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Data from the Collaborative HIV Paediatric Study (CHIPS) Reports up to March 2013*

Data from the Collaborative HIV Paediatric Study (CHIPS) Reports up to March 2013* * Numbers are based on reports received rather than children seen to the end of March 2013. 2012/13 data are subject to reporting delay and may therefore be incomplete. Background to CHIPS.

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Data from the Collaborative HIV Paediatric Study (CHIPS) Reports up to March 2013*

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  1. Data from the Collaborative HIV Paediatric Study (CHIPS) Reports up to March 2013* * Numbers are based on reports received rather than children seen to the end of March 2013. 2012/13 data are subject to reporting delay and may therefore be incomplete.

  2. Background to CHIPS • The Collaborative HIV Paediatric Study (CHIPS) was established in April 2000 and is a multi-centre cohort study of HIV-1 infected children in the UK and Ireland. • The collaboration is between • 65 clinics in the UK and Ireland that care for HIV-infected children, some of whom are enrolled in PENTA trials (PENTA 16 BREATHER and PENTA 18 KONCERT) • the National Study of HIV in Pregnancy and Childhood (NSHPC), and • the MRC Clinical Trials Unit

  3. Follow-up status of 1835 children enrolled in CHIPS * 94 deaths prior to 2008, 6 in 2008, 8 in 2009, 2 in 2010, 1 in 2011+

  4. Age group by year first presented to medical services in the UK/Ireland (N=1835*) Up to 2008 2009 2010 2011 2012+ Total At birth 164 (10%) 6 (8%) 3 (5%) 5 (11%) 1 (20%) 179 (10%) <1 yr 341 (21%) 6 (8%) 5 (9%) 2 (5%) 0 (0%) 354 (19%) 1-4 yrs 499 (30%) 13 (17%) 7 (12%) 6 (14%) 0 (0%) 525 (29%) 5-9 yrs 409 (25%) 21 (27%) 12 (21%) 5 (11%) 2 (40%) 449 (24%) 10-14 yrs 226 (14%) 25 (32%) 25 (44%) 18 (41%) 2 (40%) 296 (16%) ≥15 yrs 13 (1%) 6 (8%) 5 (9%) 8 (18%) 0 (0%) 32 (2%) Total 1652 (100%) 77 (100%) 57 (100%) 44 (100%) 5 (100%) 1835 (100%) * Includes all children (those still in follow-up and those who have died, lost to follow-up, left the UK & Ireland or transferred to adult care)

  5. Age* of children in paediatricfollow-up by year, 1996-2012 Year No.Median (IQR) -------------------- Age group ------------------ age < 1 yr 1-4 yrs 5-9 yrs 10-14 yrs 15 yrs 1996 357 5.1 (2.9-7.6) 26(7%) 146(41%) 144(40%) 40 (11%) 1 (0%) 1997 414 5.4 (3.1-8.2) 29(7%) 152(37%) 174(42%) 55 (13%) 4 (1%) 1998 493 6 (3.2-8.9) 22(4%) 172(35%) 211(43%) 78 (16%) 10 (2%) 1999 559 6.5 (3.7-9.8) 26(5%) 172(31%) 232(42%) 111(20%) 18 (3%) 2000 658 7.2 (4-10.4) 23(3%) 196(30%) 257(39%) 143(22%) 39 (6%) 2001 757 7.6 (4.5-10.9) 20(3%) 202(27%) 291(38%) 197(26%) 47 (6%) 2002 859 8 (5-11.7) 21(2%) 190(22%) 344(40%) 237(28%) 67 (8%) 2003 987 8.5 (5.6-12) 22(2%) 188(19%) 388(39%) 300(30%) 89 (9%) 2004 1088 8.9 (5.9-12.4) 19(2%) 187(17%) 417(38%) 347(32%) 118(11%) 2005 1164 9.5 (6.5-12.9) 18(2%) 155(13%) 447(38%) 392(34%) 152(13%) 2006 1237 10.2 (6.9-13.4) 17(1%) 151(12%) 433(35%) 436(35%) 200(16%) 2007 1289 10.8 (7.6-14) 10(1%) 142(11%) 394(31%) 510(40%) 233(18%) 2008 1306 11.4 (8.2-14.5) 13(1%) 126(10%) 362(28%) 521(40%) 284(22%) 2009 1310 12.1 (9-15.1) 9 (1%) 105(8%) 320(24%) 539(41%) 337(26%) 2010 1274 12.8 (9.5-15.4) 7 (1%) 82 (6%) 259(20%) 564(44%) 362(28%) 2011 1250 13.5 (10.1-15.9) 6 (0%) 60 (5%) 230(18%) 526(42%) 428(34%) 2012 957 13.6 (10.5-15.9) 5 (1%) 37 (4%) 169(18%) 395(41%) 351(37%) *Age is taken to be age at start of the year, or age at presentation if child presented during that year. Note: Data are for children and young people receiving paediatric care; those who have transferred toadult clinics are not included here.

