2009 HIV/AIDS Implementers’ Meeting
Windhoek, Namibia 10-14 June 2009
Evolving Challenges in Treatment, Laboratory, Care and Support Services
2009 HIV/AIDS Implementers MeetingWindhoek, Namibia - 10-14 June, 2009
Rappourteur Session
14 June 2009 Evolving Challenges in Treatment, Laboratory, Care and Support ServicesRapporteur Presentation
2009 HIV/AIDS Implementers’ Meeting
Windhoek, Namibia 10-14 June 2009
Rapporteur Team
• Kate Anteyi (CDC Nigeria)• Helen Chun (DOD)• Bill Coggin (OGAC)• John Eyres (USAID Vietnam)• Christian Gunneberg (WHO)• Brad Hersh (WHO)
• Charles Holmes (OGAC) • Nancy Knight (CDC Nigeria)• Heidi Mihm (USAID)• Linda Parsons (CDC)• Pratima Raghunathon (CDC Rwanda)• Souleymane Sawadago (CDC Namibia)
Marco Vitoria, MD, WHO
14 June 2009 Evolving Challenges in Treatment, Laboratory, Care and Support ServicesRapporteur Presentation
2009 HIV/AIDS Implementers’ Meeting
Windhoek, Namibia 10-14 June 2009
Some numbers…
• 14 sessions (6, 7, 13, 16, 20, 23, 30, 37, 41, 47, 54, 55, 57 and 59)
• 64 oral presentations
• 24 posters
14 June 2009 Evolving Challenges in Treatment, Laboratory, Care and Support ServicesRapporteur Presentation
2009 HIV/AIDS Implementers’ Meeting
Windhoek, Namibia 10-14 June 2009
Major Topics
Costing of ART scale upART monitoring strategiesQA for laboratory servicesAdherence monitoringAccess to treatment & early mortalityART and treatment retentionHIVDR & PharmacovigilanceTB/HIV (3Is, collaborative activities & clinical management)OI & Cancer diagnosis and managementLinking ART services to community & other services
14 June 2009 Evolving Challenges in Treatment, Laboratory, Care and Support ServicesRapporteur Presentation
2009 HIV/AIDS Implementers’ Meeting
Windhoek, Namibia 10-14 June 2009
How will the economic crisis affect HIV treatment programmes?
14 June 2009 Evolving Challenges in Treatment, Laboratory, Care and Support ServicesRapporteur Presentation
2009 HIV/AIDS Implementers’ Meeting
Windhoek, Namibia 10-14 June 2009
Country Options on Costs of Treatment Scale up: More Funds, Lower Prices or More Efficiency?
• The current trend is to start ART earlier, use less toxic drugs and promote more lab monitoring.
• ART scale up will cost more irrespective of the regimens or criteria adopted
• Under a constrained budget, increasingly important that nationalprograms, funders and other stakeholders have a sound understanding of the costs, social policy choices and tradeoffs inherent in their decisions.
• We have to look at opportunity costs and balance continued treatment scale up with investments in prevention and systems strengthening
14 June 2009 Evolving Challenges in Treatment, Laboratory, Care and Support ServicesRapporteur Presentation
Session 7 (Abstracts 61, 233, 888, 2006, 6033, 6101)
2009 HIV/AIDS Implementers’ Meeting
Windhoek, Namibia 10-14 June 2009
Can CD4 cell count predict virologic failure?
14 June 2009 Evolving Challenges in Treatment, Laboratory, Care and Support ServicesRapporteur Presentation
Virological Profile in Immunological
Failure Cases
Intermediate
Group
Concordant
Group
Time to Failure with both Virologic and immunologic Failure (n=1331)
VL failure prior to CD4 failure n=441
CD4 failure prior to VL failure n=216
CD4 and VL failure at same time n=674
ANUSUYA et al (Abs 1275)
Kanki (Abs 6039)
2009 HIV/AIDS Implementers’ Meeting
Windhoek, Namibia 10-14 June 2009
Is Viral Load Testing Cost Effective Strategy in ART Failure ?
