PRIORITIES FOR HIV/AIDS PROCUREMENT AND PRODUCT DEVELOPMENT

Transcription

1 PRIORITIES FOR HIV/AIDS PROCUREMENT AND PRODUCT DEVELOPMENT Dr Chewe Luo MMed (Paeds), Mtrop Paed, PhD Senior Adviser and Team Leader Country Programme Scale up HIV Section Programme Division UNICEF, NY 1

2 Presentation outline Global Burden of Disease and HIV treatment needs Progress: Current access to diagnostics and treatment to date Future considerations for procurement and production 2

3 Global Burden of HIV Disease Number of people living with HIV in 2013 > Total 35,000,000 > Adults 31,800,000 > Pregnant women 1,450,000 (4%) > Children 3,200,000 (9%) People newly infected with HIV in 2013 > Total 2,100,000 > Adults 1,900,000 > Children 240,000 (12.6%) 3

4 Population in need of treatment has expanded as WHO guidelines have emerged 28.6 m 34 m 17.6 m 15 m 11 m CD4 350 Recommended since 2010 CD TB/HIV +TB/HBV CD TB/HIV +TB/HBP ART regardless * Serodiagnosi * Pregnant wo * Children <5 y 4

5 Paediatric HIV population will remain high despite progress in efforts to eliminate mother to child transmission and expand treatment 3,500,000 3,000,000 2,500,000 2,000,000 1,500,000 1,000, ,000 3,193,775 2,836,736 2,665,191 2,302,510 1,960,718 1,829, LMIC 21 PMTCT Priority Countries Generalized epidemic countries Source: Penazzato, PADO meeting, Dakar,

6 Trends in children in need of antiretroviral treatment in the 21 Priority countries in sub-saharan Africa by age group 2,500,000 2,000,000 MAX Adult ART coverage 95% PMTCT coverage 95% Paediatric ART coverage 100% 1,500,000 1,000, , to 2 3 to 4 5 to 9 10 to 14 Source: Penazzato, PADO meeting, Dakar,

7 We have made tremendous progress Globally, 12,9M people on ART at the end of 2013 out of the 15M targeted. 11,7M in low-and middle income countries in M more than at the end of 2012 Source: 2014 Global AIDS Response Progress Reporting (WHO/UNICEF/UNAIDS) 7

8 Almost 1 million pregnant women received combination ARVs % % 80% 70% [VALUE] 60% % % 40% % % % 10% 0% Number of pregnant women living with HIV needing ARV medicines for PMTCT Ranges Number of pregnant women living with HIV receiving any ARV medicines for PMTCT Percentage coverage Source: 2014 Global AIDS Response Progress Monitoring and estimates (WHO/UNICEF/UNAIDS) 8

9 740,000 children received ART in 2013 But Paediatric ART lags behind that of Adult ART PERCENT (%) 50% 40% 30% 20% 10% ART COVERAGE AMONG ADULTS (15+) AND CHILDREN (AGED 0-14), ALL LOW- AND MIDDLE- INCOME COUNTRIES, Paediatric ART Adult ART 740,000 The absolute number of children on ART has nearly quadrupled to 740,000 since 2007 But the gapbetween adult and pediatric coverage has actually widened. 0% Source: UNAIDS/WHO/UNICEF GARPR/Universal Access reporting and UNAIDS 2013 HIV and AIDS estimatess 9

10 UNAIDS new 2020 targets for ending AIDS epidemic by 2030 Gaps in access using 2013 data 90% 50% 90% Diagnosed 43% 90% 37% 90% On treatment 24% 38% Target Adults Children* 90% Pregnant women Virally suppressed 25% 90% *43% refers % of children tested Source: Adapted from Nkengasong, CDC at UNAIDS DAI meeting, Sept 2014 $3 10

