Accelerating access to innovative point of care HIV diagnostics Decade of Diagnostics Satellite Session Washington, DC July 22, 2012

2 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 3 1 HIV Diagnosis 2 Enrollment in HIV care 3 Blood draw 4 Test performed Continuum of Care 5 Result received 6 Clinical consultation 7 7 ART initiation 8 8 Monitoring Existing systems contribute to: 1.Late ART initiation among adults 2.Late ART initiation among infants due to limited access to HIV diagnosis 3.Late identification of first-line treatment failure due to limited access to viral load testing nd line (when necessary High Loss Few Services

Estimates of wastage with conventional diagnostics are significant Based on weighted average of data from 3 countries 1, 46% of CD4 test results were NOT received by the patient 2 (n=12 million tests in 2010) Sources: 1 Mozambique: LTFU estimated based on Jani et al (2011); Malawi; MOH Malawi; South Africa: Larson et al (2011); 2 Global volumes based on CHAI data; 2 CHAI 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; 3 A 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 patient 3 Wastage associated with CD4 and EID tops $60+ million per year and almost 6 million tests where patients do not receive the result 3

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 5 Uganda 1 Time to ART initiation: Reduced from 59 to 11 days Mozambique 3 LTFU: 50% increase in retention from diagnosis to ART initiation ART Initiation: 85% increase in ART initiation Malawi 2 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: 1 MOH Uganda; 2 MOH Malawi; 3 Jani et al (2010)

And there is a lot of unmet need and underserved patients in the market (CD4) 6 Unmet Need Conventional POC At estimated current volumes, POC CD4 represents less than 10% of volumes and more than 60% of need is unmet

Agenda Introduction Goals and activities of the project Expected impact Alignment with other initiatives 7

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 8 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 9

Funding needs for HIV is expected to grow significantly Many countries already adopting emerging products in treatment protocols Phase 1 will occur before a product becomes available and Phase 2 once it reaches the market 10 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 months6-12 Months On-going scale-upFirst phase implementation Procurement planning To 1 st Supply Registration & Evaluation 3-5 Years Rollout of new products in general, and new diagnostics in particular, is slow 2 months2 Months3 Months Example: Uganda (POC CD4) 11 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 significantly Many countries already adopting emerging products in treatment protocols Phase 1 will occur before a product becomes available and Phase 2 once it reaches the market 12 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/s upervision 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 13

14 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 planning and programming processes Evidence determining quality and impact of 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 16 1 HIV Diagnosis 2 Enrollment in HIV care 3 Blood draw 4 Test performed Continuum of Care 5 Result received 6 Clinical consultation 7 7 ART initiation 8 8 Monitoring Point of care will expand access to actionable results, reduce loss and improve patient outcomes nd line (when necessary POC CD4/ EID POC VL POC CD4/ EID Same day testing to CD4 result Same 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 17 Expected outcomes

18 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, 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 20

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

Monitoring ‘Lazarus’ was easy…

This is more tricky...

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

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

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

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

Operational Research Framework 1. Policy and Research landscape review 2. Descriptive cohort and Cross-sectional studies Cohort/cascade outcomes, Prevalence of failure and 2 nd line Prevalence of VL ranges in treated patients including threshholds Prevalence of genotypic resistance 3. Impact and costs of VL v CD4 monitoring strategies 4. Validation and costing of tools and approaches Improved lab-based options PoC tools Mhealth tools Adherence support 5. Comparison of different algorithms using validated tools 6. M&E

Comparison of multiple strategies

In conclusion… Partnership of implementers, researchers and modellers, and policy makers Define tools, strategies, and policies Reduce costs Guarantee the funding

Thanks!