Pediatric Working Group Interagency Task Team on Prevention and Treatment of HIV Infection in Pregnant Women, Mothers and their Children July 2011 Prioritizing Pediatric HIV Diagnosis, Care, Support and Treatment

Contents Current state of pediatric HIV & AIDS Global initiatives in the fight against HIV in children Why prioritize children? Bottlenecks and challenges Priority interventions

Contents Current state of pediatric HIV & AIDS Global initiatives in the fight against HIV in children Why prioritize children? Bottlenecks and challenges Priority interventions

Pediatric HIV disease remains a major global health issue The burden of pediatric HIV disease is high, despite PMTCT 2.3 million children currently living with HIV This represents 7.5% of the total number of people with HIV 370,000 new pediatric infections globally in 2009 This represents 15% of the total number of new infections each year Mortality in untreated children is very high 260,000 deaths in children with HIV annually Without treatment, 50% of infected children will die before age 2 Treatment and PMTCT interventions can reduce MTCT rates to <5% But in 2009 only 50% of HIV+ pregnant women had access to PMTCT And 30% of those received suboptimal prophylaxis with sd-NVP Overall, pregnant women have the poorest access to treatment with only 15% of those who are eligible on ART Source: Universal Access Report, 2010

Interventions to test and treat children lag significantly behind adults Early infant diagnosis (EID) is essential to identify infected infants But despite significant scale up - only 15% of HIV-exposed infants have access to EID Treatment is a life-saving intervention and all infected infants and children < 2 years are eligible for treatment Only 28% of children in need of treatment are on ART (compared to 37% eligible adults) Access for infants is even lower Adolescents living with HIV are a growing group in need of services. Source: Universal Access Report, 2010

Contents Current state of pediatric HIV & AIDS Global initiatives in the fight against HIV in children Why prioritize children? Bottlenecks and challenges Priority interventions

Treatment 2.0 – re-galvanizing efforts to reach universal access for adults and children Treatment 2.0: Is a global initiative to re-galvanize efforts to achieve universal access for adults and children living with HIV and maximize the impact of HIV treatment on HIV prevention to avert 10 million deaths by 2025 Treatment 2.0 comprises five key pillars: 1.Radically simplified HIV treatment with optimised drug regimens in once daily combinations 2.Prioritize point-of-care and other simple-to-use diagnostics 3.Reduced costs of commodities 4.Improve and decentralize service delivery 5.Strengthen community mobilization

The Global Plan to Eliminate Mother-to-Child Transmission (eMTCT) of HIV and Keep Mothers and Children Alive: Is a new effort to reduce new HIV infections in children by 90% or to fewer than 40,000 new pediatric infections globally over the next 4 years Increased efforts to improve access to maternal treatment, to PMTCT and to infant testing Elimination of MTCT – reducing new HIV infections in children by 90%

These new global initiatives offer a real opportunity to address HIV/AIDS in children Both Treatment 2.0 and eMTCT provide an unprecedented opportunity to address the burden of pediatric HIV and AIDS Elimination of MTCT will result in far fewer infected children EID scale up is necessary for global programme evaluation, and as more HIV-exposed infants are tested, more infected infants will be identified As treatment becomes simpler and more decentralized, it will become easier to provide access to children living both in urban and rural areas Even as the most effective PMTCT interventions are widely scaled-up, there will be a continuing need for pediatric treatment – both for the 2.3M children already infected and for those that become infected despite PMTCT services

Contents Current state of pediatric HIV & AIDS Global initiatives in the fight against HIV in children Why prioritize children? Bottlenecks and challenges Priority interventions

Why prioritize children? Each day that goes by, almost 800 HIV-positive children die because of lack of access to testing, treatment and care With treatment, children with HIV can survive into adulthood and live healthy and productive lives Recent innovations include the introduction of infant diagnosis using dried blood spots and the development of affordable pediatric fixed dose combination ARVs which improve quality of care for children living with HIV and greatly simplify ART Mortality from pediatric HIV contributes significantly to overall child mortality especially in high-burden countries. In order to achieve MDGs 4 & 6 by 2015, we must take action now

Contents Current state of pediatric HIV & AIDS Global initiatives in the fight against HIV in children Why prioritize children? Bottlenecks and challenges Priority interventions

