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An Isolated Viral Load Test May Generate False Positive Results for People Using Long-Acting PrEP |
A recent multi-country study revealed that a single laboratory-based HIV viral load test used for people on long-acting injectable cabotegravir (CAB-LA) PrEP can often produce false positive results. The findings, presented at the 2024 International AIDS Conference in Munich, Germany, show that while an initial positive test may be incorrect, a follow-up test with a new blood sample reliably confirms true positives.
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Dr. Jeanne Marrazzo from the National Institutes of Health (NIH) noted that this study highlights gaps in the current HIV testing protocols for CAB-LA PrEP. CAB-LA, a highly effective HIV prevention method administered every two months, can sometimes keep HIV antibody levels too low for detection by traditional antibody-based tests.
The study followed 2,620 participants from a large CAB-LA efficacy trial. Out of 29 participants who acquired HIV during the study, five were initially identified through a single positive viral load test, though two had received CAB-LA within six months and three had not been treated for over six months. Twenty-three other participants with a single positive test were later confirmed to be HIV-negative, indicating false positives. A second confirmatory test corrected these errors, with the accuracy improving to 100% with the new sample.
Dr. Raphael Landovitz, who led the study, emphasized that false positives can lead to unnecessary PrEP interruptions and significant psychological stress. However, these risks must be weighed against the benefits of earlier HIV detection.
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Previous analyses showed that using two antibody-based tests together provided a higher accuracy for CAB-LA users. This study’s results help address the limitations of current HIV testing methods and inform future PrEP implementation strategies.
The study, known as HPTN 083, is supported by NIH, ViiV Healthcare, Gilead Sciences, and other collaborators. For more details, visit ClinicalTrials.gov and search for identifier NCT02720094.
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This release was published by the National Institutes of Health on July 23, 2024.
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