  6. Age* of children in paediatric follow-up by year, 1996-2012 N 357 414 493 559 658 757 859 987 1088 1164 1237 1289 1306 1310 1274 1250 957 *Age is taken to be age at start of the year, or age at presentation if child presented during that year. Note: Data are for children and young people receiving paediatric care; those who have transferred toadult clinics are not included here.

  7. All hospital admissions during 2000-2011* Year Number Number Proportion Total Rate (# children children admitted number admissions seen admitted admissions per pyr) 2000 603 165 27 327 0.59 2001 667 178 27 313 0.51 2002 729 157 22 246 0.36 2003 833 187 22 320 0.42 2004 955 182 19 287 0.34 2005 1085 177 16 289 0.29 2006 1138 163 14 243 0.23 2007 1170 145 12 215 0.20 2008 1201 147 12 217 0.19 2009 1193 120 10 153 0.14 2010 1162 91 8 132 0.12 2011 1139 103 9 138 0.14 * Retrospective data on admissions not collected for children from clinics joining since Aug 2003. These children are counted from when they begin prospective follow-up in CHIPS. Admissions may be underreported for children in shared care where only information from the main CHIPS follow-up clinic is reported. Data for 2012/13 are incomplete and are not presented.

  8. Viral load suppression 12 months* after starting cART naïve, all agesN=1030 with measurements available (291 missing) Year Viral load (copies/ml) ≤50 or ≤lower assay limit** 1997/2000 104/222 (47%) 2001/2003 135/227 (59%) 2004/2006 185/257 (72%) 2007/2009 171/231 (74%) 2010- 68/93 (73%) Total 663/1030 (64%) * Response is based on the viral load value nearest 12 months (+/-3 months) after cART initiation **158/663 (25%) of undetectable results had a lower limit of detection >50 but ≤400c/ml and are included here.

  9. Viral load suppression 12 months* after starting cART naïve atage ≤12 yearsN=895 with measurements available (241 missing) Year Viral load (copies/ml) ≤50 or ≤lower assay limit** 1997/2000 98/213 (46%) 2001/2003 127/214 (59%) 2004/2006 156/218 (72%) 2007/2009 137/188 (73%) 2010- 43/62 (69%) Total 561/895 (63%) * Response is based on the viral load value nearest 12 months (+/-3 months) after cART initiation **146/561 (26%) of undetectable results had a lower limit of detection >50 but ≤400c/ml and are included here.

  10. Viral load suppression 12 months* after starting cART naïve at age ≥13 yearsN=135 with measurements available (50 missing) Year Viral load (copies/ml) ≤50 or ≤lower assay limit** 1997/2000 6/9 (67%) 2001/2003 8/13 (62%) 2004/2006 29/39 (74%) 2007/2009 34/43 (79%) 2010- 25/31 (81%) Total 102/135(76%) * Response is based on the viral load value nearest 12 months (+/-3 months) after cART initiation **12/102 (12%) of undetectable results had a lower limit of detection >50 but ≤400c/ml and are included here.

