Headline : An isolated viral load test may generate false positive results for people using long-acting PrEP

Read more from the original article on here at www.nih.gov.

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Analysis from large NIH study offers new insight on clinical utility of current U.S. testing algorithm.

A single laboratory-based HIV viral load test used by U.S. clinicians who provide people with long-acting, injectable cabotegravir (CAB-LA) HIV pre-exposure prophylaxis (PrEP) did not reliably detect HIV in a multi-country study. In the study, a single positive viral load test was frequently found to be a false positive result. However, a second viral load test with a new blood sample was able to distinguish true positive results from false positive results for all participants whose initial viral load test was positive. The findings were presented at the 2024 International AIDS Conference (AIDS 2024) in Munich, Germany.

“We are still learning how to optimize the package of services that accompany long-acting PrEP, including HIV testing,” said Jeanne Marrazzo, M.D., M.P.H., director of the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID). “The viral load testing findings observed in this study illuminate performance gaps in the current U.S. HIV testing algorithm for injectable cabotegravir PrEP.”

Long-acting, injectable cabotegravir PrEP, known as CAB-LA, is a highly effective HIV prevention method, administered by intramuscular injection every two months. Routine HIV status monitoring is recommended for any form of PrEP to ensure that people can promptly be aware if they acquire HIV while taking PrEP drugs. In the United States, people taking oral PrEP can do this with point-of-care rapid tests and self-tests that detect HIV antibodies, or laboratory-based HIV testing. However, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) recommend that people starting or taking CAB-LA PrEP receive a laboratory-based viral load test that detects HIV genetic material in the blood. This recommendation was made because CAB-LA can keep HIV antibodies at such low levels following acquisition that they might not be detected on an antibody-based test. To better inform the U.S. CAB-LA PrEP HIV testing algorithm, researchers examined the accuracy of viral load test results in an open-label extension of a large CAB-LA PrEP efficacy study.

Read more from the original article on here at www.nih.gov.

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