Cost-Benefit Analysis
Criteria for treatment Failure
Incre-mental Cost of testing
Total Cost
Incre-mental Cost of drugs
Total Savings (1 yr)
Net Benefit(USD)
VL detectable-515 tests, 206 undect. - 15,450 - 288,194 272,744
-repeat VL testing in 6 months, 206 pts, 10% detectable
6,180 21,630 14,690 273,504 251,874
Effect of VL Policy: Costs of Testing ProgramEffect of VL Policy: Costs of Testing ProgramProjected Annual Costs of VL Testing for ART Patients, 2010-2013
Effect of VL Policy: More Patients on 2Effect of VL Policy: More Patients on 2ndnd--Line ARTLine ARTAdditional Costs due to Faster Transition to 2nd-line ARVs, 2010-2013
Formula for calculating cost-effectiveness of VL testing for suspected treatment failure to 1st-line ARV
Cost of VL Test < Expected cost savings of each VL test in preventing unnecessary 2nd-line ARV use
Cost of VL Test < (1-PPV)(ARV2 – ARV1)
PPV = Positive Predictive Value of Clinical and Immunological Criteriafor Treatment Failure to 1st line ARV
ARV2 = Cost of 2nd line ARV drugs for 1 year
ARV1 = Cost of 1st line ARV drugs for 1 year
Nelson (Abs 6018) Colby (Abs. 1624)
14 June 2009 Evolving Challenges in Treatment, Laboratory, Care and Support ServicesRapporteur Presentation
2009 HIV/AIDS Implementers’ Meeting
Windhoek, Namibia 10-14 June 2009
More than just CD4 and VL …
14 June 2009 Evolving Challenges in Treatment, Laboratory, Care and Support ServicesRapporteur Presentation
2009 HIV/AIDS Implementers’ Meeting
Windhoek, Namibia 10-14 June 2009
High False-Positive Rates on EQA3-A5 When Testing withDetermine HIV-1/2
EQA Spec. Expected Result N NPos
(%)NInv(%)
NNeg(%)
1 A2 NEG 40 2.50 2.50 95.001 A5 NEG 42 2.38 0.00 97.622 A1 NEG 65 6.15 0.00 93.852 A4 NEG 67 1.49 0.00 98.512 A6 NEG 66 6.06 0.00 93.943 A1 NEG 98 3.06 0.00 96.943 A2 NEG 98 5.10 0.00 94.903 A5 NEG 97 24.74 0.00 75.26
Jani et al (Abs 602)
Evolving Challenges in Treatment, Laboratory, Care and Support ServicesRapporteur Presentation
14 June 2009
2009 HIV/AIDS Implementers’ Meeting
Windhoek, Namibia 10-14 June 2009
Monitoring ART Adherence: Multiple methodologies and potential new thresholds
Pharmacy Refill Adherence Associated with
HIV Suppression in Resource Limited Settings
Nachega, J. B. et. al. Ann Intern Med 2007;146:564-573
Stirratt (Abs 6006)Haberer (Abs 6005) & Stirratt (Abs 6006)
14 June 2009 Evolving Challenges in Treatment, Laboratory, Care and Support ServicesRapporteur Presentation
2009 HIV/AIDS Implementers’ Meeting
Windhoek, Namibia 10-14 June 2009
Role of CD4 on Promoting Early Access to Treatment
Determining missed opportunity for timely ART
WHO Stage # of patients # Eligible for ART based on CD4 + WHO
Percent eligible for ART
I 69 25 36%
II 56 27 48%
III 50 36 72%
IV 25 25 100%
No Stage 17 11 65%
Total 217 124 57% 8
10
CD4 at enrollment
KNOW YOUR CD4 CAMPAIGN
Mubiru et al (Abs 1208)Memiah (Abs 1318)
14 June 2009 Evolving Challenges in Treatment, Laboratory, Care and Support ServicesRapporteur Presentation
2009 HIV/AIDS Implementers’ Meeting
Windhoek, Namibia 10-14 June 2009
Impact of Early and Intensive Follow up on Mortality and Retention Probability of remaining alive & in care
