Alternative technologies: performance and regulatory status Mexico City, Mexico July 2019

Title

Most viral load labs are in major urban centre Kenya Zimbabwe Uganda Malawi These data are being updated, but primarily viral load labs are generally located in urban centres. The green circles represent the 6-24 hour radius around the labs within which blood samples can be transported to the lab. Generally, blood samples beyond this radius should not be tested, but alternative sample types or technologies considered unless infrastructure improves considerably. Note: this slide only reflects the PCR testing labs used for VL testing in the public sector. This excludes private PCR testing labs or those used for research purposes. Some circle represent multiple labs in the same city

… and so are the largest ART facilities where patients seek care 52% [38% - 90%] of ART patients1 are at facilities close to centralized labs and can transport samples within 24 hours Can be accessed using EDTA blood Fortunately, a significant proportion (48%) of ART patients seek care within 24 hours of these labs. Again, these data are being updated. However, this also indicates that in order to expand access to viral load, half of patients cannot be tested using the gold standard of plasma in the laboratory. So alternative strategies, such as dried blood spots, point-of-care, etc will need to be considered. Require alternative strategy 1 Data based on facility level ART patient numbers Eswatini, Nigeria, Rwanda, and Zimbabwe

How quickly do we need to get samples to the lab? 24 hours 8 hours 6 hours Abbott Hologic Roche Cepheid Cavidi Siemens

So how do we provide greater access to viral load testing? Plasma Dried blood spots Dried plasma spots Plasma preparation tubes Near POC VL for EID

An increasing menu of options exists WHO prequalification: Abbott RealTime m2000 Abbott m-PIMA bioMerieux EasyQ Cepheid Xpert Hologic Aptima Roche COBAS v2.0 Siemens VERSANT

Dried blood spot specimens

Dried plasma spot specimens Very similar to dried blood spot specimens, except spot the filter card with plasma Requires a centrifuge at the location of spotting, either health care facility or a hub

Plasma preparation tubes

Near point-of-care viral load technologies For consideration in 2020 Consolidated Guidelines revision

What is the impact of POC VL? There is currently no WHO recommendation to use point-of-care or near point-of-care technologies for treatment monitoring; however, impact studies and implementation considerations are ongoing. POC VL Pregnant women Infants and children Advanced disease Suspected failing Re-entering care Currently we don’t yet recommend POC VL; however, impact studies and implementation considerations are ongoing. This question will, therefore, be considered and reviewed in 2020 guideline processes, both for the general population as well as for some of these potential sub-populations.

Call for diagnostic integration Several calls for diagnostic integration using these multiplex technologies have been raised, including from WHO with an information note released in 2016 (on left). Further, Unitaid also developed a landscape document highlighting several of these technologies (right doc). Additionally, a meeting will be held here in Geneva co-hosted by ASLM and WHO HIV and TB departments in July with about 20 countries from all regions to discuss best practices and challenges of diagnostic integration. As of 31 December 2018, a total of 10,562 GeneXpert instruments (comprising 47,567 modules) had been cumulatively procured in the public sector in 136 of the 145 countries eligible for concessional pricing. Additional guidance to be developed in 2019 and 2020

Plasma preparation tubes Conclusions Plasma Dried blood spots Dried plasma spots Plasma preparation tubes Near POC VL for EID We have a number of technologies and specimens at our disposal, with regulatory approvals, that can support expansion of viral load scale-up Re-focus our diagnostic thinking on how best to implement these strategies / interventions and improving the clinical-lab interface, ensuring results are being used Let’s get viral load results into the hands of the clinicians and all recipients of care!

Acknowledgements Robert Luo, Kameko Nichols and Neil Parkin ASLM: Charles Kiyaga and Anafi Mataka CHAI: Paolo Maggiore, Maria Rosezoil Rioja and Jilian Sacks EGPAF: Jennifer Cohn USAID: Dianna Edgil, Matthew Wattleworth and Jason Williams WHO: Fatim Cham Jallow, Fausta Mosha, Mercedes Perez and Ute Stroher Link: https://apps.who.int/iris/bitstream/handle/10665/325961/9789241516211-eng.pdf