Lal Luxi, Audsley Jennifer, Murphy Dean A, Fairley Christopher K, Stoove Mark, Roth Norm, Moore Richard, Tee Ban K, Puratmaja Nalagafiar, Anderson Peter L, Leslie David, Grant Robert M, De Wit John, Wright Edwina
aThe Burnet Institute bDepartment of Infectious Diseases, The Alfred Hospital cDepartment of Infectious Diseases, Monash University dThe Peter Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne, Victoria eDepartment of Gender and Cultural Studies, University of Sydney fCentre for Social Research in Health, University of New South Wales, New South Wales gMelbourne Sexual Health Centre hCentral Clinical School, Monash University iSchool of Population Health and Preventive Medicine, Monash University jPrahran Market Clinic kNorthside Clinic lThe Centre Clinic, Victoria, Australia mUniversity of Colorado Anschutz Medical Campus, Colorado, USA nVictorian Infectious Diseases Reference Laboratory, Royal Melbourne Hospital, at the Peter Doherty Institute for Infection and Immunity, Victoria, Australia oGladstone Institutes pUniversity of California-San Francisco qSan Francisco AIDS Foundation, San Francisco, California, USA. *Luxi Lal and Jennifer Audsley equal first authors. †John De Wit and Edwina Wright equal final authors.
AIDS. 2017 Jul 31;31(12):1709-1714. doi: 10.1097/QAD.0000000000001519.
HIV preexposure prophylaxis (PrEP) decreases risk of HIV acquisition; however, its efficacy is closely dependent on adherence. There is also concern that the preventive effect of PrEP may be offset by risk compensation, notably an increase in condomless anal sex.
Multisite, open-label demonstration study that recruited people at current or recent risk of HIV infection in Melbourne, Australia.
Participants were recruited from three general practice clinics and one sexual health clinic in Melbourne and consented to take daily tenofovir/emtricitabine (TFV/FTC) for 30 months. Sexual practice data, HIV and sexually transmitted infection (STI) test results were collected at baseline and 3-monthly during follow-up. PrEP adherence was evaluated by self-report at clinical visits, online surveys, refill-based assessments and dried blood spot testing. We present a 12-month interim analysis.
A total of 114 people were recruited. We observed a significant decline in condom use which occurred concomitantly with a significant increase in STIs over the first 12 months of PrEP. Incidence (per 100 person-years) of any STI was 43.2 and 119.8 at months 0-3 and 3-12, respectively [incidence rate ratio 2.77 (1.52, 5.56)]. Adherence to PrEP medication was high by all measures, including 6 month TFV/FTC levels in dried blood spot.
We found a significant reduction in condom use and an increase in STIs over the first 12 months of follow-up. High medication adherence rates occurring with a decline in condom use and a rise in STIs, suggest that prevention, early detection and treatment of STIs is a chief research priority in the current era of HIV PrEP.
HIV暴露前预防（PrEP）可降低感染HIV的风险；然而，其疗效密切依赖于依从性。也有人担心PrEP的预防效果可能会被风险补偿抵消，尤其是无保护肛交行为的增加。
多中心、开放标签示范研究，在澳大利亚墨尔本招募当前或近期有HIV感染风险的人群。
参与者从墨尔本的三家普通诊所和一家性健康诊所招募，同意每日服用替诺福韦/恩曲他滨（TFV/FTC）30个月。在基线期以及随访期间每3个月收集性行为数据、HIV和性传播感染（STI）检测结果。通过临床访视时的自我报告、在线调查、基于药物 refill 的评估以及干血斑检测来评估PrEP依从性。我们呈现一项为期12个月的中期分析结果。
共招募了114人。我们观察到在PrEP治疗的前12个月中，避孕套使用显著减少，同时STI感染显著增加。在0 - 3个月和3 - 1年月期间，任何STI的发病率（每100人年）分别为43.2和119.8 [发病率比2.77（1.52，5.56）]。通过所有测量方法评估，PrEP药物的依从性都很高，包括干血斑中6个月的TFV/FTC水平。
我们发现在随访的前12个月中避孕套使用显著减少，STI感染增加。在避孕套使用减少和STI感染增加的同时出现较高的药物依从率，这表明在当前HIV PrEP时代，STI的预防、早期检测和治疗是主要的研究重点。