p=0.009
0.75
0.80
0.85
0.90
0.95
1.00
0100
200300
Days since cART initiation
Routine CareExpress Care
Proportion surviving and in care
0.75
0.80
0.85
0.90
0.95
1.00
0100
200300Days since cART initiation
Routine Care
Express Care
Proportion surviving
p<0.001
Factors Associated with Retention at 6 and 12 Months after ART Initiation
Baseline clinical
(1.19-2.43)1.70(1.25-2.85)1.89Prescribed CTX at baseline
(1.05-2.78)1.71(1.93-4.04)2.79Baseline BMI ≥ 18.5
(1.56-2.56)1.99(1.90-2.68)2.26Baseline Hb ≥ 8 g/dL
(95% CI)AOR(95% CI)AOR
1.131.69 (0.79-1.60)(1.33-2.14)Baseline CD4 ≥ 200 cells/µl
12 Months6 Months
Braitstein et al (Abs 1556)
Mbofana et al (Abs 1608)
Relative hazard of mortality:
ART-LINC vs. ART-CC
unadjusted HR
adjusted HR
(adjusted for cohort,
age, sex, baseline CD4,
ART-regimen, disease
stage)
ART-LINC Collaboration,
The Lancet 367(9513): 817-
824. 2006
14 June 2009 Evolving Challenges in Treatment, Laboratory, Care and Support ServicesRapporteur Presentation
2009 HIV/AIDS Implementers’ Meeting
Windhoek, Namibia 10-14 June 2009
HIV Early Warning Indicators: an Accessible Tool to Assess Drug Resistance
9
HIVDR Early Warning Indicators (EWI)
Prescribing practices
Proportion lost to follow-up during the
first 12 months of ART
Patient retention on first-line ART
On-time ARV drug pick up
ART appointment
-keeping
Drug supply continuity
Site-level ART Program
Function
Viral load suppression @12 months
Pill count/ adherence
Where is the EWI data available?Republic of Namibia
Ministry of Health and Social Services
EWI
ADT site
Non-ADT
Site
Comment
% appropriate initial ART regimen
prescriptions (EWI 1a.1, 1a.2,1b)
√√# # only from 2
facilities
% starting first-line ART lost to follow-
up at 12 months
√√* *Only from 1
facility
% starting first-line ART retention on
first-line ART at 12 months (EWI
3a,3b)
√√* *Only from 1
facility
% on ART picking up all ART drug on
time (EWI 4a,4b)
√x
Months with no ARV drug stock-outs
(EWI 6a1,6a2, 6b, 6c)
xx
Summary of EWI at 14 Sites
Early Warning Indicator (EWI) EWI Target for all sites (Time Period)
No. of sites that meet EWI target (% of sites that meet target) N = 14
Percentage of appropriate initial ART regimen prescriptions
100% (Oct 2006 - Mar 2007) 7/14 (50%)
Percentage of patients starting first-line ART, lost to follow-up at 12 months of ART
≤20% (Oct 2006 - Mar 2007) 2/14 (14.3%)
Percentage of patients starting first-line ART, who are still on first-line ART at 12 months
≥70% (Oct 2006 - Mar 2007) 14/14 (100%)
Percentage of patients on ART picking up all ART drugs on time
≥90% (Oct 2006 - Mar 2007 to Oct 2007
- Mar 2008) 0/14 (0%)
Percentage of patients on ART keeping all clinical appointments on time
≥90% (Oct 2006 - Mar 2007 to Oct. 2007
- Mar 2008) 0/14 (0%)
Percentage of months with no ARV drug stock-outs
100% (2007) 5/10* (50%)
Vitoria (Abs 6037)
Ekra et al (Abs 1115) & Pereko et al (Abs 1997)
14 June 2009 Evolving Challenges in Treatment, Laboratory, Care and Support ServicesRapporteur Presentation
2009 HIV/AIDS Implementers’ Meeting
Windhoek, Namibia 10-14 June 2009
Creating a culture of “drug safety”using Pharmacovigilance
