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STRONG CORRELATION BETWEEN CONCENTRATIONS OF TENOFOVIR (TFV) EMTRICITABINE (FTC) IN HAIR AND TFV DIPHOSPHATE AND FTC TRIPHOSPHATE IN DRIED BLOOD SPOTS IN THE IPREX OPEN LABEL EXTENSION: IMPLICATIONS FOR PRE-EXPOSURE PROPHYLAXIS ADHERENCE MONITORING
PrEP
Adherence
Dried blood spot (DBS) concentrations
Hair concentrations
iPrEx Open Label Extension (OLE)
Pharmacologic monitoring
Pre-exposure prophylaxis
Tenofovir/emtricitabine
Author
Affilliation
University of California. Department of Medicine. USA.
University of California. Department of Epidemiology and Biostatistics. USA.
San Francisco Department of Public Health. University of California Bridge HIV. Department of Medicine. USA.
University of Colorado. Department of Pharmaceutical Sciences. Denver, USA.
University of California. Department of Bioengineering and Therapeutic Sciences. USA.
Gladstone Institutes. San Francisco, USA.
Investigaciones Medicas en Salud. Lima, Peru.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Chiang Mai University. Research Institute for Health Sciences. Thailand.
University of Cape Town. The Desmond Tutu HIV Centre. South Africa.
University of California Gladstone Institutes. Department of Medicine. San Francisco, USA.
University of California. Department of Epidemiology and Biostatistics. USA.
San Francisco Department of Public Health. University of California Bridge HIV. Department of Medicine. USA.
University of Colorado. Department of Pharmaceutical Sciences. Denver, USA.
University of California. Department of Bioengineering and Therapeutic Sciences. USA.
Gladstone Institutes. San Francisco, USA.
Investigaciones Medicas en Salud. Lima, Peru.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Chiang Mai University. Research Institute for Health Sciences. Thailand.
University of Cape Town. The Desmond Tutu HIV Centre. South Africa.
University of California Gladstone Institutes. Department of Medicine. San Francisco, USA.
Abstract
Self-reported adherence to pre-exposure prophylaxis (PrEP) has limitations, raising interest in pharmacologic monitoring. Drug concentrations in hair and dried blood spots (DBS) are used to assess long-term-exposure; hair shipment/storage occurs at room temperature. The iPrEx Open Label Extension collected DBS routinely, with opt-in hair collection; concentrations were measured with liquid chromatography/tandem mass spectrometry. In 806 hair-DBS pairs, tenofovir (TFV) hair levels and TFV diphosphate (DP) in DBS were strongly correlated (Spearman coefficient r = 0.734; P < .001), as were hair TFV/DBS emtricitabine (FTC) triphosphate (TP) (r = 0.781; P < .001); hair FTC/DBS TFV-DP (r = 0.74; P < .001); hair FTC/DBS FTC-TP (r = 0.587; P < .001). Drug detectability was generally concordant by matrix. Hair TFV/FTC concentrations correlate strongly with DBS levels, which are predictive of PrEP outcomes.
Keywords
HIV preventionPrEP
Adherence
Dried blood spot (DBS) concentrations
Hair concentrations
iPrEx Open Label Extension (OLE)
Pharmacologic monitoring
Pre-exposure prophylaxis
Tenofovir/emtricitabine
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