2009 HIV/AIDS Implementers Meeting Windhoek, Namibia June, 2009 Rappourteur Session

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1 Evolving Challenges in Treatment, Laboratory, Care and Support Services 2009 HIV/AIDS Implementers Meeting Windhoek, Namibia June, 2009 Rappourteur Session

2 Rapporteur Team Marco Vitoria, MD, WHO 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)

3 Some numbers 14 sessions (6, 7, 13, 16, 20, 23, 30, 37, 41, 47, 54, 55, 57 and 59) 64 oral presentations 24 posters

4 Major Topics Costing of ART scale up ART monitoring strategies QA for laboratory services Adherence monitoring Access to treatment & early mortality ART and treatment retention HIVDR & Pharmacovigilance TB/HIV (3Is, collaborative activities & clinical management) OI & Cancer diagnosis and management Linking ART services to community & other services

5 How will the economic crisis affect HIV treatment programmes?

6 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 national programs, 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)

7 Can CD4 cell count predict virologic failure? Virological Profile in Immunological Failure Cases Time to Failure with both Virologic and immunologic Failure (n=1331) VL failure prior to CD4 failure n=441 Concordant Group Intermediate Group CD4 and VL failure at same time n=674 CD4 failure prior to VL failure n=216 ANUSUYA et al (Abs 1275) Kanki (Abs 6039)

8 Is Viral Load Testing Cost Effective Strategy in ART Failure? Effect of VL Policy: Costs of Testing Program Projected Annual Costs of VL Testing for ART Patients, Cost-Benefit Analysis Criteria for treatment Failure Incremental Cost of testing Total Cost Incremental Cost of drugs Total Savings (1 yr) Net Benefit (USD) VL detectable -515 tests, 206 undect. -repeat VL testing in 6 months, 206 pts, 10% detectable - 15, , ,744 6,180 21,630 14, , ,874 Effect of VL Policy: More Patients on 2 nd -Line ART Additional Costs due to Faster Transition to 2 nd -line ARVs, Formula for calculating cost-effectiveness of VL testing for suspected treatment failure to 1 st -line ARV Cost of VL Test < Expected cost savings of each VL test in preventing unnecessary 2 nd -line ARV use Cost of VL Test < (1-PPV)(ARV2 ARV1) PPV = Positive Predictive Value of Clinical and Immunological Criteria for Treatment Failure to 1 st line ARV ARV2 = Cost of 2 nd line ARV drugs for 1 year ARV1 = Cost of 1st line ARV drugs for 1 year Nelson (Abs 6018) Colby (Abs. 1624)

9 More than just CD4 and VL

10 High False-Positive Rates on EQA3-A5 When Testing with Determine HIV-1/2 EQA Spec. Expected Result N NPos (%) NInv (%) NNeg (%) 1 A2 NEG A5 NEG A1 NEG A4 NEG A6 NEG A1 NEG A2 NEG A5 NEG June 2009 Jani et al (Abs 602) Evolving Challenges in Treatment, Laboratory, Care and Support Services

11 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: Haberer (Abs 6005) & Stirratt (Abs 6006) Stirratt (Abs 6006)

12 Role of CD4 on Promoting Early Access to Treatment KNOW YOUR CD4 CAMPAIGN Determining missed opportunity for timely ART WHO Stage # of patients # Eligible for ART based on CD4 + WHO Percent eligible for ART I % II % III % CD4 at enrollment IV % No Stage % Total % 8 Mubiru et al (Abs 1208) Memiah (Abs 1318) 10

13 Impact of Early and Intensive Follow up on Mortality and Retention Probability of remaining alive & in care Proportion surviving Proportion surviving and in care p=0.009 Routine Care Express Care Days since cart initiation p<0.001 Routine Care Express Care Days since cart initiation 1.00 Relative hazard of mortality: ART-LINC vs. ART-CC unadjusted HR adjusted HR 0.85 (adjusted for cohort, age, sex, baseline CD4, ART-regimen, disease stage) ART-LINC Collaboration, The Lancet 367(9513): Factors Associated with Retention at 6 and 12 Months after ART Initiation 6 Months 12 Months AOR (95% CI) AOR (95% CI) Baseline clinical Baseline CD4 200 cells/µl Baseline BMI ( ) 1.13 ( ) Braitstein et al (Abs 1556) 2.79 ( ) 1.71 ( ) Baseline Hb 8 g/dl 2.26 ( ) 1.99 ( ) Prescribed CTX at baseline 1.89 ( ) 1.70 Mbofana et al (Abs 1608) ( )

14 HIV Early Warning Indicators: an Accessible Tool to Assess Drug Resistance HIVDR Early Warning Indicators (EWI) Prescribing practices Drug supply continuity Proportion lost to follow-up during the first 12 months of ART Site-level ART Program Function Patient retention on first-line ART On-time ARV drug pick up Republic of Namibia Where is the EWI data available? Ministry of Health and Social Services EWI ADT site % appropriate initial ART regimen prescriptions (EWI 1a.1, 1a.2,1b) % starting first-line ART lost to followup at 12 months % starting first-line ART retention on first-line ART at 12 months (EWI 3a,3b) % on ART picking up all ART drug on time (EWI 4a,4b) Months with no ARV drug stock-outs (EWI 6a1,6a2, 6b, 6c) 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 Non-ADT Comment Site # # only from 2 facilities * *Only from 1 facility * *Only from 1 facility x x x Pill count/ adherence ART appointment -keeping Viral load months 9 Percentage of appropriate initial ART regimen prescriptions Percentage of patients starting firstline ART, lost to follow-up at 12 months of ART Percentage of patients starting firstline ART, who are still on first-line ART at 12 months 100% (Oct Mar 2007) 7/14 (50%) 20% (Oct Mar 2007) 2/14 (14.3%) 70% (Oct Mar 2007) 14/14 (100%) Vitoria (Abs 6037) Percentage of patients on ART picking up all ART drugs on time Percentage of patients on ART keeping all clinical appointments on time 90% (Oct Mar 2007 to Oct Mar 2008) 0/14 (0%) 90% (Oct Mar 2007 to Oct Mar 2008) 0/14 (0%) Percentage of months with no ARV drug stock-outs 100% (2007) 5/10* (50%) Ekra et al (Abs 1115) & Pereko et al (Abs 1997)

15 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

16 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

17 14 June HIV/AIDS Implementers Meeting Going Beyond TB Clinical Clinical signs signs of of Cryptococcal Meningitis Meningitis cases cases Prevalence of HPV types by CD4 confirmed confirmed Cryptococcal (n=122) (n=122) 100% 100% 80% 80% count levels 60% 54,1 54,1 30,3 23,8 21,3 40% 20% 20% 61,5 9 Stiff Neck Temp.>38 Wasted Restless Coma Oral thrush Focal N/deficit Signs 0% 0% HPV 16 (p<0.01) HPV 16 (p<0.01) HPV 18 (p=0.15) HPV 18 (p=0.15) HPV 33 HPV (p=0.9) 33 (p=0.9) HPV 56 HPV (p=0.9) 56 (p=0.9) HPV 59 HPV (p=0.5) 59 (p=0.5) 12 HPV 66 (p=0.04) HPV 66 (p=0.04) < >500 < >500 Any HPV Any (p<0.01) HPV (p<0.01) Oncogenic Oncogenic (p<0.01) (p<0.01) Multiple oncogenic Multiple oncogenic (p<0.01) (p<0.01) Masanika (Abs 1348) Firnhaber (Abs 612) Evolving Challenges in Treatment, Laboratory, Care and Support Services Percentage 40

18 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)

19 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"

20 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

21 Thank You / Tangi

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