Pharmacovigilance: science and activities related to detection, assessment, understanding and prevention of adverse effects to decrease morbidity and mortality
Medication Error
Adverse Drug
Reaction
14 June 2009 Evolving Challenges in Treatment, Laboratory, Care and Support ServicesRapporteur Presentation
2009 HIV/AIDS Implementers’ Meeting
Windhoek, Namibia 10-14 June 2009
TB/HIV: Success and Challenges
• Scale up for HIV testing for TB patients is remarkable but ART uptake is lagging
• TB is the major cause of death in PLWH in RLS and a more aggressive approach is needed…
• TB screening is progressing but IPT & TB Infection control not yet…
Sessions 6, 20 and 54
14 June 2009 Evolving Challenges in Treatment, Laboratory, Care and Support ServicesRapporteur Presentation
2009 HIV/AIDS Implementers’ Meeting
Windhoek, Namibia 10-14 June 2009
Going Beyond TB
Evolving Challenges in Treatment, Laboratory, Care and Support ServicesRapporteur Presentation
14 June 2009
12
Clinical signs of
Clinical signs of
confirmed confirmed Cryptococcal
Cryptococcal Meningitis cases
Meningitis cases
(n=122)(n=122)
61,5 54,154,1
30,3 23,821,3
9
0
10
20
30
40
50
60
70
Stiff Neck Temp.>38Wasted
RestlessComa
Oral thrushFocal
N/deficit
Signs
Perc
enta
ge
Prevalence of HPV types by CD4count levels
0%
20%
40%
60%
80%
100%
HPV 16(p<0.01) HPV 18(p=0.15) HPV 33(p=0.9) HPV 56(p=0.9) HPV 59(p=0.5) HPV 66(p=0.04)
Any HPV(p<0.01)Oncogenic(p<0.01) Multipleoncogenic(p<0.01)
<200 200-500 >500
0%
20%
40%
60%
80%
100%
HPV 16(p<0.01) HPV 18(p=0.15) HPV 33(p=0.9) HPV 56
(p=0.9) HPV 59(p=0.5) HPV 66(p=0.04)
Any HPV(p<0.01)Oncogenic(p<0.01)
Multipleoncogenic(p<0.01)
<200 200-500 >500
Masanika (Abs 1348)Firnhaber (Abs 612)
2009 HIV/AIDS Implementers’ Meeting
Windhoek, Namibia 10-14 June 2009
Improving Quality of Care through PLWH and Community Involvement
Community and Home Based Care Workers
Aggarwal et al (Abs 879)
Mpangile et al (Abs 895)
14 June 2009 Evolving Challenges in Treatment, Laboratory, Care and Support ServicesRapporteur Presentation
2009 HIV/AIDS Implementers’ Meeting
Windhoek, Namibia 10-14 June 2009
Final Messages• Treatment: " Be realistic and aligned to your context but continue to push for
inspirational targets“
• Laboratory:" Strengthen lab services, but don't permit absence of lab tests to be a
barrier to access treatment and care“
• Care: " Try to be simple, not simplistic“
• Support:" Promote efficient access to care and treatment with and for PLWH,
and prioritize people most in need"
14 June 2009 Evolving Challenges in Treatment, Laboratory, Care and Support ServicesRapporteur Presentation
2009 HIV/AIDS Implementers’ Meeting
Windhoek, Namibia 10-14 June 2009
Acknowledgements
• The Government and people of Namibia
• All presenters and participants
• The organizers and sponsors
• The team of rapporteurs
• The clients of HIV programs, worldwide—you give us reason to continue!
14 June 2009 Cross-Cutting Rapporteur Presentation
2009 HIV/AIDS Implementers’ Meeting
Windhoek, Namibia 10-14 June 2009
Thank You / Tangi
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