Policy Bottlenecks occur at all levels to limit access to ART for children Low level of political commitment Limited funding Poor understanding of child-specific issues Low level of political commitment Limited funding Poor understanding of child-specific issues Vertical programming not well linked to MCH Slow uptake of new pediatric drugs Few linkages from testing to treatment, so poor retention Vertical programming not well linked to MCH Slow uptake of new pediatric drugs Few linkages from testing to treatment, so poor retention Too few pediatric equipped sites Too few pediatricians to manage disease burden Low uptake of supportive interventions Too few pediatric equipped sites Too few pediatricians to manage disease burden Low uptake of supportive interventions Operations 2,300,000 children living with HIV 356,400 children on ART Globally, only 28% of children in need received ART Infrastructure

At policy level, there is a need to advocate for child rights and fund child interventions Incorporate child protection elements into the national discourse and legislative procedures Ensure appropriate funding allocation for pediatric activities within national and donor budgets for pediatric HIV programming

In operations, address access to child FDCs improve integration and decentralize care Focus on integration to strengthen MCH through investments in pediatric treatment and prevention Improve access to quality affordable pediatric fixed dose combinations Strengthen management capacity at national level Decentralise diagnosis, care, support and treatment

Through infrastructure, strengthen human and physical resources and capacity Build up human resource capacity to manage pediatric HIV Task shifting to nurses and other personnel enable scale-up of treatment services in areas with pediatrician shortages Empower all treatment sites to manage children in a family centred approach Offer supportive interventions especially for vulnerable populations such as adolescents

Six challenges, and six interventions for better access to pediatric testing and treatment Infants are hard to diagnose yet very vulnerable Expand access to Early Infant Diagnosis (EID) Too few pediatric specialistsTask shift pediatric ART Fragmentation of the ARV market by many similar products Rationalise pediatric ARV formularies Meet special needs of adolescents Increasing number. of adolescents with particular needs Increase pediatric retention Too many children are LTFU – all along the care continuum Set higher targets for pediatric testing and treatment Access to pediatric treatment lags partly due to low targets

Contents Current state of pediatric HIV & AIDS Global initiatives in the fight against HIV in children Why prioritize children? Bottlenecks and challenges Priority interventions

Priority intervention 1: Expand access to EID Key Challenge: Infants are the most vulnerable to disease progression, and EID is essential to diagnose infection in infants Access to EID is currently limited (15% exposed infants globally) but is an essential 1 st step to begin pediatric treatment Diagnosis of HIV infection in infants <18 mos. requires PCR or other types of virologic testing Innovative technologies and improved communication strategies are now available to scale-up access to EID services even in resource-constrained settings

Priority intervention 1: Expand access to EID Several countries have successfully scaled up EID programs and improved access to treatment for infants using centralized PCR, sample transport, electronic result return and strong linkages to care To increase EID coverage, different entry points for HIV exposed infants need to make active referrals

Task Shift pediatric ART Key Challenge: There are too few pediatric specialists in resource limited countries – task shifting is critical to increase access Shortage of pediatricians in developing countries limits scale up of pediatric HIV care and treatment Task shifting to alternative personnel including to nurses is a cost-effective way to address human resource gaps while maintaining a high standards of care Effective task shifting includes adjusting policy, defining clear roles and appropriate supervision Most of the evidence to date on task shifting in HIV has focused on adult services. Care must be exercised in task shifting to account for special issues associated with diagnosing, caring for, and treating children. Priority intervention 2: Task shifting for pediatric ART

Priority intervention 2: Task shifting for pediatric ART Multiple resource-limited countries (see map) have been able to demonstrate successful ART initiation by training non-physician health workers NIGERIA: Nurse ART treatment helped reduce waiting time by 4 hours (Udegboka et al, 2009) LESOTHO: Nurses treated both children and adults, leading to increased enrollment of patients, increased enrollment of children in care and decreased numbers of adults with very low CD4 counts (<50). (Cohen, Lynch et al. 2009) SOUTH AFRICA: Compared outcomes between nurse and doctor-led management of adults (neither group had previous HIV experience) found no difference in mortality viral failure or immune recovery. (Sanne, Orrell et al. 2010). ZAMBIA: Good pediatric outcomes reported in clinics managed by clinical officers and nurses (Bolton- Moore Mubiana-Mbewe et al. 2007) UGANDA: Both nurses and clinical officers demonstrated strong agreement with physicians in assigning clinical staging and deciding whether to initiate antiretroviral therapy (Vassar, Kenya Mugisha et al. 2009) MOZAMBIQUE: Non-physician caregivers achieved higher levels of adherence to ARVs in the first 6 months after initiating ART and were less likely to be LTFU than those seen by physicians (Sherr, Micek et al 2010)