11 Considerations for diagnostics procurement and product development 11

12 1. Aligning country policy guidelines with changing WHO Recommendations TARGET POPULATION (ARV-NAIVE) 2010 ART GUIDELINES 2013 ART GUIDELINES HIV+ ASYMPTOMATIC CD4 350 cells/mm 3 cells/mm 3 CD4 500 cells/mm 3 (CD4 350 HIV+ SYMPTOMATIC PREGNANT AND BREASTFEEDING WOMEN WITH HIV HIV/TB CO-INFECTION HIV/HBV CO-INFECTION HIV+ PARTNERS IN SD COUPLE WHO clinical stage 3 or 4 regardless of CD4 cell count CD4 350 cells/mm 3 or WHO clinical stage 3 or 4 Presence of active TB disease, regardless of CD4 cell count Evidence of chronic active HBV disease, regardless of CD4 cell count No recommendation established as a priority) No change Regardless of CD4 cell count or WHO clinical stage No change Evidence of severe chronic HBV liver disease,regardless of CD4 cell count Regardless of CD4 cell count or WHO clinical stage Source: Doherty, WHO

13 2. With WHO now recommending use viral load for ART monitoring, the total market will grow substantially Total Viral Load Testing volumes in LMICs 10 Total market to grow substantially over the next few years Millions Source: Adopted from UNICEF-CHAI Market forecast, March

14 3. Aligning diagnostic needs to programme needs along the treatment Cascade Cascade Pathway Related laboratory services HIV testing and diagnosis HIV serology for adults and p24, DNA PCR for children Staging to initiate of antiretroviral treatment Monitoring of HIV disease and treatment Viral load suppression CD4 count Chemistry, hematology & Testing opportunistic infections Viral load and HIV drug Resistance testing Source: adapted from John Nkengason, CDC 14

15 4. Understanding Access Bottlenecks relative to population size: Estimated infant early infant HIV diagnosis need vs. demand DRC [PERCENTAGE] Ethiopia 3% Angola 1% Cameroon 3% Malawi 5% Cote divoire 2% Zimbabwe 6% Zambia 6% Lesotho 1% Ghana Chad Botswana 1% 1% 1% Namibia 1% Swaziland 1% [CATEGORY NAME] <1% South Africa 20% Nigeria 15% Ethiopia 1% Namibia 1% Nigeria 2% Cameroon Malawi 2% 2% Swaziland 2% Tanzania [PERCENTAGE] Kenya 7% Zimbabwe 7% Lesotho 1% Botswana 1% Ghana 1% Cote divoire 1% Angola 1% DRC [PERCENTAGE] South Africa 41% [CATEGORY NAME] [CATEGORY <1% NAME] <1% Kenya 6% Mozambique 8% Uganda 9% Estimated number of HIV-exposed infants, 2013 (Estimated Need) Tanzania [PERCENTAGE] Mozambique 7% Uganda 9% Zambia 9% Reported number of HIV-exposed infants receiving EID, 2013 (Current Demand) Source: UNAIDS 2013 HIV and AIDS estimates, July Estimated number of pregnant women living with HIV delivering used as a proxy for HIV-exposed infants. Source: UNAIDS, WHO, UNICEF 2014 Global AIDS Response Progress Reporting (GARPR),

16 5. Forecasting: Optimizing use of diagnostic technologies in national programmesin relation to capacity and population size at different levels National hospitals and reference labs (high capacity service points and labs) HIV diagnostic (Ab, virologic) CD4, VL, Regional or district level facilities (Near POC/POC, regional high volume labs) Medium capacity ART, PMTCT, Paediatric treatment HCT, TB/HIV services HIV diagnostic (Ab, virologic) CD4, VL Primary facility and health posts (POC) HCT settings Facility and home based AB testing and self testing and?poc CD4 and EID 16

17 6. Programme realities and where do we place the technology? Uganda Facility Coverage of emtct, EID and Paediatric ART Services (2014) Uganda Facilites and Population density 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% EMTCT Early Infant Diagnosis Adult ART Paediatric ART Sites providing service Faciltiy gap People needing service Source: Peter Elyanu, Uganda, MoH

