Department of Medicine, Center for AIDS Prevention Studies.
Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco.
AIDS. 2019 Aug 1;33(10):1657-1662. doi: 10.1097/QAD.0000000000002237.
Antiretroviral treatment (ART) adherence is often suboptimal in the perinatal period. We measured hair tenofovir (TFV) concentrations as a metric of adherence in postpartum women to understand patterns and predictors of adherence throughout this critical period. In addition, we examined the association between hair TFV concentrations and virologic outcomes.
Between 12/2012 and 09/2016, hair samples were collected longitudinally from delivery through breastfeeding from women on ART in the Promoting Maternal and Infant Survival Everywhere study (NCT01061151) in sub-Saharan Africa. Hair TFV levels were measured using validated methods. Using generalized estimating equations, we estimated the association between hair TFV levels and virologic suppression (<400 copies/ml) over time and assessed predictors of hair TFV levels.
Hair TFV levels were measured at 370 visits in 71 women from delivery through a median of 14 months (interquartile range 12-15) of breastfeeding. Levels ranged from below detection (0.002) to 1.067 ng/mg (geometric mean: 0.047). After at least 90 days on ART, 69 women had at least one viral load measured (median 5 measures, range 1-9); 18 (26%) experienced viremia at least once. Each doubling of TFV level more than doubled odds of concurrent virologic suppression [odds ratio 2.35, 95% confidence interval (CI): 1.44-3.84, P = 0.0006] and was associated with 1.43 times the odds of future suppression (95% CI: 0.75-2.73, P = 0.28). Relative to the first 3 months after delivery, hair levels were highest in months 6-12 (1.42-fold higher, 95% CI: 1.09-1.85, P = 0.01).
Hair TFV levels strongly predicted concurrent virologic suppression among breastfeeding women. Objective adherence metrics can supplement virologic monitoring to optimize treatment outcomes in this important transition period.
抗逆转录病毒治疗(ART)在围产期往往不尽人意。我们测量了产后妇女头发中的替诺福韦(TFV)浓度,以了解整个关键时期的依从性模式和预测因素。此外,我们还研究了头发 TFV 浓度与病毒学结果之间的关系。
2012 年 12 月至 2016 年 9 月,在撒哈拉以南非洲的促进母婴生存 everywhere 研究(NCT01061151)中,从分娩开始,通过母乳喂养,对接受 ART 的女性进行了纵向头发样本采集。使用经过验证的方法测量头发 TFV 水平。使用广义估计方程,我们估计了头发 TFV 水平与病毒学抑制(<400 拷贝/ml)随时间的关系,并评估了头发 TFV 水平的预测因素。
在 71 名女性中,从分娩开始,通过中位数为 14 个月(12-15 个月)的母乳喂养,共进行了 370 次头发 TFV 水平测量。水平范围从低于检测下限(0.002)到 1.067ng/mg(几何平均值:0.047)。在至少 90 天接受 ART 治疗后,69 名女性至少有一次测量了病毒载量(中位数为 5 次,范围为 1-9 次);18 名(26%)至少有一次病毒血症。TFV 水平每增加一倍,同时发生病毒学抑制的几率就增加一倍[比值比 2.35,95%置信区间(CI):1.44-3.84,P=0.0006],并且未来发生抑制的几率增加 1.43 倍(95%CI:0.75-2.73,P=0.28)。与分娩后前 3 个月相比,头发水平在 6-12 个月时最高(高 1.42 倍,95%CI:1.09-1.85,P=0.01)。
头发 TFV 水平强烈预测了母乳喂养女性同时发生的病毒学抑制。客观的依从性指标可以补充病毒学监测,以优化这一重要过渡时期的治疗结果。