africa: Larson et al (2011); 2Global volumes based on CHAI data;2CHAI data; Assuming ~1,400 tests demanded per year at average health center across 9 African countries; CD4: 5.5 million results not received/$58 million wasted; EID: half estimated 300k tests results not received/$7.5m wasted; 3A Multi-Country Review of HIV Early Infant Diagnosis Service Delivery 2009

Based on an average of 3 countries from a 2009 UNICEF review of EID service delivery,

50% of positive EID test results are NOT received by the patient3

Wastage associated with CD4 and EID tops $60+ million per year and almost 6 million tests where patients do not receive the result3

50%50%Results not receivedResults received

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

POC CD4 increases the number of people initiating ART by cutting LTFU and reducing time to initiation

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Uganda1

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

Mozambique3

• LTFU: 50% increase in retention 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 increase 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 (2010)

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

And there is a lot of unmet need and underserved patients in the market (CD4)

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Unmet NeedConventionalPOC

At estimated current volumes, POC CD4 represents less than 10% of volumes and more than 60% of need is unmet

Tanzania0%

50%

100%

Kenya0%

50%

100%

Mozamb...0%

50%

100%

Zimbabwe0%

50%

100%Malawi

0%

50%

100%

Ethiopia0%

50%

100%

Uganda0%

50%

100%

Total Market0%

25%

50%

75%

100%

Agenda

Introduction

Goals and activities of the project

Expected impact

Alignment with other initiatives

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• Creating and sustaining a healthy competitive market for POC diagnostics where– The most patients have access to diagnostics– There continues to be innovation for increased value– New products can easily enter the market

• Signaling commitment to the POC market through uptake• Growing the demand side of the market

• Accelerating normative guidance on the use of HIV POC diagnostics

• Supporting the entry and uptake of new, quality products

• Achieving substantial public health impact

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CHAI, UNICEF, and UNITAID are together committed to:

Market Preparation

(POC CD4, EID and VL)Catalytic

Implementation(POC CD4 and EID)

Commodity Donation

(POC CD4 and EID)Phase 1

Phase 2a

Phase 2b

In order to achieve the overarching goals, the project will roll out in two phases

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Funding needs for HIV is expected to grow significantlyFunding needs for HIV is expected to grow significantlyMany countries already adopting emerging products in treatment protocolsPhase 1 will occur before a product becomes available and Phase 2 once it reaches the market

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Phase 1: Market Preparation• Engage with suppliers to

accelerate market entry and negotiate pricing

• Support regulatory approvals and policy adoption by facilitating evaluations

• Conduct operational research to support normative guidance on the impact, cost-effectiveness, and appropriate use of POC

• Support national planning processes for POC

Example: Regulatory and policy barriers to market entry

6-18 months 6-12 Months 6-12 Months

On-going scale-upFirst phase implementation

ProcurementplanningTo 1st Supply

Registration& Evaluation

3-5 Years

Rollout of new products in general, and new diagnostics in particular, is slow

2 months 2 Months 3 Months

Example: Uganda (POC CD4)

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The project will facilitate each step in this process to support regulatory approvals

Began writing protocol – Sept 2010

Protocol approved – Nov 2010

Pilot began – January 2011

Product and scale-up approved – April 2011

Illustrative

Funding needs for HIV is expected to grow significantlyFunding needs for HIV is expected to grow significantlyMany countries already adopting emerging products in treatment protocolsPhase 1 will occur before a product becomes available and Phase 2 once it reaches the market

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Phase 1: Market Preparation• Engage with suppliers to

accelerate market entry and negotiate pricing

• Support regulatory approvals and policy adoption by facilitating evaluations

• Conduct operational research to support normative guidance on the impact, cost-effectiveness, and appropriate use of POC

• Support national planning processes for POC

Phase 2a: Commodity Donation • Donation (half of estimated need) and

consolidation of demand through a single procurement system

• Leveraging volumes to negotiate ceiling prices

Phase 2b: Catalytic Implementation• Product agnostic implementation

systems, planning and support for uptake (training, etc)

• Coordination and collaboration with other initiatives

• Responsibly transition procurement and operations support for lasting impact

Example: Product agnostic implementation

1

Product Selection

2

Procurement/ Tendering

3

Operator Training

4

QA/QC

5

Patient Flow

6

Data management

7

Data Analysis

8

Mentoring/supervision

In order for POC testing to be effective, new systems for implementation must be created. These can be product agnostic.

