Cure research: Monitoring HIV Viral Load during ATI’s

Analytical treatment interruptions (ATIs) are structured and temporary interruptions of antiretroviral therapy (ART) performed in the context of HIV cure clinical studies. ATIs are commonly used to assess the efficacy of cure interventions aimed at achieving durable virological control in the absence of ART or achieving ART-free HIV remission.  

Monitoring HIV viral load (VL) during ATIs is a requirement to assess the efficacy of the intervention and to ensure the safety of healthcare clients. VL is measured by molecular tests that require a high level of technical expertise and laboratory capacity.  

In many low- and middle-income countries, VL testing is performed at centralized laboratories and the time to delivery of results is lengthy. This prevents timely monitoring of VL while subjects are receiving cure interventions.  

In these settings, VL monitoring requires coordinated transportation of specimens and return of results between clinical sites and centralized laboratories. Sending samples to a central laboratory poses risks of significant delays, misplacing or losing samples and results, as well as necessitating multiple client visits.  

VL testing with point‐of‐care (POC) platforms that can be used near clients can potentially be easy to use, cost effective and give quick results; they could replace central or reference VL testing platforms. But PoC platforms do have shortcomings. PoC testing requires a constant power supply, proper assay maintenance and quality assurance, and supply chain capacity to stock, store and safely dispose of cartridges and reagents. Cost and sensitivity are additional important factors for PoC VL testing.  

Additionally, new “at-home” sampling strategies could be considered as an alternative to requiring that participants travel to clinical sites for regular testing and could reduce the number of study visits. 

This roundtable brought together representatives from the Industry Collaboration Group, researchers, clinicians and trial participants to explore how best to perform PoC VL testing in cure research involving ATIs in low- and middle-income settings. 

7 October 2022
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Chairs

Timothy Henrich

University of California San Francisco

Bonnie Howell

Merck

Speakers

Timothy Henrich

University of California San Francisco

Analytical Antiretroviral Treatment Interruption (ATI) in cure research

Bonnie Howell

Merck

Engaging diagnostics developers

Sinead Delany-Moretlwe

Director of Research

Wits RHI

Lessons from monitoring Viral Load during treatment with LA-ARV

Lydie Trautmann

Associate Professor

Oregon Health & Science University

Non-viral load measurements (Early markers of cell activation)

Chris Parkhouse

Cepheid

Challenges of developing Viral Load PoC assays – An Industry perspective

Elliot Raizes

PEPFAR

Challenges with measuring viral load in low- and middle-income countries

Sarah Fidler

Imperial College London

How to monitor VL when designing cure trials with ATI

Thumbi Ndung’u

Africa Health Research Institute

Monitoring VL in low- and middle-income country settings and planning for access