Background

Pre-exposure prophylaxis (PrEP) has shown high efficacy in clinical trials, but few observational studies have confirmed its effectiveness when prescribed in real life to users with diverse profiles. This study aimed to assess real-world PrEP effectiveness.

Methods

We did a matched, nested case-control study among adult men at high risk of HIV infection between Jan 1, 2016, and June 30, 2020, using data from the French national health data system. Men who were newly diagnosed with HIV infection up to Dec 31, 2020, were individually matched with up to five controls for age, socioeconomic status, place of residence, calendar year, and follow-up duration. PrEP use was characterised on the basis of tenofovir disoproxil fumarate plus emtricitabine dispensing over time. Conditional logistic regression was used to calculate the adjusted odds ratios (ORs) of PrEP use associated with HIV infection. PrEP effectiveness (computed as 1–adjusted OR), was estimated overall, by mode of PrEP use, and by individuals’ sociodemographic characteristics.

Findings

Among a total of 46 706 individuals, 256 patients with HIV infection were identified and matched with 1213 controls. PrEP users accounted for 29% of cases and 49% of controls. PrEP effectiveness was 60% (95% CI 46 to 71) overall, reaching 93% (84 to 97) for a high amount of PrEP consumption, and 86% (78 to 92) if excluding periods after PrEP discontinuation. PrEP effectiveness was significantly reduced in people younger than 30 years (26% [–21 to 54]) and in those who were socioeconomically deprived (–64% [–392 to 45]), both of which groups showed low amounts of PrEP consumption and high rates of PrEP discontinuation.

Interpretation

PrEP effectiveness appears to be lower in real-world conditions than is reported in clinical trials. Strengthening efforts to improve the monitoring of PrEP compliance will be essential to ensure PrEP effectiveness, especially among young and socioeconomically deprived recipients.

Funding

None.

中文翻译：

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法国 HIV 感染高危男性暴露前预防的真实效果：一项巢式病例对照研究

背景

暴露前预防 (PrEP) 在临床试验中显示出很高的疗效，但很少有观察性研究证实其在现实生活中向具有不同特征的用户开处方时的有效性。本研究旨在评估真实世界的 PrEP 有效性。

方法

我们使用来自法国国家卫生数据系统的数据，在 2016 年 1 月 1 日至 2020 年 6 月 30 日期间对 HIV 感染高风险的成年男性进行了匹配的巢式病例对照研究。截至 2020 年 12 月 31 日，新诊断为 HIV 感染的男性分别与最多五名年龄、社会经济地位、居住地、日历年和随访时间的对照进行匹配。PrEP 的使用是基于富马酸替诺福韦酯加恩曲他滨随时间分配的特征。条件逻辑回归用于计算与 HIV 感染相关的 PrEP 使用的调整优势比 (OR)。PrEP 有效性（计算为 1 调整的 OR）通过 PrEP 使用模式和个人社会人口学特征进行总体估计。

发现

在总共 46 706 人中，识别出 256 名 HIV 感染患者并与 1213 名对照者相匹配。PrEP 使用者占病例的 29% 和对照组的 49%。总体而言，PrEP 的有效性为 60%（95% CI 46 至 71），大量 PrEP 消耗达到 93%（84 至 97），如果不包括 PrEP 停药后的时期，则达到 86%（78 至 92）。30 岁以下人群 (26% [–21 至 54]) 和社会经济剥夺者 (–64% [–392 至 45]) 的 PrEP 有效性显着降低，这两个群体的 PrEP 消耗量均较低和高 PrEP 停药率。

解释

在现实条件下，PrEP 的有效性似乎低于临床试验中报告的结果。加强努力以改进对 PrEP 合规性的监测对于确保 PrEP 的有效性至关重要，尤其是在年轻和社会经济贫困的接受者中。

资金

没有任何。