Transcript Preventing HIV Drug Resistance with Programmatic Action

Preventing HIV Drug Resistance with
Programmatic Action
Michael R. Jordan MD MPH
World Health Organization HIV Drug Resistance
Surveillance and Monitoring Strategy

Successful scale-up of ART
– Standardized, population based approaches
– Inexpensive, generic, fixed dose combinations

Emergence of HIV drug resistance (HIVDR) is
inevitable
– High replication and mutation rate
– Necessity for lifelong treatment
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World Health Organization HIV Drug Resistance
Surveillance and Monitoring Strategy

Universal access to ART accompanied by
comprehensive global strategy to assess HIVDR

WHO in collaboration with HIVResNet is leading
global HIVDR surveillance and monitoring efforts

WHO’s global HIVDR strategy provides actionable
information for national ART programmes and clinics
to support evidence-based recommendations at local,
national and regional levels
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World Health Organization HIV Drug Resistance Surveillance
and Monitoring Strategy
Surveillance of Transmitted
HIVDR in Recently Infected
Populations
Surveillance of HIVDR in
Populations Initiating ART
Monitoring of
HIVDR Early
Warning
Indicators
Surveillance of HIVDR in
Children <18 months of Age
Surveillance of Acquired HIVDR
in Populations Receiving FirstLine ART
World Health Organization HIV Drug Resistance Surveillance
and Monitoring Strategy
Surveillance of Transmitted
Drug Resistance (TDR) in
Recently Infected Populations
Surveillance of HIVDR in
Populations Initiating ART
Monitoring of
HIVDR Early
Warning
Indicators
Surveillance of HIVDR in
Children <18 months of Age
Surveillance of Acquired HIVDR
in Populations Receiving FirstLine ART
Early Warning Indicators of HIV Drug
Resistance

WHO EWIs are quality of care indicators which assess
factors associated with virological failure and emergence
of HIVDR

Designed to be monitored at all ART clinics as part of
routine monitoring and evaluation

Standardized definitions and targets

Results provide clinic specific information offering an
opportunity for corrective action
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WHO-recommended HIVDR EWIs
(2004-2011)
EWI
EWI Target
1. Prescribing practices
100%
2. Lost to follow-up at 12 months
≤ 20%
3. Retention on first-line ART at 12
months
4. On-time drug pick up
≥ 70%
5. On-time appointment keeping
≥ 80%
6. Drug supply continuity
100%
7. Viral load <1000 copies/ml at 12
months
≥ 70%
≥ 90%
Bennett DE et al., Antivir Ther 2008
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50 countries; >2100 clinics; >131 000 patients
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HIVDR EWI –
Proportion of Clinics Achieving WHORecommended Targets
Reports from 2107 clinics (2004-2009)
Prescribing practices 100%
75%
Loss to follow-up ≤20%
69%
Retention on first-line ART ≥70%
67%
On time drug pick-up ≥90%
17%
On time appointment keeping ≥80%
58%
Drug supply continuity 100%
65%
Viral load suppression 12 months
≥70%
85%
0%
20%
40%
60%
80%
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100%
EWI Summary
•
Although EWI methods are designed to provide
representative data of national ART programme
functioning, the small number of clinics reporting
and non-representative sampling used by most
countries preclude generalization of results
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Available data indicate that adherence,
procurement and supply distribution and
retention remain important programme
challenges
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ART Programme Actions Resulting from
EWI Monitoring
•
Strengthened record keeping systems1,2,3,4
•
Defaulter tracing initiatives to trace patients with
unknown outcomes, support re-engagement into care
and ART adherence1,3
•
Procurement of funding from partners to scale-up EWI5
•
Increase access to viral load testing6
•
Routine review of patient pill pick-up and establishment
of formal referral system to document transfers of care3
et al. JAIDS 2010; 2Jack N et al. CID 2012; 3Daonie et al. CID 2012; 4Nhan DT el al. CID 2012; 5Paula Mundari, Uganda
National ART Programme, IAS 2010, Vienna; 6Ye M et al. CID 2012
1Hong
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Important Lessons from the Field
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Some EWIs more closely linked to HIVDR than others
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Simplification of definitions, harmonization with other
reported indicators, and revision of targets required
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Integration into routine monitoring and evaluation
necessary to achieve maximum benefit