18 Considerations for ARVs and other medicines procurement and product development 18

19 1. Forecasting need in the light of changing WHO guidelines: WHO AIDS Medicines and Diagnostics Service Forecast for Global Demand of Antiretrovirals Number of people receivingantiretroviral therapy or Antiretroviral drugs for preventing mother-to-child transmission Average number of adults receiving treatment (millions) Average number of Children receivingtreatment (millions) Average number of people receiving treatment (millions) Proportion of people receiving First-line treatment 96.0% 95.8% 95.2% 94.8% Proportion of people receiving second- line treatment 4.0% 4.2% 4.8% 5.2% Average number of women receiving antiretroviral drugs for preventing mother-to-child transmission (based of two projections) Source: AMDS, WHO

20 2. Alignment to changing WHO Recommendations: Topic When to start CD4 200 CD4 200 CD Consider CD4 350 for TB CD Irrespective CD4 for TB and HBV CD Irrespective CD4 for TB, HBV, PW and SDC - CD4 350 as priority 1 st Line 8 options - AZT preferred 4 options - AZT preferred 8 options - AZT or TDFpreferred - d4t dose reduction 6 options &FDCs - AZT or TDF preferred - d4t phase out 1 preferred option & FDCs - TDF and EFV preferred across all populations 2 nd Line Boosted and non-boosted PIs Boosted PIs -IDV/r LPV/r, SQV/r Boosted PI - ATV/r, DRV/r, FPV/r LPV/r, SQV/r Boosted PI - Heat stable FDC: ATV/r, LPV/r Boosted PIs - Heat stable FDC: ATV/r, LPV/r 3 rd Line None None None DRV/r, RAL, ETV DRV/r, RAL, ETV Source: Doherty, WHO

21 2. WHO recommendations for 1st Line for children under 3 years of age Age group Prior exposure to PMTCT ARV s recommendations recommendations <12 months Exposed LPV/r + 2 NRTIs LPV/r plus 2 NRTIs 12 to <36 months Not Exposed Exposure unknown Regardless of exposure NVP + 2 NRTIs AZT + 3TC ABC + 3TC d4t + 3TC If LPV/r not available, NVP-based Plus NRTI backbone: AZT or ABC + 3TC (d4t+3tc*) When HIV RNA monitoring is available, consider to substitute LPV/r with NNRTI after virological suppression is sustained Source: Shaffer, WHO

22 2. Istline for children >3 years Age group 2010 recommendations 3-19 years NVP or EFV plus 2 NRTIs in preferential order: AZT + 3TC ABC + 3TC d4t + 3TC TDF + FTC + EFV to be used as preferred regimen if HIV/HBV coinfectionand >12 years and > 35 Kg Age group 2013 recommendations 3-10 years (Including> 10 yrs who weighing <35kg) years (weighing 35 kg) (align with adults) NNRTI 2NRTIs NNRTI 2NRTIs EFV is preferred NVP as alternative In preferential order: ABC + 3TC AZT or TDF + 3TC or FTC EFV is preferred NVP as alternative In preferential order: TDF + FTC or 3TC ABC+ 3TC AZT +3TC Source: Shaffer, WHO 2013

23 3. Harmonisingguidelines and procurement of paediatricarvs: UNICEF/WHO/IATT optimal formulary list products 10 products 23

24 4. Aligning to reality on the ground: Current uptake 2013 ARV guidelines increases Adult initiation <CD 500 Paediatic ART <5 years PMTCT Option B+ ART in SD couples ART in liver disease 52% 39% 45% 48% 40% * * or 75% of 22 EMTCT Global Plan countries 0% 20% 40% 60% 80% 100% Percentage of 58 WHO HIV Focal Countries with confirmed adoption of select WHO 2013 ARV recommendations, June 2014 Source: WHO HIV Country Intelligence Database, June

25 4. Aligning to ralitieson the ground: Adoption of option B/B+ in the 22 priority countries 25

26 5. Supply Management Prices continue to decrease, but stockouts remain of concern Median prices of WHO-preferred first-line regimens per person per year, in US dollars, in low-and middle-income countries, Source: Weiler, IAC, Melbourne

27 Conclusion Changing programming landscape Population size Evolution of WHO guidance Decentralisationof services to reach more people UNICEF/ZIMA /Pirozzi Thank you For more efficient and effective programmes and use of resources: Enhance supply management support in countries Increase investment in and regular reporting of country data on need and consumption 27