Early Infant Diagnosis: Challenges and Solutions A special session IAS, Vienna 2010

Since 2005 there has been significant progress in paediatric HIV care and treatment Source: UNICEF stocktaking report 2009 Globally at the end of 2009, 355,000 children were estimated to be on ART. Combined treatment numbers from 20 countries with the highest burden of disease show that on average ~40% of paediatric “need” has been met

EID access has improved – in some countries >50% of exposed babies are tested But, infant testing is linked to PMTCT and where PMTCT coverage is low, so is infant testing coverage Globally only ~15% of exposed infants get a test But average age at initiation is still at ~5 years. Poor access to infant diagnosis is a key barrier 0 50, , , , ,000 Exposed Infants Untested, 2008 (WHO/UNAIDS) PCR Tests, 2009 PCR Tests in 2008 Women Receiving ARVs for PMTCT (WHO/UNAIDS) CHAI/UNITAID data Dec 2009

Moreover, even when there is access to EID, positive infants do not necessarily get on to ART Estimated Scope of Loss Across the Pediatric Care Continuum N=4970 across 5 countries CHA 2009: Data based on 5 country analyses of EID results and follow up outcomes. (total n=4970; Cameroon: n=136, LTFU= 65.4%, Swaziland: n=176, LTFU= 82.4%, Zambia: n= 3420, LTFU=36.8%, Ethiopia: n=1048, Kenya: n=190, LTFU=39.5%)

Moreover, even when there is access to EID, positive infants do not necessarily get on to ART Estimated Scope of Loss Across the Pediatric Care Continuum N=4970 across 5 countries 53% CHA 2009: Data based on 5 country analyses of EID results and follow up outcomes. (total n=4970; Cameroon: n=136, LTFU= 65.4%, Swaziland: n=176, LTFU= 82.4%, Zambia: n= 3420, LTFU=36.8%, Ethiopia: n=1048, Kenya: n=190, LTFU=39.5%)

The 2010 WHO guidelines seek to prioritize the identification and treatment of infected infants All infants with unknown HIV exposure being should have their HIV exposure status ascertained asap. (Strong recommendation) All known exposed infants should have a virological test at 4–6 weeks of age or asap thereafter. (Strong recommendation) Virological test results should be returned to the clinic or patient asap but at the very latest within 4 weeks. Positive results should be fast-tracked. (Strong recommendation) HIV-infected infants under 12 months of age (Strong recommendation) and between 12 and 24 months of age (Conditional recommendation) should start ART asap irrespective of CD4 count or WHO clinical stage.

What do the guidelines imply? Find exposed and infected children through all points of the health system not just through PMTCT ie at immunization clinics, well child clinics, paediatric wards, emergency rooms, primary and tertiary care settings (inc TB clinics, paediatric specialty clinics) Treat all infected infants and children under 24 months of age irrespective of CD4 and clinical stage

Collaborative Effort

What do we hope to get from this session What are some of the practical approaches to increase access to EID testing? Given the testing methodologies that are available today - what can we do to improve service delivery beyond ensuring access to a test? What does the future of PoC EID look like?

IAS-Industry Liaison Forum Initiatives Initiative of International AIDS Society Mission - to accelerate scientifically promising, ethical HIV research in resource-limited countries –with a particular focus on the role and responsibilities of industry as sponsors and supporters of research.

Strategic Plan Committed to –scientific, ethical and policy issues related to the needs of women and children affected by HIV, –to identify the gaps in this research area and –find ways to bridge these gaps

Achievements Consensus statement, –“Asking the Right Questions: Advancing an HIV Research Agenda for Women and Children”, Released Mar 8, 2010 Environmental Scan –“Mapping Research Priorities for Women and Children”, published July 2010 Clinical research, pMTCT & Pediatric Treatment Clinical Research, Women & Antiretroviral therapy Operations Research – Delivering treatment to women