The UNITAID-funded MSF diagnostics project: Plans to incorporate the new WHO recommendations and how best practices will be shared with, and disseminated by, WHO Teri Roberts Diagnostics Advisor Médecins Sans Frontières, Access Campaign 7th International AIDS Conference 2 July 2013

MONITORING ‘LAZARUS’ WAS EASY….. …MONITORING 'UNDETECTABLE’ IS MORE CHALLENGING

Virological monitoring detects treatment failure earlier than clinico-immunological monitoring

Viremic patients can re-suppress following an adherence intervention Bonner K et al. J Acquir Immune Defic Syndr Jun 14

The importance of preserving first line, affordable, robust, one-pill-a-day regimens Ref: Untangling the Web of ARV Price Reductions 16 th Edition, July 2013

Implementation is done in support of, and in collaboration with, the Ministries of Health and reference laboratories

The UNITAID-funded MSF diagnostics project Goal: Improved clinical outcomes for PLWHA in resource-constrained settings through models of care for optimal use of PoC CD4, laboratory-based and PoC viral load and EID testing 3 year project – $28.7 million Eight sites in seven countries – Lesotho, Malawi (2), Mozambique, South Africa, Swaziland, Uganda and Zimbabwe. MSF field missions will compare the feasibility, outcomes and cost-effectiveness of point-of-care testing versus district- or regional-level laboratory-based testing for CD4 and viral load & EID through comparative operational research MSF Access Campaign will perform market intelligence work and ensure price transparency along the value chain Evidence-based findings will be disseminated and used to influence policy Expected results on market: helping the market launch of products, increasing competition, decreasing pricing, breaking monopolies

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 thresholds Prevalence of genotypic resistance 3. Impact and costs of VL vs CD4 monitoring strategies 4. Validation and costing of tools and approaches Improved lab-based options PoC tools M-health tools Adherence support 5. Comparison of different algorithms using validated tools 6. M&E

Plans to incorporate the new WHO recommendations MSF is pleased with, and intends to provide support to implement, the new WHO guidelines by: 1.Demonstrating HOW to implement the guidelines 2.Demonstrating the ADDED VALUE of the new guidelines 3.Supporting QUALITY (scale-up without mess-up) 4.Working with partners to SUPPORT implementation (e.g. so that Ministries of Health can make informed decisions) and with WHO wherever possible

How best practices will be shared with, and disseminated by, WHO Evidence-based results provided to the WHO wrt POC CD4 testing will include: 1.Use of point-of-care CD4 to plug the leaky cascade between test and treat Evidence-based results provided to the WHO wrt routine viral load monitoring will include: 1.Feasibility of real-world implementation of tools and best tools for RLS (including the use of dried blood spots and m-health) 2.Possibilities for decentralisation and task shifting 3.Benefits of routine VL testing plus adherence support vs targeted VL testing and clinico-immunological testing 4.Dropping CD4 monitoring of treated patients who are virologically suppressed 5.In what situations or contexts point-of-care testing makes sense 6.Best algorithm and threshold for diagnosing treatment failure 7.Modelling data that is built on credible, real-world data (so that long-term outcomes can be modelled) 8.Psychological benefits to patients (e.g. motivation, empowerment) 9.Costing: cost-effectiveness of different strategies as well as cost-saving methods e.g. sample pooling 10.Transparent and comprehensive in-country pricing and market intelligence data

THANK YOU MSF gratefully acknowledges: UNITAID as co-funders The Ministries of Health and Laboratories with which we work