2009 HIV/AIDS Implementers Meeting Windhoek, Namibia - 10 ... · 9Costing of ART scale up ... 331)...

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



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




Some numbers…

• 14 sessions (6, 7, 13, 16, 20, 23, 30, 37, 41, 47, 54, 55, 57 and 59)

• 64 oral presentations

• 24 posters




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




How will the economic crisis affect HIV treatment programmes?




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


Session 7 (Abstracts 61, 233, 888, 2006, 6033, 6101)



Can CD4 cell count predict virologic failure?


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)



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)




More than just CD4 and VL …




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



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)




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)




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




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)




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




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




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)



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)




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"




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



Thank You / Tangi

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