Cairns Gus, McCormack Sheena, Molina Jean-Michel
aNAM Publications/Aidsmap.com, London, UK bEuropean AIDS Treatment Group, Brussels, Belgium cMedical Research Council Clinical Trials Unit at UCL, University College London, London, UK dINSERM U941, University of Paris Diderot, Sorbonne Paris Cité eDepartment of Infectious Diseases, Hôpital Saint Louis, APHP, Paris, France.
Curr Opin HIV AIDS. 2016 Jan;11(1):74-9. doi: 10.1097/COH.0000000000000223.
The review describes the European epidemic and the challenges in moving from clinical trials of preexposure prophylaxis (PrEP) to routine practice.
Two European trials conducted in gay and other MSM and transgender women reported a high and consistent reduction in HIV incidence using oral PrEP with tenofovir/emtricitabine (TDF/FTC). The incidence of HIV infection in the control group was much higher than anticipated, based on routine surveillance data in MSM, in spite of the highest standard of HIV prevention available.
Recent results have highlighted the urgent need to make PrEP available to key populations in Europe as an additional prevention tool. Gilead has not yet submitted an application to use TDF/FTC as PrEP in Europe. Although regulatory approval would accelerate implementation, countries are already dispensing TDF/FTC as postexposure prophylaxis without this. Services for prevention are diverse across countries ranging from free, walk-in services for the diagnosis and treatment of HIV and other sexually transmitted infections, to insurance-dependent reimbursement of private clinical services. Momentum is gathering in Europe with PrEP demonstration projects in MSM and a growing demand from community organizations. Each Member State urgently needs to identify their key populations and determine the service best placed to provide this new prevention strategy within a comprehensive prevention package.
本综述描述了欧洲的疫情以及从暴露前预防(PrEP)临床试验过渡到常规应用所面临的挑战。
在男同性恋者及其他男男性行为者(MSM)和跨性别女性中开展的两项欧洲试验报告称,使用替诺福韦/恩曲他滨(TDF/FTC)口服PrEP可使HIV发病率显著且持续降低。尽管采取了最高标准的HIV预防措施,但基于MSM的常规监测数据,对照组的HIV感染率仍远高于预期。
近期结果凸显了在欧洲向关键人群提供PrEP作为额外预防工具的迫切需求。吉利德尚未在欧洲提交将TDF/FTC用作PrEP的申请。尽管监管批准会加速实施,但即使没有此项批准,各国也已在将TDF/FTC用作暴露后预防药物。各国的预防服务多种多样,从免费的、无需预约的HIV及其他性传播感染诊断和治疗服务,到依赖保险报销的私人临床服务。随着针对MSM的PrEP示范项目以及社区组织需求的不断增加,欧洲的势头正在增强。每个成员国都迫切需要确定其关键人群,并确定在全面预防方案中最适合提供这一新预防策略的服务。