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ICASA IAS. Scaling up Treatment Delivery Programmes: Issues, Challenges & Best Practices Siobhan Crowley HIV Department WHO Geneva. % Pregnant women with HIV who received ARVs to reduce MTCT increased 2004-2007 - but 49% still received only single dose nevirapine.

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Icasa ias

ICASA IAS

Scaling up Treatment Delivery Programmes: Issues, Challenges & Best Practices

Siobhan Crowley

HIV Department

WHO Geneva


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% Pregnant women with HIV who received ARVs to reduce MTCT increased 2004-2007 - but 49% still received only single dose nevirapine

Percentage of pregnant women with HIV receiving ARVs for PMTCT in low- and middle-income countries

Distribution of ARV regimens, 2007

Towards Universal Access – Scaling up priority HIV/AIDS interventions in the health sector. WHO/UNAIDS/UNICEF, June 2008


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Progress has been made

  • More children are receiving ART

  • Increased from 75,000 in 2005 to almost 200,000 in 2007

  • 19 of 20 countries with highest PMTCT burden are in sub-Saharan Africa

  • 90% of burden is in 20 countries

  • East,S and SE Asia increase coverage from 18% to 25% in 2008

Towards Universal Access: Scaling up priority HIV/AIDS interventions in the health sector, WHO/UNAIDS/UNICEF 2008


Who a public health approach

WHO - A Public Health Approach

Goal

Maximize survival with improved quality of life

Principles:

  • Population-based approach

  • Evidence-based standards of care

  • Simplified standardised treatment regimens & patient monitoring

  • Decentralised and integrated service delivery


Core elements of the a public health approach

Core elements of the a Public Health Approach

  • Comprehensive approach to HIV prevention, care and ART

  • Provider-initiated Testing and Counselling

  • Prevention for those who test negative

  • Positive prevention for those who test positive

  • Pre-ART care for those who do not need ART immediately

  • Continuum of care

  • Decentralised and integrated service delivery

  • Treatment literacy, adherence and chronic care

  • Simplified clinical monitoring & basic laboratory


Harmonised art policy guidance

Harmonised ART Policy Guidance

IMAI/IMCI Implementation tools


Audience for who guidelines

Audience for WHO guidelines

  • Primarily national planners and policy makers engaged in public sector ART and in target-setting

    • Which ARVs to make available in public sector for

      first and second-line regimens

    • How to use: the four Ss of clinical management:

      when to start, substitute, switch and stop

  • Care implementers - basic knowledge to use ARVs effectively according to national policy recommendations

  • Trainers, M&E experts – to design appropriate tools and materials to support national policy recommendations


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When to start ART


Recommendations for initiating antiretroviral treatment in adults

Recommendations for initiating antiretroviral treatment in adults


Issues for when to start

Issues for -when to start

Earlier initiation of adult ART with CD4 350 – 500

  • Reduced non AIDS events from cohort data not RCTs, and in industrialised settings

  • May further reduce HIV transmission

  • ? Feasibility of CD4 dependent strategy

  • No's - estimates for disease burden rise > 30%

  • Associated costs

  • Health systems demands – increase # providers/sites

  • Caution with NVP in women + CD4 > 250, men >400


Areas for 2008 review in criteria to start art adults

Areas for 2008 review in criteria to start ART adults


When to start in pregnant women

When to start in pregnant women

Currently WHO recommends

  • ART in all symptomatic women with CD4 < 350,

  • Consider ART for all pregnant women with CD4 < 350

  • Prophylaxis (AZT + 3TC tail + Sd NVP ) for non ART eligible

    Being evaluated:

  • ? combination prophylaxis for all pregnant women <350 or < 500 +/- combination prophylaxis for all women who are breast-feeding

  • ? Treat all pregnant women irrespective of CD4

  • Extended infant prophylaxis if breastfeeding


Key issues art pregnancy

Key issues ART & pregnancy

  • ? Safety of stopping post-partum: SMART data

  • Access to CD4 in ANC

  • Feasibility in universal ART antenatal / MCH clinic settings

  • ? What to use – NVP contraindicated CD4 > 250, Efavirenz – teratogenic, concerns re TDF, PIs and metabolic complications not

  • Complexity and health systems demands

  • Equity: very different ART access for pregnant

  • ? Adherence in well women

  • ? adverse pregnancy outcomes


Children

Children


Starting art when severely immunodeficient increases mortality

6% excess mortality

Starting ART when severely immunodeficient increases mortality

Arrive E et al. 14th CROI, Los Angeles, CA, 2007 Abs. 727

  • 73% median age > 5 years of age, > 50% start with severe immune deficiency, most deaths within 6 months of starting ART

    • Risk factors for death:

      • low CD4

      • < 18 months age

      • WHO stage 3/4

      • viral load greater than 6·0 log

      • severe malnutrition

Sutcliffe et al. Lancet Infect Dis 2008;8: 477–89


Cd4 increase in children on cart in ssa

CD4% Increase in Children on cART in SSA

Sutdiffe CG et al. Lancet Infect Dis 2008;8:447-89


Cher study 76 reduction in the risk of death with immediate compared to deferred art

1.00

0.80

Deferred

Immediate

0.60

0.40

0.20

0.00

0

3

6

9

12

Month 0

Month 3

Month 6

Month 9

Month 12

Deferred

125

104

72

44

22

Immediate

252

213

145

99

52

CHER STUDY : 76% Reduction in the Risk of Death with Immediate Compared to Deferred ART

P = 0.0002

Most deaths occurred within

first 6 months (i.e., before age 10 months)

Failure Probability

16%

deferred

4%

immediate

Time to Death (months)

Patients at risk


Revised who guidelines 2008 when to start antiretroviral therapy in hiv infected children

Revised WHO Guidelines 2008 : When to Start Antiretroviral Therapy in HIV-Infected Children

*If Viral test is not possible, use presumptive diagnosis of severe HIV (thrush, severe pneumonia or sepsis) in infants with +ve HIV antibody test and with clinical symptoms of severe HIV – confirm infection status as soon as possible.


