Tenofovir-Diphosphate and Emtricitabine-Triphosphate Adherence Benchmarks in Dried Blood Spots for Persons With HIV Receiving Tenofovir Alafenamide and Emtricitabine–Based Antiretroviral Therapy (QUANTI-TAF)

作者：Ryan P Coyle, Mary Morrow, Sarah Mann, Vincent Mainella, Samuel L. Ellis, Stefanie Schwab, Corwin Coppinger, Nicholas Barker, Lucas Ellison, Jia‐Hua Zheng, Subhi Al Zuabi, Pamela E Alpert, Tony C Carnes, D Eric Buffkin, Peter R. Chai, Lane R. Bushman, Jennifer J. Kiser, Samantha MaWhinney, Kristina M. Brooks, Peter L. Anderson, José Castillo‐Mancilla · 发表于：Clinical Infectious Diseases · 年份：2024 · DOI：10.1093/cid/ciae212 · 被引用次数：9 · 研究领域：HIV/AIDS Research and Interventions、HIV-related health complications and treatments、Biosimilars and Bioanalytical Methods

BACKGROUND: QUANTI-TAF aimed to establish tenofovir-diphosphate (TFV-DP)/emtricitabine-triphosphate (FTC-TP) adherence benchmarks in dried blood spots (DBS) for persons with human immunodeficiency virus (PWH) receiving tenofovir alafenamide/emtricitabine (TAF/FTC)-based antiretroviral therapy (ART). METHODS: For 16 weeks, PWH received TAF/FTC-based ART co-encapsulated with an ingestible sensor to directly measure cumulative (enrollment to final visit) and 10-day adherence. At monthly visits, intraerythrocytic concentrations of TFV-DP and FTC-TP in DBS were quantified and summarized at steady-state (week 12 or 16) as median (interquartile range). Linear mixed-effects models evaluated factors associated with TFV-DP/FTC-TP. RESULTS: Eighty-four participants (11% female, 4% transgender) predominantly receiving bictegravir/TAF/FTC (73%) were enrolled. Ninety-two percent completed week 12 or 16 (94% unboosted ART). TFV-DP for <85% (7/72), 85%-<95% (9/72), and ≥95% (56/72) cumulative adherence was 2696 (2039-4108), 3117 (2332-3339), and 3344 (2605-4293) fmol/punches. Adjusting for cumulative adherence, TFV-DP was higher with boosted ART, lower body mass index, and in non-Black participants. FTC-TP for <85% (14/77), 85%-<95% (6/77), and ≥95% (57/77) 10-day adherence was 3.52 (2.64-4.48), 4.58 (4.39-5.06), and 4.96 (4.21-6.26) pmol/punches. All participants with ≥85% cumulative and 10-day adherence had TFV-DP ≥1800 fmol/punches and FTC-TP ≥2.5 pmol/punches, respectively. Low-level vir...