Baek Yae Jee, Lee Yongseop, Lee Jung Ah, Ahn Sangmin, Han Min, Seong Jaeeun, Lee Sang-Guk, Kim Jung Ho, Ahn Jin Young, Choi Jun Yong
Division of Infectious Diseases, Department of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea.
Division of Infectious Diseases, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
J Korean Med Sci. 2025 Jun 9;40(22):e102. doi: 10.3346/jkms.2025.40.e102.
Pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) is effective in preventing human immunodeficiency virus (HIV), however, its feasibility has not been evaluated in the Republic of Korea (Korea). Therefore, this study aimed to assess the feasibility of PrEP in men who have sex with men (MSM) in Korea. This is the first demonstration study in Korea, in which PrEP medication, laboratory tests, and clinic visit fees were provided without charge to participants.
HIV-negative MSM were prescribed daily TDF-FTC and followed up at an outpatient clinic. At each visit, adverse reactions, adherence, and sexual behavior were assessed using a questionnaire, and residual pills and blood and urine samples were collected. Tenofovir diphosphate (TFV) concentrations were measured in plasma and urine.
One hundred participants were enrolled and followed up for a median of 392 days. The retention-in-care was 77%. The incidence of HIV and other sexually transmitted infections (STIs) was 0.98 and 13.67 per 100 person-years, respectively. No serious adverse events were detected. Among the participants, 55.3% (47/85) and 41.7% (25/60) had plasma TFV concentrations > 40 ng/mL at weeks 28 and 52, respectively. Residual pill counts and self-reported adherence were not correlated with plasma TFV levels. Participants with positive STI test results were significantly more likely to have plasma TFV concentrations > 40 ng/mL (adjusted odds ratio, 3.67; = 0.034). The reported proportion of episodes of non-condom receptive anal intercourse decreased during the study.
Daily oral PrEP was safe and effective in MSM and not associated with increased sexual risk behavior. To our knowledge, this is the first analysis of risk compensation among PrEP users in East Asia.
富马酸替诺福韦二吡呋酯和恩曲他滨（TDF-FTC）暴露前预防（PrEP）在预防人类免疫缺陷病毒（HIV）方面有效，然而，其在大韩民国（韩国）的可行性尚未得到评估。因此，本研究旨在评估PrEP在韩国男男性行为者（MSM）中的可行性。这是韩国的第一项示范研究，其中向参与者免费提供PrEP药物、实验室检查和门诊就诊费用。
为HIV阴性的MSM每日开具TDF-FTC处方，并在门诊进行随访。每次就诊时，使用问卷评估不良反应、依从性和性行为，并收集剩余药丸以及血液和尿液样本。测量血浆和尿液中的二磷酸替诺福韦（TFV）浓度。
招募了100名参与者，中位随访时间为392天。治疗保留率为77%。HIV和其他性传播感染（STI）的发病率分别为每100人年0.98例和13.67例。未检测到严重不良事件。在参与者中，分别有55.3%（47/85）和41.7%（25/60）在第28周和第52周时血浆TFV浓度>40 ng/mL。剩余药丸计数和自我报告的依从性与血浆TFV水平无关。STI检测结果呈阳性的参与者血浆TFV浓度>4 ng/mL的可能性显著更高（调整后的优势比，3.67；P = 0.034）。在研究期间，报告的无保护被动肛交事件比例有所下降。
每日口服PrEP在MSM中安全有效，且与性风险行为增加无关。据我们所知，这是东亚地区对PrEP使用者风险补偿的首次分析。
