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

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
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DOI:
10.1093/cid/cix1086
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发表时间:
2018-06-01
影响因子:
11.8
通讯作者:
Holtz, Timothy H.
Holtz, Timothy H.
中科院分区:
医学1区
文献类型:
--
作者:
Grant, Robert M.;Mannheimer, Sharon;Holtz, Timothy H.

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背景。与每日给药相比,非每日给药的口服暴露前预防 (PrEP) 可以提供同等的性事件覆盖率。方法。与男性发生性行为的高危男性和跨性别女性被随机分配至 3 种给药方案中的 1 种:每天 1 片、每周两次 1 片,性交后剂量(时间驱动)或性行为前后各 1 片(事件驱动),并通过每周自我报告、药物浓度和电子药物监测测量性行为前和性后剂量,跟踪性事件的覆盖情况。结果。从2012年7月到2014年5月,357名参与者被随机分组​​。在曼谷,每日组的性事件覆盖率为 85%,而时间驱动组的性事件覆盖率为 84% (P=.79),事件驱动组的覆盖率为 74% (P=.02)。在哈莱姆区,这些群体的覆盖率分别为 66%、47% (P=.01) 和 52% (P=.01)。在曼谷,血液中的 PrEP 药物浓度与前一周报告性行为时超过 95% 的就诊中每周使用 >= 2 片的情况一致,而在哈莱姆区,此类药物浓度发生在日常组中的 48.5%、时间驱动组中的 30.9% 和事件驱动组中的 16.7%(P
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