  11. Time to viral rebound (>1000c/ml) for children suppressing viral load ≤400c/ml within 12 months of starting cART naïve, 2000-2003 Age at cART <2 years 2-4 years 5-9 years 10+ years

  12. Time to viral rebound (>1000c/ml) for children suppressing viral load ≤400c/ml within 12 months of starting cART naïve, 2004-2011 Age at cART <2 years 2-4 years 5-9 years 10+ years

  13. Viral load 12 months1 after starting 1st and 2nd line cART for those switching2 to 2nd line (N=318 children switched to 2nd line after at least 12 months on 1st line3) 1 Response is based on viral load value closest to 12 months (+/-3 months) after starting 1st/ 2nd line, for those starting cART naive and remaining on 1st line for at least 12 months and 2nd line for at least 12 months. 2 Defined as any switch of ≥3 ART drugs (regardless of reason for switch) or a switch of 2 ART drugs with reported reasons being ‘failure’ (immunological/virological/clinical failure or resistance), with viral load >50 copies/ml. 3 58/318 had missing viral load after 12 months on 2nd line, and a further 64/318 had missing viral load after 12 months on 1st line. 4 53 (16%) undetectable results had a lower limit of detection >50 but ≤400c/ml and are included.

  14. Data on 1131 children who are in active follow-up (1111 in CHIPS clinics and 20 who have transferred to non-CHIPS clinics) Those who have died, lost to follow-up, left the UK & Ireland or transferred to adult care are excluded.

  15. Demographics (N=1131) (Data provided by NSHPC) • 585 (52%) are female • 539 (48%) born UK/Ireland, 575 (51%) born abroad (place of birth not known for 17 children) • Ethnicity: • Diagnosis of maternal infection (N=1085 vertically infected):

  16. Regional distribution ofmain follow-up clinic for 1131 children alive and followed up in CHIPS 47 (4%) Scotland 5 (<1%) N. Ireland 439 (39%) Rest of England 61 (5%) Ireland 14 (1%) Wales 564 (50%) London Children who have died, lost to follow-up, left the UK & Ireland or transferred to adult care are excluded

  17. Year of last follow-up (N=1131)

  18. Clinical stage by age at last follow-up (N=1131)

  19. Antiretroviral drug experience N=1090 children with follow-up since January 2011

  20. ART at last follow-upN=903 children with follow-up since Jan 2011 were on treatment17 on mono, 35 on dual, 792 on 3-drug, 53 on 4-drug and 6 on 5(+)-drug therapy

  21. Most recent CD4% (N=1048)Children followed up since January 2011 (missing for 42 children)

  22. Most recent CD4 count (N=1048)Children ≥ 5 years old followed up since Jan 2011 (missing for 38 children)

  23. Most recent viral load (N=1053)Children followed up since January 2011 (missing for 37 children) **4/675 (<1%) of undetectable results had a lower limit of detection >50 but ≤400c/ml and are included here.

  24. Outcome 1: Retention in carePercentage of newly diagnosed children in 2010 who had ≥2 CD4 and ≥2 VL measurements within 12 months of diagnosis Percentage (%) Notes: The y axis shows percentages, and at the top of each bar shows the number of children

  25. Outcome 2: Retention on ARTPercentage of patients newly starting ART in 2009 who were still on ART in 2010 Percentage (%) Notes: The y axis shows percentages, and at the top of each bar shows the number of children

  26. Outcome 3A: Immune status in children <5 yrsPercentage of children aged <5 years with ≥1 CD4 measure ≥25% in 2010, by ART status Percentage (%) Notes: The y axis shows percentages, and at the top of each bar shows the number of children

  27. Outcome 3B: Immune status in children ≥5 years Percentage of children aged ≥5 years with ≥1 CD4 measure ≥350 cells/mm3 in 2010, by ART status Percentage (%) Notes: The y axis shows percentages, and at the top of each bar shows the number of children

  28. Outcome 4A: Virologic response on ART Percentage of children on ART with ≥2 VL measures <50c/mland <400c/ml, in 2010 Percentage (%) Dotted bar: VL <50c/ml Plain bar: VL <400 c/ml Notes: The y axis shows percentages, and at the top of each bar shows the number of children

  29. Outcome 4B: Virologic response on ART, age≥13yrsPercentage of young people aged ≥13 years on ART with ≥2 VLmeasures <50c/ml, and <400 c/ml, in 2010 Percentage (%) Dotted bar: VL <50c/ml Plain bar: VL <400 c/ml Notes: The y axis shows percentages, and at the top of each bar shows the number of children

