Preexposure Prophylaxis for HIV Prevention in a Large Integrated Health Care System: Adherence, Renal Safety, and Discontinuation.
Preexposure Prophylaxis for HIV Prevention in a Large Integrated Health Care System: Adherence, Renal Safety, and Discontinuation.
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DOI：
10.1097/qai.0000000000001129
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发表时间：
2016-12-15
期刊：
影响因子：
--
通讯作者：
Volk JE
中科院分区：
文献类型：
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作者：
Marcus JL;Hurley LB;Hare CB;Nguyen DP;Phengrasamy T;Silverberg MJ;Stoltey JE;Volk JE
安慰剂对照和开放标签研究已经证明了每日口服暴露前预防(PrEP)在预防艾滋病毒感染方面的安全性和有效性，但关于PrEP实际使用的数据有限。我们从2012年7月到2015年6月对发起PrEP的北加州Kaiser Permanente成员进行了一项队列研究。我们评估了药物补充剂的依从性和停药情况，估计的肾小球滤过率(EGFR)的下降，以及性传播感染(STI)/艾滋病毒的发生率。总体而言，972人启动了PrEP，累计使用PrEP 850人年。总体平均依从性为92%。黑人种族/民族[调整后的风险比(ARR3.0；95%可信区间：1.7至5.1P<；0.001]、高共同津贴(ARR2.0；1.2至3.3P=0.005)和吸烟(ARR1.6至2.3P=0.025)与80%的依从性相关。停用PREP 219人(22.5%)；女性(ARR2.6；1.5至4.6，P<；0.001)和滥用药物/酒精(ARR1.8；1.3至2.6，P=0.002)与停药有关。其中14 1例(15.5%)患者的−为70 mL.min 1·1.73m−2，5例(0.6%)患者因EGFR值较低而停用。直肠衣原体感染(P<；0.001)和尿路淋病(P=0.012)的季度性传播感染阳性率很高，并且随着时间的推移而增加。在使用PrEP期间没有发生艾滋病毒血清转换；然而，2例发生在失去保险覆盖后停止使用PrEP的个人。在临床实践中，Prep依从性很高，这与PrEP使用期间缺乏HIV血清转换是一致的。由于肾毒性而停药的情况很少见。按照当前指南的建议，每6个月进行一次性传播感染筛查可能是不够的。需要制定战略，在保险覆盖面出现缺口时增加初级保健计划的可及性。
Placebo-controlled and open-label studies have demonstrated the safety and efficacy of daily oral preexposure prophylaxis (PrEP) in preventing HIV infection, but data are limited on real-world PrEP use. We conducted a cohort study from July 2012 through June 2015 of Kaiser Permanente Northern California members initiating PrEP. We assessed pharmacy refill adherence and discontinuation, decreases in estimated glomerular filtration rate (eGFR), and sexually transmitted infection (STI)/HIV incidence. Overall, 972 individuals initiated PrEP, accumulating 850 person-years of PrEP use. Mean adherence was 92% overall. Black race/ethnicity [adjusted risk ratio (aRR) 3.0; 95% confidence interval: 1.7 to 5.1, P < 0.001], higher copayments (aRR 2.0; 1.2 to 3.3, P = 0.005), and smoking (aRR 1.6; 1.1 to 2.3, P = 0.025) were associated with <80% adherence. PrEP was discontinued by 219 (22.5%); female sex (aRR 2.6; 1.5 to 4.6, P < 0.001) and drug/alcohol abuse (aRR 1.8; 1.3 to 2.6, P = 0.002) were associated with discontinuation. Among 909 with follow-up creatinine testing, 141 (15.5%) had an eGFR <70 mL·min−1·1.73 m−2 and 5 (0.6%) stopped PrEP because of low eGFR. Quarterly STI positivity was high and increased over time for rectal chlamydia (P < 0.001) and urethral gonorrhea (P = 0.012). No HIV seroconversions occurred during PrEP use; however, 2 occurred in individuals who discontinued PrEP after losing insurance coverage. PrEP adherence was high in clinical practice, consistent with the lack of HIV seroconversions during PrEP use. Discontinuation because of renal toxicity was rare. STI screening every 6 months, as recommended by current guidelines, may be inadequate. Strategies are needed to increase PrEP access during gaps in insurance coverage.