Simplification, cost-reduction strategies and examples from the field Teri Roberts Diagnostics Advisor Médecins Sans Frontières, Access Campaign 7th International AIDS Conference 2 July 2013
Virological monitoring detects treatment failure earlier than clinico-immunological monitoring
How viral load testing fits into the package of care to ensure people stay undetectable Early treatment Routine viral load Adherence support Community- based & self- managed therapy Drop routine CD4 monitoring for virally suppressed ART treated PLWHA and rather use routine VL monitoring to trigger the need for CD4 testing (is CD4 over 200 cells/ul?)
Viremic patients can re-suppress following an adherence intervention
The importance of preserving first line, affordable, robust, one-pill-a-day regimens
Implementation is done in support of, and in collaboration with, the Ministries of Health and reference laboratories SAMBA CAVIDI BIOMERIEUX BIOCENTRIC
G. Patten et al. Poster TUPDD0106 (Oral abstract session: The point of point of care (Tuesday)) Youth and adolescents have been identified as a particularly vulnerable group, at greater risk of loss from both pre-ART and ART care. MSF supported clinic in Khayelitsha, Cape Town, South Africa: implemented POC CD4-testing at a clinic dedicated to youth aged 12 to 25 years. POC CD4 testing significantly improved assessment for ART eligibility, ensuring that most youth were made aware of their treatment needs on the day of HIV diagnosis. Does point-of-care (POC) CD4 testing reduce losses from care between HIV diagnosis, assessment for ART eligibility and ART initiation among HIV-positive youth in Khayelitsha, South Africa?
Group A (Before)Group B (After) HIV Testing Blood sample drawn for CD4 counting WHO Staging* ART preparation counselling sessions ART Initiation CD4 Result ART eligibility assessed Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 HIV Testing Blood sample drawn for CD4 counting WHO Staging ART preparation counselling session ART Initiation CD4 Result ART eligibility assessed Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 44% 50% 34 days 28 days P=0.6
Point-of-care versus laboratory-based tests for viral load testing Regional-level laboratory tests will use dried blood spot samples that can use finger or heel prick blood
Diagnostic accuracy of DBS using the COBAS Ampliprep/COBAS TaqMan HIV-1 v2.0 (CAP/CTM) NMRL, Harare, Zimbabwe in collaboration with MSF Sekesai Mtapuri-Zinyowera (WEPE610 - Poster Exhibition on Wednesday) 118 finger prick DBS, venous blood DBS and plasma specimens from ART patients attending two rural OI clinics in Buhera and Tsholotsho districts and one urban OI clinic in Harare good sensitivity of DBS compared to HIV-1 RNA plasma but very low specificity, which translated in a higher rate of false positive results with DBS at lower VLs (<3.5log) COBAS ® AmpliPrep/COBAS ® TaqMan ® HIV-1 Test Dried Fluid Spot Procedure RUO Sample Collection ±70 μL of capillary and EDTA blood (air dry min. 3h) detach and transfer 1 spot (Ø 12 mm) 56 0 C, 10 min, 1000 rpm+1000 μL SPEX S-input tube Controls Fully automated nucleic acid extraction and amplification/detection Pre-extraction
Pooling methods, in combination with the use of fingerprick DBS as a sample type for VL testing, can importantly reduce costs while maintaining accuracy Efficiency expressed as cost savings: Example of Thyolo District – Population: 620,000 – HIV prevalence: 14,5% – # VL tests needed/year: 23,000 – Price per VL test: $24 Total cost/year = 23,000 x $24 = $552,000 – Efficiency at 1,000 cps/mL = 28,6% => $157,800 saved – Efficiency at 5,000 cps/mL = 51,4% => $283,700 saved Sample µL 100 µL Pool 500 µL Viral load testing 100 µL Sample µL Sample µL Sample µL Sample µL What to do with pooled results? 1. Pooled VL result no further testing 2. Pooled VL result > threshold => further testing MSF has previously validated the use of fingerprick DBS on the bioMerieux NucliSENS EasyQ HIV-1 platform, which is RNA-specific
Reports: IAS poster TUPDD0102 and Oral abstract session: The point of point of care (Tuesday) 2013