key consideration for ensuring access to hiv …

Key Consideration for Ensuring Access to HIV Diagnostics: FORECASTING Presented by: Lama Suleiman 30 September 2014 Contracts Manager , Malaria Prevention and diagnostics Unit ,Health Technology Center - Supply Division

Geneva – Switzerland AIDS Medicines and diagnostics (AMDS) Annual stakeholders & Partners meeting

1

ACKNOWLEDGMENT

UNICEF Programme Division

• Dr Chewe Luo

• Ravikiran Bhairavabhotla

UNICEF Supply Division

• Helene Moller

• Ludo Scheerlinck

• Bibiana Zambrano

• Etleva Kadilli

• Lama Suleiman

• Irene Iyako

• Ignacio Gimenez

AIDS Medicines and diagnostics (AMDS) Annual stakeholders & Partners meeting 2

Global Burden of Disease, treatment and diagnostic needs

Key considerations to estimate demands

Conclusion

Presentation outline

3

AIDS Medicines and diagnostics (AMDS) Annual stakeholders & Partners meeting

4 AIDS Medicines and diagnostics (AMDS) Annual stakeholders & Partners meeting

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%)

HIV Diagnostic Testing, Staging and Monitoring

Viral Load

Infant testing CD4

HIV Rapid Testing


CD4≤200

Recommended since 2003

CD4≤350

Recommended since 2010

CD4≤350

+ TB/HIV

+TB/HBV

CD4≤500

+TB/HIV

+TB/HBP

ART regardless of CD4 count:

* Serodiagnosis

* Pregnant women

* Children <5 years

All HIV+

Test and Treat

11 m

15 m

17.6 m

28.6 m 34 m

Population in need of treatment has expanded as WHO guidelines have emerged

UNAIDS new 2020 targets for ending AIDS

epidemic by 2030

Gaps in access using 2013 data


90%

Diagnosed

90%

On treatment

90%

Virally suppressed

Source: Adapted from Nkengasong, CDC at UNAIDS DAI meeting, Sept 2014

90%

90%

90%

50%

43%

37%

24%

38%

25%

Target

Adults

Children*

Pregnant women

*43% refers % of children tested

Considerations for diagnostics forecasting

procurement and product development


1. Aligning country policy guidelines with changing

WHO Recommendations

TARGET POPULATION (ARV-NAIVE)

2010 ART GUIDELINES 2013 ART GUIDELINES

HIV+ ASYMPTOMATIC CD4 ≤350 cells/mm3 CD4 ≤500 cells/mm3 (CD4 ≤ 350 cells/mm3 as a priority)

HIV+ SYMPTOMATIC WHO clinical stage 3 or 4 regardless of CD4 cell count

No change

PREGNANT AND BREASTFEEDING WOMEN WITH HIV

CD4 ≤350 cells/mm3 or WHO clinical stage 3 or 4

Regardless of CD4 cell count or WHO clinical stage

HIV/TB CO-INFECTION Presence of active TB disease, regardless of CD4 cell count

No change

HIV/HBV CO-INFECTION

Evidence of chronic active HBV disease, regardless of CD4 cell count

Evidence of severe chronic HBV liver disease, regardless of CD4 cell count

HIV+ PARTNERS IN SD COUPLE No recommendation established Regardless of CD4 cell count or WHO clinical stage


Source: Doherty, WHO 2013


* Aligning to reality on the ground: Current uptake 2013 ARV guidelines increases

40%

48%

45%

39%

52%

0% 20% 40% 60% 80% 100%

ART in liver disease

ART in SD couples

PMTCT Option B+

Paediatic ART <5 years

Adult initiation <CD 500

Percentage of 58 WHO HIV Focal Countries with confirmed adoption of select WHO 2013 ARV recommendations, June 2014

* or 75% of 22 EMTCT Global Plan countries

*

Source: WHO HIV Country Intelligence Database, June 2014


* Aligning to realities on the ground:

Adoption of option B/B+ in the 22 priority countries

2. 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

CD4 count

Chemistry, hematology & Testing opportunistic

infections

Monitoring of HIV disease and treatment

Viral load suppression Viral load and HIV drug Resistance testing

Source: adapted from John Nkengason, CDC


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

3. Forecasting: Optimizing use of diagnostic technologies in national programmes in relation to capacity and population size at different

levels


4. Understanding Access Bottlenecks relative to population size: Estimated infant early infant HIV diagnosis need vs. demand

South Africa 20%

Nigeria 15%

Uganda 9%

Tanzania [PERCENTAGE]

Mozambique 8%

Kenya 6%

Zambia 6%

Zimbabwe 6%

Malawi 5%

Cameroon 3%

Ethiopia 3%

DRC [PERCENTAGE]

Cote dIvoire

2%

Angola 1%

Lesotho 1%

Ghana 1%

Chad 1% Botswana

1%

Namibia 1%

Swaziland 1% [CATEGORY

NAME] <1%

Estimated number of HIV-exposed infants, 2013 (Estimated Need)

South Africa 41%

Zambia 9%

Uganda 9%

Mozambique 7%

Zimbabwe 7%

Kenya 7%

Tanzania [PERCENTAGE]

Swaziland 2%

Cameroon 2%

Malawi 2%

Nigeria 2%

Ethiopia 1% Botswana

1%

Namibia 1%

Lesotho 1%

Ghana 1% Cote

dIvoire 1%

Angola 1%

DRC [PERCENTAGE]

[CATEGORY NAME]

<1%

[CATEGORY NAME]

<1%

Reported number of HIV-exposed infants receiving EID, 2013 (Current Demand)

Source: UNAIDS 2013 HIV and AIDS estimates, July 2014. 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), 2014.


© UNICEF/ZIMA2011-00003/Pirozzi

Conclusion • Changing demand profile

• Population size • Evolution of WHO guidance • Decentralisation of services to

reach more people

• 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

Thank you

key consideration for ensuring access to hiv …

Documents