What to use

What to use


Adults children 1 year or over

Adults & children (1 year or over)

Clinical and/or

immunological criteria

to start ART

Standard first line regimen

NNRTI + 2NRTI

< 3 years

NVP + AZT + 3TC

> 3 years

EFV + AZT + 3TC

Standard second line regimen

PI + 2 new NRTI


What art to start in infants 2008 revision

What ART to Start in infants –2008 revision

NVP triple ART

No infant or

maternal

ARV exposure

Baby 18%

Mum 34%

PI triple ART#

Sd NVP or NNRTI containing ART

MTCT ARV

Exposure

NVP triple ART

No NNRTI exposure

Unknown infant

maternal MTCT

Exposure

NVP triple ART

# If no PI is available use NVP triple ART


Revised simplified dosing infants children

Revised simplified dosing infants & children


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WHO FDC ARV tablet regimen superimposed

1 ADULT FDC AM & PM

1 ADULT FDCAM & 0.5 PM

0.5 ADULT FDC AM + PM

2 BABY FDC AM & PM

2 BABY FDC AM & 1 PM

1 BABY FDC AM & 1 PM

Most dose adjustments done in 1st year

Same dosing

irrespective of FDC, or same dosing for all three single ARV agents

Adapted from T. NUNN


Percentage of adults and children on 1st and 2 nd line regimens 2007

Percentage of adults and children on 1st and 2nd line regimens (2007)


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Median transaction prices for one years treatment

Transaction prices for ARVs Summary Report form GPRM Oct 2008


First line failure when to switch

First line failure – when to switch


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Clinical

Virologic

Immunologic

Failure / When to Switch

Clinical

criteria

CD4 count

Viral load

"Late Switch"

"Early Switch"


Who art failure meeting major conclusions

WHO ART Failure Meeting: Major Conclusions

Time on ART :

Clinical: WHO Stage 3 or 4 after at least 1 year on ART

CD4: confirmed CD4 < 100-200 after at least 1 year on ART

(check/reinforce adherence before switching decision)

HIV RNA threshold :

Maintain 10,000 as a switch point (little immediate immune damage).

Action when VL> 1,000 (adherence, toxicity, drug interaction assessment) and start to consider switching

More efficient use of VL (targeted strategy)

Confirm immunologic/clinical failure (?discordance)

Pregnant women

Adherence monitoring


What to switch to second line

What to switch to……..second line


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# if anaemia use alternative ABC or d4T


Summary of regimen options adults

Summary of Regimen options - adults


Options for adult second line art

Options for adult second-line ART


Managing co infection with tb

Managing co-infection with TB


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Geographical distribution of estimated HIV-positive TB cases, 2006


Opportunistic illnesses

Opportunistic Illnesses


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Intensified TB case finding and IPT provision among people living with HIV, 2006

Number of people receiving the intervention as % of estimated PLHIV in reporting Countries

0.96%

12%

0.08%

(Number of Countries reporting; % of total estimated HIV+ TB patients accounted for by those Countries)


Who the 3 is

WHO the 3 'Is'

  • Intensified case finding

  • Infection control for TB

  • Isoniazid preventive therapy


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Country HIVDR

Committees

HIVDR monitoring & surveys

The WHO HIVResNet is a global group of experts, laboratories, and organizations constituted to support HIVDR prevention, surveillance, and monitoring as antiretroviral treatment (ART) is rolled out worldwide.

Steering Committee

WHO Secretariat

  • WHO HIVResNet

  • Laboratory Network

  • Surveillance and Monitoring Network

WG

Modeling of

The emergence and transmission of resistance

WG

Operational Research

Time-Limited

Subject Matter

Working Groups

WG

Mutation lists for

Surveillance and monitoring

WG

WG

Global Laboratory

Network: Criteria,

Protocols, Training,

QA

HIVDR database development

and support

WG

Public Health Assessment Tool

For evaluation of country HIVDR data


Transmitted hiv drug resistance

Transmitted HIV drug resistance

Articles reporting results from HIVDR transmission surveys in 7 countries

all showed <5% DR in incident cases


Interface between prevention and care

Interface between prevention and care

PRIMARY PREVENTION

Prep and PEP

  • POSITIVE PREVENTION

  • Pre ART care – condoms safer sex

  • Disclosure & partner testing

  • MTCT prevention

  • OI & STI prevention

Lancet, November 26, 2008

  • ART CARE

  • Reduce Viral load

  • Likely reduction transmission


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HIV ART

No ART

Current ART

Proposed Universal ART


Acknowledgments

Acknowledgments:

Paediatric and adult Guideline groups

HIV DR team

HIV- dept staff

Paediatric ARV dosing working group

Charlie Gilks. Marco Vitoria, Lynne Mofenson, Ying-ru Lo,

HIV -AMD & GPRM

HIV- SIR Yves Soutyrandy

Thank you


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