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

被引：6

作者：

Coyle, Ryan P. ^{[1
]}

Morrow, Mary ^{[2
]}

Mann, Sarah C. ^{[3
]}

Mainella, Vincent ^{[1
]}

Ellis, Samuel L. ^{[4
]}

Schwab, Stefanie ^{[1
]}

Coppinger, Corwin ^{[1
]}

Barker, Nicholas ^{[1
]}

Ellison, Lucas ^{[1
]}

Zheng, Jia-Hua ^{[1
]}

Al Zuabi, Subhi ^{[1
]}

Alpert, Pamela E. ^{[5
]}

Carnes, Tony C. ^{[5
]}

Buffkin Jr, D. Eric ^{[5
]}

Chai, Peter R. ^{[6
,7
,8
]}

Bushman, Lane R. ^{[1
]}

Kiser, Jennifer J. ^{[1
,9
]}

MaWhinney, Samantha ^{[2
]}

Brooks, Kristina M. ^{[1
]}

Anderson, Peter L. ^{[1
,11
]}

Castillo-Mancilla, Jose R. ^{[3
,10
]}

机构：

[1] Univ Colorado, Skaggs Sch Pharm & Pharmaceut Sci, Dept Pharmaceut Sci, Anschutz Med Campus, Aurora, CO USA

[2] Univ Colorado, Colorado Sch Publ Hlth, Dept Biostat & Informat, Anschutz Med Campus, Aurora, CO USA

[3] Univ Colorado, Dept Med, Div Infect Dis, Anschutz Med Campus, Aurora, CO USA

[4] Univ Colorado, Skaggs Sch Pharm & Pharmaceut Sci, Dept Clin Pharm, Anschutz Med Campus, Aurora, CO USA

[5] etectRx, Gainesville, FL USA

[6] Harvard Med Sch, Brigham & Womens Hosp, Dept Emergency Med, Boston, MA USA

[7] MIT, Koch Inst Integrated Canc Res, Cambridge, MA USA

[8] Fenway Inst, Boston, MA USA

[9] Merck & Co Inc, Med Affairs, Rahway, NJ USA

[10] ViiV Healthcare, Clin Dev, Durham, NC USA

[11] Univ Colorado, Dept Pharmaceut Sci, Anschutz Med Campus, 12850 Montview Blvd, C238, Aurora, CO 80045 USA

来源：

CLINICAL INFECTIOUS DISEASES | 2024年 / 79卷 / 05期

基金：

美国国家卫生研究院;

关键词：

adherence benchmarks; dried blood spots; low-level viremia; tenofovir alafenamide; tenofovir diphosphate; PREEXPOSURE PROPHYLAXIS; HIV; MULTICENTER; MEN; SEX;

D O I：

10.1093/cid/ciae212

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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 viremia (HIV-1 RNA 20-199 copies/mL) occurred at 18% of visits in 39% of participants with similar TFV-DP (3177 [2494-4149] fmol/punches) compared with suppressed visits (3279 [2580-4407] fmol/punches). Conclusions. TFV-DP >= 1800 fmol/punches and FTC-TP >= 2.5 pmol/punches represent DBS benchmarks for >= 85% adherence to unboosted TAF/FTC-based ART. Among PWH with high adherence, low-level viremia was common. Clinical Trials Registration NCT04065347.

引用

页码：1233 / 1241

页数：9

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