EGPAF experience in scaling up pediatric HIV testing and treatment Francesca Celletti

Our Contribution to Pediatric ART Coverage ) 1 in 6 children on ART in the countries where we have C&T programs were provided treatment by EGPAF

Number of children newly initiated on ART Number of children newly initiated on ART has doubled in the last three years. *Cameroon and Ariel are excluded from this figure

Differentiated models for testing, care and treatment Differentiation by clinical and VL suppression Differentiation by demographics (age) 0-5 POC and PITC Higher rates of failure and death More intensive care (e.g. frequent VL monitoring) 5-12 PITC, community Relatively lower failure rates May consider care simplification/decentralization 12-18 Adolescent friendly HIV testing Increased failure – social change, non-adherence Focus on social adjuncts to care Entry into care Care package stable patients Care package: Clinically unstable patients On ART Care package suppressed Care package detectable

Source: HIV/AIDS Diagnostics Technology Landscape, UNITAID, 2015 POC NAT pipeline ZIVA™ Cavidi 2015 2014 2016 SAMBA II EID DRW Kenya, Uganda Alere™ q HIV-1/2 Detect Alere CE Mark Xpert® HIV-1 Qual Cepheid LYNX HIV p24 NWGHF Micronics Iquum/Roche Lumora Under development QuantumDx Ustar DFA TaqMan® HIV-1 Qual v2.0 Roche DBS CE Mark RealTime Qual HIV-1 Abbott DBS CE Mark (2011) SAMBA I Semi-Q EID * Reported November 2015 - timeline and sequence may change no specific market launch date; DBS assay CE Mark noted for laboratory products ** In addition, open polyvalent platforms are currently available for HIV VL and EID testing GeneXpert Omni Cepheid Conventional EID – POC EID Alere Q and Cepheid 1 Source: HIV/AIDS Diagnostics Technology Landscape, UNITAID, 2015 5

EGPAF/UNITAID POC EID project Goal: to increase the number of HIV-exposed infants whose HIV status is known and facilitate early initiation on treatment. Scale: 9 countries 4 years (2015 – 2019) $63 million Targets: 320,000 infants 13,562 HIV+ (4.2%) Results within 2 day EID coverage 20% ART initiation by 14 days Market shaping for POC

Overall Testing Summary Overall testing summary and yield among children and adolescents supported through EGPAF-Kenya CDC project (Oct 2015-May 2016) Overall Testing Summary   0-9 Years 10-14 Years 15-19 Years Tested 86,327 53,223 69,439 Positive 708 317 800 Yield 0.8% 0.6% 1.1% Yield per testing point / strategy by age group for children and adolescents 0-19 years What do we do differently for adolescents in ANC and labour and vct (women come with the children) Source: EGPAF, Kenya, Children and Adolescent Testing and Yield Data

Neonatal/Infant ART Choices Liquid formulations: 5 NRTIs (3TC and ZDV) liquids 1 NNRTI (NVP) 1 boosted PI (LPV/rtv) – starting at 14 days of age and 42 weeks gestational age Sprinkles and powder: 1 Integrase Inhibitor (RAL) powder – starting at 4 weeks of age 1 boosted PI (LPV/rtv) sprinkles – starting at 3 months of age

Decentralization for delivery of pediatric ART in 5 countries Primary health facility Secondary and tertiary health facility D. Innovative service delivery model such as decentralization, task shifting, and pediatric HIV treatment in the context of the family centered approach. Promote decentralized service delivery models – we can see in this 2013 study that when children were initiated in a decentralized facility as compared to secondary and tertiary facility LTFU and mortality decreased. Lost to follow-up/ 100 PY on ART Mortality rate/100PYs on ART Fayorsey et al. Aquir Immune Defic Syndr, 2013

Viral suppression on ART EGPAF programs, 2015 Do these samples reflect general population on ART or are they biased toward more adherent patients and those retained in care – ie, falsely high rate of viral suppression? Or could they be biased toward those showing more signs of clinical failure, ie, falsely low rate of viral suppression? Source: EGPAF Kenya country data review, May 2015 EGPAF Malawi country data review, Oct 2015 * Malawi data refer to viral load <1000 c/mL

Treatment failure and drug resistance Mozambique Ariel, 2013-14 Vaz P, et al., 7th HIV Pediatric Workshop, 2015,Vancouver, Abs. P- 31 6 facilities in Maputo 713 children on ART for median of 60 mo 256 (36%) treatment failure Aug 2013-Mar 2014 Also, the issue of drug resistance and its impact on treatment outcomes is not well studied. One good study in Mozambique by our Ariel colleagues revealed very high rates of drug resistance among children experiencing treatment failure. This will have implications for long-term outcomes and reinforces the need to enhance treatment adherence and retention in care.

Continuous investment in R&D Increased investment Getting to 1.6M Find the children Start them on ART early Continuous investment in R&D Increased investment

At this time in history, there is an urgent need to unify everybody’s effort under a common and cohesive umbrella to have more impact, improve efficiency and effectiveness along with quality of HIV services, and overall save more children’s lives. We know that appropriately and adequately addressing pediatric HIV can be complex – it requires organization, commitment and attention to detail. Yet if appropriately treated, monitored, and supported, HIV-positive children will not only survive, but will thrive. Although young children cannot pass on HIV and do not contribute to the spread of the epidemic, they are individuals with a right to care and treatment and should be given the priority that, like all children, they deserve.   With sustained and increased commitment and financial resources and a paradigm change on how to deliver HIV testing, treatment and retention services, the global HIV/AIDS community will end pediatric AIDS. Because children do not have the voice to advocate for themselves, we must all speak on their behalf if pediatric AIDS is to be addressed and ultimately, brought to an end. And we really should be able to think that when the story of these times gets written, we want it to say that we did all we could, and it was more than anyone could have imagined. When the story of these times gets written, we want it to say that we did all we could, and it was more than anyone could have imagined