Mayer Kenneth H, Jones Daniel, Oldenburg Catherine, Jain Sachin, Gelman Marcy, Zaslow Shayne, Grasso Chris, Mimiaga Matthew J
*The Fenway Institute, Fenway Health, Boston, MA;†Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA;‡Department of Medicine, Harvard Medical School, Boston, MA;§Proctor Foundation, University of California San Francisco, San Francisco, CA;‖Department of Medicine, Albert Einstein College of Medicine, Bronx, NY;Departments of ¶Epidemiology;#Behavioral and Social Health Sciences; and**Psychiatry and Human Behavior, Brown University, Providence, RI.
J Acquir Immune Defic Syndr. 2017 Aug 15;75(5):535-539. doi: 10.1097/QAI.0000000000001440.
The study evaluated elvitegravir/cobicistat/tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) ("Quad pill") for postexposure prophylaxis (PEP).
HIV-exposed individuals may benefit from PEP, but completion rates have been suboptimal because of regimen complexity and side effects. Newer antiretroviral combinations coformulated as single daily pills may optimize PEP adherence.
One hundred HIV-uninfected individuals who presented to a Boston community health center after an acute HIV sexual exposure were enrolled and initiated PEP with the daily, single-pill combination Quad pill for a 28-day course.
Side effects and medication completion rates from study participants were compared with historical controls who had used PEP regimens consisting of TDF/FTC daily and raltegravir twice daily, or earlier regimens of twice daily zidovudine (AZT)/lamivudine (3TC) and a protease inhibitor, using χ tests for independence.
Of the 100 participants who initiated the Quad pill for PEP after a high-risk sexual exposure, 71% completed the 28-day Quad pill regimen, which was significantly greater than historical controls who used TDF/FTC and raltegravir (57%, P < 0.05) or AZT/3TC plus a protease inhibitor (39%, P < 0.001). The most common side effects reported by Quad pill users were as follows: abdominal discomfort or pain, gas or bloating (42%), diarrhea (38%), fatigue (28%), nausea or vomiting (28%), headache (14%), or dizziness or lightheadedness (6%). Most symptoms were mild, limited, and did not result in medication discontinuation. No participants became HIV infected.
Fixed-dose combination of elvitegravir/cobicistat/TDF/FTC was safe and well tolerated for PEP, with higher regimen completion rates than more frequently dosed PEP regimens.
本研究评估了埃替拉韦/考比司他/富马酸替诺福韦二吡呋酯（TDF）/恩曲他滨（FTC）（“四联片”）用于暴露后预防（PEP）的效果。
暴露于HIV的个体可能从PEP中获益，但由于治疗方案复杂和副作用，完成率一直不理想。新的抗逆转录病毒联合制剂制成每日单片剂型可能会优化PEP的依从性。
100名在急性HIV性暴露后前往波士顿社区健康中心的未感染HIV个体入组，并开始使用每日单片的四联片进行28天疗程的PEP。
将研究参与者的副作用和药物完成率与使用由每日TDF/FTC和每日两次拉替拉韦组成的PEP方案，或每日两次齐多夫定（AZT）/拉米夫定（3TC）和一种蛋白酶抑制剂的早期方案的历史对照进行比较，采用独立性χ检验。
在100名在高危性暴露后开始使用四联片进行PEP的参与者中，71%完成了28天的四联片疗程，这显著高于使用TDF/FTC和拉替拉韦的历史对照（57%，P<0.05）或AZT/3TC加一种蛋白酶抑制剂的历史对照（39%，P<0.001）。四联片使用者报告的最常见副作用如下：腹部不适或疼痛、气体或腹胀（42%）、腹泻（38%）、疲劳（28%）、恶心或呕吐（28%）、头痛（14%）或头晕或眩晕（6%）。大多数症状轻微、有限，且未导致停药。没有参与者感染HIV。
埃替拉韦/考比司他/TDF/FTC的固定剂量组合用于PEP是安全且耐受性良好的，与给药更频繁的PEP方案相比，疗程完成率更高。
