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Simplification, cost-reduction strategies and examples from the field

Simplification, cost-reduction strategies and examples from the field . Teri Roberts Diagnostics Advisor MSF Access Campaign. Virological Monitoring Detects Treatment Failure Early On. Adapted from Bartlett et al. Lancet Infect Dis 2009.

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Simplification, cost-reduction strategies and examples from the field

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  1. Simplification, cost-reduction strategies and examples from the field Teri Roberts Diagnostics Advisor MSF Access Campaign

  2. Virological Monitoring Detects Treatment Failure Early On Adapted from Bartlett et al. Lancet Infect Dis 2009

  3. Across programmes: 2% of treated patients are on 2nd-line ART In South Africa (Khayelitsha), where routine virological monitoring is available: 12% on 2nd-line after 5 years

  4. HIV Policy and Progress Indicators Across 16 Countries OPT: optional; REQ: required; LTD: limited Lynch et al. Science 2012

  5. How to increase access to virological monitoring? • Reduce complexity • Reduce price • Market entry • Volume • Competition • Open and polyvalent platforms • Price transparency • Field validate new and current tests (point of care and lab-based) • Perform operational research to define best adapted and most feasible tests for different settings • Introduce viral load testing in a phased in approach • Define testing frequency • Replace CD4 monitoring with viral load monitoring • Implement evidence-based algorithms to prioritise patients

  6. Simplifying sample transport by using DBS • Quick processing of whole blood • Inefficient sample networks • Alternative: dried blood spots • Long distances, ambient temperature • Time to result: e-health, m-health • Fingerprick DBS • NucliSENSEasyQ® HIV-1 v2.0 viral load test (bioMerieux) for DBS • MSF validation of fingerprick DBS in Malawi • Other tests for use with DBS?

  7. NucliSENSEasyQ® HIV-1 v2.0 (bioMérieux) 1. Extraction room • Thyolo district hospital, Malawi • DBS validated • Real time NASBA (isothermal signal amplification), RNA specific • Logistical challenges: • laboratory infrastructure • unreliable power supply • unreliable water supply • provision of RNAse-free water • unreliable air-conditioning • non-adherence to cold chain transportation, especially at customs • inability to find local laboratory technicians with molecular biology expertise • lack of in-country trouble-shooting and maintenance services 2. Amplification room

  8. Generic HIV viral load assay (Biocentric) • Nhlangano health center, Swaziland • Open system, low cost • Real time RT-PCR (DNA and RNA) • Logistical challenges • Use of plasma as a sample type (use of DBS is research use only) • Most of the other challenges as for the NucliSENS test

  9. ExaVirTM Load Version 3 (Cavidi) • Yangon, Myanmar (field site is in Shan state) • Subtype independent, relatively low cost, minimal lab requirements, not as prone to contamination and not as dependent on precision pipetting as molecular lab tests • ELISA of HIV reverse transcriptase activity • Challenges include: • Must be performed on plasma • Plasma must be frozen at -20°C • Need for back-up vacuum pump • Relatively low through-put for lab test • Good water quality is essential • Positive and negative controls must be supplied in-house • Sample preparation to isolate the reverse transcriptase enzyme is labour- intensive

  10. Formore information, please grab a copy of our viral load report (also available on our website: www.msfaccess.org)

  11. Performance evaluation of SAMBA semi-quantitative HIV viral load test for therapy monitoring in resource-poor settings Dr. Suna Balkan MSF Aids Working Group

  12. Scaling-up in the MSF project Chiradzulu district, Malawi 7000 6000 5000 4000 3000 2000 1000 0 2001 2002 2003 2004 2005 Inclusions/month Cumulated patients under ART Task shifting Need for a POC VL Decentralisation

  13. SAMBA system characteristics All HIV1 subtypes & recombinants Threshold 1,000 copies/ml Heat stability at 50°C Robust & simple instrument No or minimum electricity Minimum handling No risk of contamination Turn around time allowing same day result Affordable cost Can detect Groups M, N, O & recombinants Cut-off at 1,000 copies/ml Heat stable reagents; no cold chain transport or storage Isothermal amplification with simple visual detection Low power requirement 350W Preloaded reagents in a closed cartridge Test time = 90 minutes with throughput of 24/day at 6.5 hr working day MSF requirements SAMBA

  14. Visual readout of SAMBA semi-quant VL test <1,000 cp/ml ≥1,000 cp/ml

  15. SAMBA system SAMBA-prep (sample extraction) SAMBA-amp (amplification) 1 to 4 samples per run

  16. Evaluation of SAMBA London St Thomas & Royal London Hospitals in 134 clinical samples Roche Taqman v2 (copies/ml) * Roche TaqMan accuracy: +/- 0.3 Log per package insert Concordance between SAMBA & Roche = 97.8 % (131/134)

  17. Malawi 13.2 million population mainly rural 1 million HIV-infected MSF project based in a rural district 1 hospital (laboratory),10 health centres HIV care in 2000,decentralisation in 2003 25 000 patients followed under ART 80% followed in the 10 decentralised health centres Integrated project with MOH MSF Chiradzulu project background

  18. MSF Arua project background • Northwestern Uganda • Arua + catchment population : • 1,5 M • HIV prevalence 3% • ART project since 2002 • Arua District Hospital • 7000 patients followed under ART • Integrated project with the MOH

  19. SAMBA field trials in Malawi and Uganda 200 HIV+ patients in Malawi 154 HIV+ patients in Uganda recruited from HIV clinic during routine visit 200 µl fresh plasma Frozen plasma shipped directly SAMBA tested on-site by MSF technician Roche TaqMan v2 at Royal London Hospital Discordant SAMBA/Roche Abbott RealTime PCR at Addenbrooke Results to MSF All testing blinded to each other

  20. Malawi results – SAMBA vs Roche TaqMan v2 Roche TaqMan version 2 * Roche TaqMan accuracy is +/- 0.3 Log per package insert Overall concordance with Roche v2 = 98% (196/200)

  21. Uganda results – SAMBA vs Roche TaqMan v2 Roche TaqMan v2 * Roche TaqMan is 0.3 Log accuracy (package insert) Overall concordance with Roche v2 = 96.1% (148/154)

  22. Conclusion SAMBA platform is much simpler than currently available molecular technologies which require highly-trained personnel and sophisticated infrastructure only available in centralised laboratories SAMBA device is much easier to handle and being a closed system, prevents contamination by amplicons Staff training requirement for SAMBA is minimal SAMBA can be implemented in lower healthcare levels such as district hospitals or health centres with a basic laboratory but supplied with electricity Routine use of Samba will be now implemented in Arua and Chiradzulu with on going evaluation Will improve HIV care in a decentralization & task shifting strategy

  23. Virological efficacy of ART over time at MSF sites in Arua and Chiradzulu n = 284 > 65 % of patients on ART have VL < 40 cp/ml after 6 months > 80 % of patients on ART have VL < 1,000 cp/ml after 6 months

  24. Distribution of viral loads in treated and untreated individuals in Malawi & Uganda 1,000 cp/ml <100 <40 1x105 1x104 1x103 1x102 1,000 cp/ml 1,000 cp/ml 1,000 cp/ml 1x105 1x104 1x103 1x102 <100 <40 1x105 1x104 1x103 1x102 <100 <40 1x105 1x104 1x103 1x102 <100 <40

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