Closing the Treatment Gap of Children Living with HIV The burden of paediatric HIV and the impact of 2013 Guidelines change on the treatment of children with HIV Martina Penazzato and Raul Gonzalez-Montero HIV Department, WHO (Geneva)

OUTLINE Global burden and ART coverage New Guidelines Potential impact Challenges

Number of children acquiring HIV infection in low- and middle-income countries, 1996-2012 No PMTCT PMTCT 220 500 (22 priority countries) MTCT rates declined overall from an estimated 33% in 2005 to 18% in 2012 Total number of children is 220 500 21/09/2018

Early Infant Diagnosis 35% coverage Among the Global Plan priority countries, in 2012 only South Africa and Swaziland were providing early infant diagnosis for more than 80% of infants in need, and only Namibia, Zambia and Uganda had achieved early infant diagnosis coverage of 50–80% for HIV exposed infants

Entry points for initiating ART (2010) Country data on the ages at which children initiate ART remain limited. In 2012, UNICEF and WHO supported rapid assessments of care for children in Swaziland, the United Republic of Tanzania and Zimbabwe. In Zimbabwe, the median age when initiating ART was 7-years old; most children were referred from hospitals, which indicates that they had already presented with AIDS-related conditions or they “progressed slowly”. In the United Republic of Tanzania, the median age at initiation was 4.3 years, and only 15% of children initiating ART were referred from the PMTCT programme. In Swaziland, the median age when initiating ART was 4.9 years in 2010 and 3.4 years in 2011 (80). Fig. 3.8 depicts the main entry points through which children initiate ART. The late initiation of treatment reflects several weaknesses in the treatment cascade, ranging from inadequate identification of children living with HIV to weak linkage to care (9). Source: A rapid assessment of paediatric care and treatment in four countries: Swaziland, Tanzania, Uganda and Zimbabwe (UNICEF)

Number of children eligible for and receiving ART in low- and middle-income countries, 2005-2012 On ART A global estimate of the number of children eligible for ART in 2012 is not yet available. However, the 22 priority countries1 identified in the Global Plan towards the elimination of new HIV infections among children by 2015 and keeping their mothers alive (3)2 account for nearly 90% of the pregnant women living with HIV and for a similar percentage of the children living with HIV. In these 22 countries, the number of children eligible for ART (based on the 2010 WHO treatment guidelines) fell by 60 000, from 1.72 million [1.59 – 2.03 million] in 2011 to 1.66 million [1.53 – 1.95 million] in 2012.

34% ART coverage in 22 priority countries A stronger focus on expanding ART for children remains essential, especially in the 22 priority countries. As Table 1.2 shows, ART coverage in these countries increased from 29% [25–31%] in 2011 to 34% [29–36%] in 2012 – much lower than the Global Plan 2015 target of providing ART to all children in need. Botswana and Namibia have already achieved universal access >80% of the children eligible for ART receiving it Several others have shown encouraging increases in coverage. Very low coverage in Angola, Cameroon, Côte d’Ivoire, the Democratic Republic of the Congo and Nigeria is a serious concern.

Key 2013 Recommendations Treat All children < 5 years Prioritize children ≤ 2 years or with WHO stage 3 or 4 or CD4 count ≤ 750 cells/mm³ or < 25% Treat children 5 years and older if WHO stage 3 or 4 or CD4 < 500 cells/mm3 prioritizing CD4 ≤350 cells/mm³ Start LPV/r in children < 3 years IF NOT FEASIBLE USE NVP!! consider PI-sparing strategies where viral load monitoring is available Consider 3 NRTIs regimen as an option in TB-cotreatement Harmonize first-line with Adults in children > 3 years Prefer EFV over NVP Include Non-Thymidin in the 1° line backbone TDF to be prefered for adolescents but to be considered as an option for children 3-10 years too Phase in VL Monitoring Lack of treatment monitoring should not be a barrier to treatment initiation Where VL is not available CD4 monitoring should be used despite low sensitivity of existing criteria to define ART failure

Impact on ART eligibility 750,000 This slide shows breakdown in numbers accessing and needing ART according to different eligibility criteria. At the end of 2011 there were 8 million people on ART. An additional 6.4 million adults and 1.4 million children were eligible for treatment under 2011 criteria but not on ART. (15.8 Million) The new guidelines proposed for 2013 would increase those eligible for ART by adding 4.5 million adults with CD4 counts 350-500, 750,000 HIV+ children between the ages of 2 and 5, an 5.2 million in special population groups with CD4 count above 500 700,000 pregnant women, 3.9 million sero-discordant couples, 500,000 HIV+/TB+ adults) and another 1.2 million key populations (SW, MSM, PWID) would be eligible if offered early treatment. TOTAL ~ 26 MILLION Conclusions: New guidelines on eligibility for ART, if adopted by all countries, would dramatically increase the number eligible for treatment. National programs will need to consider how to effectively reach these new population groups and maintain high quality treatment while expanding the numbers on treatment.

Impact of PMTCT coverage on 1st line ART for infants

Impact of PMTCT coverage on 1st line ART for infants

Starting all <3 years with LPV/r-based regimen

Challenges Ahead Scale up EID and PITC Ensure young children are prioritized for ART Maximize retention in care Find creative ways to supply LPV/r existing formulation and strongly advocate for better formulations to be available Make available TDF containing FDC to allow harmonization with adults regimens Phase in VL monitoring Develop 2nd line options with appropriate formulations

Treatment 2.0 Framework

Aknowledgements HIV Department-WHO, Geneva Gottfried Hirnschall Meg Doherty Lulu Muhe Nathan Shaffer Nathan Ford Gundo Weiler Chika Hayashi Lisa Nelson