University of California, San Diego.
University of Southern California, Keck School of Medicine, Los Angeles.
Clin Infect Dis. 2018 May 2;66(10):1566-1572. doi: 10.1093/cid/cix1055.
BACKGROUND: Adherence is critical for efficacy of tenofovir disoproxil fumarate/emtricitabine (FTC) as preexposure prophylaxis (PrEP). METHODS: Between February 2013 and February 2016, 398 men who have sex with men and transgender women were randomized 1:1 to receive individualized texting for adherence building (iTAB) or standard care (SoC) for 48 weeks. The primary endpoint was dried blood spot (DBS) tenofovir diphosphate (TFV-DP) concentrations at both week 12 and the last on-drug visit of >719 fmol/punch (ie, adequate adherence). Secondary outcomes included DBS TFV-DP concentrations of >1246 fmol/punch (ie, near-perfect adherence) and plasma FTC >350 ng/mL (consistent with dosing within the past 24 hours). RESULTS: Concentrations >719 fmol/punch of TFV-DP were found in 88.6% of participants at week 12 and 82.5% at week 48. For the primary endpoint, the study arms did not differ (72.0% in iTAB and 69.2% in SoC; P > .05). For the secondary composite endpoint of >1246 fmol/punch the iTAB arm was superior to SoC (33.5% vs 24.8%; P = .06), reaching statistical significance when adjusting for age (odds ratio, 1.56 [95% confidence interval, 1.00-2.42]; P < .05). At week 48, iTAB was superior to SoC for near-perfect adherence (51.0% vs 37.4%; P = .02). At week 12, iTAB was superior to SoC for dosing in past 24 hours by plasma FTC (47.5% vs 33.3%; P = .007), but not at weeks 24, 36, and 48 (all P > .05). CONCLUSIONS: Automated text messaging is a low-burden tool that improves durability of near-perfect PrEP adherence. CLINICAL TRIALS REGISTRATION: NCT01761643.
背景：替诺福韦二吡呋酯/恩曲他滨（FTC）作为暴露前预防（PrEP）的疗效取决于用药依从性。
方法：2013 年 2 月至 2016 年 2 月，398 名男男性行为者和跨性别女性被随机分为 1:1 组，分别接受个体化短信辅助用药依从性建立（iTAB）或标准护理（SoC），为期 48 周。主要终点是在第 12 周和最后一次服药访视时，干血斑（DBS）中替诺福韦二磷酸（TFV-DP）浓度＞719fmol/点（即充分的用药依从性）。次要终点包括 DBS 中 TFV-DP 浓度＞1246fmol/点（即接近完美的用药依从性）和血浆 FTC＞350ng/ml（提示在过去 24 小时内进行了用药）。
结果：在第 12 周和第 48 周时，分别有 88.6%和 82.5%的参与者 DBS 中 TFV-DP 浓度＞719fmol/点。在主要终点方面，两组间无差异（iTAB 组为 72.0%，SoC 组为 69.2%；P＞0.05）。在次要复合终点即 DBS 中 TFV-DP 浓度＞1246fmol/点时，iTAB 组优于 SoC 组（33.5% vs 24.8%；P=0.06），在调整年龄后有统计学意义（比值比，1.56[95%置信区间，1.00-2.42]；P＜0.05）。在第 48 周时，iTAB 组在接近完美的用药依从性方面优于 SoC 组（51.0% vs 37.4%；P=0.02）。在第 12 周时，iTAB 组在过去 24 小时内通过血浆 FTC 进行用药方面优于 SoC 组（47.5% vs 33.3%；P=0.007），但在第 24、36 和 48 周时无差异（均 P＞0.05）。
结论：自动化短信是一种低负担的工具，可提高接近完美的 PrEP 用药依从性的持久性。
临床试验注册：NCT01761643。
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