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Clin Infect Dis. 2018 May 17;66(11):1712-1721. doi: 10.1093/cid/cix1086.

Daily and Nondaily Oral Preexposure Prophylaxis in Men and Transgender Women Who Have Sex With Men: The Human Immunodeficiency Virus Prevention Trials Network 067/ADAPT Study.

Author information

1
Gladstone Institutes, University of California, San Francisco AIDS Foundation.
2
Harlem Hospital and Mailman School of Public Health, Columbia University, New York, New York.
3
University of Washington, Seattle, Washington.
4
Fred Hutchinson Cancer Research Center, Seattle, Washington.
5
ICAP, Mailman School of Public Health, Columbia University, New York, New York.
6
Thailand Ministry of Public Health, Nonthaburi.
7
Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.
8
University of Michigan, Ann Arbor.
9
Johns Hopkins University, Baltimore, Maryl.
10
University of Colorado Anschutz Medical Campus, Aurora.
11
FHI 360, Durham, North Carolina.
12
National Institutes of Health, Bethesda, Maryl.
13
Gilead Sciences, Foster City, California.
14
Thai Red Cross AIDS Research Center, Bangkok.
15
Division of Preventive Medicine, University of California, San Francisco.

Abstract

Background:

Nondaily dosing of oral preexposure prophylaxis (PrEP) may provide equivalent coverage of sex events compared with daily dosing.

Methods:

At-risk men and transgender women who have sex with men were randomly assigned to 1 of 3 dosing regimens: 1 tablet daily, 1 tablet twice weekly with a postsex dose (time-driven), or 1 tablet before and after sex (event-driven), and were followed for coverage of sex events with pre- and postsex dosing measured by weekly self-report, drug concentrations, and electronic drug monitoring.

Results:

From July 2012 to May 2014, 357 participants were randomized. In Bangkok, the coverage of sex events was 85% for the daily arm compared with 84% for the time-driven arm (P = .79) and 74% for the event-driven arm (P = .02). In Harlem, coverage was 66%, 47% (P = .01), and 52% (P = .01) for these groups. In Bangkok, PrEP medication concentrations in blood were consistent with use of ≥2 tablets per week in >95% of visits when sex was reported in the prior week, while in Harlem, such medication concentrations occurred in 48.5% in the daily arm, 30.9% in the time-driven arm, and 16.7% in the event-driven arm (P < .0001). Creatinine elevations were more common in the daily arm (P = .050), although they were not dose limiting.

Conclusions:

Daily dosing recommendations increased coverage and protective drug concentrations in the Harlem cohort, while daily and nondaily regimens led to comparably favorable outcomes in Bangkok, where participants had higher levels of education and employment.

Clinical Trials Registration:

NCT01327651.

PMID:
29420695
PMCID:
PMC5961078
[Available on 2019-05-17]
DOI:
10.1093/cid/cix1086

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