  30. Outcome 5: Description of deaths in 2010 Two paediatric deaths were reported to CHIPS in 2010. • Aged 20.1 years, cause of death was: Respiratory – unspecified. First presented aged 12 years with CD4% of 1% and 7 cells/mm3. At time of death was taking DRV and exposed to a total of 9 drugs. Was seen 5 times in the 12 months prior to death. • Aged 9.8 years, causes of death were: Tuberculosis meningitis, advanced HIV disease / general deterioration/HIV encephalopathy / dementia/ADC/ encephalitis. First presented aged 7.1 years with CD4% of 33% and 644 cells/mm3. At time of death was taking 3TC+ABC+EFV and exposed to total of 3 drugs. Was seen 4 times in the 12 months prior to death.

  31. Involvement in PENTA trials BREATHER (PENTA 16) enrolment is ongoing in 2013. Please contact penta@ctu.mrc.ac.uk for further details about BREATHER and KONCERT. KONCERTBREATHER London – 13 Oxford – 2 London – 14 Leicester – 2 Birmingham – 1 Liverpool – 1 Birmingham – 2 Bristol – 2 Bristol – 1 Ireland – 1 Ireland – 3 Nottingham – 2 Nottingham – 2 Recent PENTA publications: • Harrison L, Ananworanich J, Hamadache D, Compagnucci A, Penazzato M, et al. on behalf of the Paediatric European Network for Treatment of AIDS (PENTA) 11 Trial Team Adherence to Antiretroviral Therapy and Acceptability of Planned Treatment Interruptions in HIV-Infected Children. AIDS Behav. 2013 January; 17(1): 193–202. • Bunupuradah T, Duong T, Compagnucci A, McMaster P, Bernardi S, et al. on behalf of the PENTA 11 Extension Study Group. Outcomes after reinitiating antiretroviral therapy in children randomized to planned treatment interruptions in the PENTA 11 Study. AIDS. 2012 Nov 6. • Bastiaans DET, Forcat S, Lyall HEG, Cressey TR, Chalermpantmetagul S, et al. Pharmacokinetics of 100/25 mg lopinavir/ritonavir tablets in children when dosed twice daily according to FDA weight bands. 4th International Workshop on HIV pediatrics 2012. July 20-21, 2012. L'Enfant Plaza Hotel, Washington DC, USA. Poster 41. • Mbisa JL, Hue S, Buckton AJ, Myers RE, Duiculescu D, et al. Phylodynamic and Phylogeographic Patterns of the HIV-1 Subtype F1 Parenteral Epidemic in Romania. AIDS Res Hum Retroviruses 2012 Jan 18.

  32. Recent CHIPS-related publications(based either wholly or partly on CHIPS data) • European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) study group in EuroCoord. Use of combination neonatal prophylaxis for the prevention of mother-to-child transmission of HIV infection in European high-risk infants. AIDS – in press. • Donegan K, Doerholt K, Judd A, Lyall H, Menson E, Butler K, Tookey P, Riordan A, Shingadia D, Tudor-Williams G, Gibb DM, Walker AS, on behalf of the Collaborative HIV Paediatric Study (CHIPS). Lopinavir dosing in HIV-infected children in the UK and Ireland. PIDJ 2013; 32: 45-50. • Wittkop L on behalf of the EuroCoord-CHAIN subtype project team. Effect of HIV-1 subtypes on virological and immunological response to initial combination antiretroviral therapy (cART) – a European multicohort study. CROI, Atlanta, 2013 • Duong T et al. Long-term virological outcomes in HIV-infected children on ART in the UK/ Ireland. 17th International Workshop on HIV Observational Databases, Croatia, 2013. • RojoConejo P on behalf of the PLATO II project team of COHERE. Higher rates of triple class virologic failure in perinatally HIV-infected teenagers compared to heterosexually infected young adults in the PLATO II study. 17Th International Workshop on HIV Observational Databases, Croatia, 2013.

  33. Acknowledgements We thank the families and staff at hospitals which participate in CHIPS.CHIPS is funded by the NHS (London Specialised Commissioning Group), and has received additional support from Bristol-Myers Squibb, Boehringer Ingelheim, GlaxoSmithKline, Roche, Abbott, and Gilead. For further information on CHIPS, please visit: www.chipscohort.ac.uk

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