Dr. Natella Rakhmanina Senior Technical Advisor, Elizabeth Glaser Pediatric AIDS Foundation October 2018

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1 Dr. Natella Rakhmanina Senior Technical Advisor, Elizabeth Glaser Pediatric AIDS Foundation October

2 Number of young people living with HIV (aged years) by mode of HIV acquisition, 25 countries,* Number Sexual and unsafe injection transmission Mother-to-child transmission ** The 25 countries included in the analysis are Botswana, Brazil, Cameroon, Côte d Ivoire, Democratic Republic of the Congo, Ethiopia, Haiti, India, Indonesia, Iran (Islamic Republic of), Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Eswatini, Thailand, Uganda, Ukraine, United Republic of Tanzania, Zambia and Zimbabwe. Source: UNAIDS special analysis, 2016; for more details, see annex on methodology. 2

3 Increase in people receiving ART over time Source: UNAIDS/WHO estimates 3

4 HIV testing and care continuum (2017) Source: UNAIDS/WHO estimates 4

5 Pretreatment Drug Resistance WHO Resistance Report, 2017 WHO Resistance Report,

6 Pretreatment Drug Resistance WHO Resistance Report,

7 Why does it Matter? 1982 records; 18 studies with efficacy data; five studies on regimens in children failing first-line ART, four in children with multidrug resistance, and nine in children with variable treatment experience. Only 10/18 studies reported week 48 or month 12 outcomes. On the second or third line ART, the average proportion of children with virologic suppression at week 48 was 61.8% (range %, 10 studies). 71.0% (range %, three studies) of children failing first-line NNRTIbased ART were suppressed at week % (range %,seven studies) of children with variable levels of treatment experience were virologically suppressed at week 48 Lazarus E,et al. HIV Reports,

8 Regimen Sequencing, WHO Guidelines,

9 Regimen Sequencing, WHO Guidelines,

10 Our Vision A world in which young people living with HIV lead full and healthy lives, achieve their aspirations and reach their potential. Our Mission Through our collective effort, we will advance a holistic, integrated approach to high quality and sustainable pediatric HIV care and treatment with a specific focus on those in need of 3 rd -line medicines. 10

11 Our Goals Contribute to UNAIDS target Ensure that global HIV response addresses the critical unmet needs of children & adolescents Promote treatment equity between adults & children Link 5,000 pediatric patients to 2 nd - and 3 rd -line care & access to J&J treatment by

12 Meeting the Needs of Young People Living with HIV Partners and Collaborators Objectives Donation Program: In collaboration with country MoHs Health System Strengthening: Improving care & treatment through public health approach Focus Areas Drug Access Capacity Building Drug Delivery Donation Operations & Formulations Enabling Platforms & Outputs Healthcare Worker Capacity Tools, Training, Technical Assistance Operational Research, Cohort Analysis, Publications & Info Sharing HIV+ Youth/Patient Engagement 12

13 PARTNER ROLES Interventions Along the Clinical Pathway Diagnosis confirmed via VL monitoring, CD4 monitoring, or clinical observation Resistance test VL >1000 Children failing 2 nd - line treatment Adherence counseling VL <1000 Repeat VL Country partners Capacity building, data collection, moderating applications No treatment resistance Treatment resistance Supply chain support Switch to 3 rd - line treatment Repeat VL Global pediatric HIV research priorities VL >1000 VL <1000 Capacity building for data systems Continue treatment 90% virologic suppression Training for health care providers 13

14 Donation Program: Products, Eligibility & Timeline Donated products Darunavir (DRV) and Etravirine (ETR) in pediatric and adult formulations Donated product for use in children and adolescents up to 19 years of age Countries accepting DRV must provide ritonavir for pharmacokinetic boosting of DRV MOH or designees in sub-saharan Africa and/or least developed countries can apply Enrollment of patients allowed until 2020 Donation provided to participating countries until

15 New Horizons Collaborative Timeline 2014: New Horizons Collaborative launched eswatini, Kenya, South Africa, Zambia join 2015: Lesotho joins 2016: Uganda joins 2017: EOI Changed, Pilot Data Collected and Published 2018: Cameroon, Ethiopia, Nigeria, Rwanda, and Zimbabwe join 15

16 New Horizons Resources Available: Pediatric HIV online training module (PaedsHIVLearning.com) Resistance training workshops PENTA training workshops Data harmonization and capacity building Second- and third-line dosing cards Management of treatment failure algorithm: Disclosure toolkit Upcoming: Transition and adherence tools 16

17 New Horizons Website & Workshops 17

18 Working Groups and Conferences AIDS 2017 WHO and IATT technical working groups New Horizons Workshop 2017 New Horizons Technical Workshops AIDS 2018 CROI, AIDS, Pediatric & Adolescent HIV Workshops 18

19 Thank you! 19

20 Panel Discussion: stakeholders in adolescent advanced treatment outcomes eswatini Tema Mkhonta & Menzi Ginindza Kenya Job Akuno & Leon Nyangwara 20

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