Rationalize pediatric ARV formularies Key Challenge: The pediatric ARV marketplace has become fragmented by numerous duplicative products, which threatens sustainability The CHAI-UNITAID program has served as one mechanism to decrease cost of pediatric treatment by pooling procurement and rationalizing choices of pediatric ARVs, however this program is ending in 2012 In order to ensure the sustainability of pediatric HIV treatment programs pediatric ARV formularies should be optimized around the least number of products and programs should phase out outdated formulations and regimens Priority intervention 3: Rationalize the pediatric ARV formulary

Priority intervention 3: Rationalize the pediatric ARV formulary The optmization of the pediatric formulary is essential not just to decrease costs but also to ensure sustainable and assured access to current and new pediatric drugs Governments should be encouraged to rationalize their pediatric formulary and identify single-drug products and syrups that can be phased out in favor of cheaper, easier to use dispersible FDC formulations To secure uninterrupted supply of pediatric ARVs national HIV programs and their partners should consider Rationalizing pediatric ARV formularies Accelerating the phase out of old formulations Participating in pooled procurement / coordinating buying mechanisms

Meet special needs of adolescents Key Challenge: Current programs do not address the needs of a growing adolescent population More children with HIV are now surviving into adolescence and adulthood Adolescents living with HIV face a unique set of challenges not met through pediatric or adult focused programs Adolescent specific services are needed to address both physical and psychological needs of this group Priority intervention 4: Provide services for adolescents Whether infected at birth or later in life, adolescents living with HIV face a variety of unique challenges that the health sector is only now beginning to recognise

Important areas of focus for this special population include: Mental health Transition from pediatric to adult care Sexual reproductive health issues Meaningful involvement of adolescents living with HIV is essential to the design, delivery, evaluation of treatment, care and support services. Priority intervention 4: Provide services for adolescents

Increase pediatric Retention Key Challenge: Too many children are lost along the continuum of care Over 50% of positive pediatric patients are estimated to be lost across the between testing and initiation of treatment Children have particular vulnerabilities that make pediatric retention a more complex issue Priority intervention 5: Improve pediatric retention. Source: CHAI 2010 (Pediatric HIV) 1 Testing here refers to Early Infant Diagnosis testing only, based on a 5-country analysis of all patients from sites available to CHAI (n=4970) in Cameroon, Ethiopia, Kenya, Swaziland, and Zambia. 2 Based on 8-country analysis of all patient charts from sites at which data were made available to CHAI (n=18,077) in Cameroon, Dominican Republic, Ethiopia, Kenya, Nigeria, Rwanda, Swaziland, and Zambia.

Strategies to improve pediatric retention in care include: 1.Improving quality of service 2.Enhancing linkages between testing programs such as EID and treatment 3.Focusing on Pre-ART patients 4.Addressing costs of care to families Priority intervention 5: Improve pediatric retention

Aim higher for pediatric targets Key Challenge: Target setting is not aggressive and access to pediatric treatment still lags significantly behind adults Resource-constrained HIV-programs often neglect specific needs of pediatric patients ART coverage is not equitable and far fewer children have access to ART compared to adults Setting new and ambitious targets for pediatric treatment prioritizes the need to close this gap and save lives Targets for testing and treatment should be set at national, district and facility levels Priority intervention 6: Set ambitious targets for pediatric testing and treatment

Priority intervention 6: Set ambitious targets for pediatric testing and treatment Countries should develop and utilize improved national pediatric treatment targets that reflect and include the following: An overall goal of at least 80% of children in need receiving ART Sub-national numeric targets based upon the goal of at least 80% coverage The same access to ART for children as for adults Specific targets for ART in children under age 2 WHO recommendations for universal testing of infants in high burden settings

Summary Current state of pediatric HIV & AIDS Pediatric treatment currently is currently lagging and thousands of children are dying every year Global initiatives in the fight against HIV in children Ambitious global commitments have been made towards battling HIV in children, including Treatment 2.0 and the Campaign to eliminate MTCT Why prioritize children? Expanding access to pediatric prevention, care and treatment is an essential part of meeting global targets and necessary to prevent 800 deaths/day Bottlenecks and challenges New technologies and strategies are being developed to expand access to testing and treatment for all children in need Priority Interventions Key interventions to increase access to pediatric care and treatment should be used to help achieve the goal of providing a better future for our children