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. 2023 Jun 1;37(7):1109-1113.
doi: 10.1097/QAD.0000000000003520. Epub 2023 Feb 16.

Point-of-care urine tenofovir testing to predict HIV drug resistance among individuals with virologic failure

Suzanne M McCluskey  1   2   3 , Katya Govender  4 , John Adamson  4 , Monica Gandhi  5 , Matthew A Spinelli  5 , Mahomed-Yunus Moosa  6 , Winnie Muyindike  7 , Pravi Moodley  6   8 , Melendhran Pillay  8 , Godfrey Masette  7 , Henry Sunpath  6 , Selvan Pillay  9 , Geoffrey Chen  1 , Bethany Hedt-Gauthier  3   10 , Vincent C Marconi  11   12 , Mark J Siedner  1   2   3   4   6   7
Affiliations

Point-of-care urine tenofovir testing to predict HIV drug resistance among individuals with virologic failure

Suzanne M McCluskey et al. AIDS. .

Abstract

Objective: We sought to evaluate the utility of a point-of-care (POC) urine tenofovir (TFV) assay, developed to objectively assess adherence, to predict HIV drug resistance (HIVDR) in people failing first-line antiretroviral therapy (ART).

Design: We retrospectively analyzed TFV levels as a biomarker of adherence in urine specimens collected during a clinical trial that enrolled adults with virologic failure on first-line ART in Uganda and South Africa.

Methods: Urine specimens were analyzed from participants on TFV-containing regimens who had a viral load >1000 copies/ml and paired genotypic resistance test (GRT) results. We assessed recent ART TFV adherence with a qualitative POC lateral flow urine assay with a cut-off value of 1500 ng/ml. We then calculated performance characteristics of the POC urine TFV assay to predict HIVDR, defined as intermediate or high-level resistance to any component of the current ART regimen.

Results: Urine specimens with paired plasma GRT results were available from 283 participants. The most common ART regimen during study conduct was emtricitabine, tenofovir disoproxil fumarate, and efavirenz. The overall prevalence of HIVDR was 86% ( n = 243/283). Of those with TFV detected on the POC assay, 91% ( n = 204/224) had HIVDR, vs. only 66% ( n = 39/59) among those with no TFV detected ( P- value < 0.001). Positive and negative predictive values of the assay to predict HIVDR were 91% and 34%, respectively.

Conclusions: In populations with a high prevalence of HIVDR, the POC urine TFV assay can provide a low-cost, rapid method to guide requirements for confirmatory resistance testing and inform the need for regimen change.

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Figures

FIGURE 1.
FIGURE 1.
Proportion with HIV Drug Resistance in Participants with and without Detectable Urine Tenofovir, Stratified by HIV-1 RNA Viral Load, Age, and Duration of Antiretroviral Therapy. We calculated the proportion with HIV drug resistance among participants with and without detectable tenofovir in urine using the point of care assay, stratified by HIV-1 RNA viral load, age, and duration of ART. Using the Stanford algorithm [12], HIV drug resistance was defined as intermediate to high-level resistance to any component of the current antiretroviral therapy regimen. TFV=tenofovir, VL=viral load, ART=antiretroviral therapy, HIVDR=HIV drug resistance
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References

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