Adherence to Pre-Exposure Prophylaxis for HIV Prevention in a Clinical Setting.
Adherence to Pre-Exposure Prophylaxis for HIV Prevention in a Clinical Setting.
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DOI：
10.1371/journal.pone.0157742
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发表时间：
2016
期刊：
影响因子：
3.7
通讯作者：
Chan PA
中科院分区：
文献类型：
--
作者：
Montgomery MC;Oldenburg CE;Nunn AS;Mena L;Anderson P;Liegler T;Mayer KH;Patel R;Almonte A;Chan PA
艾滋病毒在美国的流行对同性恋、双性恋和其他男男性行为者（MSM）的影响尤为严重。使用富马酸替诺福韦二氧吡酯（TDF）和恩曲他滨（FTC）联合配制的暴露前预防（PrEP）已被证明对降低男男性接触者的艾滋病毒发病率有很高的疗效。然而，据报道，在主要疗效试验中，依从性较低，这可能对PrEP的成功实施构成重大障碍。在美国“现实世界”的临床环境中，PrEP的依从率在很大程度上仍然未知。我们回顾了在罗德岛普罗维登斯参加临床PrEP项目的前50名患者的人口统计和临床数据。我们分析了参加三个月或六个月随访预约的患者自我报告的药物依从性以及干血斑（DBS）中的药物浓度。我们进一步评估了一名服用PrEP同时进行血清转化的患者的药物浓度和耐药情况。在前50名服用PrEP的患者中，62%的患者在3个月时参加了随访预约，38%的患者在6个月时参加了随访预约。在任何时间点参加预约的患者中（70%,n = 35）， 92%和95%分别报告在3个月和6个月时服用±4剂/周。对参加随访预约的35名患者中的20名随机抽样进行药物浓度测定。这些患者中90%的TDF水平与±4剂量/周一致。自我报告的依从性与药物浓度之间存在显著相关性（r = 0.49, p = 0.02）。一名服用PrEP的患者在三个月的随访中转化为血清。患者的药物浓度与每日剂量一致。群体测序和超灵敏等位基因特异性PCR检测到M184V突变，但没有检测到其他TDF或ftc相关突变，包括那些作为次要变异存在的突变。在这个临床PrEP项目中，依从性很高，自我报告的药物依从性准确地反映了DBS测量的药物浓度。
The HIV epidemic in the United States (US) disproportionately affects gay, bisexual, and other men who have sex with men (MSM). Pre-exposure prophylaxis (PrEP) using co-formulated tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) has demonstrated high efficacy in reducing HIV incidence among MSM. However, low adherence was reported in major efficacy trials and may present a substantial barrier to successful PrEP implementation. Rates of adherence to PrEP in “real-world” clinical settings in the US remain largely unknown. We reviewed demographic and clinical data for the first 50 patients to enroll in a clinical PrEP program in Providence, Rhode Island. We analyzed self-reported drug adherence as well as drug concentrations in dried blood spots (DBS) from patients who attended either a three- or six-month follow-up appointment. We further assessed drug concentrations and the resistance profile of a single patient who seroconverted while taking PrEP. Of the first 50 patients to be prescribed PrEP, 62% attended a follow-up appointment at three months and 38% at six months. Of those who attended an appointment at either time point (70%, n = 35), 92% and 95% reported taking ±4 doses/week at three and six months, respectively. Drug concentrations were performed on a random sample of 20 of the 35 patients who attended a follow-up appointment. TDF levels consistent with ±4 doses/week were found in 90% of these patients. There was a significant correlation between self-reported adherence and drug concentrations (r = 0.49, p = 0.02). One patient who had been prescribed PrEP seroconverted at his three-month follow-up visit. The patient’s drug concentrations were consistent with daily dosing. Population sequencing and ultrasensitive allele-specific PCR detected the M184V mutation, but no other TDF- or FTC-associated mutations, including those present as minor variants. In this clinical PrEP program, adherence was high, and self-reported drug adherence accurately reflected drug concentrations as measured by DBS.