Data abstraction and reporting should be delegated to
ART clinics to foster ownership and local use of data
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WHO HIVDR EWI 2012 Revisions
EWIs were evaluated using
GRADE method for association
with HIVDR and for optimal
target
 EWIs without strong
association with HIVDR were
eliminated
 Each EWI retained evaluated

– Minimize overlap of
information obtained by each
indicator
– Maximize efficiency of data
abstraction
– Harmonize definitions with
other reported indicators,
whenever possible
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http://www.who.int/hiv/topics/drugresistance/en/index.html
2012 HIVDR EWI Updates
• Package of 4 indicators each with one standardized
definition and target grounded in available medical
literature
• VL suppression at 12 months is “conditional” 5th indicator
but should only be monitored at clinics where VL testing
is routinely performed on all patients 12 months after
ART initiation
• New guidance on representative sampling of ART clinics
• Data abstraction reporting responsibilities delegated to
ART clinics to foster ownership and local use of data
• Simplified scorecard reporting
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http://www.who.int/hiv/topics/drugresistance/en/index.html
2012 Revised EWI Reporting: Scorecard
Red
Poor performance, below desired level
Amber
Fair performance, progressing toward desired
level
Green
Excellent performance, achieving desired level
Grey
Data not available
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2012 Revised WHO HIVDR Early Warning
Indicator Package
Early Warning Indicator
Target

Red: <80%
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Amber: 80–90%
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Green: >90%
Red: <75% retained after 12 months of ART
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Amber: 75–85% retained after 12 months of ART
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Green: >85% retained after 12 months of ART
3. Pharmacy stock-outs
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Red: <100% of a 12-month period with no stock-outs
4. Dispensing practices
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Green: 100% of a 12-month period with no stock-outs
Red: >0% dispensing of mono- or dual therapy
1. On-time pill pick-up
2. Retention in care*
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5. Viral load suppression 
at 12 months


Green: 0% dispensing of mono- or dual therapy
Red: <70% viral load suppression after 12 months of ART
Amber: 70–85% viral load suppression after 12 months of ART
Green: >85% viral load suppression after 12 months of ART
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* Retention in care definition equal to UNGASS #24 and PEPFAR #T1.3.D
National level at-a-glance assessment of
ART clinic performance
Clinic EWI 1 On-time pill pick-up EWI 2 Retention
1
95%
77%
2
70%
95%
3
100%
82%
4
85%
….
5
97%
60%
….
….
….
….
….
….
100
100%
100%
EWI 3 Drug stock-outs
100%
100%
75%
100%
95%
…..
….
100%
EWI 4 Dispensing practices
95%
88%
0%
0%
0%
….
….
0%
Scorecard facilitates:
•Reporting of results
•Interpretation at clinic and national levels
•Strategic allocation of resources
EWI 5 VL suppression
95%
98%
75%
95%
50%
….
….
100%
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WHO HIVDR EWI Conclusions (1)

Between 2004 and 2009, 50 countries monitored one or
more EWI at select clinics

Although no global trends can be assessed, experiences
show important gaps in service delivery and programme
performance particularly with respect to fragility of drug
procurement and supply systems and inadequate
adherence and clinic retention
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WHO HIVDR EWI Conclusions (2)
•
EWI analyze routinely collected data through a
drug resistance lens
•
EWIs are the first line in preventing HIVDR
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Routine monitoring of EWIs should be part of
programme monitoring and evaluation and
continuous quality improvement initiatives
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WHO HIVDR EWI Conclusions (3)
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EWI monitoring identifies weaknesses at ART
clinic and programme levels associated with
population-level emergence of HIVDR
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Monitoring identifies clinics that can serve as best
practice models to other clinics
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2012 EWI revisions will facilitate uptake and
integration into routine clinic practice
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Acknowledgments

The Bill & Melinda Gates Foundation

Silvia Bertagnolio, WHO-Geneva
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Diane Bennett, United States-CDC
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Elliot Raizes, United States-CDC
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Mark Myatt, Brixton Health, UK
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Karen Kelley, PEPFAR
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WHO HIVDR Early Warning Indicator Working Group
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Neil Parkin, Data First Consulting
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Countries, ART programmes and clinics reporting data
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