Sepodes Bruno, Rocha João, Batista Jorge, Figueira Maria-Eduardo, Dráfi František, Torre Carla
Faculdade de Farmácia da Universidade de Lisboa, Department of Pharmacy, Pharmacology and Health Technologies, Lisbon, Portugal.
Laboratory of Systems Integration Pharmacology, Clinical & Regulatory Science-Research Institute for Medicines of the University of Lisbon (iMED.ULisboa), Lisbon, Portugal.
Front Med (Lausanne). 2021 Aug 25;8:722247. doi: 10.3389/fmed.2021.722247. eCollection 2021.
Pre-exposure prophylaxis (PrEP) is a significant public health intervention with proven efficacy and safety in the prevention of human immunodeficiency virus (HIV) infection, which has taken a considerable amount of time to reach Europe in relation to their transatlantic counterparts, namely, the United States of America (USA). There, it is perceived as being an essential prevention tool to be integrated within existing medical, behavioral and structural interventions in place for the management and containment of HIV infection in men who have sex with men (MSM). In a region such as Europe, with approximately double the USA population, it is estimated that not even 10% have proper access to PrEP, and given the lack of coordination with healthcare, taking PrEP has to be at their own expense. Here, we identify the reasons behind the 4-year lag in the approval of PrEP in the European Union/European Economic Area (and Europe in general) and explore the efficacy and effectiveness of PrEP needed to be confirmed with some implementation or demonstration studies conducted in the region. Independent of the data gathered, access of MSM to PrEP is far from ideal in Europe and much still needs to be done. The demonstration of the cost-effectiveness of PrEP alongside other social and behavioral factors needs to be addressed, while the clear populations within MSM that will benefit from this intervention are properly identified and make use of the latest recommendations of the World Health Organization that consider not only daily PrEP but also event-driven PrEP. The momentum for the proper implementation of PrEP in the EU is not lost, and with the existence of generics and even new formulations, there is a renewed opportunity for unleashing the public health benefits arising from this pharmacological tool with other interventions in place (e.g., condoms, testing, and counseling).
暴露前预防（PrEP）是一项重要的公共卫生干预措施，在预防人类免疫缺陷病毒（HIV）感染方面已证实具有疗效和安全性。与大西洋彼岸的美国相比，PrEP在欧洲普及花费了相当长的时间。在美国，PrEP被视为一种重要的预防工具，应纳入现有的医疗、行为和结构干预措施中，用于管理和控制男男性行为者（MSM）中的HIV感染。在欧洲这样一个人口约为美国两倍的地区，估计甚至不到10%的人能够合理获得PrEP，而且由于缺乏与医疗保健的协调，服用PrEP必须自费。在此，我们确定了欧盟/欧洲经济区（以及整个欧洲）PrEP批准延迟4年的背后原因，并探讨了需要通过在该地区进行的一些实施或示范研究来确认PrEP的疗效和效果。无论收集到的数据如何，在欧洲，MSM获得PrEP的情况远不理想，仍有许多工作要做。需要解决PrEP的成本效益与其他社会和行为因素的关系，同时要正确识别MSM中能够从这种干预措施中受益的明确人群，并利用世界卫生组织的最新建议，这些建议不仅考虑每日PrEP，还考虑事件驱动的PrEP。在欧盟正确实施PrEP的势头并未丧失，并且由于有仿制药甚至新配方的存在，有了一个新的机会来释放这种药物工具与其他现有干预措施（如避孕套、检测和咨询）相结合所带来的公共卫生效益。
