Pharmacologic Drug Detection and Self-Reported Adherence in the HPTN069/ACTG5305 Phase II PrEP Trial.

Autor: Cooper SE; Division of Infectious Diseases, Weill Cornell Medicine, 525 East 68th Street, Baker 24, New York, NY, 10065, USA. sec9059@med.cornell.edu., Zhang S; Fred Hutchison Cancer Center, Seattle, WA, USA., Haines D; Fred Hutchison Cancer Center, Seattle, WA, USA., Mayer KH; Fenway Health, Harvard Medical School, Boston, MA, USA., Amico KR; University of Michigan, Ann Arbor, MI, USA., Landovitz RJ; University of California, Los Angeles, CA, USA., Hendrix CW; Johns Hopkins University School of Medicine, Baltimore, MD, USA., Marzinke MA; Johns Hopkins University School of Medicine, Baltimore, MD, USA., Chege W; DAIDS, NIAID, NIH, Bethesda, MD, USA., McCauley M; Durham, NC, FHI 360, USA., Gulick RM; Division of Infectious Diseases, Weill Cornell Medicine, 525 East 68th Street, Baker 24, New York, NY, 10065, USA.
Jazyk: angličtina
Zdroj: AIDS and behavior [AIDS Behav] 2024 Nov; Vol. 28 (11), pp. 3710-3718. Date of Electronic Publication: 2024 Jul 31.
DOI: 10.1007/s10461-024-04451-7
Abstrakt: Adherence drives efficacy in PrEP clinical trials. We compared drug concentrations and self-reported adherence in HPTN069/ACTG5305, a double-blinded, randomized trial of the safety and tolerability of candidate PrEP regimens that included maraviroc (MVC), tenofovir (TDF), and emtricitabine (FTC). Plasma drug concentrations and self-reported adherence by computer-assisted self-interview (CASI) were assessed at study weeks 24 and 48. Descriptive statistics and a generalized linear model were used to assess the association between selected demographic factors, self-report of daily medication adherence and plasma drug concentrations consistent with daily adherence. Among 718 paired observations from 370 participants, 43% (306/718) reported daily adherence by CASI, 65% (467/718) had drug concentrations consistent with daily adherence and 11% (81/718) had CASI responses that reported daily adherence despite having drug concentrations consistent with less-than-daily adherence. In adjusted analyses, participants who were assigned male at birth (aOR 1.42 [95% CI 1.02, 1.97]), older (5-year increments aOR 1.10 [95% CI 1.09, 1.11]), White (aOR 2.2 [95% CI 1.88, 2.56]), had advanced education (aOR 3.89 [95% CI 2.97, 5.09]), were employed (aOR 1.89 [95% CI 1.50, 2.40]), or partnered/married (aOR 2 [95% CI 1.72, 2.32]) were more likely to have drug concentrations consistent with daily adherence. Participants who were not employed (aOR 2.7 [95% CI 1.31, 5.55]) or who were single/not partnered (aOR 2.33 [CI 95% 1.25, 4.34]) were more likely to have drug concentrations that did not reflect daily adherence despite self-reported PrEP adherence. These findings support the need for ongoing adherence counseling in clinical trials of new PrEP regimens.
(© 2024. The Author(s).)
Databáze: MEDLINE
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