Study on Pre-Exposure Prophylaxis Regimens among Men Who Have Sex with Men: A Prospective Cohort Study

Background: There are limited studies on the medication regimen of pre-exposure prophylaxis (PrEP) among men who have sex with men (MSM) in China. This study compared the effectiveness of and adherence to two prophylactic HIV medication regimens, which provided evidence and guidance for the application and promotion of the PrEP strategy in the MSM population in China. Methods: We conducted an open, non-randomized, multicenter, parallel, controlled clinical intervention study in western China. Subjects were recruited by convenience sampling at research centers in Chongqing, Guangxi, Xinjiang and Sichuan, China from April 2013 to March 2015, and they were categorized into the daily PrEP, event-driven and blank control groups. Tenofovir disoproxil fumarate (TDF; 300 mg/dose) was administered to subjects in the daily PrEP and event-driven groups, and all subjects were followed up every 12 weeks for 96 weeks. Demographic, behavioral, psychological characteristics and AIDS-related attitudes were assessed using self-completed questionnaires. TDF serum concentrations in subjects in Chongqing and Sichuan were quantified after systematic sampling. Results: Of the 2422 enrolled MSM, 856 were eligible for statistical analysis (PrEP group: 385 and event-driven group: 471); 30 and 32 subjects in daily PrEP and event-driven groups, respectively, were HIV-positive; the incidence of HIV infection was as follows: daily PrEP group, 6.60 cases/100 person-years and event-driven group, 5.57 cases/100 person-years (relative risk (RR) 95% confidence interval (CI) was 0.844 (0.492-1.449)); HIV incidence did not differ significantly when stratified by medication adherence or sites. When the medication adherence rate was ≥80%, the median TDF serum concentrations were 0.458 mg/L, and 0.429 mg/L in the daily PrEP, and event-driven groups, respectively (not significant; p > 0.05); Subjects who were in the event-driven PrEP group (OR = 2.152, 95% CI: 1.566-2.957), had fewer male sexual partners in the last two weeks (OR = 0.685, 95% CI: 0.563-0.834), were one year older on average (OR = 1.022, 95% CI: 1.002-1.043), considered that medication kept them safe, were less worried about others knowing they took medicine and were more likely to have high adherence. Conclusions: The efficacies of daily TDF and event-driven TDF use were not significantly different in preventing new infections among HIV-negative MSM. Event-driven TDF use is economical and effective and is worth popularizing. Our results provide evidence for the application and promotion of the PrEP strategy in the MSM population in China.