MTN-017: A Rectal Phase 2 Extended Safety and Acceptability Study of Tenofovir Reduced-Glycerin 1% Gel
MTN-017: A Rectal Phase 2 Extended Safety and Acceptability Study of Tenofovir Reduced-Glycerin 1% Gel
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DOI：
10.1093/cid/ciw832
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发表时间：
2017-03-01
影响因子：
11.8
通讯作者：
McGowan, Ian
中科院分区：
文献类型：
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作者：
Cranston, Ross D.;Lama, Javier R.;McGowan, Ian
背景人类免疫缺陷病毒（艾滋病毒）对男男性行为者（MSM）和变性妇女（TGW）的影响不成比例。安全和可接受的局部艾滋病毒预防方法，针对直肠是必要的。MTN-017是一项II期、3阶段、随机序列、开放标签、扩展安全性和可接受性交叉研究，比较了直肠应用的减少甘油（RG）1%替诺福韦（TFV）和口服恩曲他滨/TFV富马酸二异山梨酯（FTC/ TDF）。在每个8周的研究期间，参与者被随机分配到每日RG-TFV直肠凝胶，或接受性肛交（RAI;或在没有RAI的情况下至少每周两次）之前和之后的RG-TFV直肠凝胶，或每日口服FTC/TDF.Results.从美国、泰国、秘鲁和南非的8个研究中心入组了MSM和TGW（n = 195），平均年龄为31.1岁（范围18-64）。每日凝胶（发生率比[IRR]，1.09; P = .59）或RAI凝胶（IRR，0.90; P =.51）与FTC/TDF相比，≥ 2级不良事件发生率无差异。高依从性（通过未使用的产品返回和短信系统报告评估>= 80%的处方剂量）在每日凝胶方案中不太可能（比值比[OR]，0.35; P < .001），与FTC/TDF相比，参与者报告未来每日凝胶用于HIV保护的可能性较小（OR，0.38; P < .001）。RG TFV凝胶直肠应用在MSM和TGW中是安全的。间歇性凝胶和每日口服FTC/TDF方案的依从性和产品使用可能性相似，但每日凝胶方案较低。
Background. Human immunodeficiency virus (HIV) disproportionately affects men who have sex with men (MSM) and transgender women (TGW). Safe and acceptable topical HIV prevention methods that target the rectum are needed.Methods. MTN-017 was a phase 2, 3-period, randomized sequence, open-label, expanded safety and acceptability crossover study comparing rectally applied reduced-glycerin (RG) 1% tenofovir (TFV) and oral emtricitabine/TFV disoproxil fumarate (FTC/ TDF). In each 8-week study period participants were randomized to RG-TFV rectal gel daily, or RG-TFV rectal gel before and after receptive anal intercourse (RAI; or at least twice weekly in the event of no RAI), or daily oral FTC/TDF.Results. MSM and TGW (n = 195) were enrolled from 8 sites in the United States, Thailand, Peru, and South Africa with mean age of 31.1 years (range 18-64). There were no differences in = grade 2 adverse event rates between daily gel (incidence rate ratio [IRR], 1.09; P = .59) or RAI gel (IRR, 0.90; P = .51) compared to FTC/TDF. High adherence (>= 80% of prescribed doses assessed by unused product return and Short Message System reports) was less likely in the daily gel regimen (odds ratio [OR], 0.35; P < .001), and participants reported less likelihood of future daily gel use for HIV protection compared to FTC/TDF (OR, 0.38; P < .001).Conclusions. Rectal application of RG TFV gel was safe in MSM and TGW. Adherence and product use likelihood were similar for the intermittent gel and daily oral FTC/TDF regimens, but lower for the daily gel regimen.