Prioritizing Advanced HIV Disease and Overcoming Barriers to Access Carolyn Amole Senior Director, HIV Access Program, CHAI Satellite: Saving Lives Today: Accelerating Access to Diagnostics and Drugs for Advanced HIV Disease

There is an ineffective global response to advanced HIV disease (AHD), and an urgent need to accelerate access to critical, life-saving products for diagnosis, prevention, and treatment of AHD Reduction in HIV-related mortality has stagnated globally, in spite of increased ART coverage and a reduction in the number of new infections. Number of AHD related deaths globally (1990-2018) Number of AHD related deaths In 2016, UN member states agreed to the target of cutting deaths from AIDS to less than 500,000 per year. In 2018, there were 770,000 AIDS-related deaths. With six months until 2020 we are far from achieving the target. 1

10% will die within 3 months Advanced HIV disease remains a persistent challenge globally for both newly initiating patients and increasingly for ART experienced patients as well People living with HIV presenting to care 1 in 3 people living with HIV present to care with advanced disease 10% will die within 3 months An increasing proportion of those presenting with AHD are ART experienced 2 Source: WHO Management of Advanced Disease Guidelines, 2017.

Coordinate the market for AHD commodities The Unitaid Advanced HIV Disease Initiative, implemented by CHAI, aims to reduce morbidity and mortality and improve cost efficiencies by accelerating access to affordable, optimal products for preventing, testing and treating key opportunistic infections Project Countries Malawi, Nigeria, South Africa, Tanzania, Uganda and some support in Botswana and Lesotho Reduce the price of priority health products through supply-side market interventions Coordinate the market for AHD commodities Unitaid-CHAI Advanced HIV Disease Initiative Accelerate product introduction and build demand for AHD commodities through catalytic procurement and adoption and rollout support Jan. 2019 – Dec. 2020 Priority Health Products CD4 TB urine-LAM CrAg LFA rapid test Diagnostic TB prevention therapy Amphotericin B (classic and liposomal) Flucytosine Fluconazole Therapeutics 3

A number of key barriers are limiting access on both demand and supply sides of the market to these critical AHD commodities (CD4, TB LAM, CrAg LFA, TPT, AmB and L-AmB, 5FC, Fluc) Demand Barriers Supply Barriers CD4 deprioritized in favor of funding VL scale-up limits AHD case-finding Gaps in national guidelines lead to uncoordinated implementation of the AHD package of care Lack of registration of LAmB and 5FC Poor implementation of elements of the AHD package of care, including inadequate training and facility readiness Poor community engagement and lack of AHD awareness Poor visibility around the size of the CM treatment market Lack of economies of scale due to small, fragmented, and unpredictable demand High prices and long lead times for critical commodities Lack of prioritization of AHD commodities in donor procurement plans Limited supplier base for AHD diagnostic and treatment products 4

Key insights from across focal countries are shaping our strategy to accelerate market access and enable successful implementation CD4 is the critical gateway for AHD diagnosis and treatment, but there is limited use of CD4 for AHD screening at baseline and in cases of treatment failure Key insights from in-country AHD engagement Utilization of sustainable procurement mechanisms, such as the Global Fund’s Wambo platform, will assist in transition of procurement and support greater long-term sustainability for countries Scale-up of the AHD package of care requires a coordinated capacity-based approach that leverages existing capability and expertise in country Implementation support from partners for training and capacity building will be required to enable successful national scale-up 5

Facility Level Support CHAI and partners are working with governments across the product introduction pathway to facilitate rapid introduction of critical AHD commodities in countries Building the investment case for AHD, and updating national AHD treatment guidelines based on WHO package of care Community engagement and sensitization on AHD, and development of patient literacy materials on AHD Coordination of partners to ensure a capacity-focused AHD package of care Adoption Product Registration Procurement Community Engagement Transition Planning Facility Level Support Monitoring Uptake Support product registration of AHD commodities Support catalytic procurement in countries and work with suppliers to ensure sustainable supply at affordable pricing MoH-led AHD implementation plans; develop AHD materials trainings and job aides Include AHD commodities in all stock and patient monitoring and reporting tools 6

As countries scale up the AHD package of care, it is essential to ensure that strong training and tools are in place to facilitate proper use and drive countries towards the ultimate goal of reducing morbidity and mortality Coming Soon: The AHD Toolkit A consortium of partners are working to bring together a consolidated set of AHD materials that are openly accessible for countries to adopt and contextualize for their national AHD programs. Toolkit Highlights HCW training package to diagnose and treat AHD both in hospital and  ambulatory care Clinical workshops Patient flow manuals Adherence counselling tools Facility posters AHD Toolkit Text Programmatic Tools Job aids SOPs Training materials Community sensitization With contributions from: 7

-CAB meeting participant CHAI and Unitaid partnered with AfroCAB to launch a new community initiative for AHD, kicking off with a Community Advisory Board meeting held in South Africa in March Community Advisory Board (CAB) Over 40 participants from 12 countries discussed civil society's role in building demand around HIV treatment, diagnostics, and AHD. CAB meeting in Pretoria, South Africa “The information and knowledge gained in these CAB meetings has been invaluable. The knowledge acquired has enabled the CAB members to be effective in their work and bring this knowledge back to others. It felt like we were the experts.”   -CAB meeting participant 8

“If you want to go fast, go alone. If you want to go far, go together “If you want to go fast, go alone. If you want to go far, go together.” Partnership on AHD will be essential to ensuring that we go far – and fast – in achieving our goals of reducing AIDS-related deaths. Unitaid and CHAI have established an AHD Implementation Steering Committee to ensure effective coordination of efforts among implementers and funders. Chaired by WHO, the role of the AHD Implementation Steering Committee is to: Track progress on AHD activities and provide strategic input to ensure activities best meet the needs of PLHIV Enable collaboration where there are synergies between organizations Share evidence, experience, and learnings Work in collaboration to advocate for increased focus on addressing mortality at both global and country levels Committee members include: This initiative is calling on all partners – including governments, donors, suppliers, implementing partners & the HIV community – to join together to fight advanced HIV disease 9

Thank you! CHAI’s work in Advanced HIV Disease is made possible by the generous support and partnership of Unitaid Thanks to the CHAI team – James Conroy, Richard Borain, Ikechukwu Amamilo, Katie Lamp, and Tara Schoenborn for contributing to this presentation, and a big thanks to Benvy Caldwell for leading the planning for this satellite session. 10