FEM-PrEP: Adherence Patterns and Factors Associated With Adherence to a Daily Oral Study Product for Pre-exposure Prophylaxis
FEM-PrEP: Adherence Patterns and Factors Associated With Adherence to a Daily Oral Study Product for Pre-exposure Prophylaxis
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DOI：
10.1097/qai.0000000000000158
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发表时间：
2014-07-01
影响因子：
3.6
通讯作者：
Van Damme, Lut
中科院分区：
文献类型：
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作者：
Corneli, Amy L.;Deese, Jennifer;Van Damme, Lut
背景：多项临床试验已证明口服富马酸替诺福韦二吡呋酯 (TDF)（联合或不联合恩曲他滨 (FTC)）作为暴露前预防 (PrEP) 降低 HIV 感染风险的安全性和有效性。在女性中进行的 2 项 PrEP 临床试验（FEM-PrEP 以及控制流行病的阴道和口腔干预研究）中，对研究产品的依从性不足以证明 FTC/TDF 的有效性，但对这些研究中依从性的进一步分析可能会为 PrEP 示范项目和未来的 HIV 预防临床试验提供信息。 方法：我们在 3 个 FEM-PrEP 地点（Bondo、Bondo、肯尼亚；南非布隆方丹；和南非比勒陀利亚）根据每 4 周访视间隔采集的血浆替诺福韦和细胞内替诺福韦二磷酸盐药物浓度，检查随时间变化的依从性水平并评估与依从性相关的因素。结果：我们观察到，当药物可供使用时，28.5% 的访视间隔中药物浓度与良好的依从性一致，但只有 12% 的参与者在整个研究参与过程中实现了良好的依从性。在多变量分析中，布隆方丹遗址 [比值比 (OR)：2.43； 95% 置信区间 (CI)：1.32 至 4.48] 和喜欢药丸颜色（OR：2.93；95% CI：1.18 至 7.27）与良好的依从性呈正相关，而入组时使用口服避孕药与良好的依从性呈负相关（OR：0.37；95% CI：0.18 至0.74).结论：大多数参与者在整个试验参与过程中并未定期坚持使用研究产品，尽管少数人这样做了。在 FEM-PrEP 中几乎没有发现与研究产品良好依从性相关的因素。
Background:Several clinical trials have demonstrated the safety and effectiveness of oral tenofovir disoproxil fumarate (TDF), with or without emtricitabine (FTC), as pre-exposure prophylaxis (PrEP) for reducing the risk of HIV acquisition. Adherence to the study product was insufficient to demonstrate the effectiveness of FTC/TDF in 2 PrEP clinical trials conducted among women (FEM-PrEP and the Vaginal and Oral Interventions to Control the Epidemic study), but further analyses of adherence in these studies may inform PrEP demonstration projects and future HIV prevention clinical trials.Methods:We randomly selected a subcohort of 150 participants randomized to FTC/TDF in 3 FEM-PrEP sites (Bondo, Kenya; Bloemfontein, South Africa; and Pretoria, South Africa) to examine adherence levels over time and to assess factors associated with adherence, based on plasma tenofovir and intracellular tenofovir diphosphate drug concentrations in specimens collected at 4-week visit intervals.Results:We observed drug concentrations consistent with good adherence in 28.5% of all visit intervals when drug was available to use, but only 12% of participants achieved good adherence throughout their study participation. In multivariate analysis, the Bloemfontein site [odds ratio (OR): 2.43; 95% confidence interval (CI): 1.32 to 4.48] and liking the pill color (OR: 2.93; 95% CI: 1.18 to 7.27) were positively associated with good adherence, whereas using oral contraceptive pills at enrollment was negatively associated with good adherence (OR: 0.37; 95% CI: 0.18 to 0.74).Conclusions:Most participants did not regularly adhere to the study product throughout their trial participation, although a small minority did. Few factors associated with good adherence to the study product were identified in FEM-PrEP.