• Objective selection criteria

• Exclusion criteria to determine eligibility

• Volume discounts and leasing

• Service and maintenance

• Standardized sample collection

• Systems training on clinic workflow

• Participation in global EQA schemes

• Daily internal controls

• Timing of ART and OI treatment

• Patient movement through services

• 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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Agenda

Introduction

Goals and activities of the project

Expected impact

Alignment with other initiatives

Components necessary for smooth, rapid uptake of new diagnostics

Uptake

Normative

Evidence

CostRegulatory

OperationsPolicy

Speedy, transparent pathways for quality

diagnostics

Strong, swift normative

support for high quality, impactful

products

National policy approval and

inclusion in planningand programming

processes

Evidence determining

quality and impactof new

diagnostics

Cost-effectiveness and cost-impact data

to guide investment In new testing

systems

Guidance on appropriate use

alongside existing diagnostics

infrastructure

POC will upend current limitations on HIV care and treatment

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1

HIV Diagnosis

2

Enrollment in HIV care

3

Blood draw

4

Test performed

Continuum of Care

5

Result received

6

Clinical consultation

7

ART initiation

8

Monitoring

Point of care will expand access to actionable results, reduce loss and improve patient outcomes.

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2nd line (when necessary

POC CD4/EID

POC VL

POC CD4/EID

POC CD4/EID

Same day testing to CD4 resultSame day EID to ART initiation

• Healthy, competitive market with multiple competing products in each product class (CD4, EID, VL)

• Improved patient outcomes from earlier ART/2L initiation and decreased LTFU

• Regulatory and policy approvals for a range of products in focus countries • Research to support appropriate deployment and implementation systems• Improved market intelligence and encouragement for new suppliers to

invest in POC according to approved norms• Coordinated response among governments and partners for sustainable

gains

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Expected outcomes

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Agenda

Introduction

Goals and activities of the project

Expected impact

Alignment with other initiatives

Limited access to HIV diagnostics has been highlighted as a priority in the Treatment 2.0 Framework

Five priority work areas have been highlighted in the Treatment 2.0 framework

The Treatment 2.0 Framework for Action: Catalysing the Next Phase of Treatment, Care and Support, http://data.unaids.org/pub/Outlook/2010/20100713_outlook_treatment2_0_en.pdf

Priority work area 2: Provide Access to Point-of-Care and Other Simplified Diagnostics and Monitoring Tools

MSF UNITAID Project alignment

MSF aims to show if and how simplified testing can work in remote and resource-limited settings and to provide an evidence base for the range of products, or combination of products, to use in which contexts (e.g. lab vs clinic, urban vs rural)

Synergy:• Evidence on the efficiency and use of diagnostics – alignment on OR

questions• Access to CHAI/UNICEF procurement agreements • Sharing work on implementation systems• Using evidence to determine appropriate deployment and integration

with existing diagnostics

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Implementation of CD4 and Viral Load Testing in decentralised remote and resource-limited settings in

MSF-supported HIV programmes:Operational Research Priorities

Dr Tom Ellman,SAMU

MSF South Africa

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Monitoring ‘Lazarus’ was easy…

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This is more tricky...

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Across programmes: 2% of treated patients are on 2nd-line ARTIn South Africa (Khayelitsha), where routine virological monitoring is available: 12% on 2nd-line after 5 years

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The patient, their bodily fluids, the health worker, the tests and test results

Patient Sample Test

Result in LabResult with

Health worker

Result with Patient

Something Useful Happens...

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Rise of the PoC

Reduce risk of not testing, of death or of loss to follow-up

• HIV testing• CD4 screening pre-ART• Early Infant Diagnosis• Tuberculosis

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Rise of the PoC

Reduce risk of not testing, of death or of loss to follow-up

• HIV testing• CD4 screening pre-ART• Early Infant Diagnosis• Tuberculosis

Reduce risk of not testing, not receiving result, not acting on result

• 3 or 6 month Viral load• Routine viral load• Before TDF switch• At delivery

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Operational Research Framework1. Policy and Research landscape review2. Descriptive cohort and Cross-sectional studies

• Cohort/cascade outcomes,• Prevalence of failure and 2nd line• Prevalence of VL ranges in treated patients including

threshholds• Prevalence of genotypic resistance

3. Impact and costs of VL v CD4 monitoring strategies4. Validation and costing of tools and approaches

• Improved lab-based options• PoC tools• Mhealth tools• Adherence support

5. Comparison of different algorithms using validated tools6. M&E

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Comparison of multiple strategies

Overview of outputs

Lesotho Malawi T Mozambique S. Africa Zimbabwe Swaziland Malawi C UgandaPoint of care CD4 PI MA ✓ ✓ ✓ ✓ ✓

Partec miniPOC ✓Daktari ✓Zyomyx ✓ ✓

Lab-based viral load bioMerieux (DBS) ✓ ✓ ✓Biocentric ✓Roche (DBS) ✓pooled testing ✓ ✓ ✓ ✓

Simplified viral load GeneXpert ✓ ✓SAMBA ✓ ✓Alere ✓ ✓ ✓Liat ✓

EID SAMBA/Biocentric ✓ ✓ ✓Viral load alone ✓ ✓ ✓Viral load + CD4 ✓ ✓ ✓ ✓mHealth for reporting ✓ ✓ ✓

head-to-head comparison

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In conclusion…

• Partnership of implementers, researchers and modellers, and policy makers

• Define tools, strategies , and policies

• Reduce costs• Guarantee the funding

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Thanks!